A steady overall survival and objective response rate benefit with nivolumab vs everolimus was observed across baseline factors in patients with previously treated advanced renal cell carcinoma (RCC), as well as a consistent overall survival benefit across specific prior therapies, according to a study presented at the 2016 Genitourinary Cancers Symposium in San Francisco, CA.1
The phase 3 trial that compared nivolumab with everolimus in 821 previously treated patients with advanced or metastatic RCC demonstrated a superior overall survival benefit with nivolumab. Researchers reported outcomes by key baseline factors, prior therapy, and subsequent anticancer therapy.
For the study, participants were randomly assigned to receive nivolumab 3 mg/kg intravenously every 2 weeks or everolimus 10 mg orally once daily.
Results of this analysis showed that patients who had received 1 prior antiangiogenic therapy had a median overall survival of 23.6 months (95% CI, 20.8 – NE) with nivolumab vs 19.9 months (95% CI, 17.7 – 24.7) with everolimus. Objective response rate was 24.3% (95% CI, 19.7 – 29.4) and 5.4% (95% CI, 3.2 – 8.6), respectively. A similar benefit was observed in patients who had received 2 prior antiangiogenic therapies.
With respect to baseline Karnofsy performance status (KPS), patients with KPS of 90% to 100% had a not estimable median overall survival with nivolumab (95% CI, 26.7 – NE) vs 29.0 months (95% CI, 24.3 – NE) with everolimus, and an objective response rate of 26.1% (95% CI, 21.0 – 31.7) vs 6.8% (95% CI, 4.1 – 10.6), respectively. For those with a KPS of less than 90%, median overall survival was 18.1 months (95% CI, 14.3 – 22.2) with nivolumab and 10.1 months (95% CI, 7.9 – 12.8) with everolimus. Objective response rate was 23.1% (95% CI, 16.3 – 31.2) and 2.7% (95% CI, 0.7 – 6.8), respectively.
Furthermore, among patients in favorable, intermediate, or poor Heng risk groups, there was a consistent benefit with nivolumab over everolimus in terms of median overall survival and objective response rate.
The study also demonstrated that in patients who had prior sunitinib, median overall survival was 23.6 months with nivolumab vs 19.8 months with everolimus. In those who had prior pazopanib, median overall survival was not estimable and 17.6 months, respectively. For the 10% of patients who had prior interleukin-2, median overall survival was not estimable for nivolumab and 17.2 months for everolimus.
- Motzer RJ, Sharma P, McDermott DF, et al. CheckMate 025 phase III trial: Outcomes by key baseline factors and prior therapy for nivolumab (NIVO) versus everolimus (EVE) in advanced renal cell carcinoma (RCC). J Clin Oncol. 2016; 34 (suppl 2S; abstr 498).