Positive Phase 3 Results for Opdivo in Renal Cell Carcinoma

Bristol-Myers Squibb announced positive results from CheckMate -025, a Phase 3 study comparing Opdivo (nivolumab) to everolimus in advanced renal cell carcinoma (RCC) after prior anti-angiogenic treatment.

CheckMate -025 is a Phase 3 randomized, open-label study of Opdivo vs. everolimus in previously treated patients with advanced clear-cell RCC after prior anti-angiogenic treatment. Patients received either Opdivo (n=410) 3mg/kg IV every two weeks or everolimus (n=411) 10mg orally once daily. The primary endpoint was overall survival (OS).

Results from CheckMate -025 mark the first and only Phase 3 study to demonstrate a significant survival advantage in previously treated patients with advanced RCC vs. standard of care. In the trial, Opdivo achieved a median OS of 25 months compared to 19.6 months for everolimus (hazard ratio: 0.73; [98.5% CI, 0.57–0.93; P=0.0018]), with comparable OS benefit seen across PD-L1 expression levels. In addition to improving OS, Opdivo demonstrated a superior objective response rate (ORR) of 25% vs. 5% for everolimus (P<0.0001), with one out of four patients experiencing a response. Detailed results were presented at the 2015 European Cancer Congress and will be published in The New England Journal of Medicine.

RELATED: Opdivo Receives Breakthrough Therapy Status for Renal Cancer Use

CheckMate -025 was halted early in July 2015 due to a conclusion by the Data Monitoring Committee (DMC) that the study met its primary endpoint, demonstrating superior OS in patients receiving Opdivo vs. the control arm. The Food and Drug Administration (FDA) granted Opdivo Breakthrough Therapy designation for advanced RCC based on results from this trial.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor currently FDA-approved for the treatment of unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor, and for the treatment of metastatic squamous (SQ) non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

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