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THANK YOU TO OUR SPONSORS!
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A Tale of THREE Meetings! 1. ASCO – American Society of Clinical Oncology (Chicago, IL) 45,000 attendees in all areas of Oncology
2. International Myeloma Working Group (IMWG) Summit (Milan, Italy) Nearly 200 attendees including IMWG members
3. European Hematology Association (EHA) Annual Congress – Milan, Italy) 18,000 attendees in all areas of Hematology 4
Outline for Today 1. Smoldering Myeloma 2. Frontline Therapy 3. Early Relapse 4. Late Relapse 5. New Definition of High Risk Myeloma
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1. SMOLDERING MYELOMA
6
The 20-2-20 model • •
Risk Category
• •
median follow-up: ~6.2 years 29% cumulative progression rate at 2 years
% of cohort
TTP months
2-year PD rate
5-year PD rate
Low
34.3%
109.8
9.7%
22.5%
Intermediate
29%
67.8
26.3%
46.7%
High
36.7%
29.2
47.4%
81.5%
• • • •
Risk factors BMPC% > 20%, M-protein > 2 g/dL, and FLCr > 20
Single center n = 421 patients, with SMM diagnosis in 2003-2015 Excluded those with SLiM (retrospectively) Advanced imaging in 124 (29.4%)
Lakshman A et al BCJ 2018
median follow-up: 3 years 22% cumulative progression rate at 3 years
Risk Category
• • • •
% of cohort
TTP months
2 year PD rate
Low
38.3%
>120 months
6.2%
Intermediate
32.7%
~78 months
17.9%
High
29.1%
~30 months
44.2%
Multicenter n = 1363 patients, with SMM diagnosis in 2004-2018 Excluded those with SLiM Advanced imaging in unknown number Mateos MV et al BCJ 2020
Percentage of patients surviving without disease progression
AQUILA: Progression to MM by IMWG SLiM-CRAB Criteria (IRC Assessment)
100
Median follow-up: 65.2 months 79.9%
80
63.3%
60 40 20 0
Daratumumab Median: not reached 63.1%
HR, 0.49 (95% CI, 0.36-0.67) P <0.001
Active monitoring Median: 41.5 months 40.8%
DARA treatment 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 63 66 69 72
Months since randomization
No. at risk Daratumumab 194188181179166156149145142139138135129121118114106102 99 96 90 67 41 17 6 Active monitoring 196180175160142131120111100 91 87 83 78 71 67 65 60 55 51 50 49 33 19 8 2
• • •
DARA significantly reduced the risk of progression to MM or death by 51% versus active monitoring for all subsets and risk categories, more pronounced in high risk SMM The benefit continued beyond 36 months May 20, 2025: FDA ODAC positive vote
Dimopoulos MA et al N Engl J Med 2025
8
Dr. Joe’s Take on Smoldering Myeloma •
The AQUILA trial study was critical to really prove we can delay the progression to active myeloma and even improve survival with 3 years of daratumumab
•
It underscores the important of a DISCUSSION with the health care team as many options can be offered to patients with high risk smoldering MM
•
There will me MANY more trials coming in this area, with even more intense therapies like combinations and even CAR T Cell therapy...
What does the panel think of treating Smoldering? 9
2. FRONTLINE THERAPY
10
Subcutaneous Daratumumab (Dara) + Bortezomib/Lenalidomide/Dexamethasone With Dara + Lenalidomide Maintenance in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma: Analysis of Sustained Minimal Residual Disease Negativity in the Phase 3 PERSEUS Trial Philippe Moreau1, Pieter Sonneveld2, Hermann Einsele3, Hang Quach4, P Joy Ho5, Meral Beksac6, Cyrille Hulin7, Elisabetta Antonioli8, Xavier Leleu9, Silvia Mangiacavalli10, Aurore Perrot11, Michele Cavo12, Angelo Belotti13, Annemiek Broijl2, Huiling Pei14, Anna Sitthi-Amorn15, Robin L Carson15, Paula Rodríguez-Otero16, Meletios A Dimopoulos17, Mario Boccadoro18 1University Hospital Hôtel-Dieu, Nantes, France; 2Erasmus MC Cancer Institute, Rotterdam, Netherlands; 3Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany; 4University of Melbourne, St. Vincent’s Hospital, Melbourne, VIC, Australia; 5Royal Prince Alfred Hospital, Sydney, Australia; 6Ankara University, Ankara, Turkey; 7Hôpital Haut Lévêque, University Hospital, Pessac, France; 8Careggi Hospital and University of Florence, Firenze, Italy; 9CHU Poitiers, Poitiers, France; 10Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy; 11Centre Hospitalier Universitaire de Toulouse, Oncopole, Toulouse, France; 12IRCCS Azienda Ospedaliero-Universitaria di Bologna, Seràgnoli Institute of Hematology, Bologna University School of Medicine, Bologna, Italy; 13ASST Spedali Civili di Brescia, Brescia, Italy; 14Johnson & Johnson, Titusville, NJ, USA; 15Johnson & Johnson, Spring House, PA, USA; 16Cancer Center Clínica Universidad de Navarra, Cima, Pamplona, Navarra, Spain; 17National and Kapodistrian University of Athens, Athens, Greece; 18University of Turin, Turin, Italy
Presented by P Moreau at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 30–June 3, 2025; Chicago, IL, USA & Virtual
https://www.congresshub.com/Oncology/ AM2025/Daratumumab/Moreau Copies of this presentation obtained through Quick Response (QR) Codes are for personal use only and may not be reproduced without permission from ASCO® or the author of this presentation.
Add QR code here on slide master
• Transplanteligible NDMM • Age 18‒70 years • ECOG PS ≤2
Induction
Consolidation
Maintenance
VRd
VRd
R
DVRdb
4 cycles of 28 days
SINGLE TRANSPLANT
Key eligibility criteria
1:1 randomization (N=709)a
PERSEUS: Study Design
DVRdb
2 cycles of 28 days
DR
Minimum 2 y
MRD positive Sustained MRD Negative ≥12 months
Continue DR until PD Stop Dara and continue R
Restart Dara per criteria
28-day cycles
• MRD-negativityc rate was defined as the proportion of patients achieving MRD negativity and ≥CR in the ITT population – Patients who were not evaluable or had indeterminate results were considered MRD positive – MRD was evaluated post consolidationd at the time of suspected CR/sCR; at 12, 18, 24, 30, and 36 months after cycle 1 day 1; and yearly thereaftere
aStratified by ISS stage and cytogenetic risk. bDara 1800 mg co-formulated with rHuPH20 (2000 U/mL; ENHANZE ® drug delivery technology, Halozyme, Inc., San Diego, CA, USA); VRd administered as in the VRd group. cMRD was
assessed using the clonoSEQ assay (v.2.0; Adaptive Biotechnologies, Seattle, WA, USA) in patients with ≥VGPR post consolidation and at the time of suspected ≥CR. dIn patients with ≥VGPR. eIn patients who achieved CR/sCR and remained on study. CR, complete response; Dara, daratumumab; DR, daratumumab and lenalidomide; DVRd, daratumumab, bortezomib, lenalidomide, and dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, International Staging System; ITT, intent-to-treat; MRD, minimal residual disease; NDMM, newly diagnosed multiple myeloma; PD, progressive disease; rHuPH20, recombinant human hyaluronidase PH20; R, lenalidomide; sCR, stringent complete response; VGPR, very good partial response; VRd, bortezomib, lenalidomide, and dexamethasone; y, year. 4
PERSEUS: Sustained MRD-Negativity (10‒5) ≥CR Rates Sustained MRD-negativitya (10–5) ≥CR rate ≥12 monthsb
90
Δ 35%
80 70 60
64.8%
50 40 30 20 10 0
29.7%
100 Patients with sustained MRD negativity, %
Patients with sustained MRD negativity, %
100
Odds ratio, 4.42 (95% CI, 3.22‒6.08) P<0.0001c
Sustained MRD-negativitya (10–5) ≥CR rate ≥24 monthsd
DVRd VRd Presented by P Moreau at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 30–June (n=355) (n=354) 3, 2025; Chicago, IL, USA & Virtual
90
Odds ratio, 4.36 (95% CI, 3.15‒6.05) P<0.0001c
80
Δ 33%
70 60 50
55.8%
40 30
22.6%
20 10 0
DVRd (n=355)
VRd (n=354)
DVRd more than doubled the rates of sustained MRD negativity for both ≥12 and ≥24 months vs VRd aMRD-negativity rate was defined as the proportion of patients who achieved both MRD negativity and ≥CR. MRD was assessed using bone marrow aspirates and evaluated via NGS (clonoSEQ assay, version 2.0; Adaptive
Biotechnologies, Seattle, WA, USA). bSustained MRD negativity is defined as MRD negative and confirmed by at least 1 year apart without MRD positive in between. cP value was calculated from the stratified Cochran-Mantel-Haenszel Chi-Squared test. dSustained MRD negativity is defined as 2 consecutive MRD-negative reads at least 24 months (‒3) apart without MRD positive in between. CR, complete response; DVRd, daratumumab, bortezomib, lenalidomide, and dexamethasone; MRD, minimal residual disease; NGS, next-generation sequencing; VRd, bortezomib, lenalidomide, and dexamethasone. 8
16
GMMG-CONCEPT Trial design ND HRMM N=245
Arm A Induction TE and Isa-KRd ≤70 years 6 cycles n=219
Consolidation
Maintenance
Isa-KRd 4 cycles
Isa-KR 26 cycles
28-day cycles
28-day cycles
28-day cycles
Isa-KRd 8 cycles
Isa-KRd 4 cycles
Isa-KR 26 cycles
Stem cell mobilization after cycle 3
Arm B TNE or >70 years n=26
HDT + ASCT
Isa: 10 mg/kg D1,8,15,22 in C1; D1,15 in C2+; K: 20 mg/m² D1,2 of C1; 36 mg/m² D8,9,15,16 of C1 and D1,2,8,9,15,16 in C2+; from 2021 onwards: 56 mg/m² on D1,8,15 and 70 mg/m² on D1,15 in maintenance; R: 25 mg D1-21 all Cycles; d: 40 mg D1,8,15,22 all Cycles (20 mg age >75).
Arm A: app. 15-18 months after inclusion Arm B: app. 12 months after inclusion
HRMM criteria: ISS stage II or III PLUS ≥1 of: del(17p), t(4;14), t(14;16) and/or ≥3 copies 1q21 (amp1q21) Primary objective: MRD negativity after consolidation (NGF, 10-5) Secondary objective: PFS; Selected tertiary objectives: ORR, OS ASCT, autologous stem-cell transplant; d, dexamethasone; HDT, high-dose therapy; HRMM, high-risk multiple myeloma; Isa, isatuximab; ISS, International Staging System; K, carfilzomib; MRD, minimal residual disease; ND, newly-diagnosed; NGF, next-generation flow; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; R, lenalidomide; TE, transplant-eligible; TNE, transplant-ineligible. Following a protocol amendment in 2021, carfilzomib application was switched to once weekly 56 mg/m2.
PRESENTED BY:
Lisa B. Leypoldt, MD
17
Progression-free and Overall Survival • Median follow-up of 43 months (0-90.2 months) 1st cohort: 69 months (0-90.2 months) 2nd cohort: 33 months (5.5-43.3 months) mPFS 72.8 months
mOS not reached
5Y-OS-rate: 72% (65.0-78.9%) 6Y-OS-rate: 69% (61.2-76.8%)
TE, transplant-eligible; mOS, median Overall Survival; mPFS, median Progression-free Survival. Results for TE patients. Clinical data cut-off: April 28, 2025. PRESENTED BY:
Lisa B. Leypoldt, MD
Results Sustaining MRD-negativity was associated with increased PFS
Multivariable time-dependent Coxregression analysis showed a prognostic PFS benefit for remaining in MRD negativity versus non–MRD negativity with a hazard ratio of 0.15 (95% CI, 0.07-0.29, p<0.0001)
CI, confidence interval; HR: hazard ratio; MRD, minimal residual disease. Clinical data cut-off: April 28, 2025. Results for TE patients. Figure shows a Simon-Makuch plot illustrating the estimated survival while staying in the state of MRD-negativity compared to the estimated survival while staying in the state of MRD-positivity. Patients may switch between the two states under therapy. PRESENTED BY:
Lisa B. Leypoldt, MD
Dr. Joe’s Take on Frontline 1. Quadruplets are the standard of care, and in transplant eligible patients, dual maintenance of daratumumab-lenalidomide provides the best sustained MRD 2. MRD will guide more therapy with time – in the interim, there is no more need of tandem transplant and the role of single transplant may be questioned if this correlates with PFS outcomes 3. High risk MM remains challenging to treat, but it requires an intense approach with sustained MRD as the goal 4. There is greater use of Carfilzomib as the PI in upfront quadruplets 5. Future options include Belantamab or Bispecific antibodies What does the panel think?
3. EARLY RELAPSE
20
Isatuximab (Isa) subcutaneous (SC) via an on-body delivery system (OBDS) vs Isa intravenous (IV), plus pomalidomide and dexamethasone (Pd) in relapsed/refractory multiple myeloma (RRMM): Results of the randomized, non-inferiority, Phase 3 IRAKLIA study Sikander Ailawadhi1, Ivan Špička2, Jin Lu3, Albert Oriol4, Silvia Ling5, Fredrik Schjesvold6, Alejandro Berkovits7, Marek Hus8, Meletios-Athanasios Dimopoulos9, Péter Rajnics10, Vania Hungria11, Maria del Rosario Custidiano12, Gurdeep Parmar13, Xavier Leleu14, Tondre T Buck15, Jiří Minařík16, Rick Zhang17, Dorothée Sémiond17, Maya Stefanova-Urena17, Philippe Moreau18 1Division of Hematology/Oncology, Mayo Clinic, Jacksonville, FL; 2Departments of Medicine and Hematology, First Faculty of Medicine, Charles University and General Hospital, Prague, Czech Republic; 3Peking University People’s Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China; 4Institut Català d'Oncologia, Hospital Germans
Trias i Pujol, Barcelona, Spain; 5Sydney Adventist Hospital, Wahroonga, NSW, Australia; 6Oslo Myeloma Center, Department of Hematology, Oslo University Hospital, Oslo, Norway; 7Inmunocel, Las Condes, Santiago, Chile; 8Samodzielny Publiczny Szpital Kliniczny, Lublin, Poland; 9Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece; 10Mór Kaposi Teaching Hospital, Department of Hematology, Kaposvár and Faculty of Health Sciences, Institute of Diagnostics, University of Pécs, Pécs, Hungary; 11Department of Hematology and Oncology, Clínica São Germano, São Paulo, Brazil; 12Servicio de Hematología y Trasplante Hematopoyético Instituto Alexander Fleming Buenos Aires, Argentina; 13Illawarra Cancer Care Centre, Wollongong, NSW, Australia; 14Service d'Hématologie et Thérapie Cellulaire, CHU and CIC Inserm 1402, Poitiers Cedex, France; 15Spartanburg Medical Center, Center for Hematology/Oncology, Spartanburg, SC; 16Department of Hemato-Oncology, Faculty of Medicine and Dentistry, Palacký University and University Hospital Olomouc, Olomouc, Czech Republic; 17Sanofi, Cambridge, MA; 18Hematology Department, CHU Nantes, Nantes, France
7506 PRESENTED BY:
Prof Xavier Leleu; Presentation at the 2025 ASCO Annual Meeting | May 30–June 3, 2025
22
On-body delivery injector (OBI) • A sterile, single-use, userfilled* wearable injector, nested in a filling base1-4 • No batteries or electronics3,5
Fill Gauge
Adhesive tab Adhesive backing secures the device and assists with removal post-injection1,3,4,6
Pressing the center button initiates isatuximab SC delivery and signals completion1,3,6,7 Button
Window The window lets users track fill gauge progress during administration3,8
Key attributes of isatuximab SC administration with OBI** Flat dose†: No adjustments for body weight9,10 Hands-free administration‡,6,11-15 Hidden, ~30G needle: User does not see needle before, during, or after administration3,6,11,12,15,16 Sharps injury prevention feature7 No hyaluronidase1,3 10 mL injection volume9,10 Individualized flow rate based on subcutaneous interstitial pressure13 Potential at-home administration¶,2,11,16,17
*During clinical studies OBI is filled using a disposable luer lock syringe. Future iterations of the filling mechanism are under development; **The OBI is an investigational device; isatuximab SC formulation is not approved by any regulatory authority. Sanofi represent that the device is safe or effective for the purposes for which it is being investigated. †Flat dose investigated in TCD15484 study. ‡No user intervention required from when injection is started until completion (device ready for removal). ¶At-home administration of isatuximab SC by OBI will be tested in EFC15951.1. OBI, on-body injector; SC, subcutaneous. 1. Enable Injections. Press release. Available at: https://enableinjections.com/a-new-frontier-self-administration-of-lyophilized-large-volume-subcutaneous-biologics/ [accessed May 2025]; 2. Carey M. AJMC 2024;30:SP352; 3. Data on file; Technical Dossier Investigational OBDS EFC1595; 4. Quach H, et al. IMS 2023; Poster 306; 5. OncodrugDelivery. Wearable injectors. Available at: https://www.ondrugdelivery.com/wp-content/uploads/2019/09/Wearable-Injectors-ONdrugDelivery-Issue-100-September-2019-MR.pdf [accessed May 2025]; 6. Data on file; SAN-015369 Rev 02 CD38sc Transfer Needle IFU; 7. Data on file. Tested in according with U.S. FDA Guidance, Medical Devices with Sharps Injury Prevention Features, August 9, 2005; 8. Taylor NP. FiercePharma. Press release. Available at: https://www.fiercepharma.com/drug-delivery/vcs-infuse-215m-into-sanofi-backed-wearablesubcutaneous-drug-delivery-player-enable [accessed May 2025]; 9. Quach H, et al. Haematologica 2024;109:4078–82; 10. Quach et al. ASCO 2022; P8025; 11. Desai M, et al. Drug Deliv 2025;32:2484278; 12. Sánchez Avello N, et al. IMS 2024; Poster P-418; 13. Press release. PR Newswire. Available at: https://www.prnewswire.com/news-releases/enable-injections-enters-into-strategic-partnership-with-sanofi-300859890.html [accessed May 2025]; 14. Sarclisa. Press release 2025. Available at: https://www.sanofi.com/en/media-room/press-releases/2025/2025-01-09-06-00-00-3006798 [accessed May 2025]; 15. Rahman O. et al. ONdrugDelivery 2024;164:28–31; 16. Desai M, et al. Curr Med Res Opin 2024;17:1–12; 17. Enable injections. Meet enFuse. Available at: https://enableinjections.com/technology [accessed May 2025]. Image sources: Data on file; SAN-015369 Rev 02 CD38sc Transfer Needle IFU; Quach H, et al. IMS 2023; Poster 306; and Desai M, et al. Drug Deliv 2025;32:2484278.NCT05704049. PRESENTED BY:
Prof Xavier Leleu
23
Key takeaways
1
The results of IRAKLIA demonstrate that Isa SC on-body injector (OBI) offered the same level of efficacy and pharmacokinetics as Isa IV, meeting non-inferiority.
2
Patients receiving Isa SC OBI hands-free expressed higher satisfaction with their injection method than Isa IV patients.
3
Isa SC OBI had a similar safety profile to Isa IV and no unexpected safety signals.
Isa, isatuximab; IV, intravenous; MM, multiple myeloma; OBI, on-body injector; SC, subcutaneous. PRESENTED BY:
Prof Xavier Leleu
24
DREAMM-7: study design Treatment period
Recruitment period
Stratification: • Prior lines of treatment (1 vs 2 or 3 vs ≥4) • R-ISS stage (I vs II/III) • Prior bortezomib (yes vs no)
Cycles 1-8
Cycle 9+
Belamaf
Belamaf monotherapy
2.5 mg/kg IV q3w +
2.5 mg/kg IV q3w
bortezomib 1.3 mg/m2 SC on days 1, 4, 8, and 11 of cycles 1-8 (21-day cycles) + dexamethasone 20 mg on the day of and day after bortezomiba in cycles 1-8
Daratumumab
16 mg/kg IV qw in cycles 1-3; and q3w in cycles 4-8 + bortezomib 1.3 mg/m2 SC on days 1, 4, 8, and 11 of cycles 1-8 (21-day cycles) + dexamethasone 20 mg on the day of and day after bortezomiba in cycles 1-8
Daratumumab monotherapy
End-of-treatment visit
Arm A (BVd) Arm B (DVd)
1:1 randomization
Eligibility criteria • Adults with MM • ≥1 prior line of MM therapy and documented PD during or after most recent therapy • No prior treatment with anti-BCMA • Not refractory to or intolerant of daratumumab or bortezomib
Follow-up period
Until end of study, withdrawal of consent, PD, death, or unacceptable toxicity
≈13 months from FPI (May 7, 2020) to LPI (June 28, 2021)
Follow-up for PFS q3w (for patients who discontinue due to reasons other than PD)
Follow-up for OS q12w (for patients who discontinue due to PD or other reasons)
Disease assessments q3w
16 mg/kg IV q4w in cycle 9+
Median follow-up (ITT) 28.2 months (range, 0.1-40.0 months)
Disease assessment visits: q3w from cycle 1 day 1 until PD Primary endpoint: PFS (IRC assessed)
Additional secondary endpoints: CRR, ORR, CBR, TTR, TTP, PFS2, AEs, ocular findings, and QOL AE, adverse event; BCMA, B-cell maturation antigen; CBR, clinical benefit rate; CRR, complete response rate;endpoints: DOR, duration of response; FPI, first patient in; IRC, independent review committee; ITT, intent-to-treat; IV, intravenous; LPI, last patient in; MM, multiple myeloma; MRD, Key secondary minimal residual disease; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; q3w, every 3 weeks; q4w, every 4 weeks; q12w, every 12 weeks; QOL, quality of life; qw, once weekly; R-ISS, Revised International Staging System; SC, OS, DOR, and MRD subcutaneous; TTP, time to progression; TTR, time to response. a Starting dose of dexamethasone may be reduced to 10 mg for patients aged >75 years, who have a body-mass index of less than 18.5, who had previous unacceptable side effects associated with glucocorticoid therapy, or who are unable to tolerate the starting dose.
PRESENTED BY:
María Victoria Mateos, MD, PhD
25
DREAMM-7: ITT population
BVd led to a significant increase in PFS vs DVd 18 months
PFS probability, %
1.0
69%
0.8
Median 36.6 months
0.6 0.4 0.2 0.0
No. at risk
Median 13.4 months
BVd
43%
DVd
PFSa
BVd (N=243)
DVd (N=251)
Events, n (%)
91 (37)
158 (63)
PFS, median (95% CI), mob
36.6 (28.4-NR)
13.4 (11.1-17.5)
HR (95% CI)c
0.41 (0.31-0.53)
P valued
<.00001
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 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41
Time since randomization, months
BVd
243 230 220 211 205 200 192 183 175 171 163 158 155 150 147 140 137 131 128 127 125 122 120 118 115 110 105 94
79
72
56
41
31
25
15
11
8
6
3
2
1
0
DVd
251 230 214 205 194 183 176 155 148 141 132 124 115 107 103 99
39
33
22
19
12
11
5
2
1
1
1
1
0
0
94
91
87
80
78
73
68
67
65
61
59
52
BVd demonstrated a statistically significant and clinically meaningful PFS benefit, with a median PFS that was 23 months longer than that with DVd (36.6 vs 13.4 months) Median follow-up: 28.2 months (range, 0.1-40.0 months)
HR, hazard ratio; ITT, intent to treat; NR, not reached; PFS, progression-free survival; R-ISS, Revised International Staging System. a Two patients in the ITT population were randomized, not treated, rescreened, and rerandomized. They are counted as 4 unique patients in this output. b CIs were estimated using the Brookmeyer-Crowley method. c HRs were estimated using a Cox proportional hazards model stratified by the number of lines of prior therapy (1 vs 2 or 3 vs ≥4), prior bortezomib, and R-ISS stage at screening (I vs II/III), with a covariate of treatment. d P value from 1-sided stratified log-rank test. PRESENTED BY:
María Victoria Mateos, MD, PhD
26
Dr. Joe’s Take on Early Relapse 1. The On Body Injector (OBI) for Isatuximab is a novel method for SQ delivery that is easy to administer and could even be used at home – it will make using Isatuximab dramatically easier 2. Belantamab will have a significant impact in early relapse due to its efficacy in triplet combinations with bortezomib and pomalidomide – its exact niche in sequencing therapies is yet to be determined, but will be attractive in more frail patients not eligible for CAR T 3. Linvoseltamab may be the next approved bispecific antibody – it does not appear to have a clear differentiating feature but combines well with other agents What does the Panel think? 27
4. LATE RELAPSE
28
Long-Term (≥5 Year) Remission and Survival After Treatment With Ciltacabtagene Autoleucel in CARTITUDE-1 Patients With Relapsed/Refractory Multiple Myeloma Peter M Voorhees1, Thomas G Martin2, Yi Lin3, Adam D Cohen4, Noopur Raje5, Myo Htut6, Abhinav Deol7, Mounzer Agha8, Jesus G Berdeja9, Binod Dhakal10, Andrzej J Jakubowiak11, Samir Parekh12, Hui Li13, Rocio Montes de Oca14, Huabin Sun15, Nikoletta Lendvai15, Deepu Madduri15, Mythili Koneru16, Nitin Patel16, Sundar Jagannath12 1Atrium Health/Levine Cancer Institute, Wake Forest University School of Medicine, Charlotte, NC, USA; 2University of California, San Francisco, CA, USA; 3Mayo Clinic, Rochester, MN, USA; 4Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 5Massachusetts General Hospital Cancer Center, Boston, MA, USA; 6City of Hope Comprehensive Cancer Center, Duarte, CA, USA; 7Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA; 8UPMC Hillman Cancer Center, Pittsburgh, PA, USA; 9Tennessee Oncology, Nashville, TN, USA; 10Medical College of Wisconsin, Milwaukee, WI, USA; 11University of Chicago, Chicago, IL, USA; 12Icahn School of Medicine at Mount Sinai, New York, NY, USA; 13Johnson & Johnson, Shanghai, China; 14Johnson & Johnson, Spring House, PA, USA; 15Johnson & Johnson, Raritan, NJ, USA; 16Legend Biotech USA Inc., Somerset, NJ, USA
Presented by PM Voorhees at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 30–June 3, 2025; Chicago, IL, USA & Virtual
https://www.congresshub.com/Oncology/ AM2025/Cilta-cel/Voorhees Copies of this presentation obtained through Quick Response (QR) Codes are for personal use only and may not be reproduced without permission from ASCO® or the author of this presentation.
CARTITUDE-1 Long-Term Remission: One-Third of Patients Were Progression-Free for ≥5 Years Patients progression-free and alive, %
Overall population (N=97); median follow-up: 61.3 months 100
Progression-free survival
75
50
25
0 0
10
20
30
Presented by PM Voorhees at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 30– June 3, 2025; Chicago, IL, USA & Virtual
40
50
60
70
36
16
1
Months since cilta-cel infusion
Patients at risk
97
77
63
52
39
32 of 97 (33%) patients were treatment- and progression-free at ≥5 years cilta-cel, ciltacabtagene autoleucel. 6
CARTITUDE-1 Long-Term Remission: Conclusions • One-third (33%, n=32) of the patients with a historical mPFS of <6 months remain progression-free for ≥5 years following a single cilta-cel infusion with no maintenance or subsequent therapy – Of the progression-free patients, 12 from a single center with serial MRD assessments were all MRD- and imaging-negative at year 5 or longer, suggesting potential cure • Long-term remission was not limited to standard-risk disease – Patients with high-risk cytogenetics [ie, del17p, t(14;16), or t(4;14)] and those with extramedullary plasmacytomas were equally likely to be progression-free • Patients in long-term remission had more immune-fit drug products and higher E:T ratio at peak expansion • Median OS of 5 years sets a new benchmark in this population
Long-term follow-up from CARTITUDE-1, with one-third of patients remaining treatmentand progression-free for at least 5 years after a single infusion, shows the curative potential of cilta-cel in RRMM
cilta-cel, ciltacabtagene autoleucel; E:T, effector to target; mPFS, median progression-free survival; MRD, minimal residual disease; OS, overall survival; RRMM, relapsed/refractory multiple myeloma. Presented by PM Voorhees at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 30–June 3, 2025; Chicago, IL, USA & Virtual
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First-in-Human Study of JNJ-79635322 (JNJ-5322), a Novel, Next-Generation Trispecific Antibody, in Patients With Relapsed/Refractory Multiple Myeloma: Initial Phase 1 Results Niels WCJ van de Donk1, Gala Vega2, Aurore Perrot3, Sébastien Anguille4, Albert Oriol5, Monique C Minnema6, Martin Kaiser7, Hans Lee8, Alfred L Garfall9, Jeffrey V Matous10, Larysa Sanchez11, Azra Borogovac12, Lionel Karlin13, Saad Z Usmani14, Joseph Weidman15, Sangmin Lee15, María-Victoria Mateos16, Paula Rodríguez-Otero17, Cyrille Touzeau18, Rakesh Popat19
https://www.congresshub.com/Oncology/ AM2025/Trispecific/Donk Copies of this presentation obtained through Quick Response (QR) Codes are for personal use only and may not be reproduced without permission from ASCO® or the author of this presentation.
1Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; 2START Madrid-FJD, Hospital Fundación Jiménez Díaz, Madrid, Spain;
3Centre Hospitalier Universitaire de Toulouse, Oncopole, Toulouse, France; 4Vaccine and Infectious Disease Institute, University of Antwerp, Center for Cell Therapy and Regenerative Medicine, Antwerp University Hospital, Edegem, Belgium; 5Institut Català d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain; 6University Medical Center Utrecht, Utrecht, Netherlands; 7The Royal Marsden, NHS Trust, London, UK; 8The University of Texas MD Anderson Cancer Center, Houston, TX, USA; 9Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 10Colorado Blood Cancer Institute and Sarah Cannon Research Institute, Denver, CO, USA; 11Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 12City of Hope National Medical Center, Duarte, CA, USA; 13Centre Hospitalier Lyon Sud, Pierre-Bénite, France; 14Memorial Sloan Kettering Cancer Center, New York, NY, USA; 15Johnson & Johnson, Spring House, PA, USA; 16University Hospital of Salamanca/IBSAL/CIC/CIBERONC, Salamanca, Spain; 17Cancer Center Clínica Universidad de Navarra, CIMA, Pamplona, Spain; 18Service d’Hématologie, Centre Hospitalier Universitaire (CHU) Hotel Dieu, Nantes, France; Centre de Recherche en Cancérologie Et Immunologie Intégrée Nantes Angers, INSERM, Centre National de la Recherche Scientifique, Université d’Angers, Université de Nantes, Nantes, France; Site de Recherche Intégrée sur le Cancer, Imaging and Longitudinal Investigations to Ameliorate Decision-making (ILIAD), French National Cancer Institute– French Ministry of Health–INSERM 12558, Nantes, France; 19University College London Hospitals, NHS Foundation Trust, London, UK
Presented by NWCJ van de Donk at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 30–June 3, 2025; Chicago, IL, USA & Virtual
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JNJ-5322 Trispecific: Novel Binding Domains Targeting CD3, BCMA, and GPRC5D
Molecule
Implications •
Dual-Targeted Molecule to Bind Both BCMA and GPRC5D
Novel CD3, BCMA, and GPRC5D Binding Domains
•
• • •
Enhanced myeloma cell targeting due to “double lock-down” effect of binding 2 myeloma antigens More comprehensive targeting of myeloma cells • BCMA-/GPRC5D+, BCMA+/GPRC5D-, and dual BCMA+/GPRC5D+ Prevention of antigen escape Potential to improve GPRC5Drelated safety profile Manageable CRS profile with only 1 step-up dose needed
3 3
BCMA, B-cell maturation antigen; CRS, cytokine release syndrome; GPRC5D, G protein–coupled receptor family C group 5 member D. Presented by NWCJ van de Donk at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 30–June 3, 2025; Chicago, IL, USA & Virtual
JNJ-5322 Trispecific: ORR in Patients Naive or Exposed to BCMA/GPRC5D Therapies BCMA/GPRC5D exposed
100.0
BCMA/GPRC5D naive
100.0% (27/27)
sCR CR
100.0% (8/8)
VGPR
ORR, %
80.0
60.0
PR
55.0% (11/20)
66.7% (14/21) 14.3
≥CR: 70.4%
55.6
≥VGPR: 96.3%
15.0 23.8
40.0 15.0 20.0
0.0
20.0 5.0 50–300 mg
19 9.5 50 mg Q4W
75.0
14.8
25.9 3.7
100 mg Q4W (RP2D)
25.0
At the RP2D in patients naive to BCMA/GPRC5D (n=27) Median followup, months (range)
12.2 (7.4–18.6)
Median time to first response, months (range)
1.2 (0.3–5.2)
Median time to best response, months (range)
5.9 (0.3–11.1)
300 mg Q4W
Data cut-off date: April 15, 2025. Median follow-up 16.4 months in the 300 mg Q4W cohort. RP2D selected as 100 mg Q4W with one 5 mg SUD. BCMA, B-cell maturation antigen; CR, complete response; GPRC5D, G protein–coupled receptor family C group 5 member D; ORR, overall response rate; PR, partial response; Q4W, every 4 weeks; RP2D, recommended phase 2 dose; sCR, stringent complete response; SUD, step-up dose; VGPR, very good partial response. Presented by NWCJ van de Donk at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 30–June 3, 2025; Chicago, IL, USA & Virtual
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JNJ-5322 Trispecific: Treatment-Emergent Adverse Events Most common TEAEs,a n (%) Hematologic TEAEs (≥10% of total) Neutropenia Lymphopenia Anemia Thrombocytopenia Leukopenia Nonhematologic TEAEs (≥30% of total) Infections Taste relatedb CRS Nail relatedc Skin (non-rash)d Hypogammaglobulinemiae Diarrhea Fatigue
• •
RP2D (n=36)
All doses (N=147)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
15 (41.7) 16 (44.4) 6 (16.7) 8 (22.2) 5 (13.9)
11 (30.6) 15 (41.7) 3 (8.3) 3 (8.3) 3 (8.3)
72 (49.0) 55 (37.4) 37 (25.2) 27 (18.4) 19 (12.9)
61 (41.5) 52 (35.4) 22 (15.0) 12 (8.2) 11 (7.5)
29 (80.6) 21 (58.3) 19 (52.8) 22 (61.1) 23 (63.9) 10 (27.8) 11 (30.6) 13 (36.1)
12 (33.3) NA 0 0 0 1 (2.8) 1 (2.8) 3 (8.3)
111 (75.5) 85 (57.8) 83 (56.5) 81 (55.1) 73 (49.7) 53 (36.1) 49 (33.3) 48 (32.7)
42 (28.6) NA 0 0 1 (0.7) 4 (2.7) 5 (3.4) 4 (2.7)
Presented by NWCJ van de Donk at the American Society of Clinical Oncology (ASCO) Annual Meeting; May 30– June 3, 2025; Chicago, IL, USA & Virtual
At the RP2D, 1 DLT (neutropenia) and 1 grade 5 TEAE (pneumonia) Across all other doses, 4 DLTs (maculopapular rash, palmar-plantar erythrodysesthesia syndrome, pneumonia, and respiratory failure) and 4 grade 5 TEAEs (adenoviral encephalitis [drug related], embolic stroke, multiple organ dysfunction syndrome, and pulmonary hemorrhage)
Data cut-off date: April 15, 2025. Median follow-up: 11.6 months (RP2D) and 9.3 months (all doses). RP2D selected as 100 mg Q4W with one 5 mg SUD. aTEAEs graded by CTCAE v5.0; CRS per ASTCT criteria. bDysgeusia, ageusia, hypogeusia, and taste disorder; maximum grade is 2 per CTCAE. cNail discoloration, nail disorder, onycholysis, onychomadesis, onychoclasis, nail dystrophy, nail toxicity, and nail ridging. dSkin exfoliation, dry skin, pruritus, and palmarplantar erythrodysesthesia syndrome. ePresented as a TEAE only. ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; DLT, dose-limiting toxicity; NA, not applicable; Q4W, every 4 weeks; RP2D, recommended phase 2 dose; SUD, step-up dose; TEAE, treatment-emergent adverse event. 6
Phase 2 Study of Talquetamab + Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma and Extramedullary Disease: RedirecTT-1 Shaji Kumar1, María-Victoria Mateos2, Jing Christine Ye3, Shebli Atrash4, Hila Magen5, Hang Quach6, Michael P Chu7, Suzanne Trudel8, Joshua Richter9, Paula Rodríguez-Otero10, Hun Chuah11, Moshe Gatt12, Eva Medvedova13, Shahzad Raza14, Dok Hyun Yoon15, Tadao Ishida16, Jeffrey V Matous17, Laura Rosiñol18, Koichi Onodera19, Surabhi Bajpai20, Vikram Kurra20, Emma Scott21, Christoph Heuck21, Jenny Zhang21, Todd Henninger22, Lisa O’Rourke21, Payal Thakkar22, Mariacristina Festa23, Lin Huang21, Jiashen Lu24, Nicholas Au21, Maria Krevvata21, Ashwini Kumar21, Saad Z Usmani25, Yaël C Cohen26
https://www.congresshub.com/EHA2025/Oncology/ Talquetamab/Kumar-Phase-2 The QR code is intended to provide scientific information for individual reference, and the information should not be altered or reproduced in any way
1Mayo Clinic Rochester, Rochester, MN, USA; 2University Hospital of Salamanca/IBSAL/CIC/CIBERONC, Salamanca, Spain; 3MD Anderson Cancer Center, University of Texas, Houston, TX, USA;
4Levine Cancer Institute-Atrium Health, Charlotte, NC, USA; 5Chaim Sheba Medical Center, Ramat-Gan, Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel; 6University of Melbourne,
St Vincent’s Hospital, Melbourne, VIC, Australia; 7Alberta Health Services, Edmonton, AB, Canada; 8Princess Margaret Cancer Centre, Toronto, ON, Canada; 9Mount Sinai Medical Center, New York, NY, USA;
10Cancer Center Clínica Universidad de Navarra, Cima, Pamplona, Spain; 11Royal Perth Hospital, Perth, WA, Australia; 12Hadassah Medical Cener, Hebrew University of Jerusalem, Jerusalem, Israel;
13Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA; 14Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA; 15Asan Medical Center, University of Ulsan College of
Medicine, Seoul, Republic of Korea; 16Japanese Red Cross Medical Center, Tokyo, Japan; 17Colorado Blood Cancer Institute and Sarah Cannon Research Institute, Denver, CO, USA; 18Hospital Clínic de Barcelona, IDIBAPS, Barcelona, Spain; 19Tohoku University Hospital, Sendai shi, Miyagi, Japan; 20Perceptive Imaging, Boston, MA, USA; 21Johnson & Johnson, Spring House, PA, USA; 22Johnson & Johnson, Raritan, NJ, USA; 23Johnson & Johnson, Leiden, Netherlands; 24Johnson & Johnson, Shanghai, China; 25Memorial Sloan Kettering Cancer Center, New York, NY, USA; 26Tel Aviv Sourasky (Ichilov) Medical Center, Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel
Presented by S Kumar at the European Hematology Association (EHA) 2025 Hybrid Congress; June 12–15, 2025; Milan, Italy
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RedirecTT-1 Phase 2 Tal + Tec: Dual-Antigen Targeting in Patients With True EMD Led to Higher ORR and ≥CR Rate 100
Tal + Tec combination in RedirecTT-1 78.9% (69.0–86.8)
100
sCR
≥CR: 54.4%
43.3 ≥VGPR: 70.0%
40
11.1 20
0
CR VGPR PR
80
15.6 8.9 Tal + Tec (N=90)
ORR (95% CI)b
ORR (95% CI)a,b
80
60
Tal or Tec monotherapy in patients with EMDc
60
40
43.5% (34.0–53.4) ≥CR: 14.8%
13.9 0.9 14.8
20
43.4% (29.8–57.7) ≥VGPR: 29.6%
≥CR: 18.9%
18.9 ≥VGPR: 37.7% 18.9
13.9 0
Tal monotherapy (N=108)
5.7
Tec monotherapy (N=53)
Higher ORR and deeper responses in patients with EMD with Tal + Tec combination vs Tal or Tec monotherapy Data cut-off date: March 18, 2025. aORR was assessed by independent review committee per IMWG criteria. bDue to rounding, individual response rates may not sum to the ORR. cData on file. Presented by S Kumar at the European Hematology Association (EHA) 2025 Hybrid Congress; June 12–15, 2025; Milan, Italy
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Abstract S201 Phase 2 Registrational Study of Anitocabtagene Autoleucel for Relapsed and/or Refractory Multiple Myeloma (RRMM): Updated Results from iMMagine-1 Gurbakhash Kaur, MD; Ciara L. Freeman, MD, PhD; Binod Dhakal, 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; Krina Patel, MD, MSc; and Matthew J. Frigault, MD, MS
iMMagine-1: Overall Response Rate and MRD Negativity Efficacy Evaluable Patients, N=117 ORR=97% 12%
At a median follow-up of 12.6 months, ORR was 97% and sCR/CR rate was 68%
18%
93% (n=70/75) of evaluable patients were MRD negative at minimum of 10-5 sensitivity ≥VGPR 85%
68%
sCR/CR 68%
Evaluable Patients
Months (min - max)
Median time to first response
114
1.0 (0.9 – 13.4)
Median time to MRD negativity of ≤10-5
70
1.0 (0.9 – 6.4)
N=117 Best Response:
sCR/CR
VGPR
PR
Responses are investigator assessed per IMWG criteria, ORR defined as partial response or better; MRD evaluable patients had an identifiable malignant clone in the baseline bone marrow sample and had a post-treatment bone marrow sample sufficient to assess MRD negativity CR, complete response; MRD, minimal residual disease; ORR, overall response rate; PR, partial response; sCR, stringent complete response; VGPR, very good partial response Kaur et al, European Hematology Association 2025, Abstract S201
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iMMagine-1: PFS and OS Rates Estimated by Kaplan-Meier
N=117
PFS Rate (%) (95% CI)
OS Rate (%) (95% CI)
6-Month
91.9% (85.0%, 95.7%)
96.6% (91.1%, 98.7%)
12-Month
79.3% (68.6%, 86.7%)
95.2% (88.7%, 98.0%)
Median follow-up of 12.6 months (range: 5 to 29 months) PFS, progression-free survival; OS, overall survival Kaur et al, European Hematology Association 2025, Abstract S201
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iMMagine-1: Immune-effector Cell-associated Neurotoxicity Syndrome (ICANS) ICANS Per ASTCT criteria
Maximum ICANS Grade (N=117) 108 (92%)
N=117
Median onset (min-maxa)
7 days (2-10a days)
Median duration (min-maxb)
4 days (1-12b days)
Supportive Measures
No ICANS
4 (3%)
4 (3%)
Grade 1
Grade 2
3% (3/117)
1 (1%)
0 (0%)
0 (0%)
Dexamethasone
5% (6/117)
Grade 3
Grade 4
Grade 5
Anakinra
1% (1/117)
Siltuximab
1% (1/117)
8% (9/117) of patients had ICANS of any grade; all cases resolved
No delayed or non-ICANS neurotoxicities were observed, including no incidence of Parkinsonism, no cranial nerve palsies, and no GuillainBarré syndrome (n=117; median follow-up of 12.6 months, range: 5-29 months)
Tocilizumab
a With the exception of n=1 Grade 1 ICANS (confusion) on day 31 post infusion
that rapidly resolved b With the exception of n=1 max Grade 2 ICANS with 29-day duration to resolution
Similarly, no delayed or non-ICANS neurotoxicities have been observed in the Phase 1 study1 (n=38; median follow-up of 38.1 months, range: 25-56 months)
1. Bishop MR, et al. Blood (2024) 144 (Supplement 1): 4825 as presented in poster #4825 at ASH 2024. ASTCT, American Society for Transplantation and Cellular Therapy. Kaur et al, European Hematology Association 2025, Abstract S201
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Dr. Joe’s Take on Late Relapse 1. The long term results of CARTITUDE-1 is VERY impressive with 33% of patients disease free at 5 years – it is triggering a discussion about CURE 2. The BCMA-GPRC5D trispecific has strong efficacy and significantly less toxicity than a combination of the drugs – it has the potential to supplant sequential use of bispecific antibodies 3. The BCMA-CD38 trispecific also has impressive efficacy and tolerability and may confer another option for relapsed MM 4. The combination of teclistamab and talquetamab is impressive in patients with EMD 5. Anitocel is a promising CAR T with a high response rate and minimal neurotoxicity What does the panel think?
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6. NEW DEFINITION OF HIGH RISK MM
43
IMS/IMWG consensus on high risk myeloma definition Del17p
in more than 20% of sorted plasma cells
TP53 mut (no threshold VAF)
Biallelic Del(1p32)
t(4;14) or t(14;16) or t(14;20) 2 among
Gain/amp 1q
β2M ≥5.5mg/L
(if creat <1.2mg/dL)
Monoallelic del(1p32) Avet-Loiseau et al. J Clin Oncol, in print, 2025
Conclusion • The IMS Panel recommends the use of this HRMM definition in all clinical trials going forward and in routine practice. • The HR subset should represent around 20% of NDMM patients. • Represents an important step toward risk-stratified therapeutic approaches in routine. • We hope that this definition will promote the design and conduct of clinical trials FOCUSED on patients with HRMM. • NGS-based definition, but available data with FISH (report the cut-offs positivity used). • Risk features should be also evaluated at relapse* and prior to participation in a clinical trial. (*the risk status at relapse supplants risk status at diagnosis, unless the patient was deemed high-risk at diagnosis). • Do we need an ultra high risk definition ?
Dr. Joe’s Take on The New High Risk Definition This remains a very challenging area in MM as clearly outcomes are worse in high risk disease This new system will require more sophisticated testing than the usual FISH test There are many ways to define high risk, and this new definition narrows the group to about 20% of MM – but of course is not perfect We need more options for high risk MM and hopefully this will help – especially those with “ultra” high risk disease....
What does the panel think? 46
Final Takeaways 1. Frontline therapy has evolved to quadruplets in most patients, along with continued therapy with a CD38 Ab and lenalidomide 2. MRD will be more incorporated into our treatment strategy and may result in less use of transplant 3. CAR T cell therapy is emerging as the most effective therapy in relapsed MM – even in heavily relapsed patients outcomes are unprecedented with 33% disease free at 5 years 4. Other novel approaches with antibody-drug conjugates and bispecific antibodies will increase their presence in early lines of therapy in multiple combinations All of this will provide for MANY more options for patients! 47
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IMF Myeloma Community Workshop: What’s Next? – Managing Myeloma at Relapse July 29, 2025, 3:00PM Pacific Time
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