Top Myeloma Research Presented at ASCO and EHA 2024
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TOP 10 TOPICS
Ø ICELAND Updates
Ø MGUS, SMM, & DYNAMIC MODELING OF PROGRESSION
Ø FRONTLINE THERAPY
Ø MRD as EARLY RESPONSE ENDPOINT
Ø MRD in Maintenance
Ø Belantamab Drug Conjugate
Ø FasTCAR Update
Ø Teclistamab Real-World Data
Ø Role of CELMoDs
Ø The Future and Cure
ICELAND UPDATES
The iStopMM study
80,759 participants
Active myeloma * N=28
*FLC ratio >100 or M-protein >30 g/L
3,725 with MGUS
Previously known MGUS excluded N=237
RNo further work-up
N=1,164 IMWG
Recommendations N=1,159
Intensive arm N=1,164
Recent iStopMM Findings
ØObesity Linked to MGUS
ØScreened MGUS NOT LINKED to Autoimmunity
Ø
Prediction of Need for Bone Marrow
Ø
Changing the Face of Myeloma – Less CRAB
KEY EARLY DISEASE QUESTION
How to Predict Disease Progression?
Risk score to predict progression risk in SMM
New Dynamic Model
Dynamic Score for Progression
KEY FRONTLINE QUESTION
Are 4 Drugs (QUAD Therapy)
Better Than 3 Drugs?
FRONTLINE THERAPY
Isatuximab VRd... New Standard of Care?
DARA VRd vs VRd: PERSEUS Trial Update
(Sonneveld et al, EHA 2024)
At 36 months
MRD Neg @ 10-6 64% (Dara VRd) vs 31% (VRd)
PFS CLEARLY SUPERIOR
Sonneveld P, Moreau P, Dimopoulos MA, et al. Daratumumab + bortezomib/lenalidomide/dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma: analysis of minimal residual disease in the PERSEUS trial. Presented at: EHA 2024 Congress; June 15, 2024; Madrid, Spain
i2TEAMM:
FDA ODAC Meeting on MRD as an
Early Endpoint for RRMM Clinical Trials
IMF Chief Scientific Officer
Dr. Brian G.M. Durie
IMF Mission
Dr. Nikhil Munshi
(Jerome Lipper Myeloma Center, Dana -Farber Cancer Institute Boston, MA)
Dr. Jesus San Miguel
Miguel (Clinica Universidad de Navarra Pamplona, Spain)
Dr. Bruno Paiva
(CIMA Laboratory Diagnostics, University of Navarra Pamplona, Spain)
Dr. Qian Shi
The Mayo Stats Team
(Mayo Clinic Rochester, MN)
Dr. Kenneth Anderson
(Dana -Farber Cancer Institute and Harvard Medical School Boston, MA)
International Independent Team for Endpoint Approval
of Myeloma Minimal Residual Disease (i2TEAMM)
Academic Sites
International Independent Team for Endpoint Approval
of Myeloma Minimal Residual Disease (i2TEAMM)
Academic Sites and Industry Global Trials
High Individual-Patient-Level Correlation Supports Consideration of Early Endpoint For Accelerated Approval
• Consistent high individual-patient-level correlations provide strong evidence that 9 months MRDneg-CR rate at 10-5 threshold reasonably likely predicts clinical benefit of PFS in NDTE, NDTinE and RR MM populations
‒ Promising trial-level correlations pooling 3 populations provide supportive evidence
‒ Similar results were seen for 12 months MRDneg-CR rate at 10-5 threshold
‒ Similar results were seen for OS, except in the scenarios with low events
MRDneg-CR rate classified at 10-5 threshold at 9 and 12 months IS reasonably likely to predict clinical benefit in NDTE, NDTinE, and RR MM settings
9 months MRDneg-CR Status, Classified at 10-5 Threshold
Clinical Endpoint: Progression-Free Survival
#106:
Trial
Ø 47/83 able to discontinue maintenance Ø 40 MRD negative at 10-7: 3-year PFS was 85%
5 [11%] disease progression; 6 [13%] became MRD positive at 10-6
2 developed
DREAMM-7 TRIAL (ASCO 2024)
DREAMM-8 TRIAL (ASCO 2024)
BELA SUMMARY DATA: PFS BENEFIT
- Bela + Pd better than VPd Bela is back!
Ø DREAMM-7
- Bela + Vd better than Dara + Vd
Ø DREAMM-8
Fast CAR-T (GCO12F) at EHA 2024
Ø FRONTLINE GCO12F .. FasT CAR T : Newly diagnosed high risk patients
Ø novel manufacturing gives * young phenotype * T cells
Ø VRd followed by CAR T as induction
Ø ORR 100 % and MRD negative @ 10-6 also 100%
Ø Well-tolerated : all CRS grade 1 or 2 within 4 days
EXCELLENT RESULTS : PFS and OS AWAITED
(ASCO 2024)
BENEFIT RETAINED & TOXICITY LESS WITH REDUCED SCHEDULE
The Future and CURE
Ø Improved Drug Access a PRIORITY
Ø Dara/Isa VRd Frontline
Ø Early CAR T or Bispecific
Ø Establish Niche for OTHER AGENTS
Ø High-Risk Intensification
Ø Limit Treatment to 2-3 Years
Curative Strategy for HR SMM: CESAR Trial
ASCENT KRd-Dara: MRD Neg 84%
THE FUTURE IS BRIGHT!
Video Replay
A replay of the webinar will be made available on our website early next week. You can find it under the Publications and Broadcasts Tab, and then under IMF Broadcasts. A replay link will be directly emailed to all who registered for this webinar.
We Want to Hear From You!
Feedback Survey
At the close of the meeting a feedback survey will pop up. Click “continue” to complete the survey. This will also be emailed to you shortly after the workshop.
Please take a moment to complete this survey.
• Open the Q&A window, allowing you to ask questions to the host and panelists. It will be sent to our moderator and panelists for discussion.
• If you have a question that does not get answered today, you can contact our