US-based pharmaceutical company Bristol-Myers Squibb (BMS) has announced that it will discontinue the Phase III RELATIVITY-123 clinical trial of nivolumab plus relatlimab to treat microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients.

The trial is being cancelled due to futility based on a planned analysis carried out by an independent data monitoring committee.

The fixed-dose combination regimen was intended for patients whose disease had progressed after between one and four previous lines of therapy.

The open-label, randomised and multi-centre trial was designed to assess nivolumab and relatlimab versus regorafenib or trifluridine with tipiracil in nearly 700 adult subjects.

Following the independent analysis, BMS concluded that the study was not likely to meet its primary endpoints after completion.

The company also said the committee’s recommendation to halt the trial was not based on safety issues. 

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In addition, the safety profile of the fixed-dose combination of nivolumab plus relatlimab matched that recorded in previous trials.

Various other tumour studies involving the nivolumab-relatlimab combination therapy will not be impacted by the trial cancellation, which will also not affect the presently approved indication in unresectable or metastatic melanoma for patients aged 12 years or older.

BMS vice-president and global programme lead Jeffrey Walch said: “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. 

“We continue to be committed to the development of I-O therapies, including Opdivo (nivolumab) and Yervoy (ipilimumab), in MSI-H/dMMR colorectal cancers, and we thank the investigators, patients and their loved ones who participated in this trial.”

In January 2023, BMS reported topline data from the Phase I/II TRANSCEND CLL 004 trial of Breyanzi in adult patients with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma.