Study summary

Adding bezuclastinib to sunitinib nearly doubled time before growth

PEAK trial · 413 people, phase 3, randomized · Topline November 2025; presented at ASCO May 2026

+7.3 molonger before growth: 16.5 vs 9.2 months

What was tested

Bezuclastinib, a KIT-blocking pill, plus sunitinib, against sunitinib alone, for GIST that grew on imatinib.

What they found

Median time before growth was 16.5 vs 9.2 months; risk of growth halved.
Tumors shrank in 46% vs 26%.
No new safety problems beyond those of sunitinib.

What it means

Likely a new standard second treatment. The FDA set a decision date of November 30, 2026.

Targeted Oncology ↗ ← Back to the outlook

Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.