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 four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

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The KarMMa pivotal study was an open-label, single-arm, multicenter trial that evaluated the efficacy and safety of ABECMA®.1,2 ABECMA reached its primary endpoint (≥PR as assessed by an IRC*) with an ORR of 72% (95% Cl, 62-81) (n=72/100) at primary analysis (median follow-up of 13.2 months, range: 0.2-21.0) in KarMMa.1,3†

Survival at 24-month Follow-up Analysis1,2,4‡




(95% CI, 6.08-12.22)

mPFS with sCR



(95% CI, 14.39-NE)




(95% CI, 18.96-NE)

OS was a secondary endpoint of KarMMa and was not statistically tested in the setting of a single-arm trial. OS data are not in the USPI and should be interpreted with caution in a single-arm trial. The statistical significance of OS is not known. Median follow-up of 19.9 months (range 0.2-31.5): 50 events and 50 deaths occurred prior to data cutoff December 2020.

Median OS by best response

Median OS by Best Response Graph
Median OS by Best Response Graph

Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma.

Primary analysis data: sCR 28% (95% CI, 19-38), VGPR 25% (95% CI, 17-35), PR 19% (95% CI, 12-28). Of the 135 patients who underwent leukapheresis, the efficacy-evaluable population included 100 patients (74%) who received ABECMA in the dose range of 300-460 x 106 CAR-positive T cells.

Efficacy data based on long-term follow-up analysis (median time from ABECMA infusion to data cutoff 27.3 months [range: 24.1 to 33.1]; N=100); ORR 72% (95% CI, 63.2-80.8). Data were generally consistent with the primary analysis.

IRC=Independent Response committee; mOS=median overall survival; mPFS=median progression-free survival; NE=not estimable; ORR=overall response rate; OS=overall survival; PR=partial response; sCR=stringent complete response; TTNT=time to next treatment; VGPR=very good partial response.

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