Phase 2 Results of Teclistamab in Relapsed or Refractory Multiple Myeloma

By Patrick Daly - Last Updated: September 19, 2023

Teclistamab is approved for the treatment of relapsed or refractory multiple myeloma (RRMM) in patients who previously received immunomodulatory, proteasome inhibitor, and anti-CD38 antibody therapies.

In a study published in Targeted Oncology, researchers characterized the pharmacokinetics and exposure-response of intravenous and subcutaneous (SC) teclistamab based on data from the phase 1/2 MajesTEC-1 study.

According to the study’s authors, body weight, myeloma type, and International Staging System stage statistically significantly affected the pharmacokinetics of teclistamab in patients with RRMM, though not with a clinically relevant change in efficacy. The study also defined the exposure-response of teclistamab and identified a recommended phase 2 dose (RP2D) for SC teclistamab of 0.06 and 0.30 mg/kg step-up doses, followed by a weekly dose of 1.5 mg/kg.

Teclistamab Outcomes at Recommended Phase 2 Dose

The study included 4840 serum concentration samples from 338 evaluable patients with RRMM who received teclistamab in MajesTEC-1. In the dose-expansion phase, the objective response rate reached a plateau at the concentration range associated with the RP2D, while patients who started at the RP2D showed a flat exposure-response curve.

The typical population value of time-independent and time-dependent teclistamab clearance were 0.449 L/day and 0.547 L/day, respectively. After 8 weeks of treatment, time-dependent clearance decreased to <10%. There were no apparent associations between duration of response, progression-free survival, overall survival, or the rate of grade 3 or higher adverse events.

“These analyses support the RP2D of teclistamab (1.5 mg/kg SC administered weekly, with the first treatment dose preceded by step-up doses of 0.06 mg/kg and 0.30 mg/kg) for the treatment of patients with RRMM,” authors concluded.


Related: Black Patients With Multiple Myeloma Under-Enrolled in IMWG Data

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