Bristol-Myers Squibb has announced the early closure of its phase 3 CheckMate-025 trial evaluating nivolumab (Opdivo) compared with everolimus for the treatment of previously-treated patients with advanced or metastatic renal cell carcinoma.
The study was stopped early because an independent Data Monitoring Committee assessment found that nivolumab is superior to everolimus in this patient population.
“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 RCC by providing improved survival.”
For the open-label trial, 821 previously-treated patients with advanced or metastatic clear-cell renal cell carcinoma were randomly assigned to receive either everolimus 10 mg orally daily or nivolumab 3 mg/kg intravenously until unacceptable toxicity or disease progression. The primary endpoint was overall survival with objective response rate and progression-free survival as secondary endpoints.
Eligible patients receiving everolimus will be given the opportunity to continue the current treatment or initiate treatment with nivolumab as part of an open-label extension.
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Opdivo is already U.S. Food and Drug Administration (FDA)-approved for the treatment of certain patients with unresectable or metastatic melanoma and metastatic squamous non-small cell lung cancer.
Clear-cell renal cell carcinoma is the most common type of renal cell carcinoma and the most prevalent form of kidney cancer among adults.
- CheckMate-025, a Pivotal Phase III Opdivo (nivolumab) Renal Cell Cancer Trial, Stopped Early [news release]. Princeton, NJ: Bristol-Myers Squibb. July 20, 2015. http://news.bms.com/press-release/checkmate-025-pivotal-phase-iii-opdivo-nivolumab-renal-cell-cancer-trial-stopped-early. Accessed July 20, 2015.