Cogent stock doubles on strong Phase III data in gastrointestinal cancer

US biotech Cogent Biosciences (Nasdaq: COGT) has seen its share price more than double after its lead drug, bezuclastinib, delivered strong Phase III results in combination with sunitinib for patients with gastrointestinal stromal tumors (GIST) resistant or intolerant to Gleevec (imatinib).

In the pivotal PEAK study, the tyrosine kinase inhibitor pairing reduced the risk of disease progression or death by 50% compared with sunitinib alone, meeting the trial’s primary goal. The combination reached a median progression-free survival of 16.5 months versus 9.2 months on sunitinib alone, and produced a 46% response rate compared with 26% for monotherapy.

Bezuclastinib was generally well tolerated, with no new safety issues identified. Treatment discontinuations due to adverse events occurred in 7.4% of patients on the combination and 3.8% on sunitinib monotherapy. Overall survival data are not yet mature.