KRAZATI Confirms Progression-Free Survival Benefit in Phase 3 KRYSTAL-12 Trial for Advanced NSCLC Patients

The pharmaceutical company Bristol Myers Squibb has reported positive results from a major Phase 3 clinical trial for its drug KRAZATI (adagrasib). The KRYSTAL-12 study was designed to evaluate the drug's effectiveness as a single treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has the KRASG12C mutation. The trial successfully met its primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate (ORR), as determined by a blinded independent central review.

KRAZATI has demonstrated significant benefits in PFS and ORR when compared to standard chemotherapy for patients who have received prior treatment. The drug has shown no new safety concerns, and its safety profile aligns with what is already known. The study is ongoing to further assess overall survival as an additional key secondary endpoint.

Bristol Myers Squibb's vice president, Abderrahim Oukessou, M.D., highlighted the importance of targeted therapies for patients with advanced or metastatic KRASG12C-mutated lung cancer. The FDA's approval of KRAZATI in the U.S. has provided a new option for these patients, and the KRYSTAL-12 study's results are expected to bolster confidence among medical professionals and patients.

The company plans to present the findings at an upcoming medical conference and discuss them with health authorities. KRAZATI received accelerated approval from the FDA in December 2022 for treating patients with KRASG12C-mutated NSCLC who have had at least one prior systemic therapy. In 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for KRAZATI, followed by the European Commission in 2024.

KRAZATI is a highly selective and potent oral inhibitor of KRASG12C, designed to sustain target inhibition, which is crucial given the KRAS protein's regeneration cycle. KRASG12C mutations are found in approximately 14% of NSCLC cases, 3-4% of colorectal cancer cases, and 1-2% of several other cancers.

The drug is also being tested in combination with other treatments for various solid tumors, including advanced colorectal cancer and pancreatic cancer. The FDA has accepted a priority review for a supplemental new drug application for KRAZATI in combination with cetuximab for colorectal cancer.

Bristol Myers Squibb is dedicated to transforming patients' lives through scientific advancements, focusing on personalized medicine and innovative platforms to enhance cancer research and treatment. The company is committed to addressing all aspects of cancer care, from diagnosis to survivorship, aiming to empower patients with a better future.