PRINCETON, N.J. - Bristol Myers Squibb (NYSE: NYSE:BMY) has released data from its KRYSTAL-1 study, evaluating the efficacy of KRAZATI (adagrasib) in combination with cetuximab for treating KRASG12C-mutated colorectal cancer (CRC).
The findings, presented today at the American Association for Cancer Research (AACR) annual meeting, indicate a potential new treatment option for patients with this genetic mutation.
The study involved 94 patients who had previously undergone treatment for locally advanced or metastatic CRC. With a median follow-up of 11.9 months, the combination therapy showed an objective response rate of 34%, a median progression-free survival of 6.9 months, and a median overall survival of 15.9 months.
Moreover, 85% of patients achieved disease control. The safety profile was consistent with previous reports and the known safety profiles of each drug.
KRASG12C mutations serve as oncogenic drivers in approximately 3-4% of CRC cases. Historically, patients with this mutation have had limited treatment options and poor prognoses. Dr. Scott Kopetz from The University of Texas MD Anderson Cancer Center emphasized the significance of the study, suggesting adagrasib could benefit these specific patients.
Anne Kerber, senior vice president at Bristol Myers Squibb, highlighted the importance of testing for KRASG12C mutations in CRC patients to tailor treatment approaches. The combination therapy's promise comes after the FDA's acceptance in February 2024 of a supplemental new drug application for KRAZATI with cetuximab for priority review, with a decision expected by June 21, 2024.
KRAZATI, a KRASG12C inhibitor, has previously been granted accelerated approval for treating KRASG12C-mutated non-small cell lung cancer (NSCLC) after at least one prior systemic therapy. The drug's approval for NSCLC is contingent upon the verification of clinical benefit in confirmatory trials.
The study was funded by Mirati Therapeutics (NASDAQ:MRTX), Inc., a Bristol Myers Squibb company, which extended thanks to the patients and investigators involved in the KRYSTAL-1 clinical trial. As the company continues to explore new cancer treatments, this recent development marks a step forward for individuals battling KRASG12C-mutated CRC.
This article is based on a press release statement from Bristol Myers Squibb.
InvestingPro Insights
As Bristol Myers Squibb (NYSE: BMY) advances its oncology portfolio with promising clinical trial results for KRAZATI in colorectal cancer, investors are closely monitoring the company's financial health and market position. An analysis of recent data from InvestingPro shows a company with a strong financial foundation and a commitment to shareholder value.
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