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(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.
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). Data were generally consistent with the primary analysis. See ORR at primary analysis.
mOS=median overall survival; mPFS=median progression-free survival; OS=overall survival; NE=not estimable; PR=partial response; sCR=stringent complete response; TTNT=time to next treatment; VGPR=very good partial response.