KRAZATI (adagrasib) Achieves Primary Endpoint in KRYSTAL-12 Trial for KRASG12C-Mutated NSCLC

Zai Lab and Bristol Myers Squibb have announced that the Phase 3 KRYSTAL-12 trial of the drug KRAZATI (adagrasib) has successfully met its primary endpoint of progression-free survival (PFS) and a key secondary endpoint of overall response rate (ORR) in patients with KRASG12C-mutated non-small cell lung cancer (NSCLC). The trial demonstrated that KRAZATI significantly outperformed standard chemotherapy, with no new safety concerns arising. The study is ongoing to evaluate overall survival as an additional endpoint.

The KRYSTAL-12 trial was an open-label, multicenter, randomized study that compared KRAZATI as a monotherapy to standard chemotherapy in patients with KRASG12C-mutated NSCLC who had received prior treatment. The drug showed a statistically significant benefit in PFS and ORR, with the safety profile aligning with what is already known about KRAZATI.

Zai Lab's President, Rafael G. Amado, M.D., expressed enthusiasm for the potential of adagrasib as a therapy for patients with KRASG12C mutated NSCLC, highlighting lung cancer as the most prevalent cancer in China. Zai Lab is eager to bring adagrasib to Chinese patients in need, as it is a significant product in their expanding lung cancer portfolio.

Bristol Myers Squibb plans to present a comprehensive evaluation of the trial data at an upcoming medical conference and will engage with health authorities regarding the findings. Zai Lab anticipates submitting a New Drug Application (NDA) for adagrasib to the National Medical Products Association (NMPA) in China for the treatment of KRASG12C mutated NSCLC in patients who have received at least one prior systemic therapy.

KRAZATI has also shown promise in Phase 2 trials for various other tumors, including colorectal and pancreatic cancers. The U.S. FDA has accepted for priority review a supplemental new drug application for KRAZATI in combination with cetuximab for the treatment of KRASG12C-mutated colorectal cancer.

Lung cancer remains a significant health concern in China, with high incidence and mortality rates. KRASG12C is a common mutation in NSCLC and is associated with poor prognosis. KRAZATI is a highly selective oral inhibitor of KRASG12C, designed to sustain target inhibition, which is crucial given the KRAS protein's rapid regeneration cycle.

Zai Lab is a research-based biopharmaceutical company dedicated to discovering, developing, and commercializing innovative treatments for various medical needs, with a focus on oncology, autoimmune disorders, infectious diseases, and neuroscience. They aim to make a positive impact on global health through their work.