The FDA has told Regeneron to hit the brakes on its experimental blood cancer drug trial over safety concerns.
The U.S. regulator has slapped a partial clinical hold on odronextamab, a CD20xCD3 bispecific antibody in tests for B-cell non-Hodgkin lymphoma (B-NHL), after the FDA said the company has to “further reduce the incidence of Grade 3 cytokine release syndrome (CRS),” a not uncommon safety issue in certain blood cancer trials but one that can be fatal.
This will see Regeneron pause new enrollment in the trial, allow treatment to continue for enrolled patients if they re-consent and send off a new protocol amendment to FDA, with the “goal of resuming patient enrollment in the first quarter of 2021.”
This is hitting two trials: a phase 1 monotherapy trial in B-NHL as well as midstage tests in chronic lymphocytic leukemia and a monotherapy test in “several B-NHL subtypes.”
Bio Twitter regular and biotech investor Brad Loncar said: “All CD3s have the CRS problems (I’m not aware of any program not plagued by this) so other than a short delay to amend the protocols, I don’t think this is a unique problem for REGN. Though it does speak to the competitive disadvantage of bi-specifics.”
The pharma was down 1% premarket Tuesday morning on the news.