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Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): A multicentre, open-label, single-arm, phase 1 study

The Lancet Aug 26, 2021

Usmani SZ, Garfall AL, van de Donk NWCJ, et al. - Not only the good tolerability of the recommended phase 2 dose of teclistamab but its promising efficacy was also evident with durable responses that deepened over time in patients with relapsed or refractory multiple myeloma.

  • Teclistamab is a bispecific antibody that binds B-cell maturation antigen and CD3 to redirect T cells to multiple myeloma cells.

  • This MajesTEC-1 study involved multiple myeloma patients who were relapsed, refractory, or intolerant to established therapies.

  • 157 patients (median six previous therapy lines) were treated with teclistamab (intravenous n=84; subcutaneous n=73).

  • Recommended phase 2 dose was defined as once per week subcutaneous administration of teclistamab at 1500 μg/kg.

  • 40 patients received recommended phase 2 dose after 60 μg/kg and 300 μg/kg step-up doses.

  • In part one, no dose-limiting toxicities occurred at the recommended phase 2 dose.

  • Cytokine release syndrome and neutropenia occurred in 28 (70%) and 26 (65%) patients, respectively, among the 40 cases treated at the recommended phase 2 dose.

  • The overall response rate was 65%; 58% showed a very good partial response or better.

  • Teclistamab affords a novel treatment option for relapsed or refractory multiple myeloma.

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