BMS Surpasses Amgen in Confirmatory NSCLC Trial with Krazati

Bristol Myers Squibb has announced positive outcomes from the Phase III KRYSTAL-12 clinical trial for Krazati (adagrasib), a medication for non-small cell lung cancer (NSCLC) patients with specific KRAS G12C mutations. The trial demonstrated that Krazati significantly improved progression-free survival (PFS) and overall response rate when compared to standard chemotherapy in a second-line or later setting.

Although detailed data was not disclosed, the company stated that Krazati's safety profile was as expected, with no new concerns arising from the study. The global program lead for Krazati at BMS, Abderrahim Oukessou, highlighted the trial's results as a significant milestone, reinforcing Krazati's role in treating advanced NSCLC with the KRAS G12C mutation.

BMS plans to present a comprehensive analysis of the KRYSTAL-12 data at an upcoming medical conference and will submit the findings to health authorities for review. Krazati was originally developed by Mirati and works by irreversibly inhibiting the KRAS G12C protein, thereby preventing the uncontrolled growth of cancer cells without harming healthy cells. BMS acquired Mirati for $4.8 billion in October 2023, gaining access to Krazati.

Krazati received accelerated FDA approval in December 2022 for adult patients with metastatic or locally advanced NSCLC with the KRAS G12C mutation, conditional on the outcomes of the KRYSTAL-12 confirmatory study. The FDA's accelerated approval pathway was utilized, and the recent positive results from KRYSTAL-12 will be critical for maintaining Krazati's market presence.

The success of Krazati positions BMS ahead of its competitor Amgen, whose KRAS blocker Lumakras (sotorasib) failed to secure full FDA approval in December 2023. The FDA's Oncologic Drugs Advisory Committee rejected Lumakras due to concerns over the reliability of data from Amgen's CodeBreaK 200 study. Amgen has been instructed to complete an additional confirmatory study by February 2028 to support full approval of Lumakras.

The KRYSTAL-12 study's results are a significant development in the treatment of NSCLC, offering a promising alternative for patients with KRAS G12C mutations and showcasing the potential of targeted therapies in oncology.