Bristol-Myers Squibb said that a five-year follow-up of the phase 3 CheckMate -025 study showed that Opdivo (nivolumab) delivered superior five-year survival results in patients with renal cell carcinoma (RCC).
The company said that 26% of patients with previously treated advanced or metastatic renal cell carcinoma are alive at five years of treatment with Opdivo.
According to Bristol-Myers Squibb, the programmed death-1 (PD-1) immune checkpoint inhibitor delivered superior overall survival (OS) and objective response rates (ORR) in the patient population compared to those who were treated with everolimus.
The company said that 18% of patients treated with everolimus were alive at the extended minimum follow-up of 64 months for everolimus.
Apart from that, the percentage of patients who achieved an objective response was 23% for the PD-1 immune checkpoint inhibitor, compared to 4% for everolimus. The median duration of response (mDOR) for Opdivo was also sustained longer for 18.2 months compared to 14 months for everolimus, said Bristol-Myers Squibb.
CheckMate -025 study lead investigator Robert Motzer said: “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.
“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.”
Furthermore, the overall safety profile was in line with what was noted in previously reported analyses from the CheckMate -025 trial in patients with RCC. There were no new safety signals or drug-related deaths that occurred during the extended follow-up, said the pharma company.
Bristol-Myers Squibb genitourinary cancers development lead Brian Lamon said: “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.
“This study represents exciting progress in our mission to improve survival outcomes for all patients.”
The PD-1 immune checkpoint inhibitor has been approved in various countries as a monotherapy or in combination with other drugs for the treatment of various types of cancer.