Bristol-Myers Squibb's Opdivo Phase III Study Stopped Early on More Good Cancer Therapy News
Published: Jul 21, 2015
July 20, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Princeton, N.J.-based Bristol-Myers Squibb Company announced today that its Phase III trial of Opdivo (nivolumab) compared to everolimus in patients with advanced or metastatic renal cell carcinoma (RCC) was halted early because it met its endpoint.
The independent Data Monitoring Committee (DMC) agreed that the study showed superior overall survival in patients that received Opdivo compared to the control group. The study, called CheckMate -025 looked at 821 randomized patients that either received nivolumab 3 mg/kg intravenously every two weeks or everolimus 10 mg tablets daily until either seeing disease progression or adverse events. The primary endpoint is overall survival and the secondary endpoints are objective response rate and progression-free survival.
“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,” said Michael Giordano, senior vice president, head of Development, Oncology at Bristol-Myers Squibb in a statement. “Through our Opdivo clinical development program, we aim to redefine treatment expectations for patients with advanced RCC by providing improved survival.”
The trial was planned to be completed by February 2016.
On April 17, 2015, Bristol-Myers Squibb announced that its Phase III trial of Opdivo in patients with advanced non-squamous non-small cell lung cancer (NSCLC) was halted because the independent Data Monitoring Committee (DMC) decided the study had met its endpoint, superior overall survival in Opdivo patients compared to the control group.
“The results of CheckMate -057 mark the second time Opdivo has demonstrated a survival advantage in lung cancer,” said Giordano in a statement at the time. “Through our Opdivo clinical development program, we seek to bring the potential for long-term survival to a broad range of patients, across lines of therapy and stages of disease.”
In a related story, South San Francisco, Calif.-based Exelixis, Inc. announced that its Phase III clinical METEOR trial comparing Cometriq (cabozantinib) to everolims in metastatic renal cell carcinoma had positive topline results. That drug showed significant increase in progression-free survival (PFS) in the first 375 patients of the full study population of 658.
The Bristol-Myers Squibb data may take a little wind out of the sales of Exelixis, Inc.'s good news, although the RCC market is in need of good news and effective treatments. RCC is the most common form of kidney cancer in adults and causes more than 100,000 deaths annually. The five-year survival rate for patients with metastatic or advanced kidney cancer is 12.1 percent.
Another big company working on RCC is Roche , with its atezolizumab. On July 13, 2015, Genentech announced positive results for the drug in urothelial bladder cancer.
Opdivo is a new form of drug called PD-1 inhibitors. Along with CAR-T therapies, anti-PD-1 drugs are the not new property with Genentech , Amgen and Roche, Merck & Co. and Sorrento Therapeutics, Inc. all working on anti-PD-1 drugs.