Announcement • Jun 02
Cogent Biosciences, Inc. Announces Detailed Clinical Data From PEAK Phase 3 Trial With Bezuclastinib In Combination With Sunitinib In Gastrointestinal Stromal Tumors Cogent Biosciences, Inc. announced detailed clinical data from the primary analysis of the PEAK Phase 3 trial of bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. The bezuclastinib combination is the first treatment ever to demonstrate statistically significant advantage against active comparator in GIST patients; median PFS of 16.5 months versus 9.2 months (HR=0.50, CI: 0.39-0.65, p). Bezuclastinib combination provides clear PFS benefit regardless of primary or secondary KIT mutations. Mean duration of treatment estimated at 21.4 months for patients receiving bezuclastinib combination. Bezuclastinib combination well tolerated with no unique risks observed with the combination when compared to the known safety profile of sunitinib. Priority Review granted following FDA acceptance of NDA for bezuclastinib combination in GIST patients who previously received imatinib; PDUFA date scheduled for November 30, 2026. Cogent announces initiation of new clinical trial of bezuclastinib combination in 1L GIST patients. As reported in November 2025, PEAK is a global, randomized Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib monotherapy in patients with imatinib-resistant or intolerant GIST. As of the cutoff date, September 30, 2025, the bezuclastinib combination demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of PFS, reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented ORR in imatinib-resistant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. Data for overall survival remains immature. Based on the ongoing patients receiving treatment on the bezuclastinib arm as of March 31, 2026, the mean duration of treatment for the bezuclastinib combination is now estimated to be 21.4 months. Using all genotyping information available at baseline, a comparative analysis of PFS was performed across several patient subgroups based on their primary and secondary KIT mutation status. Across all subgroups, the bezuclastinib combination demonstrated a clear advantage over sunitinib monotherapy. Additional data presented demonstrate impressive benefit for patients receiving the bezuclastinib combination when measuring PFS2, defined as the time from randomization to progression on the next line of therapy or death. Median PFS2 was not reached versus 21 months (HR=0.57, 95% CI: 0.41-0.78) for patients initially treated with the bezuclastinib combination compared with sunitinib monotherapy. This finding reinforces the durability of clinical benefit for patients receiving the bezuclastinib combination. As of the data cutoff, the bezuclastinib combination was generally well tolerated, and no unique risks were observed with the novel combination when compared to the known safety profile of sunitinib. The most commonly reported Grade 3+ treatment emergent adverse events in either arm (bezuclastinib combination vs. sunitinib) included: Hypertension (29.4% vs. 27.4%), Neutropenia (15.2% vs. 15.4%), ALT/AST increased (10.8% vs. 1.4%), Anemia (9.3% vs. 4.8%) and Diarrhea (7.8% vs. 7.2%). 7.4% of patients on the bezuclastinib combination and 3.8% of patients on sunitinib monotherapy discontinued study treatment(s) due to treatment related adverse events. Hepatic adverse events were predominantly transient and manageable lab abnormalities; the majority of which were asymptomatic, low grade, non-serious and reversible. In the combination arm, ALT/AST elevations led to bezuclastinib dose reductions in 12.7% of patients with only 3 subjects (1.5%) discontinuing bezuclastinib for ALT/AST elevations. All Grade 3 ALT/AST elevations resolved, and no Grade 4 elevations were reported. Cogent also announced the initiation of a single-arm, 40 patient extension cohort of the PEAK trial investigating the safety and efficacy of the bezuclastinib combination in first-line GIST patients with KIT exon 9 primary mutations who have received limited or no imatinib treatment. This cohort is designed to prospectively measure ORR and PFS in this patient population, building upon the 25.1 mPFS reported in a subgroup of 32 patients with detectable exon 9 mutations treated with the bezuclastinib combination in the Phase 3 PEAK trial. Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. COGT
Live News • May 29
FDA Grants Priority Review to Cogent Biosciences Bezuclastinib Combo for GIST Patients FDA accepts Cogent Biosciences’ New Drug Application for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) and grants Priority Review.
The application is supported by Phase 3 PEAK trial data showing a 50% reduction in risk of disease progression or death versus sunitinib alone.
The FDA sets a PDUFA target action date of November 30, 2026, while full PEAK trial results are scheduled to be presented at the ASCO meeting on May 30, 2026.
The Priority Review and defined PDUFA date provide a clear regulatory timeline and indicate that the FDA views this filing as clinically important.
Investors may focus on the ASCO data release to review the efficacy and safety outcomes that support the NDA and to evaluate potential market adoption and development risk related to bezuclastinib. Breakeven Date Change • May 06 The 11 analysts covering Cogent Biosciences previously expected the company to break even in 2028. New consensus forecast suggests losses will reduce by 52% per year to 2027. The company is expected to make a profit of US$254.2m in 2028. Average annual earnings growth of 73% is required to achieve expected profit on schedule.
