As reported in The Lancet Oncology by Allaf et al, a planned interim analysis of the phase III PROSPER ECOG-ACRIN EA8143 trial showed no recurrence-free survival benefit with perioperative nivolumab vs observation in patients undergoing nephrectomy for high-risk renal cell carcinoma.
Study Details
In the open-label trial, 819 patients with clear cell or non–clear cell histology from sites in the United States and Canada were randomly assigned between February 2017 and June 2021 to receive perioperative nivolumab plus surgery (n = 404) or surgery alone (n = 415). Nivolumab was given every 2 weeks at 240 mg for two doses prior to nephrectomy, followed by nine adjuvant doses of 240 mg every 2 weeks. The primary endpoint of the trial was investigator-assessed recurrence-free survival.
Key Findings
At the planned interim analysis in March 2022, the Data and Safety Monitoring Committee stopped the trial due to futility.
Median follow-up was 30.4 months in the nivolumab group and 30.1 months in the observation group. At data cutoff in May 2023, recurrence-free survival events had occurred in 125 (33%) of 381 evaluable patients in the nivolumab group vs 133 (33%) of 399 evaluable patients in the observation group (hazard ratio = 0.94, 95% confidence interval [CI] = 0.74–1.21, P = .32).
Grade ≥ 3 adverse events occurred in 48% of patients in the nivolumab group and 24% of those in the observation group, with the most common in the nivolumab group being hypertension (in 7% of patients), anemia (in 6%), and elevated lipase (in 5%). Eight deaths in the nivolumab group and three in the observation group were considered related to treatment.
The investigators concluded, “Perioperative nivolumab before nephrectomy followed by adjuvant nivolumab did not improve recurrence-free survival vs surgery only followed by surveillance in patients with high-risk renal cell carcinoma.”
Naomi B. Haas, MD, of the University of Pennsylvania/Abramson Cancer Center, Perelman Center for Advanced Medicine, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by the National Cancer Institute and Bristol Myers Squibb. For full disclosures of the study authors, visit thelancet.com.
