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Article

Pharmacy Practice in Focus: Oncology

July 2020
Volume2
Issue 3

Study Results Find Teclistamab Has Manageable Safety Across All Doses Explored

The clinical trial of teclistamab sought to identify a recommended phase 2 dose for patients with RRMM, with multiple IV doses and priming doses explored.

An ongoing clinical trial of teclistamab observed a 78% overall response rate at the highest weekly treatment dose in patients with advanced relapsed/refractory multiple myeloma (RRMM), supporting further evaluation of teclistamab in expansion cohorts.1

Teclistamab is a B-cell maturation antigen (BCMA) x CD3 bispecific antibody that induces T cell-mediated cytotoxicity against BCMA-expressing myeloma cells.

The trial’s objective is to identify a recommended phase 2 dose for patients with RRMM, with multiple intravenous (IV) doses and priming doses explored.

The trial includes 66 patients receiving IV teclistamab, with a median age of 64 years; 97% were triple-class exposed, 83% were triple-class refractory, and 38% were penta-drug refractory. The most common treatment-related AEs were cytokine release syndrome (CRS) (56%), neutropenia (26%), and anemia (23%), with CRS events graded 1-2 and confined to initial doses.

Protein kinase results indicate that the half-life of teclistamab supports weekly dosing; cytokine production was modulated with step-up dosing while T-cell activation was maintained. Activity was observed starting at treatment doses ≥38.4 μg/kg, with 38% of patients achieving a response. At the highest dose, 78% of patients responded.

REFERENCE

Usmani SZ, Mateos M-V, Nahi H, et al. Phase I study of teclistamab, a humanized B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in relapsed/refractory multiple myeloma. J Clin Oncol. 2020;38(15 suppl; abstr 100). doi:10.1200/JCO.2020.38.15_suppl.100

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