BMS announces new 5-year data in advanced renal cell carcinoma

Pharma News: Bristol-Myers Squibb announced five-year follow-up study results demonstrating that Opdivo (nivolumab) treatment delivers superior overall survival (OS) and objective response rates (ORR) in patients with previously treated advanced or metastatic renal cell carcinoma (RCC) compared to those treated with Novartis’ everolimus. 

With an extended minimum follow-up of 64 months, patients treated with Opdivo in the phase III CheckMate -025 study continue to demonstrate OS benefit with 26% of patients alive compared to 18% of patients treated with everolimus. Additionally, the percentage of patients experiencing an objective response was 23% for Opdivo versus 4% for everolimus and the median duration of response (mDOR) for Opdivo was also maintained longer than for everolimus (18.2 months vs. 14 months, respectively).

The overall safety profile was consistent with that observed in previously reported analyses from CheckMate -025 in patients with RCC. No new safety signals or drug-related deaths occurred with extended follow-up.

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“Five-year survival results from the CheckMate -025 study, along with the ongoing response rates observed in the trial, highlight the potential for long-term survival and efficacy of nivolumab monotherapy for patients with previously-treated advanced RCC,” said lead investigator Robert J. Motzer, MD, Kidney Cancer Section Head, Memorial Sloan Kettering Cancer Center. “These data represent the longest follow-up for a PD-1 immune checkpoint inhibitor in this setting and underscore the potential increased survival rates nivolumab can deliver for patients with advanced RCC who have received prior antiangiogenic therapy.”

“The updated CheckMate -025 results support why Opdivo monotherapy became a standard of care for previously treated RCC patients worldwide and offer additional evidence that treatment with Opdivo has the potential to help patients live longer,” said Brian Lamon, Ph.D., development lead, genitourinary cancers, Bristol-Myers Squibb. “This study represents exciting progress in our mission to improve survival outcomes for all patients.”

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