The combination of Opdivo (nivolumab) and Yervoy (ipilimumab) was more effective in prolonging the lives of newly diagnosed metastatic renal cell carcinoma patients than the current standard of care, Sutent (sunitinib), new data from an ongoing Phase 3 trial shows.
After reviewing the data, the trial’s Independent Data Monitoring Committee recommended an early ending for the Phase 3 CheckMate-214 study (NCT02231749).
“This overall survival result from CheckMate-214 highlights the potential of the combination of Opdivo and Yervoy to provide a new treatment option for first-line advanced renal cell carcinoma patients for whom there is a considerable unmet need,” Vicki Goodman, MD, head of new asset development at Bristol-Myers Squibb, said in a press release.
The CheckMate-214 trial included patients with advanced or metastatic renal cell carcinoma who were randomly assigned the Opdivo plus Yervoy combination, or the standard of care, Sutent.
Participants in the combination arm received Opdivo 3 mg/kg plus Yervoy 1 mg/kg every three weeks, for a total of four doses, followed by Opdivo every two weeks. Those on the Sutent group received 50 mg of the drug once daily for four weeks, followed by two weeks off, before continuation of therapy.
The trial’s primary measures were overall response rate, progression-free survival, and overall survival in an intermediate to poor-risk population.
In August, Brystol-Myers reported that a larger population of patients treated with the combination had experienced tumor shrinkage (41.6%) than those receiving Sutent (26.5%), meeting one of the trial’s endpoints.
The combination also improved the time to disease progression or death by 18 percent — from 8.4 months to 11.6 months. However, the results did not reach statistical significance, raising questions about its benefits.
The new data shows that CheckMate-214 met its third co-primary outcome, with intermediate- and poor-risk patients treated with the combination living longer than those on Sutent. It also improved the overall survival in all randomized patients, one of the trial’s secondary endpoints.
The safety and tolerability profiles of the combo therapy were consistent with those reported in previous studies.
The latest results from CheckMate-214 will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress, to be held Sept. 8-12, 2017 in Madrid, Spain. The oral presentation is titled “CheckMate -214: Efficacy and safety of nivolumab + ipilimumab v sunitinib for treatment-naïve advanced or metastatic renal cell carcinoma, including IMDC risk and PD-L1 expression subgroups.”
“The company looks forward to sharing the full results with regulatory authorities and will incorporate these data into the planned European Society for Medical Oncology (ESMO) Congress presentation later this week,” Goodman said.