On August 15, Bristol-Myers Squibb Company announced topline results from the CheckMate-214 trial investigating nivolumab (Opdivo) in combination with ipilimumab (Yervoy) vs sunitinib (Sutent) in intermediate- and poor-risk patients with previously untreated advanced or metastatic renal cell carcinoma.
The study met the coprimary endpoint of objective response rate, which was 41.6% for the combination vs 26.5% for sunitinib. Median duration of response was not reached for the combination of nivolumab and ipilimumab, and was 18.17 months for sunitinib. While there was an improvement in progression-free survival (hazard ratio = 0.82; 95% confidence interval [CI] = 0.64–1.05; stratified 2-sided P = .03), it did not reach statistical significance. The median progression-free survival was 11.56 months (95% CI = 8.71–15.51) for the nivolumab and ipilimumab combination vs 8.38 months (95% CI = 7.03–10.81) for sunitinib.
The study will continue as planned to allow the third coprimary endpoint of overall survival to mature.
The tolerability profile observed in CheckMate-214 was consistent with that observed in previously reported studies of this dosing schedule.
“We are encouraged by the totality of the CheckMate-214 data. The overall response rate and durability of response favored the combination of [nivolumab and ipilimumab], and the trend for progression-free survival supports the potential of the combination in intermediate- and poor-risk advanced renal cell carcinoma, the most common type of kidney cancer. This is an important study in first-line renal cancer as these patients need new options,” said Vicki Goodman, MD, Development Lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb. “We look forward to presenting the full results from this study at an upcoming medical meeting.”
CheckMate-214 is a phase III, randomized, open-label study evaluating the combination of nivolumab and ipilimumab vs sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma.
Patients in the combination group received nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg every 3 weeks for 4 doses, followed by nivolumab at 3 mg/kg every 2 weeks. Patients in the comparator group received sunitinib at 50 mg once daily for 4 weeks, followed by 2 weeks off before continuation of treatment. Patients were treated until disease progression or unacceptable toxic effects.
The primary endpoints of the trial are progression-free survival, overall survival, and objective response rate in an intermediate to poor-risk patient population (approximately 75% of patients). Safety is a secondary endpoint.
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