The combination of Opdivo (nivolumab) and Yervoy (ipilimumab) was more effective in fighting advanced kidney cancer in previously untreated patients than the approved therapy Sutent (sunitinib), Bristol-Myers Squibb reported after analyzing data from an ongoing Phase 3 trial.
But while a larger proportion of patients treated with the combination experienced tumor shrinkage, the trial failed to meet a second primary endpoint, progression-free survival, which raises questions about its benefits as a first-line therapy.
Company representatives now plan to meet with regulatory authorities to discuss the future of an Opdivo–Yervoy combo as a first-line treatment for advanced kidney cancer.
Improved objective response rates were one of three main goals of the trial, called CheckMate-214 (NCT02231749). Data showed that 41.6% of patients treated with the combination responded to the therapy. With a response rate in the Sutent group of 26.5%, the trial met this goal.
Progression-free survival was a second primary outcome measure, and while it was seen to be better in the combination group — 11.56 months for the Opdivo–Yervoy combination compared with 8.38 months for Sutent — it was not enough to be statistically significant.
Patients receiving Sutent had a median duration of response of 18.17 months, while the median had not yet been reached for patients in the Opdivo and Yervoy combination group.
Data on overall survival — the trial’s third primary outcome measure — is not yet available.
“This is an important study in first-line renal cancer as these patients need new options,” Vicki Goodman, MD, development lead for melanoma and genitourinary cancers at Bristol-Myers Squibb, said in a press release.
“We are encouraged by the totality of the CheckMate-214 data. The overall response rate and durability of response favored the combination of Opdivo and Yervoy, and the trend for PFS supports the potential of the combination in intermediate and poor-risk advanced renal cell carcinoma, the most common type of kidney cancer,” Goodman added.
The data also showed that the treatment was considered safe, with a side effect profile similar to that seen in earlier studies.
The CheckMate-214 study included patients with advanced or metastatic renal cell carcinoma who were randomly assigned treatment with the Opdivo and Yervoy combo or with Sutent.
Patients in the combination group received Opdivo 3 mg/kg plus Yervoy 1 mg/kg every three weeks for four doses, followed by Opdivo 3 mg/kg every two weeks. Those treated with Sutent received 50 mg once daily for four weeks, followed by two weeks off before the treatment continued.
“Opdivo is now well established as standard of care in the treatment of second-line renal cell carcinoma,” Goodman said. “The company plans to share these important first-line data with regulatory authorities and we look forward to reporting overall survival when these data mature,” she added.
Researchers continue to follow the enrolled patients to gather data on overall survival and will present full data analysis at an upcoming scientific meeting.