Nivolumab (Opdivo, Bristol-Myers Squibb) showed a three-year survival benefit over everolimus (Afinitor, Novartis) in advanced renal cell carcinoma (RCC) in a phase 3 study, reducing the risk of death by 26%.
The three-year overall survival (OS) update from the CheckMate -025 study, evaluating previously treated advanced RCC patients treated with nivolumab versus everolimus, was presented November 4 at the 16th International Kidney Cancer Symposium in Miami. The data are the first of any anti-programmed death-1 (PD-1) agent to demonstrate durable survival at three years in previously treated RCC. No new safety signals were identified and the data showed a safety profile consistent with two-year results.
The median OS, the primary endpoint in this study, for nivolumab was 25.8 months compared to 19.7 months with everolimus (hazard ratio [HR], 0.74; 95.45% confidence interval [CI], 0.63–0.88; P = 0.0005). The three-year OS rate was 39% for nivolumab and 30% for everolimus..
“The updated results of CheckMate -025 reinforce the overall survival benefit and safety profile of Opdivo and provide further support for this therapeutic option as a standard of care for patients with previously treated advanced renal cell carcinoma,” said Padmanee Sharma, MD, PhD, scientific director, Immunotherapy Platform, MD Anderson Cancer Center.
At 36 months, nivolumab demonstrated an objective response rate (ORR), a secondary endpoint, of 26% compared to 5% with everolimus (95% CI, 3.82–10.06), and the median durations of response for nivolumab and everolimus were 12.3 (95% CI, 9.1–18.2) and 12 months (95% CI, 6.4–21.7), respectively. Median progression-free survival (PFS), another secondary endpoint, was 4.2 months for nivolumab and 4.5 months for everolimus (HR, 0.85; 95% CI, 0.73–0.99; P = 0.0371).
CheckMate -025 is an open-label, randomized phase 3 study of nivolumab versus everolimus in patients with previously treated advanced RCC after prior anti-angiogenic therapy. Patients (N = 803) received either nivolumab (N = 406) 3 mg/kg intravenously every two weeks or everolimus (N = 397) 10 mg orally once daily until disease progression or unacceptable toxicity.
Treatment-related grade 3/4 adverse events (AEs) were experienced by 21% of patients in the nivolumab group and 37% in the everolimus group. Treatment-related AEs leading to discontinuation were experienced by 8% of patients in the nivolumab group and 13% in the everolimus group. The most common grade 3/4 AEs in the nivolumab arm were hepatic (3%) and gastrointestinal (2%). In the everolimus arm, the most common grade 3/4 AEs were pulmonary (3%), GI (2%), and skin (1%). There were no treatment-related deaths reported in the nivolumab group and two treatment-related deaths reported in the everolimus arm at three years.
Source: Bristol-Myers Squibb; November 6, 2017.