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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ORR at primary analysis (median follow-up of 13.2 months, range: 0.2-21.0): 72% ORR (95% CI, 62-81) (n=72)†
Deep responses were achieved in MRD-evaluable patients with ≥VGPR2
93% MRD NEGATIVITY in MRD-evaluable patients||
A majority of patients responded to ABECMA, with more than half achieving ≥VGPR
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.
Primary analysis data: sCR 28% (95% CI, 19-38), VGPR 25% (95% CI, 17-35), PR 19% (95% CI, 12-28).
Response is defined as achieving ≥PR. Of the 100 patients in the efficacy-evaluable population, 25 (25%) achieved a VGPR (95% CI, 16.5-33.5) and 18 (18%) achieved a PR (95%, 10.5-25.5).4
All complete responses were sCRs.
Based on a threshold of 10-5 using ClonoSEQ, a next-generation sequencing assay (NGS). MRD negativity was defined as the proportion of patients with ≥VGPR who are MRD negative at any time point within 3 months prior to achieving ≥VGPR until the time of progression or death.
CAR=chimeric antigen receptor; CR=complete response; mDoR=median duration of response; MRD=minimal residual disease; NE=not estimable; ORR=overall response rate; PR=partial response; sCR=stringent complete response; TTNT=time to next treatment; TTR=time to response; VGPR=very good partial response.