BMS to discontinue colorectal cancer study of Opdivo, LAG-3 therapy

15 Dec 2023
firstwordpharma.com
ImmunotherapyPhase 3Drug Approval
Bristol Myers Squibb said Friday that it will stop a Phase III trial evaluating a fixed-dose combination of Opdivo (nivolumab) and the LAG-3 antibody relatlimab in certain patients with metastatic colorectal cancer (mCRC) due to futility. The company noted that the recommendation to stop the study was not based on safety concerns.
The RELATIVITY-123 study was evaluating a fixed-dose combination of Opdivo and relatlimab in 700 participants with microsatellite stable (MSS) mCRC whose disease has progressed following at least one, but no more than four prior lines of therapy for metastatic disease. The trial did not include patients with microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) tumours. The dual primary endpoints are overall survival (OS) in all-comers and in those with PD-L1 combined positive score (CPS) ≥ 1. Secondary endpoints include objective response rate (ORR), progression-free survival (PFS) and duration of response (DoR).
According to Bristol Myers Squibb, a planned analysis conducted by an independent data monitoring committee concluded that the trial was "unlikely to meet its primary endpoints upon completion." The company noted that the safety profile was in line with previously reported studies of the fixed-dose combination. Bristol Myers Squibb said it would complete a full evaluation of the RELATIVITY-123 data and share results with the scientific community.
"While we know immunotherapies have historically demonstrated limited efficacy in MSS colorectal cancers, we had hoped to demonstrate meaningful clinical benefit in this patient population and are disappointed in this outcome," remarked Jeffrey Walch, global programme lead at Bristol Myers Squibb. He added "we continue to be committed to the development of [immuno-oncology] therapies, including Opdivo and Yervoy (ipilimumab), in MSI-H/dMMR colorectal cancers."
Last year, the FDA approved a fixed-dose combination of Opdivo and relatlimab under the brand Opdualag for adult and paediatric patients aged 12 years and older with unresectable or metastatic melanoma.
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