PRINCETON - Bristol Myers Squibb (NYSE: NYSE:BMY) today announced that its Phase 3 KRYSTAL-12 study of KRAZATI (adagrasib) met its primary endpoint of progression-free survival (PFS) in treating patients with a specific mutation in advanced non-small cell lung cancer (NSCLC).
The trial, which focused on patients with the KRASG12C mutation who had previously undergone treatment, also achieved a key secondary endpoint of overall response rate (ORR).
The study remains ongoing, with the additional secondary endpoint of overall survival still under assessment. The results indicated a statistically significant improvement in PFS and ORR for patients treated with KRAZATI compared to those who received standard chemotherapy. The safety profile of KRAZATI was consistent with previous findings, with no new safety concerns reported.
KRAZATI, a targeted therapy, received accelerated FDA approval in December 2022 for patients with KRASG12C-mutated NSCLC who have undergone at least one prior systemic therapy. This approval was based on the ORR and duration of response observed in clinical trials.
Conditional marketing authorizations followed in 2023 by the UK's Medicines and Healthcare products Regulatory Agency and by the European Commission in 2024.
Beyond NSCLC, KRAZATI has shown potential benefits in Phase 2 trials for various solid tumors, including colorectal and pancreatic cancers. A supplemental new drug application (sNDA) for KRAZATI in combination with cetuximab for KRASG12C-mutated colorectal cancer is currently under priority review by the FDA, with a decision expected by June 21, 2024.
KRAZATI is designed to inhibit the KRASG12C mutation, which is prevalent in approximately 14% of NSCLC cases and a smaller percentage in other cancers. The therapy aims to sustain inhibition of the KRAS protein, which regenerates every 24-48 hours.
Bristol Myers Squibb has expressed gratitude to the patients and investigators involved in the KRYSTAL-12 clinical trial and plans to share detailed results with the scientific community soon. The company continues to focus on advancing cancer treatments, aiming to improve patient outcomes through science.
This article is based on a press release statement from Bristol Myers Squibb.
InvestingPro Insights
As Bristol Myers Squibb (NYSE: BMY) reports significant advancements in its cancer treatment studies, the company's financial health and market performance offer additional insights. InvestingPro data indicates a market capitalization of $109.66 billion, reflecting the company's substantial presence in the pharmaceutical industry.
The stock is trading at a P/E ratio of 14.01, which, when adjusted for the last twelve months as of Q4 2023, stands at an even more attractive 11.63. This low P/E ratio relative to near-term earnings growth suggests the company's earnings are robust in comparison to its share price.
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