Real-World Outcomes of Nivolumab Plus Ipilimumab Versus Pembrolizumab Plus Axitinib for First-Line Treatment of Advanced Renal Cell Carcinoma.

[BACKGROUND] In the absence of head-to-head trials, real-world (RW) outcomes of patients with advanced renal cell carcinoma (aRCC) treated with immuno-oncology combinations are important for clinicians and patients. Here, we describe treatment patterns, adverse events (AEs), and outcomes of patients with aRCC treated with first-line (1L) nivolumab plus ipilimumab (NIVO+IPI) or pembrolizumab plus axitinib (PEM+AXI).

[METHODS] This retrospective medical chart review included patients with aRCC who initiated 1L NIVO+IPI between May-2018 and May-2021 or PEM+AXI between May-2019 and May-2021. Inverse probability of treatment weighting was performed, providing balanced baseline characteristics. Physician-reported response (RW objective response rate [rwORR], duration of response [rwDOR]) and immune-related AEs are described. RW progression-free survival (rwPFS) and overall survival (rwOS) were estimated using Kaplan-Meier analysis.

[RESULTS] 225 patients were treated with 1L NIVO+IPI and 130 with 1L PEM+AXI. The median duration of 1L therapy was 15.0 months for NIVO+IPI and 14.5 months for PEM+AXI. After weighting, each cohort was ∼60% male, ∼65 years old, and ∼90% had intermediate/poor risk scores at initiation. The median follow-up post-1L initiation was 22.4 months for NIVO+IPI and 19.0 months for PEM+AXI (P = .006). The rwORR was comparable between cohorts (NIVO+IPI, 71.5%; PEM+AXI, 77.3%; P = .24), whereas the median rwDOR was significantly longer in the NIVO+IPI versus the PEM+AXI cohort (11.0 vs. 8.0 months; P < .0001). While median rwPFS and rwOS did not differ by treatment (P = .20 and 0.37, respectively), estimates for rwPFS and rwOS probability at 24 months post-1L initiation for treatment were nonsignificantly higher for NIVO+IPI versus PEM+AXI (rwPFS: 0.29 vs. 0.18, respectively; rwOS: 0.63 vs. 0.57, respectively). The overall rate of immune-related AEs was similar between cohorts (NIVO+IPI, 29.1%; PEM+AXI, 25.3%; significance not tested).

[CONCLUSIONS] Overall results from this RW study were similar for patients with aRCC who received 1L NIVO+IPI or PEM+AXI, although nonsignificant results suggest rwPFS and rwOS at later timepoints may be improved for patients who receive 1L NIVO+IPI versus PEM+AXI. Additional research with larger samples and extended follow-up is necessary to understand potential long-term differences in clinical outcomes.