Updated results from a phase 3 study demonstrated that patients with advanced renal cell carcinoma (RCC) treated with nivolumab had significantly superior rates of 3-year overall survival (OS) compared with everolimus, according to a press release.1
For the CheckMate-025 phase 3 study (ClinicalTrials.gov Identifier: NCT01668784), 803 patients with RCC previously treated with anti-angiogenic therapy were assigned to receive intravenous (IV) nivolumab every 2 weeks or oral everolimus once daily.
After a median follow-up of 3 years, patients who received nivolumab had a median OS of 25.8 months vs 19.7 months among those who received everolimus (hazard ratio [HR], 0.74; 95.45% CI, 0.63-0.88; P = .0005). The 3-year OS rates were 39% and 30% for patients treated with nivolumab compared with everolimus, respectively.
Patients in the nivolumab arm also had a superior objective response rate (ORR) compared with patients in the everolimus arm: 26% compared with 5%, respectively (95% CI, 3.82-10.06).
The median durations of response were 12.3 months (95% CI, 9.1-18.2) with nivolumab and 12 months (95% CI, 6.4-21.7) with everolimus. Median progression-free survival was 4.2 months vs 4.5 months for the nivolumab arm vs the everolimus arm, respectively (HR, 0.85; 95% CI, 0.73-0.99; P = .0371).
The safety profile of nivolumab is consistent with reports from the primary analysis. The most frequently reported treatment-related grade 3 to 4 adverse events were gastrointestinal and hepatic.
- Opdivo (nivolumab) demonstrates superior three-year survival benefit for patients with previously treated advanced renal cell carcinoma (RCC) [news release]. Princeton, NJ: Bristol-Meyers Squibb; November 6, 2017. https://news.bms.com/press-release/corporatefinancial-news/opdivo-nivolumab-demonstrates-superior-three-year-survival-ben. Accessed November 6, 2017.