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FDA places partial clinical hold on odronextamab trials in B-cell non-Hodgkin lymphomas

Jan 11, 2021
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On December 14, 2020, it was reported that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on trials of odronextamab, a CD20 and CD3 bispecific antibody, in B-cell non-Hodgkin lymphomas (B-NHL). This was based on the incidence of ≥ Grade 3 cytokine release syndrome during step-up dosing. Therefore, enrollment into the clinical trials has paused to allow for protocol amendment to reduce the incidence of this adverse event.1

The two trials currently affected are:

  • NCT02290951: a multicenter, open-label, phase I trial, investigating the safety and tolerability of odronextamab in patients with CD20+ B-NHL and chronic lymphocytic leukemia, previously treated with CD20-directed antibody therapy.1,2
    • Most recent trial results were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition and are summarized in our video interview with Rajat Bannerji.  
  • NCT03888105: a phase II, open-label trial, investigating the antitumor activity and safety of odronextamab in patients with relapsed/refractory B-NHL.1,3
    • Most recent trial results were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition as a poster presentation.4

Upon acceptance of the protocol amendment, patient enrollment is hoped to continue in the first quarter of 2021.

  1. Regeneron. Regeneron provides update on odronextamab clinical trials in B-cell non-Hodgkin lymphomas. https://investor.regeneron.com/static-files/690eeaf2-643e-44eb-9c3f-baad97eb9703. Published Dec 14, 2020. Accessed Jan 8, 2021.
  2. Clinicaltrials.gov. Study to investigate the safety and tolerability of REGN1979 in patients with CD20+ B-cell malignancies. https://www.clinicaltrials.gov/ct2/show/NCT02290951. Updated Dec 22, 2020. Accessed Jan 8, 2021.
  3. Clinicaltrials.gov. Assess the anti-tumor activity and safety of odronextamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. https://www.clinicaltrials.gov/ct2/show/record/NCT03888105. Updated Dec 21, 2020. Accessed Jan 8, 2021.
  4. Kim TM, Alonso A, Prince M et al. A phase 2 study of odronextamab (REGN1979), a CD20 × CD3 bispecific antibody, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Abstract #3029. 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; Dec 7, 2020; Virtual.

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