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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†
(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.
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.