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Talquetamab plus Teclistamab in Relapsed or Refractory Multiple Myeloma.

Fecha de publicación:

Autores de IDIVAL

Autores ajenos al IDIVAL

  • Cohen YC
  • Magen H
  • Gatt M
  • Sebag M
  • Kim K
  • Min CK
  • Yoon SS
  • Chu MP
  • Rodríguez-Otero P
  • Avivi I
  • Quijano Cardé NA
  • Kumar A
  • Krevvata M
  • Peterson MR
  • Di Scala L
  • Scott E
  • Hilder B
  • Vanak J
  • Banerjee A
  • Oriol A
  • Morillo D
  • Mateos MV
  • RedirecTT-1 Investigators and Study Group

Unidades

Abstract

BACKGROUND: Talquetamab (anti-G protein-coupled receptor family C group 5 member D) and teclistamab (anti-B-cell maturation antigen) are bispecific antibodies that activate T cells by targeting CD3 and that have been approved for the treatment of triple-class-exposed relapsed or refractory multiple myeloma. METHODS: We conducted a phase 1b-2 study of talquetamab plus teclistamab in patients with relapsed or refractory multiple myeloma. In phase 1, we investigated five dose levels in a dose-escalation study. Talquetamab at a dose of 0.8 mg per kilogram of body weight plus teclistamab at a dose of 3.0 mg per kilogram every other week was selected as the recommended phase 2 regimen. The primary objective was to evaluate adverse events and dose-limiting toxic effects. RESULTS: A total of 94 patients received treatment, with the recommended phase 2 regimen used in 44. The median follow-up was 20.3 months. Three patients had dose-limiting toxic effects (including grade 4 thrombocytopenia in 1 patient with the recommended phase 2 regimen). Across all dose levels, the most common adverse events were cytokine release syndrome, neutropenia, taste changes, and nonrash skin events. Grade 3 or 4 adverse events, most commonly hematologic events, occurred in 96% of the patients. Grade 3 or 4 infections occurred in 64% of the patients. With the recommended phase 2 regimen, a response occurred in 80% of the patients (including in 61% of those with extramedullary disease); across all dose levels, a response occurred in 78%. The likelihood of patients continuing in response at 18 months was 86% with the recommended phase 2 regimen (82% among those with extramedullary disease) and 77% across all dose levels. CONCLUSIONS: The incidence of grade 3 or 4 infections with talquetamab plus teclistamab was higher than has been observed with either therapy alone. A response was observed in a high percentage of patients across all dose levels, with durable responses with the recommended phase 2 regimen. (Funded by Janssen Research and Development; RedirecTT-1 ClinicalTrials.gov number, NCT04586426.).

Copyright © 2025 Massachusetts Medical Society.

Datos de la publicación

ISSN/ISSNe:
0028-4793, 1533-4406

New England Journal of Medicine  MASSACHUSETTS MEDICAL SOC

Tipo:
Article
Páginas:
138-149
PubMed:
39778168

Citas Recibidas en Web of Science: 38

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