The US Food and Drug Administration has put on partial hold a Phase III study of BioNTech and OncoC4’s lead cancer asset BNT316/ONC-392 (gotistobart) after a possible variance in outcomes between non-small cell lung cancer patient subgroups being tested was observed.
Gotistobart is a next-generation CTL4 inhibitor, and the two-stage, open-label PRESERVE-003 (NCT05671510) trial is evaluating its safety and efficacy as a monotherapy in patients with metastatic NSCLC who have progressed...
Key Takeaways
- BioNTech has invested heavily in multiple cancer modalities, and hopes to have its first oncology drug on the market by 2026.
- That...
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