Adjuvant therapy with the combination ofnivolumab (Opdivo) and ipilimumab (Yervoy) did not improve disease-free survival (DFS) in patients with renal cell carcinoma (RCC) who had received radical or partial nephrectomy and were at moderate or high risk of relapse.1
The findings from Part A of the phase 3 CheckMate-914 trial were reported in a press release from Bristol Myers Squibb, the developer of both immune checkpoint inhibitors. The company also noted that there were no new safety signals with nivolumab/ipilimumab compared with previous studies of the combination in solid tumors.
“Even with notable progress in the treatment of metastatic renal cell carcinoma, there are still limited treatment options available for patients with localized disease,” Dana Walker, MD, MSCE, vice president, development program lead, genitourinary cancers, Bristol Myers Squibb, stated in a press release.
“Opdivo and Opdivo-based combinations have shown survival benefits in several earlier-stage and advanced cancers, including genitourinary tumors, and we are disappointed that the final analysis of CheckMate-914 Part A did not show this same benefit for the post-surgical treatment of patients with localized RCC. Nonetheless, we are dedicated to continuing research and advancing cancer care for all patients with RCC,” added Walker.
Overall, cohort A of the double-blinded CheckMate-914 trial randomized post-nephrectomy patients at moderate or high risk of relapse to adjuvant therapy with nivolumab/ipilimumabor placebo. DFS as assessed by Blinded Independent Central Review was the primary end point of the study. The key secondary end points were overall survival and safety.
Part B of the study, which remains ongoing, is comparing single-agent nivolumab versus placebo in the adjuvant setting for the same patient population.
1. Bristol Myers Squibb Provides Update on CheckMate -914 Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) as Adjuvant Treatment of Localized Renal Cell Carcinoma. Published online July 29, 2022. Accessed July 29, 2022. https://bit.ly/3Q16Suv