Real-World Outcomes of First-Line Ipilimumab Plus Nivolumab in Advanced Renal Cell Carcinoma: A UK Multi-Centre...

Ipilimumab plus nivolumab (I + N) is established as first-line therapy for intermediate- and poor-risk advanced renal cell carcinoma (aRCC) based on CheckMate-214. However, real-world UK data remain sparse.

We retrospectively analyzed adults with clear cell aRCC treated with first line I + N at 2 UK centers (July 2019-2023). Eligible patients were IMDC intermediate/poor risk with ≥ 18 months follow-up. Outcomes included objective response rate (ORR), overall survival (OS), progression-free survival (PFS), and predictive factors using Kaplan-Meier and Cox models.

A total of 117 patients were treated. ORR was 59.8% (CR: 11.1%, PR 48.7%) and median time to response was 2.9 months. Median OS was 27.9 months (95% CI: 16.2-39.6) and median PFS 15.3 months (95% CI: 11.0-19.6). OS at 12, 24, and 36 months was 71.8%, 51.3%, and 24.7%. Patients achieving CR or PR had superior survival (median OS not reached and 40.8 months) versus PD (7.3 months). Improved OS was associated with completion of 4 I + N cycles (39.3 vs. 10.6 months, HR 0.28, p < .001), prior nephrectomy (38.3 vs. 18.7 months, HR 0.54, p = .016), and intermediate IMDC risk (31.9 vs. 13.4 months, HR 0.59, p = .039).

In this large UK real-world cohort, first-line I + N achieved high response rates and survival outcomes comparable to clinical trials, despite broader inclusion and higher-risk patients. Our results support I + N as a robust first-line option and underscore the importance of managing toxicity to enable full induction therapy.