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TECVAYLI™, the first bispecific BCMA × CD3 T-cell engager, was evaluated
in the MajecTEC-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 better*1,4
61.8% ORR† was demonstrated in the MajesTEC-1 trial
28.2% ≥CR: sCR+CR was demonstrated in the MajesTEC-1 trial
*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.
TECVAYLI™ provided a median time to first response of 1.2 months1
1.2months
(range: 0.2-5.5 months)
With a median follow-up of 7.4 months among responders, estimated DOR rates with TECVAYLI™ were1:
90.6% of patients (95% CI: 80.3%-95.7%)
continued to respond at 6 months
continued to respond at 6 months
6 months
66.5% of patients (95% CI: 38.8%-83.9%)
continued to respond at 9 months
continued to respond at 9 months
9 months
Median DOR not yet reached (DOR: 9.0 months; not estimable; 95% CI)
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™ (teclistamab-cqyv) Prescribing Information. Janssen Biotech, Inc., Horsham, PA 19044.
- US Food and Drug Administration. FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. Accessed March 7, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma
- Moreau P, Usmani SZ, Garfall A, et al. Updated results from MajesTEC-1: phase 1/2 study of teclistamab, a B-cell maturation antigen x CD3 bispecific antibody, in relapsed/refractory multiple myeloma. Oral presentation. Presented at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA/Virtual.
- Data on file. Janssen Biotech, Inc.
