Zai Lab (NASDAQ: ZLAB; HKG: 9688), a China-based biotech company, has announced positive Phase III results for Krazati (adagrasib) in the treatment of KRASG12C-mutated non-small cell lung cancer (NSCLC) as a second-line therapy. The company is now preparing to submit a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) for the drug by the end of this year.
Krazati is a highly selective oral small-molecule inhibitor of KRASG12C, designed to maintain sustained target inhibition. The drug was originated by Mirati Therapeutics and received its initial accelerated approval in the US for KRASG12C-mutated NSCLC in 2022. This drug was a significant factor in Bristol-Myers Squibb’s (BMS) decision to acquire Mirati for USD 5.8 billion, a deal that was closed in January 2024. Zai Lab acquired the rights to Krazati in Greater China from Mirati in 2021, with an upfront payment of USD 60 million and potential milestone payouts up to USD 273 million.
In the open-label, multicenter, randomized Phase III KRYSTAL-12 study, Krazati was evaluated as a monotherapy against the standard of care chemotherapy in patients with KRASG12C-mutated NSCLC who had previously received at least one line of therapy. The study not only met its primary endpoint of progression-free survival (PFS) but also achieved the secondary endpoint of overall response rate (ORR). Further analysis is underway to confirm whether the secondary endpoint of overall survival (OS) was also met.
BMS continues to develop Krazati and Krazati-based combinations in various Phase II studies, generating promising data for advanced colorectal cancer (CRC), pancreatic cancer, and other solid tumor types. A supplemental new drug application (sNDA) was submitted to the US FDA in February 2024 for Krazati in combination with cetuximab for previously treated KRASG12C-mutated locally advanced or metastatic CRC.- Flcube.com
