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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In KarMMa-3, ABECMA reached its primary endpoint in the primary analysis with a PFS of 13.3 months (95% CI, 11.8-16.1) vs 4.4 months with standard regimens (95% CI, 3.4-5.9). The mDOR was 14.8 months (95% CI, 12.0-18.6) with ABECMA and 9.7 months (95% CI, 5.4-16.3) with standard regimens. Median time to onset for CRS in patients receiving ABECMA was 1 day (range: 1 to 27 days), with a median duration of 5 days post infusion (range: 1 to 63 days). Median time to onset for neurologic toxicity in patients receiving ABECMA was 2 days (range: 1 to 148 days). In 123 of 139 patients who had resolved neurologic toxicities, a median duration of 5 days (range: 1 to 245 days). The median duration of CAR T cell-associated neurotoxicity was 8 days (range: 1 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cutoff.1,4

STUDY DESIGN: 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. Patients had received 2 to 4 prior regimens including an immunomodulatory agent, a PI, and daratumumab, and were refractory to their last regimen. Participants were randomized 2:1 to a one-time infusion of ABECMA (n=254) or continuous therapy with a standard regimen of investigator’s choice (DVd, DPd, IRd, EPd, Kd; n=132) until disease progression or unacceptable toxicity. Primary endpoint was PFS per IRC based on the IMWG Uniform Response Criteria for Multiple Myeloma. Select secondary endpoints included ORR, TTR, DOR, detection of MRD, and safety.1,4

Patients who have received an immunomodulatory agent, a PI, and an anti-CD38 monoclonal antibody.1

Median time to onset for CRS was 1 day (range: 1 to 27 days), with a median duration of 5 days (range: 1 to 63 days). Median time to onset for neurologic toxicity was 2 days (range: 1 to 148 days). In 123 to 139 patients who had resolved neurologic toxicity, the median time to resolution was 5 days (range: 1 to 245 days). The median duration of CAR T cell-associated neurotoxicity was 8 days (range: 1 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cutoff.1

Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring. A single dose of ABECMA contains a cell suspension of 300 to 510 x 106 CAR-positive T cells in 1 or more infusion bags.1

Eligibility

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Trial Results

View efficacy and safety data for triple-class exposed patients in KarMMa-3

EXPLORE THE DATA
Safety

A well-established safety profile across trials

DISCOVER

2L=second-line; CAR=chimeric antigen receptor; CI=confidence interval; CRS=cytokine release syndrome; DOR=duration of response; DPd=daratumumab, pomalidomide, dexamethasone; DVd=daratumumab, bortezomib, dexamethasone; EPd=elotuzumab, pomalidomide, dexamethasone; HR=hazard ratio; IMWG=International Myeloma Working Group; IRC=Independent Review Committee; IRd=ixazomib, lenalidomide, dexamethasone; Kd=carfilzomib, dexamethasone; mDOR=median duration of response; mPFS=median progression-free survival; MRD=minimal residual disease; ORR=overall response rate; PFS=progression-free survival; PI=proteasome inhibitor; RRMM=relapsed/refractory multiple myeloma; TTR=time to response.