According to results from a phase 3 trial perioperative nivolumab did not improve the recurrence-free survival (RFS) in patients with renal cell carcinoma at high risk for recurrence. Due to futility, the Data and Safety Monitoring Committee stopped the trial early.

This data was presented on Saturday, September 10, 2022, at the European Society for Medical Oncology Congress in Paris, France, by first author, Mohamad Allaf, MD, Johns Hopkins University School of Medicine, Boston, Massachusetts.

The phase 3, randomized, open label trial enrolled 819 patients with renal cell carcinoma expected to undergo either partial or radical nephrectomy between February 2017 and June 2021. Patients were randomized to receive either 480 mg nivolumab intravenously once every 4 weeks, with 1 dose administered prior to surgery followed by 9 adjuvant doses (n = 404) or surgery alone followed by surveillance (n = 415). The primary endpoint was RFS.

The RFS was similar between both arms (hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.74 to 1.28; one-sided P = 0.43) and median RFS was not reached. The overall survival data, while not yet mature, was not statistically different between arms (HR: 1.48; 95% CI: 0.89 to 2.48]; one-sided P = 0.93). Withdrawal rates were similar in both arms, approximately 12% (48/404 in the nivolumab arm and 50/415 in the surgery alone arm).

In the nivolumab arm, 20% of patients experienced ≥1 grade 3/4 adverse event that could be attributed to nivolumab, compared to 6% in the surgery alone arm. The most common treatment-related grade 3/4 adverse events were kidney injury, rash, and elevated lipase. There were 15 deaths from renal cell carcinoma in the nivolumab arm and 18 in the surgery alone arm.

Source:

Allaf M, Kim SE, Hashman LC, et al. “Phase III randomized study comparing perioperative nivolumab (nivo) versus observation in patients (Pts) with renal cell carcinoma (RCC) undergoing nephrectomy (PROSPER, ECOG-ACRIN EA8143), a National Clinical Trials Network trial.” Presented at European Society for Medical Oncology Congress; September 9-13, 2022. Paris, France.