Cogent Biosciences Submits NDA for Bezuclastinib after Phase 3 Trial Shows 16.5-Month PFS, 46% ORR
Cogent Biosciences filed an NDA for bezuclastinib under the FDA’s Real-Time Oncology Review program for second-line GIST patients, following Breakthrough Therapy designation. Phase 3 PEAK trial data showed a 16.5-month median PFS versus 9.2 months (hazard ratio 0.50) and a 46% ORR in imatinib-resistant patients.
1. NDA Submission Under RTOR Program
Cogent Biosciences has completed submission of its New Drug Application for bezuclastinib in second-line GIST under the FDA’s Real-Time Oncology Review program, leveraging Breakthrough Therapy designation to accelerate the review timeline.
2. Key Phase 3 PEAK Trial Results
In the global, randomized Phase 3 PEAK trial, the bezuclastinib plus sunitinib combination reduced risk of progression or death by 50% (hazard ratio 0.50) and achieved a median PFS of 16.5 months versus 9.2 months with sunitinib alone, alongside a 46% objective response rate in imatinib-resistant patients.
3. Upcoming Clinical and Regulatory Milestones
Cogent plans to present full PEAK trial data in the first half of 2026, initiate a Phase 2 study in first-line exon 9 GIST patients, and pursue an NDA for advanced systemic mastocytosis in H1 2026, supported by active expanded access programs.