Bristol Myers Squibb Company announced that CheckMate-025, a Phase 3 study investigating Opdivo (nivolumab) vs. everolimus in previously treated patients with advanced or metastatic renal cell carcinoma (RCC) was stopped early due to the primary endpoint being met.
The recommendation was made by the Independent Data Monitoring Committee (DMC) after determining that the study showed superior overall survival in patients receiving Opdivo compared to the control arm. CheckMate-025 is an open-label, randomized study of Opdivo vs. everolimus in previously-treated patients with advanced or metastatic clear-cell renal cell carcinoma. The trial randomized 821 patients to receive either nivolumab or everolimus until documented disease progression or unacceptable toxicity. The primary endpoint is overall survival.
Bristol-Myers Squibb will inform all eligible patients of the opportunity to continue or start treatment with Opdivo in an open-label extension. The company will complete a full evaluation of the final CheckMate-025 data and work with investigators on the future presentation and publication of the results. M
Opdivo is already indicated for unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. It is also approved for metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
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