▎WuXiEdited by Kant Content Team

Bristol-Myers Squibb today announced updated data from the KRYSTAL-1 clinical trial at the 2024 American Association for Cancer Research (AACR) Annual Meeting. The study evaluates its KRAS G12C inhibitor, Krazati (adagrasib), in combination with cetuximab for the treatment of tumors harboringKRASEfficacy and Safety in G12C-Mutant Pretreated Advanced or Metastatic Colorectal Cancer (CRC) Patients.Analysis shows that 85% of patients have their conditions under control.Detailed experimental results were also published simultaneously inCancer DiscoveryIn the journal. Bristol-Myers Squibb has submitted a supplemental New Drug Application (sNDA) for the relevant indications, which has been granted by the FDA.Priority Review Status，The PDUFA target date is June 21, 2024.

In 94 patients, the median follow-up time for Krazati combined with cetuximab was 11.9 months.The analysis shows,In the treatedKRAS In patients with G12C-mutant locally advanced or metastatic CRC, the objective response rate (primary endpoint) was 34%, the median progression-free survival was 6.9 months (95% CI: 5.7-7.4), and the median overall survival was 15.9 months (95% CI: 11.8-18.8). The median duration of response was 5.8 months. Disease control was achieved in 85% of patients.

▲Summary of Efficacy Results from the KRYSTAL-1 Trial (Image Source: Reference [2])

The safety of Krazati in combination with cetuximab is manageable, consistent with previous reports and the known safety profile of each drug.

▲Efficacy Results of the KRYSTAL-1 Trial (Image Source: Reference [2])

Krazati is a highly specific and potent oral KRAS G12C inhibitor designed with optimized, sustained target inhibition.Krazati has a half-life of up to 24 hours and extensive tissue distribution. It is also able to cross the blood-brain barrier, which helps maximize drug efficacy. In June 2021, the FDA granted it Breakthrough Therapy designation, and it was approved by the FDA for marketing in December 2022 for the treatment of patients carryingKRASPatients with G12C-mutant non-small cell lung cancer who have been previously treated. Zai Lab has obtained the rights for research, development, manufacturing, and exclusive commercialization of adagrasib in Greater China.

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References:

[1] KRAZATI (adagrasib) in Combination with Cetuximab Demonstrates Clinically Meaningful Activity as a Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC). Retrieved April 8, 2024 from https://www.businesswire.com/news/home/20240407754891/en

[2] Yaeger, Rona et al. “Efficacy and Safety of Adagrasib plus Cetuximab in Patients with KRASG12C-Mutated Metastatic Colorectal Cancer.” Cancer discovery, OF1-OF12. 8 Apr. 2024, doi:10.1158/2159-8290.CD-24-0217

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