TECVAYLI®, the first bispecific BCMA × CD3 T-cell engager, was evaluated
in the MajesTEC-1 trial1,2
The efficacy of TECVAYLI® was evaluated in 110 patients with relapsed or refractory multiple myeloma in the single-arm, open-label, multi-center, phase 1/2 MajesTEC-1 trial. Patients had received at least 3 therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.1
Primary Endpoint: ORR3 Key Secondary Endpoints: DOR, TTR3
Patients with a range of characteristics, including those who were heavily pretreated, were studied in MajesTEC-11
- Median prior lines of therapy: 5 (range: 2-14)
- 78% of patients had received ≥4 prior lines of therapy
- 100% of patients had received prior therapy with a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
- 76% were triple-class refractory (refractory to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody)
- 81% of patients received prior stem cell transplantation
In MajesTEC-1, TECVAYLI® delivered an ORR of 61.8%, with 57.3% of patients achieving a deep response of VGPR or better1,4*
28.2% of patients
experienced ≥CR‡
with TECVAYLI® in the MajesTEC-1 trial
TECVAYLI® provided a median time to first response of
1.2
months1 (range: 0.2-5.5 months)
Median DOR not reached1
(95% CI, 9.0-NE)
*Efficacy results were based on ORR as determined by the Independent Review Committee (IRC) assessment using International Myeloma Working Group (IMWG) 2016 criteria.
†ORR: sCR+CR+VGPR+PR.
‡≥CR: sCR+CR.
§≥VGPR: sCR+CR+VGPR
BCMA, B-cell maturation antigen; CD3, cluster of differentiation 3; CD38, cluster of differentiation 38; CI, confidence interval; CNS, central nervous system; CR, complete response; del, deletion; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System; ORR, overall response rate; PR, partial response; sCR, stringent complete response; t, translocation; TTR, time to response; VGPR, very good partial response.
References:
- TECVAYLI® [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
- Moreau P, Garfall A, van de Donk C, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387:495-505.
- Data on file. Janssen Biotech, Inc.
