Bristol-Myers’s Phase III RCC trial of Opdivo shows superior overall survival over everolimus

The open-label, randomized trial was ended early because of the assessment data reported by the independent Data Monitoring Committee (DMC).

The data showed that the trial met its endpoint, showing superior overall survival in patients receiving Opdivo compared to the control arm.

In the trial, a total of 821 patients were randomized to receive either nivolumab 3mg/kg intravenously every two weeks or everolimus 10mg tablets by mouth daily until documented disease progression or unacceptable toxicity.

The primary endpoint of the trial is overall survival, while secondary endpoints include objective response rate and progression-free survival.

Bristol-Myers Squibb Development, Oncology head and senior vice-president Michael Giordano said: "The results of CheckMate -025 mark the first time an Immuno-Oncology agent has demonstrated a survival advantage in advanced renal cell carcinoma, a patient group that currently has limited treatment options.

"Through our Opdivo clinical development program, we aim to redefine treatment expectations for patients with advanced RCC by providing improved survival."

Investigators of the CheckMate -025 trial are being informed of the decision to stop the comparative portion of the study.

Currently, the company is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension.

The company said it will complete a full evaluation of the final CheckMate -025 data and work with investigators on the future presentation and publication of the results.