There was not a significant benefit in disease-free survival with nivolumab monotherapy for patients with localized renal cell carcinoma at high risk of relapse following nephrectomy, compared with placebo, according to results from part B of the phase 3 CheckMate 914 trial.
 
These results were first presented by Robert Motzer, MD, Memorial Sloan Kettering Cancer Center, New York, New York, at the 2024 American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium.
 
The double blind, multicenter, 2-part trial evaluated nivolumab plus ipilimumab vs placebo in Part A, or nivolumab monotherapy vs placebo in Part B among patients with renal cell carcinoma. All patients underwent partial or radical nephrectomy 4 to 12 weeks prior to randomization and were at a high risk of relapse. Previously reported results from Part A found there was no DFS benefit with adjuvant nivolumab plus ipilimumab when compared with placebo in the overall study population. In Part B, patients were randomized on a 2-to-1-to-1 basis to receive nivolumab plus placebo (n = 411), nivolumab plus ipilimumab, or placebo (n = 208). The primary end point of Part B was DFS for nivolumab monotherapy vs placebo. Secondary end points included safety of nivolumab monotherapy.
 
At 27.0 months of follow-up, the primary end point of DFS for nivolumab monotherapy vs placebo was not met, with median DFS not reached in either arm (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.62 to 1.21; P = .3962). Probabilities for DFS were 83.3% vs 78.2%, respectively, at 12 months and 78.4% vs 75.4%, respectively, at 18 months. Grade 3/4 treatment-related adverse events occurred in 8.8% of patients in the nivolumab monotherapy arm and 1.9% of patients in the placebo arm. Treatment discontinuation due to adverse events occurred in 9.6% and 1.0% of patients, respectively.
 
Dr Motzer and coauthors concluded, “Part B of the CheckMate 914 trial of [nivolumab] monotherapy vs [placebo] in [patient] with localized [renal cell carcinoma] at high risk of relapse after nephrectomy did not meet the primary endpoint of DFS.”

Source:

Motzer RJ, Bex A, Russo P, et al. Adjuvant nivolumab monotherapy vs placebo for localized renal cell carcinoma at high risk of relapse after nephrectomy: Results from Part B of the randomized, phase 3 CheckMate 914 trial. Presented at the 2024 ASCO Genitourinary Cancers Symposium; January 25-27, 2024; San Francisco. Abstract LBA358