Five year positive follow up of CHECKMATE 025 study of Opdivo versus everolimus for metastatic renal cell carcinoma .- BMS

Bristol-Myers Squibb Company announced five-year follow-up results from the Phase III CheckMate -025 study, which continue to demonstrate that treatment with Opdivo (nivolumab) 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 everolimus. The data will be presented on Saturday, February 15 at the American Society of Clinical Oncology 2020 Genitourinary Cancers Symposium in San Francisco. With an extended minimum follow-up of 64 months, patients treated with Opdivo 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. “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.”