CheckMate-214: Nivolumab and Ipilimumab in Intermediate- and Poor-Risk Previously Untreated Advanced or Metastatic RCC

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.”

About CheckMate-214

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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


Advertisement

Advertisement



Advertisement

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.