Regeneron Pharmaceuticals has paused new enrolment of patients in two of its trials analysing experimental drug, odronextamab, for treating B-cell non-Hodgkin lymphomas (B-NHL).
Odronextamab is a CD20xCD3 bispecific antibody.
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The move comes after the US Food and Drug Administration (FDA) put a partial clinical hold on the trials.
The FDA sought amendments in trial protocols in order to further lower the incidence of over Grade 3 cytokine release syndrome (CRS) during step-up dosing.
According to the US National Cancer Institute, the syndrome is caused by a large, rapid release of immune substances called cytokines.
This may happen after treatment with some cancer therapies and can become severe or fatal.
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By GlobalDataThe syndrome has various symptoms such as fever, headache and troubled breathing, Reuters reported.
If given re-consent, participants who have been enrolled to the trial and are deriving clinical benefit from odronextamab may continue the therapy, Regeneron said.
The FDA clinical hold will impact a Phase I monotherapy trial analysing odronextamab in cancer patients with B-NHL and chronic lymphocytic leukaemia.
In addition, another Phase II monotherapy trial evaluating the drug in various subtypes of B-NHL will pause enrolment.
The company intends to submit a protocol amendment to the FDA in the first quarter of next year in order to restart patient enrolment.
In November, Regeneron Pharmaceuticals put a hold on enrolling patients requiring high-flow oxygen or mechanical ventilation in the trial of REGN-COV2, an antibody cocktail therapy for treating hospitalised patients with Covid-19.
The pause follows an independent data monitoring committee (IDMC) recommendation based on a potential safety signal and an unfavourable risk / benefit profile at this time.
