Welcome! Becky Bosley, BSN, RN IMF Senior Director, Support Groups Oncology Nurse | Cancer Survivor | Support Group Leader
Land Acknowledgement We acknowledge that this gathering takes place on the
traditional and ancestral homelands of the Dakota (
Dakhóta )
people. We honor their enduring connection to this land and
recognize the resilience and continued presence of Indigenous communities, past, present, and future. Eagan, Minnesota
– Traditional Homeland of the Dakota People
Welcome to the 27th Annual IMF Support Group Leaders Summit! IN -PERSON PROGRAM | JULY 16 – 19, 2026 Omni Viking Lakes - Minneapolis, MN
Hope in Action: Embracing the Science & Art of Support Group Leadership
Welcome First Time and Returning Leaders! There are
108 Support Group Leaders in attendance representing 83 Support Groups .
We are thrilled to welcome welcome back
26 first -time attendees 82 returning leaders!
and
New or Relaunched Groups Launched in 2025 - 2026 Miami, Florida Ocala, Florida Savannah, Georgia Jackson, Mississippi Houston, Texas Myeloma in the Middle
Thank You to our Sponsors!
Thank You to our Donors!
Program Information • • • • • •
Seating Today: State/Region Comfort Refreshments Wifi info on tables Tabletop Mics Q/A
Share a Memory
Welcome Bags & Folders
Program Slides & Evaluation
Friday Morning Agenda
IMF Update
Heather Cooper Ortner IMF President & CEO
HOPE IN ACTION Turning Breakthroughs into CoMMunity
Heather Cooper Ortner President & CEO
Somewhere today…
Someone heard…
“You have multiple myeloma.”
16
Somewhere else…
Someone heard…
“You’re in remission.”
17
EVERY BREAKTHROUGH begins with a person
18
Before patients believe in medicine, they need someone to believe in them.
19
Today,ago, Twenty years Hope means living . Hope meant surviving 20
HOPE HAS EVIDENCE 2024 1998 1997 •The IMF establishes the International Myeloma Working Group
•FDA approves Thalidomide for myeloma, ushing in the era of novel therapies
•The FDA’s ODAC voted 12-0 that evidence supports using MRD negativity as and endpoint for accelerated approval of new myeloma therapies
1980s
1844
•High-dose chemotherapy followed by Autologous Stem Cell Transplant improves survival
•1st documented case of multiple myeloma described by Samuel Solley
21
Research doesn't change lives. People who share it do. 22
The first phone call The calm in the chaos The translator
Who are
The supporter
you?
The listener The connector The bridge 23
You are… Hope in Action
24
Community is Medicine Medicine treats disease CoMMunity
treats isolation 25
The Quiet Heroes
26
We’re Listening.
27
We Hear the Gaps “I don’t know where to start.”
“My partner need support too.” “I feel alone.” “I’m overwhelmed.”
“I wish someone could explain this in plain language.”
“I don’t know what questions to ask.” 28
Every person. Every stage. Every community. 29
More Options
Turning Vision Into Reality
Relapse/ Refractory Living Well Treatmen t Support & Education Diagnosis 30
Meeting People
Where They Are 31
You Are
Hope in Action 32
Scientific breakthroughs change medicine. Human connection changes lives.
You make both matter. 33
Dr. Vincent Rajkumar
34
The Latest Updates on Myeloma Treatment & Research S. Vincent Rajkumar, MD IMF Chairman of the Board International Myeloma Working Group IMF Scientific Advisory Board
Care Partner Toolkit: Nurse Leadership Board Updates Teresa Miceli, BSN, RN, OCN IMF Nurse Leadership Board Rochester, MN | Smolder Bolder
Background Care Partners (CP) play a critical role in the Myeloma Journey • Navigating complex treatment and decisions • Coordinating care throughout MM disease process • Monitoring symptoms • Managing medications • Assisting ADLs • Providing emotional support • Required for certain therapy options (Ex. CAR Bi -specifics, ASCT)
-T,
IMF NLB Initiative NLB Care Partner Project Team - Samantha Shenoy, Lisa Hwa -Christenson, Teresa Miceli, Amy Pierre, Michaela Hillengass , Carrie Bellerive, Tracy King, Tiffany Richards, Rebecca Lu, Michelle Faber Review of available resources • Fragmented • May not fully address Care Partner needs
Aim to develop a comprehensive toolkits for CPs • Promote Self -care • Provide more targeted educations • Improve access to support resources
Needs Assessment “Myelo ” IMF -AI platform analysis between 1/1/2025 – 10/30/2025 • Questions submitted to Myelo – > 30,000 questions (Full Corpus) – 500 (1.6%) inquiries from Care Partners • Identified CP -specific questions – Using >50 explicit relationship terms (ex. Spouse, parent, child, etc ) • Distinct vocabulary used by Care Partners vs all users
Distinct Searched Words & Domains Care Partner Commonly Searched Words and Domains
•
Emotional needs (Cry, sad, love, admit, unknown, therapists)
•
Transportation & movement (Wheelchair, walker, mobility)
•
Financial aspects (Medicaid, spend)
•
Education (Educational, material)
Full Corpus Commonly Searched Words and Domains
• Labs (Monoclonal, serum, IgG, gamma, IFE) • MM status (Active, standard, class, MRD) • Treatment (Specialist, trial, criterial, cycle, VRD)
Demographics of Care Partners 10-Item Survey sent to the Care Partner Only Special Interest Group membership 24 of 130 Respondents • 92% - Spouses or significant others • 92% - Lives with the patient
• 79% - In the CP role for 1 -10 years • 67% - age ≥ 61 years • Common treatments CPs support – CAR T – Bi -specifics – Stem cell transplant (ASCT)
Care Partner Survey Results Challenges reported by the Care Partners: • Complexity of disease and treatments • Dealing with the physical side effects of MM & treatment • Information overload • Need for palliative care in the early stages of diagnosis The survey identified a profound need for CP -specific support to prevent burnout and isolation. • CPs reported benefits from support groups, educational organizations such as IMF, spiritual / faith care and practical assistance.
Care Partners Toolkit Focus on CAR -T care (Industry sponsorship), but provide information that can be helpful in general Components • Physical kit – Thermometer, pill organizer – Notebook including QR codes to educational resources • Digital kit – Care of Care Partners/Self -care – Care of patients – Learning modules ( ex.CRS /ICANS, infection, physical transfers) – Online resources • Confidence Certifi -Kit after completion
KEY TAKE AWAY POINTS ✓ Care partners are a vital part of the myeloma journey ✓ Resources are needed to assist people in being confident care partners ✓ The IMF and NLB are committed to helping patients AND care partners on this journey
Stretch & Morning Break
What’s on the Menu? The Microbiome and Metabolism in Myeloma Urvi A. Shah, MD, MS, Memorial Sloan Kettering Cancer Center
DipABLM
Disclosures Research Funding (to institution) BMS Janssen Sabinsa M and M labs Advisory Board Sanofi Janssen
© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
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Patient perspective
Oncologist perspective
“
“
” What is a balanced diet? % US population meeting recommended intake of
”
Fruits and vegetables: 12% Dietary fiber: <5%
Baughman et al. JAMA Onc 2024 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
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Given early detection, we have an
Opportunity for cancer prevention Pre-cancer Monoclonal Gammopath y (MGUS)
Can we tilt the scale
Cancer
Smoldering MM (SMM)
Multiple Myeloma (MM)
Genomic Alterations
Obesity/Diabetes Western/Inflammatory Diet Impaired Microbiome
MYELOMA DEVELOPMENT
Normal weight/blood sugar Healthy fiber-rich diets Diverse healthy microbiome
Immune Function Modifiable Factors Nutrition/Dietary Patterns, Obesity, Diabetes Mellitus, Microbiome ≥3% of those ≥50 years have MGUS or SMM
Obesity/Diabetes Western/Inflammatory Diet Impaired Microbiome
MYELOMA REDUCTION
Normal weight/blood sugar Healthy fiber-rich diets Diverse healthy microbiome
Key, Am J Clin Nutr 2014; Castro, Parikh …. Shah UA. Leukemia 2024; Joseph J …. Shah UA Blood Advances 2024; Chang et al. JNCI 2017; Kleinstern et al. BCJ 2022; Shah UA et al. Leukemia 2023. © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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NUTRIVENTION Trial
Primary endpoint – Feasibility defined as 1. Mean adherence >70% at 12 weeks 2. Mean body mass index reduction >5% at 12 weeks Shah UA et al. ASH 2024; Cancer Discovery 2025 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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The intervention was feasible and improved quality of life (7% reduction)
Shah UA et al. ASH 2024; Cancer Discovery 2025 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
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Improved patient reported outcomes Post Intervention Survey
4 participants self-reported being able to stop medications (insulin, bupropion, potassium supplement, hydroxychloroquine), saving a median of $65 per month (range $20-100). Shah UA, Cogrossi L et al. ASH 2024; Cancer Discovery 2025 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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Trajectory of disease progression slowed in 2 patients. A 71-yo man with MGUS and a 61-yo woman with SMM
The rest of the patients had stable disease or low baseline disease burden or limited preintervention M spike data. Shah UA, Cogrossi L et al. ASH 2024; Cancer Discovery 2025 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
Precancer states MGUS: monoclonal gammopathy SMM: smoldering myeloma
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The intervention reduced insulin resistance and increased microbiome diversity
Shah UA et al. ASH 2024; Cancer Discovery 2025 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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The intervention reduced inflammation and improved anti tumor immunity Peripheral blood and bone marrow: ↑Anti inflammatory (classical) monocytes ↓Inflammatory (non classical) monocytes
Shah UA et al. ASH 2024; Cancer Discovery 2025 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
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Cell interactions show increased cell killing potential of immune cells
Global bone marrow immune cell interaction. Myeloid cells (including monocytes) interact with • Exhausted CD8 T cells (grey) before intervention (baseline) • Cytotoxic CD8 T cells and NK CD56dim cells (green) after intervention This suggests enhanced anti-tumor immunity. Shah UA et al. ASH 2024; Cancer Discovery 2025 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
NK: natural killer Monos: monocytes MDSC: myeloid derived suppressor cell GMP: granulocyte monocyte progenitor
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High fiber diet delays precancer (SMM) to cancer (MM) progression in mice
30 weeks
12 weeks
About half the mice on the high fiber diet did not progress to myeloma whereas all the mice on the standard diet progressed to myeloma. Shah UA, Cogrossi L et al. ASH 2024; Cancer Discovery 2025 (data from Matteo Bellone, MD laboratory) © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
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“It looked pretty dark back in 2010. Thanks to this trial, I’m into the light.”
Improvement on NUTRIVENTION Before NUTRIVENTION
After NUTRIVENTION
Able to stop insulin for diabetes mellitus after 30 years https://www.mskcc.org/msk-news/summer-2023/food-as-medicine-why-one-doctor-thinks-dietcould-help-control (with patient permission) © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
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https://www.mskcc.org/news/msk-research-revealsconnection-between-diet-cancer (with patient permission) © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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NUTRIVENTION Trials Currently Enrolling NUTRIVENTION-2 (NCT06055894) trial has completed enrollment
NUTRIVENTION-3 (NCT05640843) Trial is Enrolling in NYC (MSK) and Atlanta (Emory); travel 4-6 times over a year
Supplements: Algae omega3 and curcumin with bioperine WFPBD: Whole food or high fiber plant-based diet
Email – ShahNutrivention@mskcc.org if interested in enrolling. We also have a study in clonal hematopoiesis that is currently enrolling. Shah UA ASH 2022 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
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Dietary synergism with conventional therapies
Treatment Synergy with - Checkpoint inhibitors - Bispecific antibodies - CAR T cells - Monoclonal antibodies - Vaccines - Immunomodulatory drugs - Chemotherapies Fewer comorbidities means fewer side effects and ability to give full dose treatment.
© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
Diet + Drug?
Drug?
Additive or synergistic activity of diet with standard of care? Improved • MRD Negativity? • PFS? • OS? • Quality of Life?
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Short chain fatty acids associated with disease progression and response
Garcia et al. Clin Can Res 2023 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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Fiber is associated with SCFAs and treatment response 66 patients with newly diagnosed transplant eligible multiple myeloma.
Sester et al. Bld Adv 2026 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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Fiber is associated with delayed tumor progression and improved survival in mice
Sester et al. Bld Adv 2026 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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Consistent findings with a high fiber diet in a MM mouse model for survival
Shah UA, Cogrossi L et al. Cancer Discovery 2025 (data from Matteo Bellone, MD laboratory) © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
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© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
www.nutrivention.org
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© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
www.nutrivention.org
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© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
www.nutrivention.org
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© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
www.nutrivention.org
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Study design for NUTRIVENTION-5
• • • • • • •
Receiving four 28-day cycles of DRVd or IsaRVd locally with remote participation. Enrolling patients who receive care with a myeloma doctor using Epic EMR nationally. Reach out before C1D21 DRVd or IsaRVd to enroll (earlier is better). Sample collections will be done locally and shipped to MSK Surveys and coaching will be done virtually. Meals will be delivered home. Email – ShahNutrivention@mskcc.org if interested in enrolling.
Shah UA © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
www.nutrivention.org
@UrviShahMD
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Dietary interventions in cancer survivors
Survivorship No Maintenance
In combination with maintenance therapy or as single agent
Diet and Lifestyle?
Decreasing the likelihood of a relapse once in remission.
Maintenance Drug
Reduce the risk of other medical problems and cancers.
Maintenance Drug, Diet and Lifestyle? First Remission
© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
First Relapse
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Diet & Microbiome Correlate with Sustained MRD Negativity Diversity
Butyrate Producers
Butyrate Concentration
Clinical trial at MSK Samples from patients with MM on lenalidomide maintenance therapy
Lenalidomide 10 mg 21/28 days
Total Dietary Flavonoids Healthy Eating Index 2015 Butyrate level at 3m Sustained MRD-negativity R p-value p-value Total Protein 0.5 0.004 0.02 Seafood and Plant Protein 0.45 0.009 0.02
Total anthocyanidins Total flavones Total flavanols Dietary Flavonoid Diversity Index
Butyrate level at 3m R p-value 0.47 0.01 0.48 0.01 0.42 0.02 0.46 0.008
Shah UA et al. Clin Can Res 2022 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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Hypothesis and potential mechanisms for this correlation
Shah UA et al. Clin Can Res 2022 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
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Lenalidomide induced diarrhea • Clinical trials at MSK
• Samples from patients with MM on lenalidomide maintenance therapy
Miller K …… Shah UA and Lesokhin AM (*co-last authors) Clin Can Res 2026 in press © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
LRD: lenalidomide related diarrhea
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Microbiome diversity correlates with survival Lower peri engraftment diversity in fecal samples is associated with worse survival in auto-HCT patients.
Khan et al. Blood 2021 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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Dietary effects on metabolism, microbiome, immunity and cancer Sources of dietary fiber – Unprocessed plant foods such as • Fruits • Vegetables • Whole Grains • Beans • Seeds • Nuts
Shah UA, Cogrossi L, ……….. Bellone M. Cancer Discovery 2025. Shah UA JAMA Oncology 2022 © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
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Dietary fiber may just be the original immunotherapy?
© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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Individualizing Nutrition Changes • Disease Stage – Newly diagnosed, on maintenance, relapsed • Patient Choice – Receptive to hearing about this and empowered by it or overwhelmed to hear about it and would not help • Medical issues related to the cancer – Is there significant weight loss from the cancer and side effects to treatment like nausea and diarrhea that they aren’t tolerating most foods. • Medical issues related to metabolic health – Obesity, diabetes, cardiovascular disease, high cholesterol
pictures from American College of Lifestyle Medicine
It doesn’t have to be salads & raw vegetables/fruits alone. • Gradual versus drastic changes to habits © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
Some Practical Dietary Tips to Consider Incorporating Carbohydrates – ↑ whole, unrefined
• Vitamin D (>30 ng/mL)
• ↑Whole grains (>3 servings/day)
• Vitamin B12 500 mcg weekly if 100% plant based.
• ↓Unprocessed/refined carbs/foods • ↓↓Sugary foods/drinks Fiber (↑ >30 grams/day) • ↑ Fruits/Vegetables (>5-6 servings/day)
• ↑Diversity of plant foods (>30 types/week) Protein - Plant >> Animal sources • ↑Beans/Tofu/Tempeh • ↓Red/processed meats
Fats – ↑ Unsaturated fats • ↑Nuts/Seeds, fish, olive oil, avocados • ↓Fried foods
• • • • • • • • • • •
Calorie counting/restriction are difficult to sustain long term Meal planning and preparation in advance Regular mealtimes not waiting until one is starving Ensure adequate hydration Learning to read ingredient lists and nutrition labels Gradual changes are more sustainable Making healthy swaps Make it a lifestyle and not a diet Frozen fruits/vegetable bags are just as healthy Doesn’t have to be raw salads. Cooked foods healthy too Variety of plant foods is important (>30 types of plants/week)
• ↓Dairy/Cheese
Fermented Foods: ↑ © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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Patient support groups inspired by a prior talk and our research
Patients in a support group created a 30 plants per week challenge to support each other with improving dietary quality!
© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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Acknowledgements Core NUTRIVENTION Team BMT service • Francesca Castro, RD • Sergio Giralt, MD • Jenna Blaslov, RN • Jonathan Peled, MD, PhD • Jeannen Santos • Gunjan Shah, MD • Sarah Rosenthal, MPH • Heather Landau, MD • Saki Carke • Michael Scordo, MD Epi/Biostats/Computational • Sandeep Raj, MD • Andriy Derkach, PhD • Moneeza Walji, MD • Teng Fei, PhD • Roni Tamari, MD • Susan Chimonas, PhD Leukemia Service • Mirae Baichoo, PhD • Susan DeWolf, MD Myeloma Service • Ross Levine, MD • Saad Z Usmani, MD • Eytan Stein, MD • Sham Mailankody, MD • Omar Abdel Wahab, MD • Alexander Lesokhin, MD • Tamanna Haque, MD • Neha Korde, MD • Ivan Maillard, MD • Hani Hassoun, MD • Nicola Kim, NP • Malin Hultcrantz, MD, PhD Pathology Service • Carlyn Tan, MD • Leonardo Boiocchi, MD • Kylee Maclachlan, MD, PhD Sloan Kettering Institute • Maximillian Merz, MD • Yael David, PhD • Francesco Maura, MD Postdocs/Trainees/Fellows • Hamza Hashmi, MD • Juan Jose Garces, PhD • Sridevi Rajeeve, MD • Kevin Miller, MD • Ross Firestone, MD • Nicole Walker Integrative Service SKI Core Facilities • Jun Mao, MD • Ana Gradissimo, PhD • Kevin Liao, MD • Kinga Hosszu, PhD • Annie Slingerland NUTRIVENTION • Ruben J. Ramos, PhD
trial participants
© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
• Richard Koche, PhD • Ronan Chaligne, PhD Emory University • Neil Iyengar, MD • Richa Parikh, MD • Nisha Joseph, MD City of Hope Cancer Center • Marcel van den Brink, MD, PhD • Jenny Paredes Sanchez, PhD San Raffaele Scientific Institute • Matteo Bellone, MD • Laura Cogrossi, PhD • Anna Policastro Mayo • Mrinal Patnaik, MD • Marta Chesi, PhD • P. Leif Bergsagel, MD Montefiore • Aditi Shastri, MD Ohio State • Uma Borate, MD NutritionQuest • Torin Block McGill University • Michael Pollak, MD Medical College of Wisconsin • Anita D’Souza, MD University of Miami • Ola Landgren, MD
shahnutrivention@mskcc.org shahu@mskcc.org www.nutrivention.org
NCI K12 Paul Calabresi Career Development Award American Society of Hematology Scholar Award International Myeloma Society Career Development Award
Susan and Peter Solomon Microbiome, Nutrition, and Cancer Program
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https://linktr.ee/urvishahmd
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Bob Lanza • Diagnosed with free kappa smoldering myeloma in 04/2025 • Light chain ratio >100 • Normal calcium, creatinine, hemoglobin and no bone lesions • Bone marrow plasma cells approximately 10% • Enrolled on NUTRIVENTION3 trial • Made dietary changes 07/2025 onwards
Bob’s favorite cookbook With patient permission © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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What are some high protein or calorie high fiber foods and meals and strategies? • Lentils, black beans, chickpeas, edamame • Tempeh • Tofu • Lentil/chickpea pasta, chickpea flour, hummus
• Whole grains – oatmeal, quinoa, amaranth, kamut, teff, buckwheat • Seeds – chia, hemp, pumpkin, sunflower • Nuts – pistachio, almonds, peanuts • Plant protein powders • Drinking vs eating calories (smoothies) • Calorie density: cooked vs raw foods • Frequent meals throughout the day
© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
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Fiber Requirements (example) Recommended daily intake = 30 grams (Males = 38 grams; Females = 25 grams)
Fiber
Western diet
High fiber diet
Breakfast
1 egg = 0g 3 strips bacon = 0g 1 slice wheat bread = 1g
1 cup cooked oatmeal = 4g 1 tbsp peanut butter = 1g
Lunch
Small chicken breast = 0g 1 bag frozen broccoli = 12g
1 bag frozen broccoli = 12g 1 cup lentils = 16g 1 cup brown rice = 4g
Dinner
Beef 1 serving = 0g 1 cup white rice = 1g 1 baked potato = 3g
1 cup black beans = 15g 1 medium ear corn = 2g 1 avocado = 9g
Snack
1 cup yogurt = 0g 1 slice cheese = 0g
1/4 cup almonds = 5g 1 banana = 3g
TOTAL fiber
17g
71g
© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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Protein Requirements (example) Recommended daily intake = 0.8-1.2 g/kg
Protein
Western diet
High fiber diet
Breakfast
1 egg = 6g 3 strips bacon = 12g 1 slice wheat bread = 3g
1 cup cooked oatmeal = 6g 1 tbsp peanut butter = 4g
Lunch
Small chicken breast = 23g 1 bag frozen broccoli = 7g
1 bag frozen broccoli = 7g 1 cup lentils = 18g 1 cup brown rice = 4g
Dinner
Beef 1 serving = 34g 1 cup white rice = 4g 1 baked potato = 4g
1 cup black beans = 15g 1 corn on the cob = 5g 1 avocado = 3g
Snack
1 cup yogurt = 9g 1 slice cheese = 4g
1/4 cup almonds = 8g 1 banana = 1.5g
TOTAL protein
106g
72g
60 kg person = 48-72 grams
© 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
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Plant based diets can be many of many varieties VEGAN
VEGETARIAN
HIGH-FIBER PLANT BASED
Zero animal products.
Some animal products.
Minimal animal products.
Ethical and environmental reasons.
Ethical or religious reasons.
Health reasons.
No meat, fish, eggs, dairy.
No meat or fish. Eggs and dairy allowed.
Doesn’t have to be healthy but can be very healthy.
Doesn’t have to be healthy but can be very healthy.
Focus on whole foods & mainly plants, avoids processed foods. Healthy.
High-Fiber Plant-based Vegan
High-Fiber Plant-based Vegetarian High-Fiber Plant-based Pescatarian High-Fiber Plant-based Mediterranean High-Fiber Plant-based Paleo
High-Fiber Plant-based Low Carb © 2023 Memorial Sloan Kettering Cancer Center, et al. All rights reserved.
@UrviShahMD
Hot Topics in Myeloma Joseph Mikhael, MD, MEd, FRCPC, FACP IMF Medical Advisor International Myeloma Working Group IMF Scientific Advisory Board
Outline 1. Screening for Myeloma? 2. Treating High Risk Smoldering MM
3. Bringing Immunotherapies to Frontline 4. Options at Early Relapse
5. Novel Treatments Coming 6. MRD guided treatment
7. Patient -centric approaches
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1. Screening for Myeloma? The iSTOPMM
trial will have to prove that screening saves lives
If it does, we are clearly still not there yet – just like it took years to determine the right way to screen and in WHOM to screen for breast and colon cancer, we have to determine that in MM In the interim it remains CRITICAL we raise awareness and education in the lay public and in primary care what are the signs and symptoms of MM to enhance earlier diagnosis (now it takes on average 3 primary care visits!) Dr. Joe Prediction populations
– we will screen for myeloma in the highest risk
Iceland Screens, Treats, or Prevents Multiple Myeloma iStopMM Inclusion criteria: n=80,759 (54%)
-Born ≤1975 -Icelandic resident Exclusion criteria: -Previous lymphoproliferative disease
n=29
n=75,422 (93%)
n=3,543
Only arm 2 and 3: -Previously known MGUS (excluded for this analysis) Psychiatric health: Assessed at registration, after MGUS notification, and annually Intervention arm
Control arm
MM or hrSMM: KRd for2 years irSMM: Rd for 2 years Rögnvaldsson S et al. (2021) Blood Cancer Journal; 11, 94
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2. Smoldering Myeloma •
Based on the results of the AQUILA trial, patients with high risk smoldering MM can be considered for treatment with single agent daratumumab for 3 years - this approach can delay the progression of MM and even indefinitely in some
•
Many studies are now exploring more aggressive options to potentially “cure” MM at an early stage
•
But the science of SMM is demonstrating that it may be a mix of MGUS and “almost” MM – which may even question the category of SMM
-
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We introduce the concept of genomic MM and genomic MGUS to differentiate the subsets of MGUS and SMM that are biologically malignant with genomic features indistinguishable from MM from the subset that is premalignant and unlikely to progress to malignancy.
Smoldering Myeloma • Dr. Joe Prediction
– we will better classify active MM and initiate treatment more accurately and when possible, earlier
• Bonus comment
– if we move towards SCREENING for MM, our ability to detect the disease much earlier will facilitate this early intervention...
3. Bringing Immunotherapies to Frontline • The data is very convincing in both transplant eligible and ineligible patients that the combined mechanisms of action of a quadruplet improve outcomes
• With several choices within a quad approach, this can be tailored to the individual patient with dose adjustments for the proteasome inhibitor, immunomodulatory agent and dexamethasone
• However, with the move to bring novel therapies (CAR T, bispecifics and ADCs) forward they may replace some of the components of quads
CAR -T cell Therapy Frontline CARTITUDE-5
CARTITUDE 6
• Sample Size: ~750
Arm A
1:1 Randomization
Key eligibility criteria: • Newly diagnosed Patients • Age ≥ 18 • Eligible for initial ASCT
D+VRd 28 days x 4 cycles
ASCT
D+VRd 28 days x 2 cycles
Follow-up until PD
Arm B
D+VRd 28 days x 6 cycles
Cilta-cel
Assessment of PFS Stratification factors: a) ISS staging b) Cytogenetics c) Age
R* (2 years)
R*
Long-term follow-up for survival, subseq. therapies & SPMs
(2 years)
Dual primary endpoints: • PFS • Sustained MRD neg CR
*Lenalidomide to be continued beyond 2 years per physician discretion
• Challenging
SoCs
• Fix duration
• Further
consolidation
in HR
Bispecific Antibodies in Frontline EMN 37 FITFIX FOR FRAIL trial
MagnetisMM-6
Belantamab
m afodotin
Frontline DREAMM-10
Bela-DRd
Added to SoCs or challenging SoCs mainly with continous therapy
Immunotherapy in Frontline Therapy • Dr. Joe Prediction
– CAR T, Bispecifics and Antibody Conjugates will make their way to frontline therapy, so full quads may not be necessary
• Bonus comment
-Drug
– I think we will be using stem cell transplant much LESS once these therapies move up earlier in the disease course
4. Options at Early Relapse • This may be the ”hottest” area of research right now as we have had SO many trials recently providing for many options
• Most recently we have seen three Phase 3 trials with bispecific antibodies and another with the new come!)
– MonumenTAL – MajesTEC -3 – MajesTEC -9 – Successor -2
CELMoDs
(and more to
-3
• It has resulted in a greater complexity of choice choice is always better for patients...
– but more
Phase 3, Randomized Study of Talquetamab Plus Daratumumab ± Pomalidomide vs Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: MonumenTAL-3 Peter M Voorhees1*, Roberto Mina2, Paula Rodríguez-Otero3, Wenming Chen4, María-Victoria Mateos5, Jian Li6, Philippe Moreau7, Yael C Cohen8, Chang Ki Min9, Roman Hajek10, Jing Christine Ye11, Hila Magen12, Samuel M Rubinstein13, Weijun Fu14, Vania Hungria15, Guldane Cengiz Seval16, Joao Samuel Farias17, Jakub Radocha18, Senem Maral19, Mehmet Turgut20, Youngil Koh21, Daniel O'Leary22, Jayr Schmidt Filho23, Raymond Thertulien24, Gang An25, Shang Yi Huang26, Sebastian Grosicki27, Agata Tyczynska28, Rahul Banerjee29, Matthew J Pianko30, Joaquín Martínez-López31, Pawel Steckiewicz32, Dai Maruyama33, Kentaro Fukushima34, Albert Oriol35, Jordi Lopez Pardo36, Hartmut Goldschmidt37, Charlotte Pawlyn38, Aurore Perrot39, Elena Zamagni40, Meletios Athanasios Dimopoulos41, Leo Rasche42, Jaszianne Tolbert43, William Terry43, Christelle Courtoux43, Xiao Liu44, Sandra Y Vasey43, Kaitlyn Connors45, Mariacristina Festa46, Christoph Heuck43, Angélique Langlois43, Lisa O’Rourke43, Jiangxiu Zhou43, Xiang Qin43, Jiashen Lu44, Jue Gong43, Diego Vieyra43, Meral Beksac47 1Atrium Health/Levine Cancer Institute, Wake Forest University School of Medicine, Charlotte, NC, USA; 2Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA; 3Cancer Center Clínica Universidad de Navarra, Cima, Pamplona, Spain; 4Beijing Chaoyang Hospital, Capital Medical University, Chaoyang District, Beijing, China; 5Hospital Clínico Universitario de Salamanca, Servicio de Salud de
Castilla y León (SACYL), Salamanca, Castile and León, Spain; 6Department of Hematology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China; 7Hematology Clinic, University Hospital Hôtel-Dieu, Nantes, France; 8Tel Aviv Sourasky (Ichilov) Medical Center, Tel Aviv Israel; Gray Faculty of Medical & Health Sciences, Tel Aviv University, Tel Aviv, Israel; 9Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, Republic of Korea; 10Department of Hematooncology, University Hospital Ostrava, Ostrava Czech Republic; Department of Hematooncology, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic; 11MD Anderson Cancer Center, University of Texas, Houston, Texas, USA; 12Chaim Sheba Medical Center, Ramat-Gan, Israel; Sackler Faculty of Medical and Health Sciences, Tel Aviv University, Israel; 13Division of Hematology and Oncology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA; 14Department of Hematology, Shanghai Fourth People’s Hospital, School of Medicine, Tongji University, 200434 Shanghai, China; 15Clinica Médica São Germano, São Paulo, Brazil; 16Ankara University Faculty of Medicine, Department of Hematology and Oncology, Ankara University, Ankara, Turkey; 17Liga Paranaense de Combate ao Câncer (LPCC), Curitiba, Paraná, Brazil; 184th Department of Internal Medicine – Hematology, University Hospital Hradec Kralove, Faculty of Medicine in Hradec Kralove, Charles University, Czechia; 19Medipol Mega University Hospital, Bağcılar, İstanbul, Turkey; 20Ondokuz Mayıs University, Samsun Turkey; 21Seoul National University Hospital, Seoul National University, Jongnogu, Seoul, Republic of Korea; 22University of Minnesota, Minneapolis, MN, USA; 23A.C. Camargo Cancer Center, São Paolo, Brazil; 24Novant Health Cancer Institute, Winston Salem, NC, USA; 25Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China; 26National Taiwan University Hospital, National Taiwan University College of Medicine, Zhongzheng District, Taipei, Taiwan; 27Department of Cancer Prevention, Medical University of Silesia, Katowice, Poland; 28Medical University of Gdańsk, Department of Hematology and Transplantology, University Clinical Center Gdańsk, Department of Hematology and Transplantology, Gdańsk, Poland; 29Fred Hutchinson Cancer Center, Seattle, WA, USA; 30University of Michigan Health, Ann Arbor, MI, USA; 31Hospital Universitario 12 de Octubre, imas12/ Complutense University of Madrid/CNIO/Madrid, Spain; 32Holy Cross Cancer Center, Department of Hematology and Bone Marrow Transplantation, Kielce, Poland; 33Cancer Institute Hospital, Japanese Foundation for Cancer Research (JFCR), Kotoku, Tokyo, Japan; 34The University of Osaka Graduate School of Medicine, Suita, Japan; 35Institut Català d’Oncologia and Josep Carreras Research Institute, Hospital Germans Trias I Pujol, Badalona, Spain; 36l’Hospital de la Santa Creu i Sant Pau, Barcelona, Catalonia, Spain; 37Internal Medicine V, Hematology, Oncology and Rheumatology, GMMG Study Group, Heidelberg University Hospital and National Center for Tumor Diseases, Heidelberg, Germany; 38The Institute of Cancer Research, London, UK, and The Royal Marsden NHS Foundation Trust, London, UK; 39Universite de Toulouse, Centre Hospitalier Universitaire de Toulouse, Service Hematologie, IUCT Oncopole, Toulouse, France; 40University of Bologna, Bologna, Italy; 41National and Kapodistrian University of Athens, Athens, Greece; 42University Hospital of Würzburg, Würzburg, Germany; 43Johnson & Johnson, Spring House, PA, USA; 44Johnson & Johnson, Shanghai, China; 45Johnson & Johnson, Raritan, NJ, USA; 46Johnson & Johnson, Leiden, Netherlands; 47Istinye University, Ankara University, Ankara, Turkey
Presented by P Voorhees at the European Hematology Association (EHA) 2026 Congress; June 11–14, 2026; Stockholm, Sweden
https://www.congresshub.com/EHA2026/ Oncology/Talquetamab/Voorhees The QR code is intended to provide scientific information for individual reference, and the information should not be altered or reproduced in any way.
MonumenTAL-3: Phase 3 Study Design Key inclusion criteria
Primary endpoint
Tal-DP (n=287)
• Age ≥18 years
• PFS by IRC Key secondary endpoints
• Measurable RRMM • ≥1 prior LOT including Len and a PI
• ECOG PS 0–2 Key exclusion criteria • Refractory to anti-CD38 mAb • Prior GPRC5D, Pom, or T-cell redirecting therapy within 3 months before randomization
Regimen Tal was given SC with step-up dosing at 0.01, 0.06, and 0.4 mg/kg, followed by 0.8 mg/kg
• ORRa
1:1:1 randomization N=864
Tal-D (n=287)
• MRD-negative CR • OS
4 Nov 2022 to 13 Mar 2025
C1–2c
• ≥CRa
Additional secondary endpoints
DPd (n=290)
C3–4
• Safety
Tal Q4W permitted with ≥VGPR at cycle 5–6
Tal Q4W required with ≥PR at cycle 7 and beyond
C5–6
C7+
Tal-DPb
Q2W QW
Q2W Q2W
Q2W Q2W
Q2W Q4W
Tal-Db
Q2W QW
Q2W Q2W
Q2W Q2W
Q2W Q4W
• Tal: 0.8 mg/kg • Dara: 1800 mg • Pom: - Tal-DP: 2 mg daily (D1–21)d - DPd: 4 mg daily (D1–21)
ClinicalTrials.gov identifier: NCT05455320. aResponse and disease progression were assessed by a blinded IRC per IMWG criteria. bDexamethasone, acetaminophen, and diphenhydramine premedication was required for the first 2 weeks; subsequent dexamethasone was not required thereafter. cPom is given from cycle 2. dPom dose could be increased to 4 mg at the start of cycle 3 day 1 or after per the investigator's discretion. C, cycle; CR, complete response; D, day; ECOG PS, Eastern Cooperative Oncology Group performance status; IMWG, International Myeloma Working Group; IRC, independent review committee; Len, lenalidomide; MRD, measurable residual disease; ORR, overall response rate; OS, overall survival; PR, partial response; Q2W, every 2 weeks; Q4W, every 4 weeks; QW, weekly; SC, subcutaneously; VGPR, very good partial response. Mina R, et al. N Engl J Med 2026; doi: 10.1056/NEJMoa2604657. Presented by P Voorhees at the European Hematology Association (EHA) 2026 Congress; June 11–14, 2026; Stockholm, Sweden
101
MonumenTAL-3: Prior Lines of Therapy Characteristic
Tal-DP (n=287)
Tal-D (n=287)
DPd (n=290)
Characteristic
Prior LOT, n, median (range)
2 (1–8)
2 (1–7)
2 (1–8)
Prior exposure, n (%)
Number of prior LOT, n (%)
Tal-DP (n=287)
Tal-D (n=287)
DPd (n=290)
IMiD
287 (100.0)
287 (100.0)
290 (100.0)
287 (100.0)
287 (100.0)
288 (99.3)b
33 (11.5)
34 (11.8)
33 (11.4)
0
0
3 (1.0)
Any PI
132 (46.0)
121 (42.2)
118 (40.7)
Any IMiD
253 (88.2)
250 (87.1)
250 (86.2)
Len
244 (85.0)
248 (86.4)
243 (83.8)
267 (93.0)
269 (93.7)
271 (93.4)
1a
111 (38.7)
106 (36.9)
114 (39.3)
PI
2 or 3
150 (52.3)
153 (53.3)
148 (51.0)
Anti-CD38 mAb
>3
26 (9.1)
28 (9.8)
28 (9.7)
207 (72.1)
192 (66.9)
196 (67.6)
Prior stem cell transplantation, n (%)
• ≥1/3 of patients had only 1 prior LOT • 11–12% of patients were Dara exposed
Dara Isatuximab
Refractory status, n (%)
To last prior LOT
Median of 2 prior LOT and 93.4% of patients were refractory to their last LOT aAll patients with only one prior LOT were required to be refractory to lenalidomide. b2 participants were not previously exposed to a PI. One of these patients was reported as a major protocol deviation and the second patient was
randomized but not treated due to not meeting laboratory criteria 72 hours prior to the planned dosing. Mina R, et al. N Engl J Med 2026; doi: 10.1056/NEJMoa2604657. Adapted with permission © The New England Journal of Medicine (2026). Presented by P Voorhees at the European Hematology Association (EHA) 2026 Congress; June 11–14, 2026; Stockholm, Sweden
102
MonumenTAL-3: PFS (Primary Endpoint) Tal-DP vs DPd 24-mo PFS 81.3 (95% Cl, 75.8–85.7) Tal-DP Median, NR
80
60
51.2 (95% Cl, 44.8–57.1) DPd Median, 24.4 months
40
HR for progression or death: 0.28 (95% CI, 0.20–0.40) P<0.0001
20
0
0
3
6
9
12
15
No. at risk Tal-DP 287 DPd 290
266 249
255 223
240 198
229 218 175 158 Tal-DP
18 21 Months
24
27
30
33
36
169 113 DPd
116 81
74 44
32 22
8 2
0 0
212 146
Tal-D vs DPd 24-mo PFS
100
Surviving without progression, %
Surviving without progression, %
100
77.6 (95% Cl, 71.7–82.5)
80
Tal-D Median, NR 51.2 (95% Cl, 44.8–57.1) DPd Median, 24.4 months
60
40
HR for progression or death: 0.33 (95% CI, 0.24–0.46) P<0.0001
20
0
0
3
6
9
12
15
18 21 Months
No. at risk Tal-D 287 DPd 290
262 249
256 223
238 198
225 175
216 207 158 146 Tal-D
159 113
24
27
30
33
36
98 81 DPd
62 44
30 22
8 2
0 0
Tal-DP and Tal-D significantly improved PFS vs DPd Clinical cut-off: November 3, 2025. Median follow-up of 24.6 months. The O’Brien-Fleming stopping boundary for superiority was crossed for Tal-DP and Tal-D (P<0.0001 both arms; Tal-DP boundary, P=0.0069; Tal-D boundary, P=0.0145). HR, hazard ratio. Mina R, et al. N Engl J Med 2026; doi: 10.1056/NEJMoa2604657. Adapted with permission © The New England Journal of Medicine (2026). Presented by P Voorhees at the European Hematology Association (EHA) 2026 Congress; June 11–14, 2026; Stockholm, Sweden
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MonumenTAL-3: Treatment Responsea and MRD-Negative CRb Rates OR (95% CI); all P≤0.0005 ORR: 2.27 (1.42–3.61); ≥CR: 4.93 (3.44–7.08)
OR (95% CI)
100 90 80 70 60 50 40 30 20 10 0
88.5 (254/287)
88.2 (253/287)
≥CR 71.1
53.7
17.4 13.9 3.1 Tal-DP…
77.6 (225/290)
45.6 ≥CR ≥VGPR 68.9 85.0
≥CR 34.5 ≥VGPR 82.8
23.3 13.9 5.6 Tal-D…
10-5: 5.84 (3.94–8.64), P<0.0001; 10-6: 8.05 (5.15–12.57)
sCR CR VGPR PR
24.8 9.7 23.1 20.0 DPd…
≥VGPR 57.6
60
MRD-negative CR rate, %
ORR, %
ORR: 2.34 (1.47–3.74); ≥CR: 4.40 (3.08–6.28)
10-5: 4.70 (3.16–6.98), P<0.0001; 10-6: 6.64 (4.22–10.43)
50
10-5 10-6
40 30 20
52.3 47.7
46.3 42.2
10 0
15.9
Tal-DP n=287
Tal-D n=287
10.0
DPd n=290
Tal-DP and Tal-D demonstrated significantly higher ORR, ≥CR, and MRD-negative CR (10-5) rates vs DPd Clinical cut-off: November 3, 2025. Median follow-up of 24.6 months. aResponse and disease progression were assessed by IRC per IMWG criteria. bMRD negativity was assessed in bone marrow aspirates with genetic sequencing (clonoSEQ, Adaptive Biotechnologies). MRD-negative CR was defined as the absence of malignant cells at a sensitivity threshold of 10–5 or 10–6, achieved within 3 months prior to achieving CR/sCR or at any time after CR/sCR and before progression or subsequent therapy. DOR, duration of response; NR, not reached; OR, odds ratio; sCR, stringent complete response. Mina R, et al. N Engl J Med 2026; doi: 10.1056/NEJMoa2604657. Presented by P Voorhees at the European Hematology Association (EHA) 2026 Congress; June 11–14, 2026; Stockholm, Sweden
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MonumenTAL-3: OS Tal-DP vs DPd
Tal-D vs DPd
24-mo OS
100
24-mo OS
100
89.2 (95% Cl, 84.9–92.4) Tal-DP DPd 79.1 (95% Cl, 73.7–83.6)
60
40
20
0
80
Surviving, %
Surviving, %
80
60
40
20
HR for death: 0.47 (95% Cl, 0.30–0.73) P=0.0006
0
HR for death: 0.51 (95% Cl, 0.33–0.78) P=0.0015 0
3
6
9
1 2
1 1 21 5 Months 8
2 4
2 7
3 0
33
36
0
Tal-D 287
276
275
268
264
256
251
199
130
77
40
10
0
0
DPd
278
264
255
245
226
217
173
125
78
37
4
0
0
3
6
9
1 2
2 1 1 1 8 5 Months
2 4
2 7
3 0
3 3
36
Tal-DP 287
277
276
269
262
248
238
200
141
94
48
10
DPd 290
278
264
255
245
226
217
173
125
78
37
4
No. at risk
87.9 (95% Cl, 83.0–91.5) Tal-D DPd 79.1 (95% Cl, 73.7–83.6)
No. at risk 290
Tal-DP and Tal-D resulted in clinically meaningful OS improvement vs DPd, with >87% of patients alive at 2 years; P-values did not cross the prespecified boundary for superiority (0.0001) Clinical cut-off: November 3, 2025. Median follow-up of 24.6 months. Mina R, et al. N Engl J Med 2026; doi: 10.1056/NEJMoa2604657. Adapted with permission © The New England Journal of Medicine (2026). Presented by P Voorhees at the European Hematology Association (EHA) 2026 Congress; June 11–14, 2026; Stockholm, Sweden
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MajesTEC-9: A Phase 3 Randomized Study of Teclistamab Monotherapy vs Investigator’s Choice of Pomalidomide, Bortezomib, and Dexamethasone or Carfilzomib and Dexamethasone (PVd/Kd) in Patients With Relapsed Refractory Multiple Myeloma
MajesTEC-9: A Phase 3 Randomized Study of Teclistamab Monotherapy vs Investigator’s Choice of Pomalidomide, Bortezomib, and Dexamethasone or Carfilzomib and Dexamethasone (PVd/Kd) in Patients With Relapsed Refractory Multiple Myeloma Roberto Mina,1,2 Cyrille Touzeau,3 Vania Hungria,4 Ola Landgren,5 Divaya Bhutani,6 Wenming Chen,7 Swarup Kumar,8 Chakra P. Chaulagain,9 Meletios A. Dimopoulos,10,11 Nizar J. Bahlis,12 Senem Maral,13 Niels W.C.J. van de Donk,14 Khalid Saja,15 Raphael Teipel,16 Miki Ando,17 Dai Wang,18 Susan Wroblewski, 19 Priya Shah,20 Katherine Chastain,18 Hang Quach21 Winship Cancer Institute, Emory University, Atlanta, GA, USA; 2AOU Città della Salute e della Scienza di Torino, University of Torino, Torino, Italy; 3University Hospital of Nantes, Nantes, France; Clínica Médica São Germano, São Paulo, Brazil; 5Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA; 6Columbia University Medical Center, New York, NY, USA; 7Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China; 8Neag Comprehensive Cancer Center, University of Connecticut Health, Farmington, CT, USA; 9Cleveland Clinic Florida, Weston, FL, USA; 10National and Kapodistrian University of Athens, School of Medicine, Athens, Greece; 11Korea University, Seoul, South Korea; 12Arnie Charbonneau Cancer Research Institute, University of Calgary, Calgary, AB, Canada; 13Istanbul Medipol University, Istanbul, Turkey; 14Amsterdam University Medical Center, Cancer Center Amsterdam Vrije Universiteit Amsterdam, Amsterdam, The Netherlands; 15Colchester Hospital, East Suffolk and North Essex NHS Foundation Trust, Colchester, UK; 16University Hospital Dresden, Technical University Dresden, Dresden, Germany; 17Juntendo University School of Medicine, Tokyo, Japan; 18Johnson & Johnson, Raritan, NJ, USA; 19Johnson & Johnson, Spring House, PA, USA; 20Johnson & Johnson, High Wycombe, UK; 21Clinical Haematology Service, St. Vincent's Hospital Melbourne, University of Melbourne, Melbourne, VIC, Australia.
https://www.congresshub.com/Oncology/AM2026 /Teclistamab/Mina-MajesTEC-9 The QR code is intended to provide scientific information for individual reference, and the information should not be altered or reproduced in any way.
1 4
Presented by R Mina at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 29–June 2, 2026; Chicago, IL, USA.
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MajesTEC-9: Phase 3 Study Design
MajesTEC-9: Phase 3 Study Design Key inclusion criteria
Tec
• RRMM • 1–3 prior LOTs including an anti-CD38 mAb and lenalidomide • ECOG PS score of 0–2
n=296 1:1 randomization N=593
Key exclusion criteria
Key secondary endpoints • ≥CRb • OS • MySIm-Q total symptom score Other secondary endpoints • ORR • Safety • PK and immunogenicity Exploratory endpoints • MRD-negative ≥CR (10–5)
PVd/Kda
April 28, 2023– April 3, 2025
• Prior BCMA-directed therapy
Primary endpoint • PFS per IRCb
by investigator’s choice n=297 (69% Kd)
SUDc
28-day cycles
Tec 1.5 mg/kg Tec 3 mg/kg
D1
D3
C1 QW D5
D12
D19
D1
C2 QW D8 D15
D22
D1
C3–C6 Q2Wd D8 D15
D22
D1
C7+ Q4W D8 D15
D22
Tec SC Dex (pre-med)e
Monthly Tec dosing from C7 (earlier if ≥VGPR); steroid free after C1D5 Administered per the approved schedules. Kd was administered either twice weekly (20/56 mg/m2) or once weekly (20/70 mg/m2) depending on the local clinical practice. bDisease progression and response were assessed by an IRC per IMWG 2016 criteria. cPatients received SUD of 0.06 mg/kg and 0.3 mg/kg on D1 and D3, respectively. dPatients with confirmed ≥VGPR could switch to dosing Q4W earlier than C7 per investigator’s discretion. eDexamethasone, acetaminophen, and diphenhydramine pre-med was required on C1 D1, D3, and D5. C, Cycle; CR, complete response; D, Day; Dex, dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; IMWG, International Myeloma Working Group; IRC, independent review committee; MRD, minimal residual disease; MySIm-Q, Multiple Myeloma Symptom and Impact Questionnaire; ORR, overall response rate; PK, pharmacokinetics; pre-med, pre-medication; QW, weekly; Q2W, every 2 weeks; Q4W, every 4 weeks; SC, subcutaneous; SUD, step-up dosing; VGPR, very good partial response.
a
Presented by R Mina at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 29–June 2, 2026; Chicago, IL, USA.
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4
MajesTEC-9: Baseline Demographic and Disease Characteristics Characteristic
T ec (n= 296 )
PVd /Kd (n= 297 )
Characteristic
T ec (n= 296 )
PVd /Kd (n= 297 )
Baseline ECOG PS score, n (%)
Age Median (range), years ≥75 years, n (%)
70 (34–85)
8 4 (28.4)
70 (36–86)
0
156 (52.7)
135 (45.5)
8 9 (30.0)
1
121(40.9)
137 (46.1)
2
19 (6.4)
24 (8.1)
3
0
1(0.3)
168 (56.8)
170 (57.2)
Sex, n (%) Male
150 (50.7)
153 (51.5)
Female
146 (49.3)
144 (48.5)
White
190 (64.2)
198 (66.7)
Asian
62 (20.9)
56 (18.9)
Black or African American
10 (3.4)
10 (3.4)
Othera
34 (11.5)
33 (11.1)
Race, n (%)
ISS stage, n (%) I II
86 (29.1)
82 (27.6)
III
4 2 (14.2)
4 5 (15.2)
31/292 (10.6)
40/295 (13.6)
5 4 (18.2)
65 (21.9)
BMPCs ≥60%,b n/N (%) Soft-tissue plasmacytomas, n (%) Extramedullary plasmacytomasc
19 (6.4)
22 (7.4)
Paraskeletal plasmacytomasc
43 (14.5)
52 (17.5)
105/294 (35.7) 104/296 (35.1) High-risk cytogenetics, n/N (%) Balanced baseline characteristics are reflective of a RRMM population, including high-risk disease d
“Other” includes American Indian or Alaska Native (Tec, n=2 [0.7%]; PVd/Kd, n=0), not reported (Tec, n=18 [6.1%]; PVd/Kd, n=23 [7.7%]), unknown (Tec, n=7 [2.4%]; PVd/Kd, n=6 [2.0%]), and multiple (Tec, n=7 [2.4%]; PVd/Kd, n=4 [1.3%]). bMaximum value from bone marrow biopsy or bone marrow aspirate was selected if both results were available. cA patient may have both extramedullary and paraskeletal plasmacytomas. dPresence of ≥1 of del(17p), t(4;14), or t(14;16). BMPC, bone marrow plasma cell; ISS, International Staging System. From The New England Journal of Medicine, Touzeau C, et al., Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy. Copyright © 2026 Massachusetts Medical Society. Adapted with permission from Massachusetts Medical Society. a
Presented by R Mina at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 29–June 2, 2026; Chicago, IL, USA.
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Surviving without progression, %
MajesTEC-9: Tec Significantly Improved PFS (Primary Endpoint) Estimated 18-mo PFS
100
69.8%
80
Tec Median, NR
60
40
26.9%
20
0
0 No. at risk Tec PVd/Kd
PVd/Kd Median, 8.2 months
HR, 0.29 (95% CI, 0.23–0.38); P<0.0001a Median follow-up: 17.3 months 3
6
9
12
15
18
21
24
27
30
Months 29 6 29 7
258
239
206
172
141
92
57
27
6
0
199
162
112
74
51
33
16
6
1
0
Tec significantly improved PFS, with a 71% reduction in the risk of disease progression or death in a highly refractory population
aThe P value crossed the prespecified stopping boundary for superiority for the first interim analysis (P=0.0197). CI, confidence interval; NR, not reached. From The New England Journal of Medicine, Touzeau C, et al., Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy. Copyright © 2026 Massachusetts Medical Society. Adapted with permission from Massachusetts Medical Society.
Presented by R Mina at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 29–June 2, 2026; Chicago, IL, USA.
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8
SUCCESSOR-2
Mezigdomide, carfilzomib, and dexamethasone vs carfilzomib and dexamethasone in relapsed/refractory multiple myeloma: results from the phase 3 SUCCESSOR-2 trial Paul G. Richardson,1 Fredrik Schjesvold,2 Chengcheng Fu,3 Monique A. Hartley-Brown,1 Cesar Gomez,4 Donna Reece,5 Gabor Mikala,6 Omar Alkharabsheh,7 Christopher Parrish,8 Darrell White,9 Hang Quach,10 Claudio Cerchione,11 Vania Hungria,12 Amitabha Mazumder,13 Marc S. Raab,14 Albert Oriol,15 Zehua Zhou,16 Alberto Rocci,17 Brian Yu,16 Meletios Athanasios Dimopoulos18 1Dana-Farber Cancer Institute, Boston, MA, USA; 2Oslo Myeloma Center, Department of Hematology, Oslo University Hospital, Oslo, Norway; 3The
First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology, Suzhou, Jiangsu, China; 4Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK; 5The Princess Margaret Cancer Centre, Toronto, ON, Canada; 6Semmelweis University, Budapest, Hungary; 7USA Health Mitchell Cancer Institute, University of South Alabama, Mobile, AL, USA; 8Leeds Teaching Hospitals NHS Trust, Leeds, UK; 9Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada; 10St Vincent’s Hospital Melbourne, University of Melbourne, Melbourne, VIC, Australia; 11Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; 12São Germano Clinic, São Paolo, Brazil; 13The Oncology Institute of Hope and Innovation, Pasadena, CA, USA; 14Heidelberg University Hospital, Heidelberg, Germany; 15Catalan Institute of Oncology and Josep Carreras Institute, Hospital Germans Trias i Pujol, Badalona, Spain; 16Bristol Myers Squibb, Princeton, NJ, USA; 17Celgene International Sàrl, a Bristol-Myers Squibb Company, Boudry, Switzerland; 18National and Kapodistrian University of Athens, Athens, Greece
ASCO 2026, Presentation LBA7506
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SUCCESSOR-2
CELMoD Mechanism of Action Mezi and iberdomide (Iber) are CELMoDs that bind cereblon uniquely and more effectively, delivering superior MM cell killing and immune stimulation, compared to IMiDs1
•
Faster and more complete target protein degradation
IMiD Ub Ub Ub Ub
Direct MM cell cytotoxicity and activity in IMiD resistance
Aiolos/ Ikaros
Cereblon (~20% in active state)
T/NK cell activation and mitigation of immune exhaustion
CELMoD Aiolos/ Ikaros
Cereblon (50%-100% in active state)
Single enantiomer/substrate preference potentially minimizing nonhematological effects
• Iber is being investigated in combination with DARA in RRMM in the EXCALIBER-RRMM trial,2 and as maintenance therapy3 – Iber has the potential to be the first approved CELMoD with FDA Breakthrough Therapy Designation and a PDUFA date of August 17, 2026
• Mezi is being investigated in combination with PIs in two phase 3 trials: SUCCESSOR-1 and SUCCESSOR-24 –
Mezi and PIs demonstrated preclinical synergistic antitumor activity superior to POM + PI,4 with phase 1/2 data of Mezi-d, MeziVd, and MeziKd yielding promising efficacy and a manageable safety profile5,6
DARA, daratumumab; FDA, Food and Drug Administration; Mezi-d, mezigdomide and dexamethasone; MeziVd, mezigdomide, bortezomib, and dexamethasone; NK, natural killer; PDUFA, Prescription Drug User Fee Act; PI, proteasome inhibitor; POM, pomalidomide; Ub, ubiquitin.1. Watson ER, et al. Science 2022;378:549-553. 2. Lonial S, et al. Future Oncol 2025;24:1761-1769. 3. NCT05827016. 4. Dimopoulos M, et al. Clin Lymphoma Myeloma Leuk 2024;2a:S258. 5. Richardson PG, et al. N Engl J Med 2023;389:1009-1022. 6. Sandhu I, et al. Blood 2024;144:1025.
Richardson PG, et al. ASCO 2026, Presentation LBA7506
SUCCESSOR-2
SUCCESSOR-2: Study Design Stage 2 (efficacy and safety)
Stage 1 (dose optimization)a
Confirmatory analysis group (N = 479)
− Prior treatment with LEN and an anti-CD38 mAb
Randomization 3:3:3:2 (N = 235)
• Adult participants who received ≥1 prior line of antimyeloma therapy with progressive disease
MeziKd at 1.0 mg Mezi (N = 63)b MeziKd at 0.6 mg Mezi (N = 63)
MeziKd at 0.3 mg Mezi (N = 64)
Selected Mezi dose
Randomization 3:2 (N = 371)
Key eligibility criteria
Kd (N = 45)b
MeziKdc 1.0 mg Mezi + QW 56 mg/m2 K (N = 225)
Kdc,d BW 56 mg/m2 or QW 70 mg/m2 K (N = 146)
Primary endpoint • PFS per IRC Key secondary endpoint • OS Selected secondary endpoints • Recommended Mezi dose (stage 1) • ORR, VGPR, CR • TTR, DoR • PFS2 • Safety
In the MeziKd arm, patients received: • Mezi 1.0 mg orally once daily on D1–21 of each 28-day cycle • Ke 56 mg/m² IV on D1, 8, and 15 in C1-12 and on D1 and 15 in C ≥ 13 • DEXc 40 mg orally/IV on D1, 8, 15, and 22
NCT05552976. aPatients enrolled in stage 1 on a dose of Mezi not chosen for stage 2 had the option to move to the selected dose if some criteria were met; bPatients from these stage 1 arms were included in the confirmatory analysis groups; cDEX dosing – MeziKd arm: 40 mg, option of 20 mg if > 75 years of age, BMI < 18.5 kg/m2, poorly controlled diabetes, or prior intolerance to steroid therapy; Kd arm: 20 mg, 10 mg option for stated criteria (BW regimen) or 40 mg, 20 mg option for stated criteria (QW regimen); dQW regimen made available July 2023; dK dose on C1D1 was 20 mg/m2. BMI, body mass index; BW, twice weekly; C, cycle; D, day; DEX, dexamethasone; DoR, duration of response; IRC, independent review committee; K, carfilzomib; OS, overall survival; PFS2, second progression-free survival; QW, weekly; TTR, time to response.
Richardson PG, et al. ASCO 2026, Presentation LBA7506
SUCCESSOR-2
Probability of PFS
SUCCESSOR-2: PFS (Primary Endpoint) 1.0
Median PFS
Hazard ratio
0.9
18.0 months
HR 0.48
0.8
8.3 months
(95% CI, 0.36–0.63) P < 0.0001
0.7 0.6 0.5 0.4
MeziKd
0.3 0.2
Median follow-up: 10.6 months
0.1
Kd
0 No. at risk MeziKd Kd
0
3
6
9
12
288 191
250 134
197 90
133 59
81 31
15 18 Time (months) 47 15
27 8
21
24
27
30
33
19 3
11 1
6 0
2 0
0 0
In anti-CD38 mAb- and LEN-exposed patients who had received ≥ 1 prior LOT (range 1–9), MeziKd significantly reduced the risk of progression or death by 52% Data cutoff: January 15, 2026. In the confirmatory analysis group, defined as all patients from stages 1 and 2 randomized to 1.0 mg Mezi plus Kd or Kd. CI, confidence interval; HR, hazard ratio.
Richardson PG, et al. ASCO 2026, Presentation LBA7506
5. Novel Treatments Coming CELMoDs Iberdomide (Iber -Dara -Dex) Mezigdomide (Mezi -Car -Dex)
CAR T Cell Therapy D -Domain binding CAR T ( Anitocel ) Dual Targeting CARs (AZD0120) CARs that target GPRC5D (Arlo -Cel) Bispecific Antibodies Cevostamab – targets FcRH5
6. MRD Guided Treatment • Minimal residual disease is clearly demonstrating its power as a biomarker tool in MM
• Currently 2 places it seems to have the greatest influence: 1. Standard risk patients who achieve MRD negativity with induction may not need ASCT (based on the MIDAS trial) 2. Standard risk patients on lenalidomide maintenance who have sustained MRD negativity – may be able to come off therapy after approximately 3 years
• Several trials underway using MRD to guide more or less intense therapy...
– they
Minimal Residual Disease Adapted Strategy MIDAS = MInimal residual Disease Adapted Strategy Induction
MRD evaluation
Risk-adapted consolidation and maintenance
Standard risk (MRD <10-5)
R
IsaKRD x 6 (28d cycles)
IsaKRD x 6
Lenalidomide
ASCT + IsaKRD x 2
Lenalidomide
ASCT + IsaKRD x 2
Isa - Iberdomide
Tandem ASCT
Isa - Iberdomide
(3 years)
1:1
(3 years)
Arm A
Arm B
MRD
Stem cell collection after cycle 3 (G-CSF+/- plerixafor)
R High risk (MRD >10-5)
1:1
(3 years)
(3 years)
Arm C
Arm D
Perrot A et al IMS 2024; Perrot et al Blood 2025; Perrot A et al, ASCO 2025; Perrot A et al; NEJM 2025 MRD measurable residual disease; R: Lenalidomide; d: dexamethasone; K: Carfilzomib; Isa: Isatuximab,
Ongoing trials UKMRA Myeloma XVII iFIT
Explore MRD driven approaches and immunetherapies
7. Patient -centric approaches • Of course ALL therapies should be “patient centric”! • But I am very thankful to see steps forward to make therapies even more accessible, with fewer side effect and with the promise of greater health equity
• Some of these include:
– The On Body Injector (OBI) for Isatuximab
– better than
subcutaneous? – Etentamig – bispecific antibody given monthly with the potential for no CRS – in vivo CAR T – no need for T cell collection or chemo – Allo CAR T – T cells from healthy donors given...
Isatuximab SC OBI Preparation and Administration The on-body delivery system is an investigational device evaluated in phase 3 trials for hands-free delivery of the fluid bolus over a shorter duration than IV infusion
Step 1: Fill
Step 2: Place on patient
Step 3: Administer
OBI, on-body injector; SC, subcutaneous. Images courtesy of Sikander Ailawadhi, MD. Ailawadhi S, et al. J Clin Oncol. 2025;43:2527-2537. These materials are provided to you solely as an educational resource for your personal use. Any commercial use or distribution of these materials or any portion thereof is strictly prohibited.
Prophylactic tocilizumab use with etentamig resulted in a 0% CRS incidence 100
No SUD
1 SUD
Arm B
Arm A
Arm C
30%
27%
1 SUD
Incidence of CRS (%)
80 60
+ Prophylactic tocilizumaba
Grade 1 Grade 2
57%
12
40 20
0
45 N=42
4
26
3 23
0%
N=23
N=60
n=16
Etentamig’s safety profile can overcome bispecific antibody implementation barriers and improve accessibility across treatment settings aProphylactic tocilizumab given per investigator discretion. CRS, cytokine release syndrome; dex, dexamethasone; mod, modified; SUD, step-up dose.
Arm A data cutoff: July 12, 2024; Arm B data cutoff: March 31, 2026; Arm C data cutoff: March 31, 2026.
Expanding the reach of CAR-T cells with in vivo gene delivery
Expanding the reach of CAR-T cells with in vivo gene delivery In vivo CAR T with lentiviral particles1,2
Detargeted fusogen, VSV-G mutation
Reduced cost of goods and manufacturing Simplified logistics to expand access Elimi nates preconditio ning chemothera py
KLN-1010: A modified LVV generating anti-BCMA CAR-T cells in vivo3 T cell retargeting with CD3 tropism molecule
CAR molecule In vivo CAR-T generation
Proprietary, fully-human BCMA scFv Direct infusion
4-1BB CD3ζ
No ex vivo culture may increase T-cell fitness BCMA, B-cell maturation antigen; CAR, chimeric antigen receptor; CD3, cluster of differentiation 3; CD3ζ, cluster of differentiation 3 zeta chain; LVV, lentiviral vector; scFv, single-chain variable fragment; VSV-G, vesicular stomatitis virus glycoprotein. 1. Bot A et al. Nat Rev Drug Discov. 2025 Sep 30. doi: 10.1038/s41573-025-01291-5; 2. Najibi AJ. Tcell-specific in vivo transduction with preclinical candidate KLN-1010 generates BCMA-directed CAR-T cells with potent anti-multiple myeloma activity (abstract #48). Poster presented at: AACR Annual Meeting; April 5-10, 2024. 3. Wood JTet al. Toward treatment with gene-modified B cells engineered in vivo using iGPS particles (abstract #1281). Poster presented at: ASGCT 28th Annual Meeting; May 13-17, 2025.
CB-011: a differentiated allogeneic CAR -T cell therapy for r/r MM
B2M–HLA-E protein fusion insertion
CB-011 Manufactured from healthy donor T cells with 4-1BB costimulatoryVispa-cel domain Manufactured from
healthy donor T cells
Anti-BCMA CAR insertion
TCR knockout
B2M knockout
126
1Rossi A et al. TANDEM 2026 presentation
RDE: recommended dose for expansion r/r MM: relapsed/refractory multiple myeloma
CB-011 immune cloaking strategy enhances functional persistence and antitumor act ivity
450M cell dose selected as RDE following deep, durable responses and manageable safety profile 1
CB-011 demonstrates potential to address unmet need in both BCMA-naïve and BCMA-ex posed patients
CONFIDENTIAL | EHA Presentation | June 2026 ©2026 Caribou Biosciences, Inc.
Conclusion • This is truly the “golden age” of MM with improving quantity and quality of life for patients
• We are moving towards a cure more closely than ever – in fact, we have a working definition of cure:
• Dr. Joe Prediction
– As we see a larger fraction of patients meet this definition we will using the term CURE more – but cautiously as there is much more work to do...
THANK YOU! Joseph Mikhael, MD, MEd, FRCPC Medical Advisor, International Myeloma Foundation (IMF) Professor, Translational Genomics Research Institute (TGen) City of Hope Cancer Center Director of Myeloma Research and Consultant Hematologist, HonorHealth Research Institute
jmikhael@tgen.org jmikhael@myeloma.org 128
Lunchtime 12:00
- 12:55 PM
Program Slides & Evaluation
Friday Afternoon Agenda
J&J Innovative Medicine
Legend Biotech
The Future of Immunotherapies in Myeloma Yi Lin, MD, PhD Mayo Clinic – Rochester, MN International Myeloma Working Group
Disclosure • Data and safety monitoring board – Pfizer, Sorrento Therapeutics • Research funding − Bluebird bio/A2 Seventy, Bristol Myers Squibb/Celgene, Janssen Pharmaceuticals, Kite Pharma/Gilead Sciences, Merck, Takeda
• Advisory board – Amgen, Bluebird bio/A2 Seventy, Bristol Myers Squibb/Celgene, Gamida Cell, Janssen
Pharmaceuticals, Kite Pharma/Gilead Sciences, Juno Pharmaceuticals/BMS, Legend Biotech, NexImmune, Novartis, Pfizer
• Consultancy fees – Vineti All above funding made to the institution. No personal compensation.
Presenter: Yi Lin, M.D.Ph.D. Mayo Clinic, Rochester, MN
FUTURE OF IMMUNOTHERAPY - MOVING TO ALL LINES OF THERAPY - SEQUENCES & COMBINATIONS: CHOOSE MORE WISELY - DURATION & MANAGEMENT: MANAGE MORE WISELY - MORE INNOVATIONS
MajesTEC-3: Clinical response
Discontinuation due to treatment AE: 4.6% vs 5.5%
Tec-Dara arm OS benefit despite 68.4% of the patients in the DPd/DVd arm received BsAb or CAR-T in subsequent line of therapies.
CARTITUDE-4: Cilta-cel vs SOC OS EORTC QLQ-C30 Assessment on CARTITUDE-4 Study
M-V Mateos et al. EBMT 2025
Presenter: Yi Lin, M.D.Ph.D.
Minna R et al. Lancet Haematology 2025.
100
CARTITUDE-4 ITT population 33.6 months median follow-up
1 1 PFSPFS
100
Standard-risk cyto, cilta-cel 60
High-risk cyto, cilta-cel
40
Standard-risk cyto, SOC 30-month rate
20 0
1 1 OSOS
80
80
Standard-risk cyto High-risk cyto Cilta-cel 71.0% Cilta-cel 52.3% SOC 43.2% SOC 17.5% HR 0.43 HR 0.38
0
3
6
High-risk cyto, SOC
42 87 36 51
37 31 28 84 76 73 35 32 32 49 49 49
23 20 7 3 70 55 31 14 29 27 18 9 49 46 27 9
0 7 1 2
0 2 1 1
0 0 0 0
Standard-risk cyto, cilta-cel High-risk cyto, cilta-cel
60
Standard-risk cyto, SOC High-risk cyto, SOC
40 30-month rate
20 0
9 12 15 18 21 24 27 30 33 36 39 42 45 PFS, months
Patients at risk High risk, SOC 132 111 79 65 52 High risk, cilta-cel 123 106 102 96 92 Standard risk, SOC 70 58 50 47 41 Standard risk, cilta-cel 69 59 58 57 53
Patients alive, %
Patients progression free and alive, %
PFS and OS in Patients With High-Risk and Standard-Risk Cytogenetics (ITT)
Standard-risk cyto Cilta-cel 79.7% SOC 69.6% HR 0.62
0
3
6
High-risk cyto Cilta-cel 75.5% SOC 62.1% HR 0.54
9 12 15 18 21 24 27 30 33 36 39 42 45 OS, months
Patients at risk High risk, SOC 132 130 126 116 110 103 96 91 84 81 75 38 14 6 0 High risk, cilta-cel 123 121 115 111 105 103 102 98 95 93 83 50 23 14 5 Standard risk, SOC 70 69 62 61 57 55 54 52 49 48 48 29 18 5 3 Standard risk, cilta-cel 69 65 61 59 57 57 56 56 56 55 52 35 13 5 2
0 0 0 0
In CARTITUDE-4, cilta-cel improved PFS and OS in prespecified subgroups with standard- and high-risk cytogenetics1 Compared to CARTITUDE-1 (median 6 prior lines of therapy), standard risk patients, 30 months PFS 59.9%, OS 1. Sidana S, et al. J Clin Oncol 2025;43:7539. 70.6%. Presented by L Costa at the 67th American Society of Hematology (ASH) Annual Meeting; December 6–9, 2025; Orlando, FL, USA
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160
MajesTEC-3 Study: Practice Considerations
Predictive Model to Guide Therapy Selection CHARGE Index for T-cell Engagers in MM • US MM Immunotherapy Consortium & IMF
SCOPE-MM at Pre-Leukapheresis for CAR-T
Immunotherapy Data Registry collaboration • •
996 pts from 21 centers in US, Canada, UK, Spain, Greece Teclistamab, Elranatamab, Talquetamab
• CHARGE Index: 1 point each for high risk
cytogenetics; functional high risk; prior BCMA therapy; ECOG >=2; ferritin>600; Hg<9. • 1740 pts who received ide-cel or cilta-cel in CARTITUDE-1, KarMMa-3, RWE • Only predictive model at CAR-T eval/preleukapheresis • IMWG recommendation
Zanwar S et al. ASH 2025. Manuscript under review.
Rejeski K et al. ASH 2024. Manuscript under review.
Myeloma treatment landscape in the U.S. 2nd Line
3rd Line
4th Line
Teclistamab: BCMA BSAb • Selection Based on Response to Prior Therapy • Changes between PI & IMiDs classes and or next generation
Talquetamab: GPRC5D BSAb Elranatamab: BCMA BSAb
Linvoseltamab: BCMA BSAb
Backbone of major regimens: Proteasome inhibitor (PI), Immune modulatory drug (IMiD) With and without CD38 antibodies
Transplant eligible trials: CARTITUDE-6, MajesTEC-5, MMRC HORIZON TWO, IMMUNOPLANT
Transplant not considered/ineligible trials: CARTITUDE-5, MagnetisMM-6, EMN FITFIX TRIlogy-7 Presenter: Yi Lin, M.D.Ph.D.
Ciltacabtagene autoleucel (CARVYKTI) Teclistamab + Daratumumab Idecabtagene vicleucel (ABECMA)
Belantamab + Velcade/DEX Elotuzumab (CS1 antibody) combinations Selinexor/Bortezomib/DEX
ImmunoPRISM Study: Teclistamab in SMM
Nadeem O et al. EHA 2026.
ImmunoPRISM Study: Teclistamab in SMM
Nadeem O et al. EHA 2026.
ImmunoPRISM Study: Teclistamab in SMM
Nadeem O et al. EHA 2026.
CAR-PRISM Study: Cilta-cel in SMM • 4 subjects developed IEC-cranial nerve palsies, all resolved with treatment • 3 subjects developed IECParkinsonism, ongoing residual symptoms
Nadeem O et al. AACR 2026. Nadeem O et al Nat Med 2026.
SEQUENCING & COMBINATION
Efficacy and Safety of Talquetamab + Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma and Extramedullary Disease: Updated Phase 2 Results From the RedirecTT-1 Study With Extended Follow-Up Saad Z Usmani1*, Shaji Kumar2*, María-Victoria Mateos3, Jing Christine Ye4, Shebli Atrash5, Hila Magen6, Hang Quach7, Michael P Chu8, Suzanne Trudel9, Joshua Richter10, Paula Rodríguez-Otero11, Hun Chuah12, Moshe Gatt13, Eva Medvedova14, Shahzad Raza15, Dok Hyun Yoon16, Tadao Ishida17, Jeffrey V Matous18, Laura Rosiñol19, Koichi Onodera20, Carmela Maffucci21, Emma Scott22, Christoph Heuck22, Jenny Zhang22, Todd Henninger21, Lisa O’Rourke22, Payal Thakkar21, Mariacristina Festa23, Guoqiang Zhang22, Sheetal Khedkar24, Lin Huang22, Jiangxiu Zhou22, Mikihiro Takamoto25, Lixia Pei21, Jiashen Lu26, Nicholas Au22, Maria Krevvata22, Yael C Cohen27
https://www.congresshub.com/ASH2025/ Oncology/Talquetamab/Usmani The QR code is intended to provide scientific information for individual reference, and the information should not be altered or reproduced in any way.
1Memorial Sloan Kettering Cancer Center, New York, NY, USA; 2Mayo Clinic Rochester, Rochester, MN, USA; 3University Hospital of Salamanca/IBSAL/CIC/CIBERONC, Salamanca, Spain; 4MD Anderson Cancer Center, University of Texas, Houston, TX, USA; 5Levine Cancer Institute-Atrium Health, Charlotte, NC, USA; 6Chaim Sheba Medical Center, Ramat-Gan, Faculty of Medical and Health Sciences,
Tel Aviv University, Tel Aviv, Israel; 7University of Melbourne, St Vincent’s Hospital, Melbourne, VIC, Australia; 8Alberta Health Services, Edmonton, AB, Canada; 9Princess Margaret Cancer Centre, Toronto, ON, Canada; 10Mount Sinai Medical Center, New York, NY, USA; 11Cancer Center Clínica Universidad de Navarra, Cima, Pamplona, Spain; 12Royal Perth Hospital, Perth, WA, Australia; 13Hadassah Medical Cener, Hebrew University of Jerusalem, Jerusalem, Israel; 14Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA; 15Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA; 16Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; 17Japanese Red Cross Medical Center, Tokyo, Japan; 18Colorado Blood Cancer Institute and Sarah Cannon Research Institute, Denver, CO, USA; 19Hospital Clínic de Barcelona, IDIBAPS, Barcelona, Spain; 20Tohoku University Hospital, Sendai shi, Miyagi, Japan; 21Johnson & Johnson, Raritan, NJ, USA; 22Johnson & Johnson, Spring House, PA, USA; 23Johnson & Johnson, Leiden, Netherlands; 24Johnson & Johnson, Horsham, PA, USA; 25Johnson & Johnson, Tokyo, Japan; 26Johnson & Johnson, Shanghai, China; 27Tel Aviv Sourasky (Ichilov) Medical Center, Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel *Contributed equally.
Presented by S Usmani at the 67th American Society of Hematology (ASH) Annual Meeting; December 6–9, 2025; Orlando, Florida, USA
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RedirecTT-1 Phase 2 EMD (Tal + Tec): Largest Dedicated Study in Patients With True EMD Screening
Treatment
Endpoints
Eligibility criteria • Triple-class exposed RRMMa • True EMD, defined as ≥1 nonradiated bone-independent soft tissue plasmacytoma ≥2 cm in greatest dimension confirmed by central review of PET-CT scansb,c • Prior CAR-T and non-BCMA/GPRC5D bispecific antibody therapies were permitted • Nonsecretory and oligosecretory disease were permitted
Tal 0.8 mg/kg Q2W SCd,e + Tec 3.0 mg/kg Q2W SCd,e
Primary endpoint: ORRf
Option to switch to monthly dosing after 4 cycles and ≥VGPR, or after 6 cycles (irrespective of response)
Secondary endpoints: • DORf • PFSf • OS • Safety
Step-up dosingd 2–4 days apart (Tal + Tec) SUD1: 0.01 mg/kg + 0.06 mg/kg
SUD2: 0.06 mg/kg + 0.3 mg/kg SUD3: 0.4 mg/kg + 1.5 mg/kg
aIncludes prior exposure to a proteasome inhibitor, immunomodulatory drug, anti-CD38 monoclonal antibody. bPatients may have had paramedullary plasmacytomas in addition to true EMD. cWhole-body MRI permitted with
sponsor approval. dTal and Tec administered on the same day, 30 (±10) minutes apart, for all step-up and full treatment doses. eUntil disease progression. fResponse and PFS were assessed by an independent review committee per IMWG criteria; EMD response was assessed by PET-CT or MRI whole-body scans. CAR, chimeric antigen receptor; DOR, duration of response; MRI, magnetic resonance imaging; PET-CT, positron emission tomography–computed tomography; Q2W, every other week; SC, subcutaneous; SUD, step-up dose; VGPR, very good partial response. Kumar S, et al. N Engl J Med 2025; doi:10.1056/NEJMoa2514752. Presented by S Usmani at the 67th American Society of Hematology (ASH) Annual Meeting; December 6–9, 2025; Orlando, FL, USA
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170
RedirecTT-1 Phase 2 EMD (Tal + Tec): High ORR Regardless of EMD Location
ORR (95% CI), %a,b
100
79% (69–87)
60
44
40 9 20 0
17 9 Total (N=90)
79% (67– 89)
78% (60–91)
80
≥CR: 53%
47
sCR CR VGPR PR
≥CR: 56%
43
≥CR: 52%
9
9 16
6 Organ EMD (n=32)
17 10 Non-organ EMD (n=58)
• At an overall median follow-up of 16.8 months, median DOR was not reached in organ EMD and 15.4 months in non-organ EMD (Organ EMDc: kidney, liver, lung, and others. Non-organ EMDd: lymph node and soft tissue)
• ORR highest in patients with tumor volume <25 cm2 Data cut-off date: July 18, 2025. aORR was assessed by independent review committee per IMWG criteria. bDue to rounding, individual response rates may not sum to the ORR. cFull list of organ EMD locations include adrenal gland, kidney, liver (left lobe, right lobe), lung (left, left lower lobe), pancreas, pericardium, peritoneum, and pl eura. dFull list of non-organ EMD locations include lymph node (axillary, cervical, iliac, inguinal, lymph, mediastinal, mesenteric, para-aortic, pelvic, peripancreatic, porta hepatis, retrocrural, retroperitoneal, and supraclavicular) and soft tissue (abdominal, breast, chest wall, mediastinum, muscle, omentum, other, pelvis, retroperitoneum, and skin). Presented by S Usmani at the 67th American Society of Hematology (ASH) Annual Meeting; December 6–9, 2025; Orlando, FL, USA
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171
RedirecTT-1 Phase 2 EMD (Tal + Tec): PFS and OS at 16.8 Months Median Follow-up PFS
OS 100
100
57.5%
80
Patients, % (95% CI)
Patients. % (95% CI)
80
(46.4–67.1) 60
40
20
60
40
20
Median (95% CI) PFSa: 15.0 (10.3–NE)
0
0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 PFS, months Patients at risk
90 83 79 72 68 65 64 61 54 52 52 47 45 42 38 32 23 21 14 8
73.8% (63.3–81.8)
4
2
1
1
0
0
Patients at risk
Median (95% CI) OSb: NR (19.7–NE) 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 OS, months 90 84 82 80 80 80 80 76 74 70 68 64 59 58 51 45 34 27 22 16 8
3
2
2
1
0
0
With over 1 year of median follow-up, median PFS was 15 months and median OS was not reached Data cut-off date: July 18, 2025. aAt time of data cut-off, 45 (50.0%) patients were censored for PFS. bAt time of data cut-off, 59 (65.6%) patients were censored for OS. Presented by S Usmani at the 67th American Society of Hematology (ASH) Annual Meeting; December 6–9, 2025; Orlando, FL, USA
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RedirecTT-1 Phase 2 EMD (Tal + Tec): AEs Were Consistent With Safety Profiles of Tal and Tec Common AEs (≥30% of patients) Hematologic AEs
Neutropenia Anemia Thrombocytopenia
3… 37.8 25.6
63.3 53.3
Nonhematologic AEs
a Oral Infections CRS b Non-rash skin c Nail related Weight decrease Cough Diarrhea Nausea Hypokalemia d Pyrexia e Rash related Fatigue
33.3
12.2 0.0 4.4 0.0 7.8 1.1 1.1 3.3 0.0
20.0
Any grade
86.7 80.0 77.8 68.9
4.4 0.0 0.0 0.0
72.2
55.6 53.3
Patients, %
Initial Q2W dosing (N=90)
After adjustment to Q4W dosing (n=56)g
Any-grade infections
65 (72.2)
34 (60.7)
29 (32.2)
14 (25.0)
46 (51.1)
15 (26.8)
8 (8.9)
5 (8.9)
77 (85.6)
12 (21.4)
3 (3.3)
2 (3.6)
Grade ≥3 infections Weight decrease Grade 3/4 weight decrease Oral AEsa
40.0 37.8 32.2 31.1 31.1 31.1 30.0 40.0
Outcome,f n (%)
Grade 3/4 oral AEsa
New onset of key any-grade AEs were less common with adjusted Q4W dosing 60.0
80.0
100.0
Data cut-off date: July 18, 2025. Median follow-up: 16.8 months. AEs listed are those occurring in ≥30% of the total study population. AEs were reported as treatment-emergent AEs recorded up to 30 days after the patient received last study treatment dose or until start of subsequent therapy. aIncludes ageusia, cheilitis, dry mouth, dysgeusia, dysphagia, glossitis, glossodynia, hypogeusia, mouth ulceration, oral discomfort, oral mucosal erythema, oral pain, stomatitis, swollen tongue, taste disorder, tongue discomfort, tongue erythema, tongue edema, and tongue ulceration. bIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome. cIncludes nail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging. dExcludes symptoms of CRS or ICANS. eIncludes rash, maculopapular rash, erythematous rash, and erythema. fNew-onset AEs only; AEs are only counted once either before or after switch. g34 patients did not switch to Q4W dosing. AE, adverse event; CRS, cytokine release syndrome; ICANS, immune effector cell–associated neurotoxicity syndrome; Q4W, every 4 weeks. Presented by S Usmani at the 67th American Society of Hematology (ASH) Annual Meeting; December 6–9, 2025; Orlando, FL, USA
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RedirecTT-1 Phase 2 EMD (Tal + Tec): Summary of Infections Tal + Tec (N=90)
Most common AEs (≥10% overall),a n (%) Infections URTI COVID-19 Pneumonia UTI Viral upper respiratory tract infection
• Infections were common; however, grade 3/4 infections were consistent with Tec monotherapy1
Any Grade
Maximum Grade 3/4
72 (80.0) 27 (30.0) 20 (22.2) 19 (21.1) 12 (13.3)
30 (33.3) 4 (4.4) 5 (5.6) 8 (8.9) 4 (4.4)
• At baseline, 22.2% of patients had Ig values <400 mg/dL
9 (10.0)
2 (2.2)
• 75.6% of all patients received ≥1 dose of Ig replacement
• 6.7% of patients had opportunistic infections,b 3.3% were grade 3/4
– Grade 3/4 infections mostly limited to first 6 months and then declined – Median duration of infection, 13.0 days • 71.1% of patients had posttreatment hypogammaglobulinemiac – Ig replacement was highly recommended to prevent infection
Grade 3/4 infection rate was 33%, generally consistent with Tec monotherapy in MajesTEC-11 aAEs were graded by CTCAE v5.0; patients could experience ≥1 infection. bPatients could experience ≥1 opportunistic infection; CMV infection reactivation (n=4), CMV infection (n=2), CMV esophagitis (n=1), esophageal
candidiasis (n=1), and polyomavirus viremia (n=1). cPosttreatment IgG <400 mg/dL or hypogammaglobulinemia treatment-emergent AE. Ig, immunoglobulin; CMV, cytomegalovirus; URTI, upper respiratory tract infection; UTI, urinary tract infection. 1. Moreau P, et al. N Engl J Med 2022;387:495-505. Presented by S Usmani at the 67th American Society of Hematology (ASH) Annual Meeting; December 6–9, 2025; Orlando, FL, USA
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174
Enhancing the safety of ciltacabtagene autoleucel in relapsed multiple myeloma (MM): Identification of potentially modifiable risk-factors associated with delayed neurotoxicity and non-relapse mortality Surbhi Sidana*, Brett Reid*, Danai Dima*, Lauren C. Peres, Mahmoud Gaballa, Rahul Banerjee, Oren Pasvolsky, Aimaz Afrough, Christen Dillard, Christopher Ferreri, Shebli Atrash, Cindy Varga, Andrew Portuguese, Masooma Rana, Hitomi Hosoya, Lekha Mikkilineni, Vanna Hovanky, Saurabh Zanwar, Nilesh Kalariya, Damian Mikulski, Charlotte Wagner, Christopher R. Cahoon, Omar Castaneda Puglianini, Gabe De Avila, Christian Gordillo, Eli Zolotov, Jenny Bhurtel, Ariel Grajales-Cruz, Utkarsh Goel, Aishwarya Sannareddy, Jeries Kort, Rafaella Cassano, Shonali Midha, James Davis, Rebecca Gonzalez, Megan Herr, Zhuoer Xie, Hamza Hassan, Sneha Purvey, Marcus Geer, Kimberly Green, Fabiana Perna, Hien Liu, Taiga Nishihori, Jack Khouri, Shahzad Raza, Faiz Anwer, Susan Bal, Omar Nadeem, Ciara L. Freeman, Leyla Shune, Ran Reshef, Kenneth Shain, Melissa Alsina, Rachid Baz, Doug Sborov, Saurabh Dahiya, Frederick L. Locke, David Miklos, Peter Voorhees, Larry Anderson, Luciano Costa, Noa Biran, Shaji Kumar, Yi Lin*, Krina K. Patel* , Doris Hansen*
* contributed equally ASH 2025, Abstract #1034
Non-Relapse Mortality 1-year NRM estimate: 9% 2-year NRM estimate: 10% Non-relapse mortality (NRM) events, N=63 (8%)
N (%)
Infections
35 (56%)
Acute immune mediated toxicity CRS IEC-HS ICANS
14 (22%) 4 6 4
Delayed immune mediated toxicity Parkinsonism/NINT IEC-Colitis Second primary malignancies Other
6 (9.5%) 4 2 5 (7.9%) 3 (8%)
• Infection related mortality remained relatively stable in the first year • Immune mediated toxicity deaths were uncommon after 6 months • SPMs were uncommon within the first 6 months. Sidana et al. ASH 2025, Abstract #1034
Risk Factors for NRM: Multivariable Analysis Odds Ratio
95% CI
P-value
Response to bridging: SD/PD vs PR
2.41
1.07, 6.19
0.046
No bridging therapy vs PR
2.06
0.67, 6.40
0.2
ECOG PS ≥ 2 vs 0-1
3.97
1.98, 7.77
<0.001
High Risk cytogenetics, yes vs no
2.39
1.27, 4.55
0.007
Age ≥ 70 years vs not
2.65
1.40, 5.01
0.003
A multivariate model was built using bidirectional stepwise regression using AIC criteria. Variables entered into the model included the following. For the final model, all variables selected with AIC had p <=0.05. Age ≥ 70 years, performance status, bone marrow plasma cells > 50%, EMD, Prior lines of treatment (1-3 vs. 4+), High risk cytogenetics (yes/no), Bridging response (no bridging, SD/PD, PR or better), Baseline Ferritin (<400 vs >400 ng/mL), Peak ALC (> 3k),
Sidana et al. ASH 2025, Abstract #1034
Talquetamab use during CAR-T manufacturing US MM Immunotherapy Consortium • 77 subjects received Talquetamab during bridging (median 5 prior lines of Tx) • 65 (84%) received CAR-T • 15 ide-cel • 50 cilta-cel
• 12 Uninfused • 5 manufacturing failed (4 had prior BCMA); 5 PD; 2 pt decision. Dhakal B et al. Blood 2025. Presenter: Yi Lin, M.D.Ph.D.
Talq Tox (median time 26 days)
N=77 Any Grade
Grade 3/4
CRS
52 (68%)
0
ICANS
8 (10%)
2 (2.5%)
Skin
32 (42%)
0
Nail
19 (25%)
0
Oral
43 (56%)
1 (1.2%)
Weight 9 (12%) 2 (2.5%) loss • 40/67 (60%) of patients observed complete resolution of Talq related toxicities • CAR-T post infusion toxicities appears comparable to prior SOC • CRS 72%, Gr 3/4 3% • ICANS 10%, Gr 3/4 2% • Infections 27% • Cytopenia Gr 3/4 10% • CN VII palsy 1.5%
MANAGE WISELY
Prophylactic Tocilizumab for T-cell Engagers
Kowalski A et al. Bld Adv 2025.
Hamadeh S. et al. Clin Lym Myel Leuk 2026.
Limited Duration of T-cell Engager: LimiTec Study
• 4/8 evaluable patients at PD were BCMAneg • All except 1 patient retreated with Tec did not respond • Response to subsequent treatment with Talquetamab were seen, suggesting antigen target loss was mechanism of resistance Razzo B. Et al ASH 2025.
NEXT GENERATION
Trispecific T cell Engagers: Ramantamig (JNJ-5322, Phase I) • 1 step-up dose, every 4 week SQ dosing thereafter • 12-months PFS 93%; 18months PFS 80% • CRS were low grade, incidence reduced with prophylactics tocilizumab • Grade ¾ infections 33% • 58% taste changes, Grade 1 / 2 • No significant weight loss
Van de Donk N et al ASH 2025.
Anitocabtagene autoleucel (anito-cel/CART-ddBCMA) Autologous BCMA-directed CAR T-cell therapy using a novel, D-Domain binder1,2 iMMagine-1 Study Data cut-off: October 7, 2025; Median follow-up of 15.9 months
▪ 15% of patients had no CRS
▪ 94% of patients had no ICANS ▪ Grade 3 or higher CRS 17% ▪ Grade 3 or high ICANS 1% scFv (~25 kDa)
Bivalent camelid VHH (~30 kDa)
D-Domain (~8 kDa)
▪ No delayed neurotoxicities or enterocolitis to date
D-Domain Attributes: Non-Antibody Derived Synthetic Protein1,2 Size
Structure & Stability
Binding
Small D-Domain construct facilitates high transduction efficiency and CAR positivity2-4 resulting in a low total cell dose
D-Domain CARs are stable and lack tonic signaling4,6 due to the rapid folding, lack of disulfide bonds, and hydrophobic core5,6 of the D-Domain
The D-Domain binder has a fast off-rate4 and high CAR surface expression4. This combination may allow optimal tumor cell killing without prolonged inflammation
Anito-cel was successfully manufactured for 99% of patients enrolled Leukapheresed (n=129), Dosed (n=117)
1Rotte, et al. Immuno-Oncology Insights 2022; 3(1), 13–24; 2Frigault, et al. Blood Adv. 2023; 7(5):768-777; 3Cante-Barrett, et al. BMC Res. Notes 2016; 9:13; 4Buonato, et al. Mol. Cancer Ther. 2022; 21(7):1171-1183; 5Zhu, et al. Proc. Nat. Acad. Sci.
2003; 100(26): 15486-15491; 6Qin, et al. Mol. Ther. 2019; 27(7): 1262-1274. Patel et al, American Society of Hematology 2025, Abstract 256
184
iMMagine-3 Design, Global Phase 3 Study iMMagine-3 (NCT06413498) is a global, Phase 3 trial comparing anito-cel to standard of care therapy in patients with RRMM after 1-3 prior LoT, including an anti-CD38 monoclonal antibody and an iMiD
1:1 Randomization
▪
n = Approximately 450, ~130 sites globally
Target dose: 115 (± 10) x 106 CAR+ T cells
Standard of Care Arm* KDd, PVd, DPd, Kd
Study Design ▪
Anito-cel Arm Follow-up
Lymphodepletin Chemotherapy
Bridging Therapy
Leukapheresis
Enrollment / Randomization
Screening
Anito-cel is being co-developed by Arcellx and Kite, and is being manufactured by Kite for iMMagine-3
Study Endpoints ▪ Primary Endpoints: ▪ PFS ▪ MRD-negative CR rate at 9 months ▪ Key Secondary Endpoints: CR rate, MRD, OS, safety
*Cycles will continue until unacceptable toxicity, progression as per IMWG criteria, or patient withdrawal of consent Patel et al, American Society of Hematology 2025, Abstract 256
185
GPRC5D Targeting CAR-T: Arlo-cel, Phase I study in 13 prior lines of therapy
Bal S et al EHA 2026
GPRC5D Targeting CAR-T: Arlo-cel, Phase I study in 13 prior lines of therapy
Bal S et al EHA 2026
CB-011 (CaMMouflage Phase I study): Allogeneic CAR-T
Dhakal B et al EHA 2026
Rapidly manufactured CAR-T: AZD0120 (Dual BCMA/CD19 CAR-T, DURGA-1 Study)
• Medium follow-up 9 months • BCMA CAR-T exposed: 100% ORR, 83% CR/sCR • CRS: 63%, >=Gr3 3.7% • ICANS: 6.7%, Gr 1 only
• >=Gr 3 infection: 7.4% Dhakal B et al EHA 2026
Ideal target product profile for in vivo Cell Therapy Simply infuse cell engineering material
Target product profile:
No lymphodepletion chemotherapy No wait time for ex vivo cell manufacturing
•
Off-the-shelf cell engineering material
•
Engineer resting, niche-resident immune cells - Understand cell dose level - Understand cell phenotype, composition - Understand cell persistence
•
No off-target engineering - Tumor cells - Germ cells - Vital organs
•
High particle to infectivity ratio - No or minimized infusion toxicities at effective dose
•
Low cost of manufacture
1. Mobilize stem cells
2. targeted material to 1. Infuse Infuse engineering vector or virus cells targeted immune
3.2.InInvivo vivo generation of engineered transduction immune cells (ex. CAR-T, CARmacrophages)
In vivo CAR-T: the Next Frontiers
Bot A et al. Nat Rev Drug Disc 2026.
Pierini S et al. Int J Mol Sci 2026.
Ho J et al. ASCO 2026
Ho J et al ASCO 2026.
Ho J et al ASCO 2026.
The Future of Immunotherapy • T cell engagers and CAR-T moving to front line and smoldering myeloma • Combinations & sequencing to be optimized
• Improving knowledge for use and management • Next generation innovations
ACKNOWLEDGEMENTS Mayo Clinic Rochester
Hassan Alkhateeb, M.D. Stephen Ansell, M.D., Ph.D. Nabila (Nora) Bennani, M.D. Moritz Binder, M.D., M.P.H. Sherri Braksick, M.D. Matthew Block, M.D., Ph.D. Darin Carabenciov, M.D. Grace Choong, M.D. Joselle Cook, M.B.B.S. Brian Costello, M.D. Tassos Dimou, M.D. Arkadiusz Dudek, M.D., Ph.D. Urshila Durani, M.D., M.P.H. Asmaa Ferdjallah, M.D., M.P.H. Paul Galardy, M.D. Alice Gallo De Moraes, M.D. Morie Gertz, M.D. Paul Hampel, M.D. Joerg Herrmann, M.D. Sandra Herrmann, M.D. Thanh Ho, M.D. Patrick Johnston, M.D., Ph.D. (MCR Quality Director) Zhaohui Jin, M.D. Jeffrey Johnson, M.D. Lionel Kankeu Fonkoua, M.D. Prashant Kapoor, M.D. Saad Kenderian, M.B., Ch.B. Arushi Khurana Sani Kizilbash, M.D., M.P.H. Mira Kohorst, M.D. Taxiarchis Kourelis, M.D. Shaji Kumar, M.D. Bradley Leibovich, M.D. Roberto Leon Ferre, M.D. Nelson Leung, M.D. Konstantinos Leventakos, M.D., Ph.D. Yi Lin, M.D., Ph.D., MCR Medical Director, Enterprise Chair
Mayo Clinic – Arizona Julian Molina, M.D., Ph.D. Elie Naddaf, M.D. Scott Okuno, M.D. Jonas Paludo, M.D., Ph.D. Ian Parney, M.D., Ph.D. Tobias Peikert, M.D. Lewis Roberts, M.B., Ch.B., Ph.D. Steven Robinson, M.B.B.S. Michael Ruff, M.D. Mabel Ryder, M.D. Mithun Shah, M.D., Ph.D. Uma Thanarajasingam, M.D., Ph.D. JC Villasboas Bisneto, M.D. Paschalis Vergidis, M.D. Andrea Wahner Hendrickson, M.D. Rahma Warsame, M.D. Yucai Wang, M.D., Ph.D. Harry Yoon, M.D., Mojun Zhu, M.D. Managers/Supervisors Matthew Hathcock, Clinical Program Manager Ann Strege, Senior Program Coordinator Monica Shaw, IEC Compliance Manager Jessica Sholes, CRC supervisor Andrea Hillson Jensen, DC supervisor
Cecilia Arana Yi, M.D. Fawad Aslam, M.B.B.S., M.S. Felipe Batalini, M.D. Tanios Bekaii-Saab, M.D. Leif Bergsagel, M.D. Mitesh Borad, M.D. Januario Castro, M.D., MCA Medical Director Brenda Ernst, M.D. Rafael Fonseca, M.D. Sandra Gendler, M.D. Talal Hilal, M.B., B.Ch., M.D. Jose Leis, M.D., Ph.D. Javier Munoz, M.D. Craig Reeder, M.D. Allison Rosenthal, D.O., MCA Associate Medical Director Panayiotis (Panos) Savvides, M.D., Ph.D. Erin Wiedmeier-Nutor, M.D., M.P.H. Managers/Supervisors Hollie Benson, M.H.A., Clinical Program Manager Milana Ramsey, IEC Compliance Manager Isabel Ambalada, Senior Program Coordinator Nina Palermo, R.N., Research RN Thomas Ducharme, R.N., Research RN Erick Gaxiola-Perez, CRC/DC Supervisor
Mayo Clinic – Arizona Sikander Ailawadhi, M.D. Mohamed Kharfan Dabaja, M.D., M.B.A., MCF Medical Director Muhamad Alhaj Moustafa, M.D. Steven Attia, D.O. James Foran, M.D. Madiha Iqbal, M.B.B.S., M.D. Yanyan Lou, M.D. Vikas Majithia, M.B.B.S., M.P.H. Hemant Murthy, M.D. Ricardo Parrondo, M.D. Vivek Roy, M.D. Yiyi Yan, M.D., Ph.D. Abba Zubair, M.D., Ph.D. Managers/Supervisors Nydia Matteu. Clinical Program Manager, IEC Compliance Manager Brian Eglinger, Senior Program Coordinator Jessie Wharton, M.S.N., R.N., Research RN Dustin Chapin Jr., CRC Supervisor Lisa Morelli, DC Supervisor
RN coordinators Grace Duncan Breanna Estby Grace Garrison Angie McGill Jennifer Sadler, supervisor Abigail Sonnek Gina Lange, R.N., Research RN MCCCC Novel Biotherapeutics Data Science Workstream
Patients and their families!
©2026 Mayo Foundation for Medical Education and Research | slide-196
Thank you! Lin.yi@mayo.edu
The Science of Support Group Leadership: Fireside Q&A
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Becky Bosley, BSN, RN
Leader Learning Labs & Networking Opportunities • Advocacy and You with Danielle Hillwig Doheny (Pre • Creating RSVPs for Meetings with Jill Schock (North Shore)
• Tech Help with Cecilia Romero (Valhalla) • Reimbursement & SG Fund Help with Jenn & Yara (Valhalla) • Networking by the Pool • Walk around Viking Lake • Lawn Games (Valhalla Terrace) • Rest & Relax
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5:30PM – Networking & Evening Reception (Valhalla Terrace & Prefunction North) 6:00PM – Dinner (Norse Hall)
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