Bristol Myers announces results from Phase 3 KRYSTAL-12 study

Bristol Myers Squibb announced results from the Phase 3 KRYSTAL-12 study evaluating KRAZATI compared to standard of care chemotherapy in patients with locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer who had previously received platinum-based chemotherapy, concurrently or sequentially with anti-PD-(L)1 therapy. At a median follow-up of 9.4 months, KRAZATI demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, the study’s primary endpoint, as assessed by Blinded Independent Central Review compared to docetaxel. Median PFS was 5.5 months for KRAZATI compared to 3.8 months for docetaxel. Overall response rate as assessed by BICR was also significantly higher with KRAZATI compared to docetaxel. The median duration of response was 8.31 months versus 5.36 months, respectively. KRAZATI demonstrated intracranial response among patients with central nervous system metastases at baseline, with a response rate per BICR that was more than double that observed with docetaxel. The KRYSTAL-12 study remains ongoing to assess the additional key secondary endpoint of overall survival. No new safety signals were identified for KRAZATI, and the safety data were consistent with the known safety profile. Treatment-related adverse events of any grade were reported in 94% of patients treated with KRAZATI and 86.4% with docetaxel. Grade greater than or equal to 3 TRAEs occurred in 47% and 46% of patients, respectively. In addition to KRASG12C-mutated NSCLC, KRAZATI and KRAZATI-based combinations have shown encouraging, meaningful benefit in Phase 2 clinical trials across several tumors, including advanced colorectal cancer, pancreatic cancer, and other solid tumors.