Evicenter
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Bezuclastinib

Gastrointestinal stromal tumor

Manufacturer
Cogent Biosciences
Regulatory submission
NDA submitted April 2026
Last updated
76 sources

Executive summary

Bezuclastinib efficacy and safety

1 evidence topic · 6 sources

Summary

PEAK randomized 413 participants: 204 to bezuclastinib plus sunitinib and 209 to sunitinib. Median progression-free survival by blinded independent central review was 16.5 versus 9.2 months. Objective response rates were 45.6% versus 25.8%. Grade 3 or higher ALT/AST increases were reported in 10.8% versus 1.4%. Treatment-related adverse events led to study-treatment discontinuation in 7.4% versus 3.8%. Overall-survival data remained immature in the subsequent company update.