Cogent Biosciences’ stock has soared after its lead asset, bezuclastinib plus sunitinib, outperformed sunitinib alone in a pivotal gastrointestinal cancer trial.
In the Phase III PEAK study (NCT05208047) bezuclastinib, a tyrosine kinase inhibitor (TKI), plus sunitinib in patients with Gleevec (imatinib) resistant or intolerant gastrointestinal stromal tumours (GIST), met its primary endpoint of progression free survival (PFS), reducing risk of disease progression or death compared to the current standard of care by 50%.
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The combination reached a median progression free survival (mPFS) of 16.5 months compared to 9.2 months with the sunitinib monotherapy. It also led to a 46% objective response rate (ORR) compared to 26% with sunitinib monotherapy.
As of the 30 September cut-off, data for overall survival (OS) remains immature.
On this data, Cogent Biosciences’ stock, listed on the Nasdaq exchange, soared by 119.03%, from a $14.82 close on 7 November to a $32.46 close on 10 November. The company has a market cap of $4.62bn.
On the back of this data, Cogent will submit a new drug application (NDA) to the US Food and Drug Administration (FDA) for bezuclastinib in GIST in the first half of 2026.
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By GlobalDataCogent president and CEO Andrew Robbins said the trial data have “far surpassed” its expectations in patients with imatinib-resistant or intolerant GIST, saying: “With these incredible results, including a greater than seven-month improvement on mPFS – reducing the rate of progression or death by half – the bezuclastinib combination is poised to become the new standard of care for treatment of second-line GIST patients.”
The bezuclastinib combination was generally well tolerated with no unique risks identified with the combination when compared to sunitinib alone. In addition, 7.4% of patients on the bezuclastinib combination and 3.8% of patients on sunitinib monotherapy discontinued study treatment due to treatment-related adverse events (TRAEs).
Complete analysis of the Phase III PEAK data is ongoing, and Cogent plans to present detailed results at a major medical conference in the first half of 2026.
TKIs are commonly used for GIST, with Gleevec, manufactured by Novartis, and sunitinib being the primary choices in first- and second-line treatment, respectively. As a result, finding a candidate that is efficacious in patients resistant or intolerant to Gleevec and increases the benefit of sunitinib alone is notable.
Dr Neeta Somaiah, sarcoma medical oncology professor at The University of Texas MD Anderson Cancer Center, added that if approved, she anticipates the combination to be “rapidly adopted as the new standard of care” for the majority of patients in the second-line GIST setting.
Bezuclastinib has already shown benefit in a Phase III trial in non-advanced systemic mastocytosis, leading to a submission for approval to the FDA, which is anticipated by the end of 2025. The company will also soon release Phase III data from the candidate in the pivotal APEX trial in December 2025. APEX is a registration-directed, global, open-label trial in patients with advanced systemic mastocytosis (AdvSM).
GlobalData predicts an annual sales and consensus forecast for bezuclastinib of $809m in 2031.
GlobalData is the parent company of Clinical Trials Arena.
