Issuu

Program Speakers Joseph Mikhael, MD, MEd, FRCPC, FACP, FASCO International Myeloma Foundation Chief Medical Officer Rose Simon Maitland/Central Florida Support Group Jim Shoemaker Mid-South Multiple Myeloma Support Group Robin Tuohy International Myeloma Foundation VP, Patient Support Jill Zitzewitz, PhD Central MA Multiple Myeloma Support Group 2

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Workshop Video Replay & Slides

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IMF Myeloma Voices at ASH 2025 Patients, Care Partners, Jill

Nurses, Support Group Leaders… Our Voices Matter!

e Ros

Jim

Follow the Myeloma Voices at ASH team on social media and read blogs about their experiences and impressions from attending ASH Myeloma Voices at ASH Webpa ge

ASH: American Society of Hematology ASH is the largest professional society serving both clinicians and

scientists around the world who are working to conquer blood diseases. Approximately 27,500 in person attendees and another 3,500 virtual! Record number of abstracts submitted: Over 9,000 (1000+ more than last year!) Over 1,500 related to Myeloma! including over 100 oral abstracts and 2 late breaking abstracts 10

OUTLINE The Top 10 Abstracts land in 2 major categories: 1. CAR T Cell Therapy (5 abstracts) 2. Bispecific Antibodies (5 abstracts)

Top 10 CAR T Cell Therapy 1. in vivo CAR T (LBA-1) 2. Long term follow up cilta-cel (#94) 3. Enhancing safety of cilta-cel (#1034) 4. Dual target fastcar frontline (#258) 5. Anito-cel in relapsed MM (#256) © 2025, International Myeloma Foundation. All rights reserved. IMF Confidential

LBA1 MRD-negative outcomes following a novel, in vivo gene therapy generating anti-BCMA CAR-T cells in patients with RRMM: Preliminary results from inMMyCAR, the first-in-human Phase 1 study of KLN-1010 Simon Harrison1, P. Joy Ho2, Sueh-li Lim3, Stephanie Talam2, Hannah Pahl1, Dharmesh Dingar4, Scott Currence4, Travis Quigley4, Andrew 1Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; 2Royal Prince Alfred Hospital, Spencer3 Sydney, New South Wales, Australia; 3The Alfred Hospital, Melbourne, Victoria, Australia; 4Kelonia Therapeutics, Inc., Boston, Massachusetts, United States.

Presented at the 67th ASH Annual Meeting and Exposition; December 6-9, 2025; Orlando, FL, USA.

Expanding the reach of CAR-T cells with in vivo gene delivery1,2 Ex vivo CAR T

Expansion

CAR-T engineering

In vivo CAR T with KLN-1010 lentiviral particles

Formulation

Release testing

Preparative chemotherapy

Collection of T cells

Infuse CAR-T cells into patient

Eliminates preconditioning lymphodepletion Greatly simplified logistics to expand access

In vivo CART generation

No ex vivo culture may increase T-cell fitness Direct infusion

Reduced cost of goods and manufacturing

CAR, chimeric antigen receptor. 1. Bot A et al. Nat Rev Drug Discov. 2025 Sep 30. doi: 10.1038/s41573-025-01291-5; 2. Najibi AJ. T cell-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.

Deep, ongoing MRD-negative responses were observed across first 4 patients Months post treatment 1

CR 5

Patient 1

VGPR

PR MRD negative 10-6

Patient 2

MRD negative 10-5

Patient 4

*Most sensitive result from next generation flow cytometry or sequencing

Patient 3

Involved sFLC

M-spike levels

Soluble BCMA

Post-infusion

sBCMA (pg/mL)

Post-infusion

M-spike (g/L)

sFLC (mg/L)

Post-infusion

BCMA, B-cell maturation antigen; BL, baseline; CR, complete response; D, study day; M, study month; M-spike, monoclonal protein spike; MRD, minimal residual disease; PR, partial response; SCR, screening; sFLC, serum free light chain; u, unconfirmed response; VGPR, very good partial response.

Patient 1, DL1 Patient 2, DL1 Patient 3, DL1 Patient 4, DL-1

Long-Term Progression-Free Survival Benefit With Ciltacabtagene Autoleucel in Standard-Risk Relapsed/Refractory Multiple Myeloma Luciano Costa1, Albert Oriol2, Dominik Dytfeld3, Salomon Manier4, Peter Voorhees5, Yi Lin6, Myo Htut7, Wilfried Roeloffzen8, Phoebe Joy Ho9, Urvi Shah10, Man Zhao11, Quanlin Li12, Agnes Balogh13, Katherine Li14, Ana Slaughter15, Nina Benachour13, Carolina Lonardi16, Arnab Ghosh17, Huabin Sun17, Nikoletta Lendvai17, Tamar Lengil17, Nitin Patel18, Mythili Koneru18, Erika Florendo18, Octavio Costa18, Vrinda Mahajan18, Paula Rodríguez-Otero19, Christopher Strouse20, A. Keith Stewart21, Surbhi Sidana22 University of Alabama at Birmingham, Birmingham, AL, United States; 2Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain; Poznan University of Medical Sciences, Poznań, Poland; 4University of Lille, CHU Lille, Lille, France; 5Atrium Health/Levine Cancer Institute, Wake Forest University School of Medicine, Charlotte, NC, United States; 6Mayo Clinic, Rochester, MN, United States; 7Department of Hematology and Hematopoietic Cell Transplantation, City of Hope Comprehensive Cancer Center, Duarte, CA, United States; 8Department of Hematology, University Medical Center Groningen, Groningen, Netherlands; 9Royal Prince Alfred Hospital, Sydney, Australia; 10Myeloma Service, Memorial Sloan Kettering Cancer Center, and Weill Cornell Medical College, New York, NY, United States; 11IQVIA, Shanghai, China; 12Johnson & Johnson, Apex, NC, United States; 13 Johnson & Johnson, Beerse, Belgium; 14Johnson & Johnson, Spring House, PA, United States; 15Johnson & Johnson, Zug, Switzerland; 16Johnson & Johnson, Buenos Aires, Argentina; 17 Johnson & Johnson, Raritan, NJ, United States; 18Legend Biotech USA Inc, Somerset, NJ, United States; 19Cancer Center Clínica Universidad de Navarra, Cima, Pamplona, Spain; 20 Hematology, Oncology, and Blood & Marrow Transplantation, University of Iowa, Iowa City, IA, United States; 21University Health Network and the Princess Margaret Cancer Centre, Toronto, ON, Canada; 22Stanford University School of Medicine, Stanford, CA, United States

https://www.congresshub.com/ASH2025/ Oncology/Cilta-cel/Costa 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 3

Presented by L Costa at the 67th American Society of Hematology (ASH) Annual Meeting; December 6-9, 2025; Orlando, Florida, USA

Add QR code here on slide master 2.16” x 2.16”

CARTITUDE-4: Study Design1 Screening Key inclusion criteria:

SOC arm

1:1 randomization

PVd or DPda,b

• Age ≥18 years with MM • 1–3 prior LOT (including PI + IMiD) • Lenalidomide refractory • ECOG PS ≤1 Key exclusion criteria: • Prior CAR-T or BCMA-targeting therapy

Stratified by: • Choice of PVd/DPd • ISS stage • Number of prior LOT

Bridging PVd or DPda ≥1 cycle

Day 1:

Cilta-cel infusion

(Target: 0.75 × 106 CAR+ T cells/kg)

Follow-up

Cilta-cel arm Day 1–112: Collect safety, efficacy,c PK/PD data every 28 days

Apheresis Lymphodepletion (start of study treatment) T-cell transduction and expansion

Primary endpoint • PFSd

Secondary endpoints • Efficacy: ≥CR, ORR, MRD negativity, OS • Incidence and severity of AEs

Physician’s choice. bAdministered until disease progression. cEfficacy data were collected after Day 112 every 28 days. dTime from randomization to disease progression/death. AE, adverse event; BCMA, B-cell maturation antigen; CAR, chimeric antigen receptor; CTCAE, Common Terminology Criteria for Adverse Events; DPd, daratumumab, pomalidomide, and dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; IMiD, immunomodulatory drug; ISS, International Staging System; ORR, overall response rate; PD, pharmacodynamics; PI, proteasome inhibitor; PK, pharmacokinetics; PVd, pomalidomide, bortezomib, and dexamethasone. 1. San-Miguel J, et al. N Engl J Med 2023;389:335-47. a

Presented by L Costa at the 67th American Society of Hematology (ASH) Annual Meeting; December 6–9, 2025; Orlando, FL, USA

Add QR code here on slide master 0.75” x 0.75“

100

PFSPFS 1

CARTITUDE-4 ITT population 33.6 months median follow-up

100

1 1 OSOS

80 Standard-risk cyto, cilta-cel 60

High-risk cyto, cilta-cel

Standard-risk cyto, SOC 30-month rate

20 Standard-risk cyto High-risk cyto Cilta-cel 71.0% SOC 43.2% HR 0.43 0

High-risk cyto, SOC

Cilta-cel 52.3% SOC 17.5% HR 0.38

37 31 28 84 76 73 35 32 32 49 49 49

23 20 70 55 29 27 49 46

7 3 31 14 18 9 27 9

0 7 1 2

0 2 1 1

0 0 0 0

Standard-risk cyto, cilta-cel High-risk cyto, cilta-cel

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 42 High risk, cilta-cel 123 106 102 96 92 87 Standard risk, SOC 70 58 50 47 41 36 Standard risk, cilta-cel 69 59 58 57 53 51

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

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 High risk, cilta-cel 123 121 115 111 105 103 102 98 95 93 83 50 23 Standard risk, SOC 70 69 62 61 57 55 54 52 49 48 48 29 18 Standard risk, cilta-cel 69 65 61 59 57 57 56 56 56 55 52 35 13

6 14 5 5

0 5 3 2

0 0 0 0

In CARTITUDE-4, cilta-cel improved PFS and OS in prespecified subgroups with standard- and high-risk cytogenetics1 Add QR code here on slide master 0.75” x 0.75“

1. Sidana S, et al. J Clin Oncol 2025;43:7539. Presented by L Costa at the 67th American Society of Hematology (ASH) Annual Meeting; December 6–9, 2025; Orlando, FL, USA

CARTITUDE-4 and CARTITUDE-1: PFS and OS in Patients With Standard-Risk Cytogenetics (As-Treated) PFS 100

71.7% 50

CARTITUDE-4 std risk + gain/amp(1q)

59.9% CARTITUDE-1 std risk [includes gain/amp(1q)]

No. at risk C-1 std risk: incl. gain/amp(1q) 68

Months 66

30-month OS

100

C-4 std risk: + gain/amp(1q) 105 103 101

Patients alive, %

Patients progression free and alive, %

30-month PFS

86.1% CARTITUDE-4 std risk

+ gain/amp(1q)

70.6% CARTITUDE-1 std risk

[includes gain/amp(1q)]

No. at risk C-1 std risk: 68 incl. gain/amp(1q)

Months 68

C-4 std risk: + gain/amp(1q) 105 103 101

Survival rates were higher when cilta-cel was used earlier in standard-risk disease Add QR code here on slide master 0.75” x 0.75“

Presented by L Costa at the 67th American Society of Hematology (ASH) Annual Meeting; December 6–9, 2025; Orlando, FL, USA

Summary of Cilta-cel Outcomes in Standard-Risk Myeloma (As-Treated Population) 30-month PFS rate, %

30-month OS rate, %

Cilta-cel

80.5

87.3

Cilta-cel

71.7

86.1

59.9

70.6

CARTITUDE-4 (median 2 prior lines) Standard-risk cytogenetics per protocol

Standard-risk cytogenetics per protocol + gain/amp(1q)

CARTITUDE-1 (median 6 prior lines) Cilta-cel

Standard-risk cytogenetics per protocol including gain/amp(1q)

Earlier use of cilta-cel in standard-risk RRMM led to higher survival rates Add QR code here on slide master 0.75” x 0.75“

Presented by L Costa at the 67th American Society of Hematology (ASH) Annual Meeting; December 6–9, 2025; Orlando, FL, USA

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

Toxicities with Cilta-cel Early (Days/Weeks)

Delayed (Weeks/Months)

Cytokine Release Syndrome (CRS)

Delayed neurotoxicity (Parkinsonism, cranial nerve palsy)

Neurotoxicity (ICANS)

IEC-Colitis

IEC-HS

Cytopenias and infections

Long-term (Years) Second cancers Unknown long-term effects

Study Design Population

Definitions

Analysis

•

Patients with relapsed MM receiving standard of care cilta-cel

•

Sites: 15 U.S centers

•

N=761 (May 2022 to December 2024)

•

Delayed neurotoxicity (DNT) or Non-ICANS neurotoxicity (NINT): Neurotoxicity events except ICANS including Parkinsonism, cranial nerve palsy, neuropathy, etc

•

NRM was defined as death due any cause except myeloma progression

•

Risk factors for Parkinsonism and NRM were evaluated by univariable and multivariable analysis.

•

Any NRM events occurring after disease progression were censored for analysis, except second primary malignancies Sidana et al. ASH 2025, Abstract #1034

Summary 

Non-response to bridging therapy was associated with 10x risk of Parkinsonism and a higher NRM with cilta-cel



Effective tumor debulking with bridging is critical to decrease the risk of Parkinsonism and NRM with cilta-cel



Peak ALC was significantly higher in patients who developed Parkinsonism, with peak ≥ 3000/uL associated with 12% risk of Parkinsonism.



Peak ALC ≥ 3000/uL can serve as a biomarker to identify patients for preemptive interventions and risk mitigation measures

Sidana et al. ASH 2025, Abstract #1034

Publication Number: 258

A Dual Targeting BCMA and CD19 FasTCAR-T (GC012F/AZD0120) as First-line Therapy for Newly Diagnosed Multiple Myeloma Juan Du,*1 Wanting Qiang,1 Jing Lu,1 Yanchun Jia,1 Haiyan He,1 Jin Liu,1 Pei Guo,1 Ying Yang,1 Zhongyuan Feng,1 Lina Jin,1 Xiaoqiang Fan,1 Nina Shah,2 Qi Zhang,3 Lianjun Shen,3 Jia Liu3 Department of Hematology, Myeloma & Lymphoma Center, Shanghai Changzheng Hospital, Shanghai, China 2 AstraZeneca, Gaithersburg, MD, USA 3 Gracell Biotechnologies Ltd., Shanghai, China 1

Juan Du, MD, PhD

67th ASH Annual Meeting December 6–9, 2025

GC012F/AZD0120: BCMA/CD19 dual targeting CAR-T

BCMA

Universally expressed on malignant plasma cells and a well-established target

CD19

Expressed on majority MM cells and progenitor cells 1-3

Next generation manufacturing based on FAST CAR platform

Faster availability to patients • Manufactured in <3 days

Enhanced T-cell fitness • Younger, fitter, naïve T cells

• GC012F/AZD0120 is an autologous CAR-T therapy that targets both BCMA and CD19 • GC012F/AZD0120 has demonstrated deep and durable responses with a manageable safety profile in RRMM patients4

1. Boucher K, et al. Clin Cancer Res. 2012;18:6155–6168. 2. Garfall AL, et al. JCI Insight 2018;3:e120505. 3. Jiang H, et al. Presented at: ASH Annual Meeting 2020; December 5–8, 2020; virtual. Oral presentation 178. 4. Juan Du, et al. Presented at: EHA2023 Congress; June 8-11, 2023; Frankfurt & Virtual. Poster presentation P869. MM, multiple myeloma; RRMM, relapsed / refractory multiple myeloma.

Juan Du, MD, PhD

67th ASH Annual Meeting December 6–9, 2025

100% ORR in both cohorts 3%

≥VGPR 100%

97%

ALL (N=30)

sCR 97%

95%

TE HR NDMM (N=22) sCR

•

Fast and deep responses were achieved in both groups

•

As of October 15, 2025, the median follow-up time since diagnosis was 36.5 months (19.6–53.9)

•

ORR=100% (30/30): 100% ≥VGPR

100%

97% (29/30) sCR (1 VGPR patient still in response)

•

is still in response)

•

Median time to first response post infusion was 28 days

•

Median time to best response post infusion was 68 days

TI NDMM (N=8)

VGPR

HR, high risk; NDMM, newly diagnosed multiple myeloma; ORR, overall response rate; sCR, stringent complete response; TE, transplant eligible; TI, transplant ineligible; VGPR, very good partial response.

Juan Du, MD, PhD

67th ASH Annual Meeting December 6–9, 2025

Abstract 256 Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM): Updated Results from iMMagine-1 Krina Patel, MD, MSc; Binod Dhakal, MD; Gurbakhash Kaur, MD; Richard T. Maziarz, MD; Natalie S. Callander, MD; Adam S. Sperling, MD, PhD; Carolina Schinke, MD; Andrzej J. Jakubowiak, MD, PhD; Noa Biran, MD; Douglas W. Sborov, MD, MS; Cindy Varga, MD; Larry D. Anderson, Jr., MD, PhD; Abhinav Deol, MD; Abraham S. Kanate, MD; Mehmet Hakan Kocoglu, MD; Melhem Solh, MD; Kamalika C. Banerjee, MS, MA; Krishna Rana, PharmD; Ana Kostic, MD; Enrique Granados, MD; Carolyn C. Jackson, MD, MPH; Christopher R. Heery, MD; Tim Welliver, MD, PhD; Ciara L. Freeman, MD, PhD; and Matthew J. Frigault, MD, MS

Anitocabtagene autoleucel (anito-cel/CART-ddBCMA)

Autologous BCMA-directed CAR T-cell therapy using a novel, D-Domain binder1,2 D-Domain Attributes:

Non-Antibody Derived Synthetic Protein1,2

scFv (~25 kDa)

Bivalent camelid VHH (~30 kDa)

D-Domain (~8 kDa)

Size

Small D-Domain construct facilitates high transduction efficiency and CAR positivity2-4 resulting in a low total cell dose

Structure & Stability

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

Binding

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

Rotte, 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

iMMagine-1: Overall Response Rate and Depth of Response Efficacy Evaluable Patients, N=117 ORR=96% 8%

 Responses continue to deepen over time

15%

 At a median follow-up of 15.9 months, IRC-assessed ORR was 96% and sCR/CR rate was 74% ≥VGPR 88%

sCR/ CR 74%

74%

N=117 Best Response:

sCR/CR

VGPR

Median (months)

Interquartile Range

Min, Max

Time to first response

1.0

1.0, 1.9

0.9, 13.8

Time to best response

4.8

2.1, 9.0

0.9, 23.8

Time to sCR/CR

3.2

2.0, 9.2

0.9, 23.8

Responses are per IMWG criteria and are IRC assessed; ORR defined as partial response or better. CR, complete response; IRC, independent review committee; ORR, overall response rate; PR, partial response; sCR, stringent complete response; VGPR, very good partial response Patel et al, American Society of Hematology 2025, Abstract 256

iMMagine-1: PFS and OS Rates Estimated by Kaplan-Meier Median PFS and OS were not reached

N=117

PFS Rate (%) (95% CI)

OS Rate (%) (95% CI)

6-Month

93.1 (86.7, 96.5)

95.7 (90.0, 98.2)

12-Month

82.1 (73.6, 88.1)

94.0 (87.8, 97.1)

18-Month

67.4 (55.4, 76.8)

88.0 (78.8, 93.4)

24-Month

61.7 (48.0, 72.8)

83.0 (70.7, 90.5)

Median follow-up of 15.9 months (range: 0.3 – 33.1 months) PFS, progression-free survival; OS, overall survival Patel et al, American Society of Hematology 2025, Abstract 256

iMMagine-1: Safety Update CRS, Maximum Grade (N=117) 80 (68%)

No CRS

4-day median onset (range: 1-17 days) 2-day median duration (range: 1-9 days)

19 (16%)

17 (15%) Grade 1

ICANS, Maximum Grade (N=117)

Grade 2

0 (0%)

1 (1%)

Grade 3

Grade 4

Grade 5

7-day median onset (range: 2-9 days a) 5-day median duration (range: 2-10 days b)

108 (92%)

3 (3%)

5 (4%)

1 (1%)

0 (0%)

No ICANS Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

 95% (111/117) of patients had either no CRS or CRS that resolved by ≤10 days of anito-cel infusion  No new treatment-related or treatment-emergent deaths have occurred since the previous May 1, 2025 datacut  No secondary primary malignancies of T-cell origin have occurred  No replication competent lentivirus detected No delayed or non-ICANS neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, and no immune effector cell-associated enterocolitis have been observed to date at ≥10 months since anito-cel infusion With the exception of n=1 Grade 1 ICANS (confusion) on day 31 post infusion that rapidly resolved. bWith the exception of n=1 max Grade 2 ICANS with 29-day duration to resolution Note: Updates to data resulting from ongoing data review; CRS and ICANS assessed per American Society for Transplantation and Cellular Therapy criteria CRS, cytokine release syndrome; ICANS, immune-effector cell-associated neurotoxicity syndrome a

Patel et al, American Society of Hematology 2025, Abstract 256

Dr. Joe’s Take On CAR T Cell Therapy

It remains the single most effective therapy in multiple myeloma 1. We can reduce the toxicities with careful bridging and monitoring of expansion 2. Long term outcomes are remarkable, especially in standard risk patients 3. It can feasibly and effectively be delivered in frontline therapy 4. Novel approaches include dual targeting, d-domain binding and even in vivo delivery...

Questions for the Patient Panel What does this mean for patients when deciding on CAR T? Does the long term follow up for standard risk patients mean more CAR T in earlier lines? What do you think about the new approaches like in vivo CAR T and newer molecules? Other thoughts?

Top 10 Bispecific Antibodies 6. Teclistamab-Dara in early relapse (LBA-6) 7. Teclistamab-Dara in frontline (#367) 8. Linvoseltamab post induction (#248) 9. Cevostamab post CAR T (#699) 10. Teclistamab-Talquetamab in EMD (#698) © 2025, International Myeloma Foundation. All rights reserved. IMF Confidential

A phase 2 study of teclistamab in combination with daratumumab in elderly patients with newly diagnosed multiple myeloma: the IFM2021-01 TecLille trial, cohort A S. Manier, J. Lambert, M. Macro, T. Chalopin, M. Dib, A. Rumpler, J. Gay, J.-N. Bastie, C. Jacquet, C. Sonntag, L. Vincent, A. Perrot, C. Mariette, L. Montes, S. Rigaudeau, N. Bigot, M. Doyle, D. Santra, P. Smirnov, C. Albrecht, C. Touzeau, J. Corre, P. Moreau, H. Avet -Loiseau, C. Hulin, X. Leleu, T. Facon Abstract #367

ASH 2025, Orlando

IFM 2021-01 TecLille - Study design Phase 2 study of Tec-Dara and Tec-Len in TNE NDMM (n = 74) Cohort A (n=37)

Primary endpoint

Teclistamab 2 step-up dose then 1.5mg/kg D8 and D15 then 3mg/kg Q4W thereafter NDMM Age > 65yo TNE ECOG 0-2

Daratumumab 1800 mg SC, QW for 8 weeks, Q2W for 16 weeks, Q4W thereafter Cohort B (n=37) Teclistamab 2 step-up dose then 1.5mg/kg D8 and D15 then 3mg/kg Q4W thereafter Lenalidomide 25mg per day 21/28 MRD evaluation

M18

M30

Pre-specified safety and efficacy analysis after 18 patients have received ≥ 2 cycles

•

Secondary endpoints •

Pre-specified safety and efficacy analysis after 10 and 18 patients have received ≥ 2 cycles

Rate of VGPR or better after 4 cycles

• • • • • •

Rate of responses (PR, VGPR, CR, sCR) PFS OS TTNT MRD 10-6 at 6 months Sustained MRD 10-6 Treatment-emergent adverse events

M42

Current amendment: Teclistamab 3mg/kg Q8W after C13 if CR or better and treatment interruption if 2-years sustained MRD -

NCT05572229

IFM 2021-01 TecLille – cohort A: Tec-Dara Response rates VGPR rate after 4 cycles*

Best response rate

ORR = 95% 100

VG PR PR

sCR

ORR = 100%

100

VGPR

76%

≥ VGPR = 79%

Patients, %

59%

≥ VGPR = 100%

8% 32% 16% 0

* primary endpoint

Tec-Dara n=37

All patients achieved VGPR or better at best response

IFM 2021-01 TecLille – cohort A: Tec-Dara PFS and OS Median follow up time = 10.3 months PFS

No event of progression or death occurred

A Phase 2 Trial of Abbreviated Fixed-Duration (Default 4 Cycles) Linvoseltamab ImmunoConsolidation to Deepen Responses Post Newly Diagnosed Multiple Myeloma Combination Therapy for Minimal Residual Disease Positivity (NCT06376526): The IMMUNOPLANT™ Study Dickran Kazandjian*, Benjamin Diamond, James Hoffman, Abhishek Pandey, David Coffey, Marcella Kaddoura, Brian Walker, David Lessen, Yaharini, Rodriguez, Caterine Diaz, Stephanie Mompoint, Sindy Gutierrez, Jennifer Chapman, Yi Zhou, Mike Georgiou, Russ Kuker, Kellye Koubek, Andrew Kowalski, Leslie Gallardo, Stephanie Fernandes, Fiorela Flores, Rabia Bukhari, Sunwoo Han, Michelle Armogan, Ola Landgren

*Email: dkazandjian@miami.edu

Study Design: Schema Immuno-consolidation for newly diagnosed Multiple Myeloma Using lack of MRD Negativity after initial cOmbination therapy to Pursue deeper responses with Linvoseltamab ANd delay Transplant: The Phase 2 IMMUNOPLANT™ Study)

Baseline/ Screening Evaluation

Linvoseltamab Cycles 1-4

MRD x10-6 Assessment

NDMM: ≥4 Cycles SoC Novel Combination

≥ VGPR & MRD+

Study Start

MRD(-)

Linvoseltamab Cycles 5-6

MRD(+)

Cycle 1 only

D1 D8 D15 D22

Cycle 5-6

D15

Linvoseltamab 5 mg IV Linvoseltamab 25 mg IV Linvoseltamab 200 mg IV

Cycle 2-3

D1 D8 D15 D22

Cycle 4

D15

Dexamethasone 40/10 mg IV/PO (Subsequent dosing only if CRS,etc.)

Key Eligibility –PI/IMiD/anti-CD38 triplet/quad – ≥4 cycles with MRD+ ≥VGPR –adequate organ function

Statistical Hypothesis:

Response Assessment

EoT & 30-day safety/MRD follow up

• Simon Minimax 2-Stage Design: Target MRD(-) Rate: 30%; null MRD(-) Rate: 10% • Stage I: ≥2 of 15 patients with response--> continue enrollment • Stage II: total ≥6 of 25 patients with response reject null hypothesis • One sided alpha = 0.05; Power = 80%

• SoC, e.g. maintenance, HDM-ASCT, etc. • Follow-up for MRD(-) duration, PFS & OS

Endpoints: Primary: MRD- 10-6conversion rate Secondary: Safety, sustained MRD negativity, PFS, OS

Phase 2 Study of Cevostamab Consolidation Following BCMA CAR T Cell Therapy: Preliminary Safety, Efficacy, and Correlative Data from the “STEM” (Sequential T Cell-Engagement for Myeloma) Trial Adam D Cohen, Sandra Susanibar-Adaniya, Alfred L Garfall, Dan T Vogl, Shivani Kapur, Adam Waxman, Danielle Zubka, Wei-Ting Hwang, Cynthia Diaczynsky, Julia H Noll, Matthew Ho, Luca Paruzzo, Bing Yi, Rong Xu, Elina Thai, Vanessa Gonzalez, Peter Michener, Marco Ruella, Joseph Fraietta, Edward A Stadtmauer. Abramson Cancer Center, University of Pennsylvania ASH Annual Meeting December 07, 2025 Division of Hematology/Oncology

Sequential T-Cell Engagement for Myeloma (“STEM”): Phase 2 study of cevostamab consolidation following BCMA CAR T cell therapy Hypotheses 1. Consolidation of BCMA CAR T cell therapy with cevostamab may: a) Re-invigorate persisting CAR+ T cells against residual BCMA+ MM cells b) Eliminate residual BCMA low/negative MM cells by redirecting endogenous T cells against FcRH5 c) Improve rates of sustained MRD-negativity and duration of response 2. MRD-directed, fixed duration cevostamab therapy may limit risk of infections and other complications

3.6mg IV C1D1 132mg IV C1D8 and thereafter

48hr hospitalization for C1D1 and C1D8

Primary endpoint: MRD-negative* CR rate at 12 months post-CAR T cells *Adaptive Clonoseq NGS, @ 10-5 Cohen et al, ASH 2023, TiP Abstract #3389; NCT05801939

n=up to 30 to have 26 evaluable opened July 2023

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 Memorial Sloan Kettering Cancer Center, New York, NY, USA; 2Mayo Clinic Rochester, Rochester, MN, USA; 3University Hospital of Salamanca/IBSAL/CIC/CIBERONC, Salamanca, Spain; MD 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; 10 Mount 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; 24 Johnson & 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

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.

1 4

*Contributed equally.

Presented by S Usmani at the 67th American Society of Hematology (ASH) Annual Meeting; December 6–9, 2025; Orlando, Florida, USA

Add QR code here on slide master

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

Includes 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. a

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): Deep, Durable Responses at 16.8 Months Median Follow-up

80 60

79% (69–87)

≥CR: 53%

40 9 20 0

17 9 Tal + Tec (N=90)

62.1%

sCR CR VGPR PR

Median (range) time to: • First response, 2.6 (1.0–5.8) months • Best response, 5.1 (1.0–16.6) months

Patients, % (95% CI)

ORR (95% CI), %a,b

100

DOR

100

(49.0–72.7) 60

Patients at risk

Median DOR (95% CI)c: NR (11.5–NE) 0

9 10 11 12 13 14 15 16 17 18 19 20 21 22 DOR, months

71 69 69 62 62 57 52 51 50 44 40 39 29 24 22 17 12

With additional ~4 months of median follow-up, ORR approached 80%; 62% of responders remained in response at 1 year 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. cAt time of data cut-off, 43 (60.6%) patients were censored. NE, not estimable; NR, not reached; sCR, stringent complete response. 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): PFS and OS at 16.8 Months Median Follow-up PFS 57.5%

Patients. % (95% CI)

Patients at risk

(63.3–81.8)

Median (95% CI) PFSa: 15.0 (10.3–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 PFS, months 90 83 79 72 68 65 64 61 54 52 52 47 45 42 38 32 23 21 14 8

73.8%

(46.4–67.1)

100

Patients, % (95% CI)

100

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

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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= 100

BONUS ABSTRACT

Safety and Efficacy of Elranatamab in Combination With Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma: Results from the Phase 1b MagnetisMM-30 Trial Attaya Suvannasankha,1 Jonathan L. Kaufman,2 Ashraf Badros,3 Michel Pavic,4 Hock-Choong Lai,5 Muhammad S Raza,6 Parth S Shah,7 Patrick Y. Muller,8 Jorge Acosta,8 Margaret Hoyle,9 Erik R Vandendries,10 Jay Cheng,11 Alexander Lesokhin12 Melvin and Bren Simon Comprehensive Cancer Center, Indiana University, Indianapolis, IN, USA; 2Winship Cancer Institute, Emory University, Atlanta, GA, USA; 3Greenebaum Comprehensive Cancer Center, University of Maryland, Baltimore, MD, USA; 4Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke, Quebec, QC, Canada; 5Icon Cancer Centre Townsville, Queensland, AU; 6Dr. Everett Chalmers Hospital, Halifax, NS, Canada; 7Dartmouth Hitchcock Medical Center, Hanover, NH, USA; 8Bristol Myers Squibb, Boudry, Switzerland; 9Pfizer Inc, Milan, Italy; 10 Pfizer Inc, Cambridge, MA, USA; 11Pfizer Inc, Bothell, WA, USA; 12Memorial Sloan Kettering Cancer Center, New York, NY, USA 1

Presented at the 67th ASH Annual Meeting and Exposition | December 6-9, 2025 | Orlando, FL

ORR • Overall, the confirmed ORR by investigator was 95.5% (95% CI, 77.299.9)

DL1

Median follow-upa

100%

• Responses occurred early

90%

– Median time to response was 1.4 months (range, 0.5-2.7) Patients, %

60%

≥CR: 46.2%

46.2%

40% 30%

7.8 months (range, 0.7-11.3)

ORR, 100.0% (95% CI, 66.4-100.0)

ORR, 95.5% (95% CI, 77.2-99.9)

11.1% ≥CR: 44.4%

4.5% ≥CR: 45.5%

33.3%

≥VGPR: 69.2%

50%

Overall

76 mg ELRA Q2W + 1.0 mg IBER 5.2 months (range, 4.5-6.4)

ORR, 92.3% (95% CI, 64.0-99.8)

80% 70%

DL–1

76 mg ELRA QW + 1.0 mg IBER 9.4 months (range, 0.7-11.3)

40.9% ≥VGPR: 77.3%

≥VGPR: 88.9%

23.1%

31.8%

44.4%

20% 10% 0%

23.1%

18.2%

11.1%

DL1 (n=13)

DL–1 (n=9) PR

VGPR

Overall (N=22)

sCR

Simple median of observation times. CR=complete response; DL=dose level; ELRA=elranatamab; IBER=iberdomide; ORR=objective response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response a

MagnetisMM-30 Study Design • MagnetisMM-30 (NCT06215118) is a phase 1b, open-label, multicenter, prospective study • Part 1 (dose escalation) primary objective was to assess the tolerability and safety of elranatamab in combination with iberdomide to determine the recommended doses of the combination for evaluation in Part 2 (randomized dose optimization) – A BOIN approach was used to guide dose escalation/de-escalation in Part 1 Patients with RRMM Key inclusion criteria • Age ≥18 years with MM per IMWG criteria • ECOG PS 0-1 • 2-4 prior LOTs, including ≥1 IMiD and ≥1 PIa • Relapsed or refractory to last LOT Key exclusion criterion • Stem cell transplant ≤12 weeks prior to enrollment or active GVHD • Ongoing grade ≥2 peripheral sensory or motor neuropathy; history of grade ≥3 peripheral motor polyneuropathy

Dose Level 1b

Dose Level 2

Primary endpoint • DLTs during DLT observation period

Elranatamab 76 mg QW + iberdomide 1.0 mg QD

Elranatamab 76 mg Q2W + iberdomide 1.3 mg QD

Dose Level –1b Elranatamab 76 mg Q2W + iberdomide 1.0 mg QD

Secondary endpoints • AEs and laboratory abnormalities • ORRc • CR ratec • Time-to-event endpointsc • PK • MRD negativity ratec • Immunogenicity

Dose Level –2 Elranatamab 76 mg Q2W + iberdomide 0.75 mg QD All patients must have received ≥2 consecutive cycles of an IMiD-containing regimen and ≥2 consecutive cycles of a PI or PI-containing regimen; b All patients received an initial 14-day cycle of elranatamab (12 mg on day 1, 32 mg on day 4, 76 mg on day 8) without iberdomide. Iberdomide was dosed at 21 out of 28 days for subsequent cycles; c Per IMWG criteria AE=adverse event; BOIN=Bayesian Optimal Interval Design; CR rate=complete response rate; DLT=dose-limiting toxicity; ECOG PS=Eastern Cooperative Oncology Group performance status; GVHD=graft vs host disease; IMiD=immunomodulatory drug; IMWG=International Myeloma Working Group; LOT=line of therapy; MM=multiple myeloma; MRD=minimal residual disease; ORR=objective response rate; PI=proteasome inhibitor; PK=pharmacokinetics; QD=once daily; QW=once weekly; Q2W=once every 2 weeks a

Dr. Joe’s Take On Bispecific Antibodies 1. The combination of teclistamab and daratumumab is very potent in both frontline and relapsed MM – but infection reduction is critical 2. Novel approaches immediately after CAR T include fixed duration linvoseltamab or cevostamab 3. The combination of teclistamab + talquetamab is highly effective in aggressive myeloma (EMD) 4. It is feasible and effective to combine bispecific antibodies with CelMods © 2025, International Myeloma Foundation. All rights reserved. IMF Confidential

Questions for Patient Panel What do you think about using bispecific antibodies at early relapse? What is your perspective on infections and the precautions needed? Is fixed duration therapy an important aspect of bispecific antibodies? Do you think combining two bispecific antibodies will be the way of the future? Other thoughts? © 2025, International Myeloma Foundation. All rights reserved. IMF Confidential

The Evolution of Myeloma Therapy – MORE to come!

Now

VTD VRD KRD D-VMP DRD D-VRD SCT +/- More induction D-KRD Isa-KRD Front line treatment

Induction

New

Belantamab or Bispecifics?

Panobinostat Bortezomib Lenalidomide Daratumumab Ixazomib Carfilzomib Pomalidomide Elotuzumab Lenalidomide Isatuximab Selinexor Bortezomib Idecabtagene autoleucel Ixazomib Ciltacabtagene autoleucel Lenalidomide + PITeclistamab Talquetamab Carfilzomib Elranatamab Linvoseltamab Dara + Lenalidomide Belantamab Combinations Maintenance

Consolidation

Post consolidation

CAR T or Bispecifics?

Iberdomide, Belanatamab or Bispecifics?

ASCT, autologous stem cell transplant; CAR, chimeric antigen receptor; Cy, cyclophosphamide; d- daratumumab; D/dex, dexamethasone; isa, isatuximab; K, carfilzomib; M, melphalan; PD-L1, programmed death ligand-1; PI, proteasome inhibitor; Rev, lenalidomide; V, bortezomib. Speaker’s own opinions.

Relapsed

Rescue

Novel CAR T Cell Therapies Bispecific/Trispecific Antibodies Iberdomide and Mezigdomide Venetoclax/Sonrotoclax for t(11;14)? Multiple small molecules ++++++++

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These are the core values we bring to accomplishing our mission each day. Patient Centric The patient experience is the focus of everything we do. Every interaction is an opportunity to establish a personal connection built on care and compassion which is the basis for continued support. Respect All As a team, we value honesty and transparency while creating a culture of mutual respect. We foster a myeloma community built on sincerity, authenticity, and kindness. Excellence and Innovation We value accountability, personal responsibility, and a steadfast commitment to excellence. We respect the legacy and reputation of our organization while seeking new solutions and advancements to improve outcomes, quality of life, and access to the best available resources for everyone impacted by myeloma. Honor differences We recognize each team member's skills and talents through collaboration and cooperation. Our programs aim to celebrate and support the diversity of our patients and their communities. © 2025, International Myeloma Foundation. All rights reserved. IMF Confidential

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