USFDAMay 30, 2026, 08:02 AM
Cogent Biosciences bezuclastinib combo shows 16.5-mo PFS in GIST; FDA Priority Review
AI Summary
Cogent Biosciences announced detailed positive clinical data from the PEAK Phase 3 trial of bezuclastinib in combination with sunitinib for GIST patients, demonstrating a statistically significant improvement in progression-free survival (PFS) and objective response rate (ORR). The combination achieved a median PFS of 16.5 months compared to 9.2 months for sunitinib alone, with a clear benefit across all mutational subgroups and a well-tolerated safety profile. The company also confirmed FDA Priority Review for the bezuclastinib combination, with a PDUFA date set for November 30, 2026, and initiated a new clinical trial for first-line GIST patients.
Key Highlights
- Bezuclastinib combination achieved median PFS of 16.5 months vs. 9.2 months for sunitinib (HR=0.50, p<0.0001).
- Objective Response Rate (ORR) was 46% for bezuclastinib combination vs. 26% for sunitinib.
- Median PFS2 was not reached for bezuclastinib combination vs. 21 months for sunitinib (HR=0.57).
- Mean duration of treatment for bezuclastinib combination estimated at 21.4 months.
- FDA granted Priority Review for bezuclastinib combination in GIST, with PDUFA date of November 30, 2026.
- Initiated new 40-patient clinical trial of bezuclastinib combination in 1L GIST patients with KIT exon 9 mutations.
- Combination was well tolerated; 7.4% of patients discontinued due to treatment-related adverse events vs. 3.8% for sunitinib.
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