The updated results from 2 P-II expansion dose cohorts of the P-I/II trial evaluating linvoseltamab (BCMAxCD3 bispecific Ab). At recommended 200mg dose in the (LINKER-MM1) trial, the results showed impressive efficacy with rapid, deep & durable responses
At a median follow-up of 6mos., ORR (71%), VGPR or better (59%) with 30% CR or sCR, the median time to onset of response was ≤1mos., probability of maintaining a response @6 & 12mos. (84% & 79%) & m-PFS (not reached)
54% were MRD- at 10-5 at 50 & 200mg who achieved CR or sCR with available MRD data, no new safety signals with longer follow-up in the P-I & II portions of the trial, AEs leading to treatment discontinuations (16%). The data from the trial will form the basis of planned regulatory submissions starting with the US FDA in 2023
Ref: Globenewswire | Image: Regeneron
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