Bristol-Myers Announces Positive Phase 3 Results For Kidney Cancer Drug

(RTTNews) - Bristol-Myers Squibb Co (BMY) on Friday announced positive results from a Phase 3 study comparing Opdivo to everolimus in advanced renal cell carcinoma after prior anti-angiogenic treatment, showing a significant overall survival benefit for Opdivo.

In the Phase 3 CheckMate -025 trial, Opdivo demonstrated a median overall survival (OS) benefit of 25 months compared to 19.6 months for everolimus. The safety profile is consistent with previously reported Opdivo trials.

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 versus standard of care.

The data will be presented on September 26 during the 2015 European Cancer Congress.

CheckMate -025 was stopped in July because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint, demonstrating superior OS in patients receiving Opdivo compared to the control arm.

Opdivo was granted Breakthrough Therapy Designation for advanced RCC by the U.S. Food and Drug Administration based on results from this trial and the clinical need for additional treatment approaches for RCC.

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

In addition to improving overall survival, Opdivo demonstrated a superior ORR of 25% versus 5% for everolimus, with one out of four patients experiencing a response.

The most frequent treatment-related adverse effects were fatigue, pruritus and nausea in the Opdivo arm and fatigue and stomatitis in the everolimus arm.

Abouty 30% of patients with RCC, a common type of kidney cancer in adults, present with metastatic or advanced disease at diagnosis.