The US-based drugmaker Bristol-Myers Squibb announced that CheckMate-025, a Phase 3 study investigating Opdivo (nivolumab) versus everolimus, was stopped early after the immunotherapy was found to be effective in patients with kidney cancer.
The study was stopped early after an independent data monitoring committee concluded that Opdivo provided overall survival advantage over the cancer drug, everolimus, among patients with advanced or metastatic clear-cell renal cell carcinoma.
"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, Bristol-Myers Squibb.
"Through our Opdivo clinical development program, we aim to redefine treatment expectations for patients with advanced renal cell carcinoma by providing improved survival," said Giordano.
Bristol investigators recruited 821 patients for the study, Checkmate-025, to receive either Opdivo or everolimus until documented disease progression or unacceptable toxicity. The primary endpoint is overall survival. The trial was expected to be completed by February 2016.
In April, a trial testing Opdivo was stopped early after the drug was found effective against lung cancer.