Cogent Biosciences reported that the Phase 3 PEAK trial of bezuclastinib in combination with sunitinib achieved a median progression‑free survival of 16.5 months versus 9.2 months for sunitinib alone, a 50 % reduction in the risk of disease progression or death (hazard ratio 0.50, 95 % CI 0.39‑0.65). The combination also produced an objective response rate of 46 % compared with 26 % for sunitinib monotherapy, and the safety profile was consistent with known sunitinib toxicity, with only transient hepatic events and no Grade 4 elevations.
Cogent’s data position the bezuclastinib/sunitinib regimen as a potential new standard of care for patients with imatinib‑resistant or intolerant gastrointestinal stromal tumor (GIST). The global market opportunity for this indication exceeds $4 billion annually, and the company’s Breakthrough Therapy Designation may accelerate regulatory review. Cogent plans to submit a new drug application to the FDA in the first half of 2026 and will present the full PEAK data at a major scientific conference in the same period.
The company’s Q3 2025 financials show a net loss of $80.9 million, up from $70.6 million in Q3 2024, driven by increased R&D spending of $69.0 million versus $63.6 million the prior year. A pro‑forma cash balance of $430 million as of September 30, 2025 is expected to fund operations through 2027, providing a runway for commercialization and further pipeline development.
CEO Andrew Robbins described the announcement as a “historic day” for the company and GIST patients, emphasizing that the combination therapy is poised to become the new standard of care in the second‑line setting. Dr. Neeta Somaiah of MD Anderson Cancer Center called the results “truly transformative and practice‑changing,” underscoring confidence in rapid adoption once regulatory approval is obtained.
The safety profile of the combination was well tolerated, with hepatic adverse events being predominantly transient and manageable. No new safety signals beyond the known profile of sunitinib were identified, and no Grade 4 elevations were reported.
The announcement was well received by the market, reflecting confidence in the therapy’s potential to address an unmet need in a high‑value patient population and to drive future revenue growth once the product is approved.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.