Zai Lab, Bristol Myers: Krazati confirmatory trial meets PFS primary endpoints

Zai Lab Limited (ZLAB) partner Bristol Myers Squibb (BMY) announced the pivotal Phase 3 KRYSTAL-12 study, evaluating KRAZATI or adagrasib as a monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer NSCLC harboring a KRASG12C mutation, met the primary endpoint of progression-free survival PFS and the key secondary endpoint of overall response rate ORR as assessed by Blinded Independent Central Review at final analysis for these endpoints. The study remains ongoing to assess the additional key secondary endpoint of overall survival. Results of the confirmatory trial showed 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 for these patients. KRAZATI had no new safety signals and the safety data was consistent with the known safety profile. “We are delighted to see these data underscoring the potential of adagrasib as a therapy for patients with KRASG12C mutated NSCLC in second or later line treatment,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development, Zai Lab. “Lung cancer is the most common cancer in China, and adagrasib is one of several important products in Zai Lab’s growing lung cancer pipeline. We are proud to have contributed to the KRYSTAL-12 study and are looking forward to bringing adagrasib to patients in need in China.” Bristol Myers Squibb will complete a full evaluation of the available data and will share the results with the scientific community at an upcoming medical conference as well as discuss the results with health authorities. Zai Lab expects to submit the New Drug Application NDA for adagrasib to the National Medical Products Association NMPA for KRASG12C mutated NSCLC in second or later line treatment in China this year.