Cogent Biosciences' Bezuclastinib Combo Doubles Progression-Free Survival In GIST
I'm LongbridgeAI, I can summarize articles.Cogent Biosciences announced Phase 3 PEAK trial results showing Bezuclastinib combined with Sunitinib doubled progression-free survival in GIST patients compared to Sunitinib alone. The FDA accepted the NDA for Priority Review, with a PDUFA date of November 30, 2026. Cogent plans a new first-line trial. Wedbush maintains an Outperform rating with a $55 price target.
(RTTNews) - Cogent Biosciences, Inc. (COGT) announced detailed Phase 3 results from its PEAK trial evaluating Bezuclastinib in combination with Sunitinib in patients with gastrointestinal stromal tumors previously treated with Imatnib.
The data were presented at the 2026 ASCO annual meeting and mark the first time a therapy has shown a statistically significant advantage over an active comparator in this setting.
Gastrointestinal stromal tumors (GIST), are a rare aggressive cancer of the digestive tract, often driven by mutations in the KIT gene. Standard second-line therapy with Sunitinib provides limited benefit, with median PFS of 16.5 months versus 9.2 months with Sunitinib alone (hazard ratio 0.50, p0.0001). The benefit was consistent across both primary and secondary KIT mutations, with mean treatment duration extending to 21.4 months.
Safety findings showed the regimen was well tolerated, with no new risks beyond the known profile of Sunitinib. Patients experienced manageable side effects, and no unique toxicities were observed.
The FDA has already accepted Cognet's NDA for Bezuclastinib combination and granted Priority Review, with a PDUFA date set for November 30, 2026. Cogent also announced plans to initiate a new clinical trial in first-line GIST patients later this year.
Andrew Robbins, President and CEO of Cogent Biosciences, commented: "We are thrilled with the results from the PEAK Phase 3 trial demonstrating a statistically significant and clinically meaningful improvement in progression-free survival and objective response rate with Bezuclastinib in combination with sunitinib compared to sunitinib alone. Importantly, there was a clear benefit across all mutational patient subgroups, coupled with a safety profile generally consistent with the known profile of single agent Sunitinib."
Wedbush analysts maintain an Outperform rating with a $55.00 price target.
COGT has traded between $5.10 and $43.73 over the past year. The stock closed Friday's trading (May 29, 2026) at $34.96, down 1.19%. During overnight trading the stock is up at $35.00, up 0.11%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.