Cullinan Therapeutics (Nasdaq: CGEM) and its partner Taiho Pharmaceutical have reported a win for zipalertinib, with the primary endpoint of a Phase IIb trial being met.
The companies announced that the REZILIENT1 study, which evaluated zipalertinib as a monotherapy in certain people with non-small-cell lung cancer (NSCLC), met its overall response rate goal.
The data, which include a positive safety profile, set the stage for a potential submission to the US Food and Drug Administration in the second half of 2025.
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