INDICATION
ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
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KarMMa-3 Brings the Opportunity of ABECMA® to Triple-Class Exposed* Patients Earlier in Their Treatment Journey1-3
PRIMARY ENDPOINT: Progression-free survival¶
SELECT SECONDARY ENDPOINTS: ORR, TTR, DOR, detection of MRD, safety
EXCLUSION CRITERIA: Creatinine clearance of <45 mL/min; aspartate aminotransferase or alanine aminotransferase >2.5 times upper limit of normal; left ventricular ejection fraction <45%; absolute neutrophil count <1000/μL; platelet count <75,000/μL (if plasma cells <50% of bone marrow nucleated cells); or platelet count <50,000/μL (if plasma cells ≥50% of bone marrow nucleated cells)
- KarMMa-3 was a phase 3, open-label, randomized, multicenter trial that evaluated ABECMA vs standard regimens in 386 triple-class exposed patients with RRMM
- Standard regimens were selected based on regulatory approval status and required patient involvement
Patients who have received an immunomodulatory agent, a PI, and an anti-CD38 monoclonal antibody.
Five (2%) patients did not receive leukapheresis due to patient withdrawal (n=2), adverse event (n=1) or failure to meet lymphodepleting chemotherapy treatment criteria (n=2). Twenty-four (10%) patients did not receive ABECMA either due to death (n=4), adverse event (n=4), physician decision (n=7), failure to meet LDC treatment criteria (n=6), or inability to manufacture product (n=3). Three (1.2%) patients received CAR-positive T cells that did not meet product release specifications for ABECMA (non-conforming product; n=3).
Up to 1 cycle of DPd, DVd, IRd, Kd, or EPd bridging therapy, dependent on the patient’s most recent antimyeloma treatment regimen, was permitted for disease control between apheresis and until 14 days before the start of LDC.
LDC regimen: cyclophosphamide 300 mg/m2 intravenously (IV) and fludarabine 30 mg/m2 IV for 3 days (starting 5 days prior to target infusion date of ABECMA).
At time of final PFS analysis.
¶As determined by IRC based on the IMWG Uniform Response Criteria for Multiple Myeloma.
CAR=chimeric antigen receptor; DOR=duration of response; DPd=daratumumab, pomalidomide, dexamethasone; DVd=daratumumab, bortezomib, dexamethasone; EPd=elotuzumab, pomalidomide, dexamethasone; IMWG=International Myeloma Working Group; IRC=Independent Review Committee; IRd=ixazomib, lenalidomide, dexamethasone; Kd=carfilzomib, dexamethasone; LDC=lymphodepleting chemotherapy; MRD=minimal residual disease; ORR=overall response rate; PI=proteasome inhibitor; RRMM=relapsed/refractory multiple myeloma; TTR=time to response.