Cogent Biosciences Announces Positive Outcomes from the Phase 3 PEAK Trial of Bezuclastinib in Gastrointestinal Stromal Tumors
Cogent Biosciences, Inc. announced positive topline results from its Phase 3 PEAK trial evaluating bezuclastinib plus sunitinib in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST). The combination therapy achieved a median progression-free survival (mPFS) of 16.5 months, compared to 9.2 months for sunitinib alone (HR=0.50, 95% CI: 0.39–0.65; p<0.0001). The objective response rate (ORR) was also higher with the combination (46%) versus 26% for monotherapy (p<0.0001).
Supported by these findings, ...