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

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.