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For the 61.8% of patients who achieved ORR in MajesTEC-1

61.8%ORR^* (n=68/110 [95% CI, 52.1%-70.9%])

28.2^% ≥CR^†(n=31/110) 29.1^% VGPR(n=32/110) 4.5^% PR(n=5/110)

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FINAL ANALYSIS

Choose TECVAYLI^®, the first bispecific BCMA × CD3 T-cell engager given as an off-the-shelf subcutaneous injection for adult patients with RRMM who have received at least 4 prior lines of therapy, including a PI, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.^1,2

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

*ORR: sCR+CR+VGPR+PR.
^†≥CR: sCR+CR.
MajesTEC-1 study design: The efficacy of TECVAYLI^® was evaluated in patients with RRMM in a single-arm, open-label, multi-center, phase 1/2 study. The study included patients who had previously received at least 3 prior therapies, including a PI, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.¹

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BCMA, B-cell maturation antigen; CD3, cluster of differentiation 3; CD38, cluster of differentiation 38; CI, confidence interval; CR, complete response; ORR, overall response rate; PI, proteasome inhibitor; PR, partial response; RRMM, relapsed or refractory multiple myeloma; sCR, stringent complete response; VGPR, very good partial response.

References:

TECVAYLI^® (teclistamab-cqyv) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
U.S. Food and Drug Administration. FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. Accessed March 7, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma

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