Photo: Bristol-Myers Squibb Building in Munich / iStock Tati Campero
Bristol-Myers Squibb is discontinuing a clinical trial studying a combination of Opdivo (nivolumab) and leratorimab, called Opdurag, in patients with stable microsatellite metastatic colorectal cancer.
Data from a Phase III trial of the combination, known as Relativity-123, was reviewed by an independent data monitoring board and found the trial did not meet its primary endpoint, BMS said in a statement Friday. announced. BMS said there were no safety concerns and the safety profile was consistent with other combination studies.
“Metastatic colorectal cancer is a cancer with high unmet needs and is difficult to treat. Progress has been made in the treatment of patients with microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) colorectal cancer. However, treatment options remain limited for subsequent treatment of patients with microsatellite stable (MSS) tumors,” Jeffrey said. Walch, vice president and global program leader at BMS, said in a company statement. “While we know that immunotherapy has historically had limited efficacy for MSS colorectal cancer, we wanted to demonstrate meaningful clinical benefit in this patient population, and our results It’s a shame.”
Walch added that BMS will continue to work on developing immunotherapies for colorectal cancer, but did not provide further details.
BMS also said it will continue to study the combination as a treatment for other tumors. This result does not affect the approved indication for patients with unresectable or metastatic melanoma. The drug company plans to share the data with researchers to determine next steps for patients enrolled in the trial. BMS said it would also share the data with the scientific community.
The combination of Opdrag is Approved in March last year The FDA’s announcement comes after a Phase III trial found a statistically significant improvement in progression-free survival for patients with unresectable or metastatic melanoma. Opdrag has been a significant cash cow for the New York-based drug company since its approval. Sales of $166 million In the third quarter of 2023.
BMS made several data announcements this month, announcing data from the Phase III CheckMate-8HW study showing the first-line potential of Opdivo and Yervoy in colorectal cancer. The trial achieved statistical significance. Also this month, data from BMS and 2seventy bio’s CAR-T cell therapy for multiple myeloma was published. We showed that this treatment does not statistically significantly prolong patients’ lives compared to standard treatment.
Tyler Patchen is a staff writer at BioSpace. Contact tyler.patchen@biospace.com.please follow him linkedin.