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A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

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Trial Profile

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

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

Latest Information Update: 20 May 2024

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At a glance

  • Drugs Epcoritamab (Primary) ; Bendamustine; Gemcitabine; Oxaliplatin; Rituximab
  • Indications B-cell lymphoma; Diffuse large B cell lymphoma; Follicular lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms EPCORE DLBCL-1; EPCORE&TRADE
  • Sponsors Genmab
  • Most Recent Events

    • 04 Aug 2023 Planned primary completion date changed from 1 Apr 2028 to 1 Dec 2024.
    • 22 Jun 2023 According to a Genmab media release, AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets excluding the U.S. and Japan throughout the year.
    • 22 Jun 2023 According to a Genmab media release, Epcoritamab-bysp (EPKINLY) was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory DLBCL. In October 2022, a Marketing Authorization Application was submitted for epcoritamab for the treatment of patients with R/R DLBCL after two or more lines of systemic therapy, which was validated by the European Medicines Agency.
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