MajesTEC-1 — Teclistamab in Relapsed or Refractory Multiple Myeloma (MajesTEC-1)

Phase 1/2 · 2022 · Multiple Myeloma

Design

Single-arm phase 1/2 study of the BCMA×CD3 bispecific antibody teclistamab given with step-up dosing.

Population

Relapsed or refractory multiple myeloma after at least three prior lines including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.

Primary Endpoint

overall response rate (ORR)

Key Result

ORR 63% with 39% achieving complete response or better and a median duration of response of ~18 months in heavily pretreated disease.

Guideline Impact

NCCN-listed teclistamab for triple-class-exposed relapsed/refractory multiple myeloma