Bristol Myers Squibb (NYSE: BMY) has announced the successful results of the pivotal Phase 3 KRYSTAL-12 study, which evaluated KRAZATI® (adagrasib) as a monotherapy for patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. The study met its primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate (ORR) as assessed by Blinded Independent Central Review (BICR) during the final analysis. The trial is ongoing to evaluate the additional key secondary endpoint of overall survival.
Results from the confirmatory trial revealed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment. Importantly, KRAZATI exhibited no new safety signals, with safety data consistent with its known safety profile.
Abderrahim Oukessou, M.D., vice president, global program lead, KRAZATI at Bristol Myers Squibb, highlighted the significance of these findings: “Today’s news underscores the efficacy of targeted therapy for patients with locally advanced or metastatic KRASG12C-mutated lung cancer. The FDA approval of KRAZATI in the U.S. has provided a new treatment option, and the positive results from the KRYSTAL-12 study will further instill confidence in the medical and patient communities.”
The company plans to conduct a comprehensive evaluation of the available data and intends to present the results at an upcoming medical conference while engaging with health authorities for discussions.
KRAZATI received accelerated approval from the U.S. FDA as a targeted treatment for patients with KRASG12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy in December 2022. Subsequently, in 2023, conditional marketing authorization was granted by the Medicines and Healthcare products Regulatory Agency (MHRA), followed by approval from the European Commission (EC) in 2024.
Aside from NSCLC, KRAZATI and its combinations have shown promising benefits in Phase 2 trials across various tumors, including advanced colorectal cancer and pancreatic cancer. The FDA has accepted the supplemental new drug application (sNDA) for KRAZATI in combination with cetuximab for the treatment of previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer, with a Prescription Drug User Fee Act (PDUFA) goal date set for June 21, 2024.
Bristol Myers Squibb expressed gratitude to the patients and investigators involved in the KRYSTAL-12 clinical trial.
