Regeneron Pharmaceuticals (REGN) said late Friday that two dose levels of fianlimab in combination with cemiplimab, evaluated as a first-line treatment in unresectable locally advanced or metastatic melanoma, failed to meet a primary endpoint in its phase 3 trial.
The combination demonstrated a numeric 5.1-month improvement in median progression-free survival compared to pembrolizumab monotherapy, but did not reach statistical significance for the primary endpoint, Regeneron said.
Regeneron said that detailed results from the trial will be presented at an upcoming medical meeting.
A phase 3 head-to-head trial of the high-dose fianlimab combination compared with Opdualag is ongoing, the company added.
Shares of the company were down more than 11% in Monday's premarket activity.
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