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An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

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Trial Profile

An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 27 Apr 2025

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At a glance

  • Drugs Odronextamab (Primary)
  • Indications B-cell lymphoma; Burkitt's lymphoma; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ELM-2
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 26 Feb 2025 According to a Regeneron Pharmaceuticals media release, the company announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The BLA resubmission is supported by data from the Phase 1 and pivotal Phase 2 trials (ELM-1 and ELM-2). The target action date for the FDA decision is July 30, 2025.
  • 13 Nov 2024 According to a Regeneron Pharmaceuticals media release, data from this trial will be presented at the American Society of Hematology (ASH) 2024 Annual Meeting
  • 26 Aug 2024 Results discussing Circulating Tumor DNA Analysis Association with Progression-Free Survival (PFS) with Odronextamab Monotherapy in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and Diffuse Large B-Cell Lymphomapublished in the Regeneron Pharmaceuticals media release.

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