Bristol Myers Squibb's Acquired Adagrasib Combo Therapy May Benefit Colorectal Cancer Patients With Certain Mutation

Monday, Bristol Myers Squibb & Co BMY released data from the cohorts of the Phase 1/ 2 KRYSTAL-1 study evaluating Krazati (adagrasib) in combination with cetuximab for previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer.

With a median follow-up of 11.9 months in 94 patients, Krazati plus cetuximab demonstrated an objective response rate, the primary endpoint, of 34%, median progression-free survival of 6.9 months, and median overall survival of 15.9 months.

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The median duration of response was 5.8 months. Disease control was observed in 85% of patients. The safety profile for Krazati plus cetuximab was manageable and consistent with previous reports and with the known safety profile of each drug individually.

The company announced in February 2024 that the FDA had accepted a supplemental new drug application for Krazati in combination with cetuximab as a targeted treatment option for patients with previously treated KRASG12C-mutated locally advanced or metastatic CRC for priority review and assigned a Prescription Drug User Fee Act goal date of June 21, 2024.

Mirati Therapeutics Inc., a Bristol Myers Squibb company, funded this study. 

Last week, Bristol Myers announced results from the Phase 3 KRYSTAL-12 study, evaluating Krazati (adagrasib) as a monotherapy for pretreated locally advanced or metastatic non-small cell lung cancer harboring a KRASG12C mutation.

The study met the primary endpoint of progression-free survival and the key secondary endpoint of overall response rate.

The study remains ongoing to assess the additional key secondary endpoint of overall survival. 

In 2022, Krazati was granted accelerated approval for KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer who have received at least one prior systemic therapy. In 2024, the European Commission granted conditional marketing authorization for Krazati.

Price Action: BMY shares are down 0.27% at $51.18 on the last check Monday.

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