Bristol-Myers Squibb (BMS) has reported positive phase 3 results for its clinical trial of a combination of immunotherapy drugs nivolumab (Opdivo) plus ipilimumab (Yervoy) for the treatment of people with previously untreated, advanced or metastatic renal cell carcinoma (RCC). This has led to the trial being stopped early following a planned interim analysis of the survival data.
The CheckMate-214 phase 3 trial recruited a total of 1,070 patients with previously untreated, advanced or metastatic RCC. The trial was stopped early because the results for overall survival (OS) were very good, and, according to an interim analysis of the data for intermediate- and poor-risk patients by an Independent Data Monitoring Committee, the overall survival benefit in the study was reached. The patients are still being followed in this study, and with a minimum follow-up of 17.5 months, nivolumab in combination with ipilimumab reduced the risk of death 37% compared with sunitinib, the current standard of care. The median overall survival has not yet been reached for the combination and was 26 months for sunitinib. These results were presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain.
The results also showed that patients treated with the nivolumab plus ipilimumab combination achieved a better objective response rate compared to those who were only treated with sunitinib (41.6% compared to 26.5% respectively).
Overall survival was one of the co-primary endpoints of the study, and was highly positive. On this basis, BMS can apply for marketing approval from the Food and Drug Administration (FDA) in the US. When first published about a month ago, results from CheckMate-214 were disappointing when BMS reported that the combination failed to improve progression-free survival (PFS), another co-primary endpoint in the study.
“There is an unmet need for additional treatment options in the first line setting that may provide a meaningful survival benefit including more durable, complete responses for patients with advanced renal cell carcinoma. These results for the combination of nivolumab and ipilimumab are very encouraging in patients with first-line mRCC who have a very poor prognosis,” said Dr Bernard Escudier, former chair of the genitourinary group of the Institut Gustave Roussy in Villejuif, France.