After four years of treatment, the combination of nivolumab and ipilimumab showed benefits in overall survival and durable responses in an extension of a phase three clinical trial studying the treatment of untreated advanced or metastatic renal cell carcinoma compared to sunitinib.
A release from the manufacturer noted that the combination maintained improvements in overall survival and overall response rate in intermediate and poor-risk patients, which were the co-primary endpoints. Exploratory endpoints included complete response and median duration of response.
“Nivolumab plus ipilimumab was the first immunotherapy combination to demonstrate an overall survival advantage over sunitinib in intermediate and poor-risk patients with advanced renal cell carcinoma,” said Laurence Albiges, MD, an investigator with the Gustave Roussy Institute. “Now, after four years, the durable efficacy seen in CheckMate-214 represents important progress towards the aim of changing survival expectations for these patients.”
The median overall survival was 48.1 months for intermediate and poor-risk patients treated with the combination, compared to 26.6 months in the sunitinib arm (HR 0.65; 95% CI: 0.54-0.78). The overall survival for the combination was 50% compared to 35.8% when treated with sunitinib. The overall response rate was also better in the combination treatment arm (65% to 50%).
The release noted that complete response was consistent with results seen at the 42-month mark of the trial, with 10% of patients in the combination arm reaching that endpoint compared to 1% with sunitinib. The combination treatment did not reach the median duration of response, while the sunitinib arm had a response of 19.7 months.
The updated results also included patients in the intent to treat arm. While the combination treatment did not achieve overall response across all randomized patients, the endpoint in the sunitinib arm was 38.4 months (HR 0.69; [95% CI: 0.59-0.81]). The four-year overall survival rates were 53.4% and 43.3%, respectively. The overall response rate in the combination arm was 65% compared to 52%.
The release noted that safety in the expanded data was “manageable using established treatment algorithms.” No new safety signals were detected during the extended follow-up.
The data from the extended results were presented at the virtual ESMO congress.