Phase III trial of KRAZATI meets endpoints : Bristol Myers Squibb

Bristol Myers Squibb (BMS) disclosed positive results from its Phase III KRYSTAL-12 trial of KRAZATI (adagrasib) for treating non-small cell lung cancer (NSCLC) with KRASG12C mutations.

KRAZATI, an oral small-molecule inhibitor, aims to sustain target inhibition crucial for treating KRASG12C-mutated cancers due to the KRAS protein's rapid regeneration rate.

The Phase III trial compared KRAZATI monotherapy to standard-of-care chemotherapy in patients with KRASG12C-mutated NSCLC. It met its primary endpoint of PFS (progression-free survival ) and key secondary endpoint of  ORR (overall response rate).

Although ongoing for overall survival (OS), preliminary results indicate KRAZATI's significant benefit over standard chemotherapy.

The trial showed no new safety signals, aligning with previous safety data. KRAZATI received accelerated approval from the FDA in December 2022, followed by conditional marketing authorizations from MHRA and EC.

KRAZATI-based combinations also displayed promise in Phase II trials for various tumours beyond NSCLC.