Multicenter retrospective real-world analysis of first-line ipilimumab plus nivolumab for advanced renal cell carcinoma

Ipilimumab and nivolumab are recommended as first-lin therapy for patients with metastatic or advanced renal cell carcinoma (aRCC) at IMDC intermediate or poor risk. A real-world retrospective study evaluated the first-line combination of ipilimumab and nivolumab in a cohort of 356 aRCC patients from 17 centers in Germany and Switzerland. Median age was 64 years. Most patients were male (69.1%) and had clear cell histology (74.1%). IMDC risk was intermediate in 61.8% and poor in 28.7%. About 37% of cases did not meet the inclusion criteria for the CheckMate 214 study (due to poor performance status, comorbidities, brain metastases, and impaired renal function). After a median follow-up of 17.5 months, complete response was seen in 8.7% of patients and partial response in 28.7%. Median progression-free survival was 8.0 months (95% CI 5.4-10.6) and median overall survival was 39.0 months (27.5-50.5). Patients with non-clear cell histology had shorter PFS and OS. Adverse events occurred in 76.4% of patients (35.4% grade ≥3). The authors conclude that these data support ipilimumab plus nivolumab as first-line treatment of aRCC, with robust efficacy and safety (graphical summary).