Real-world effectiveness and safety of avelumab + axitinib combination in first-line treatment of UK patients with advanced renal cell carcinoma

<h3>Background</h3> Avelumab + axitinib (A + Ax) combination use in patients with advanced renal cell carcinoma (aRCC) is growing in the United Kingdom, yet real-world evidence of its use remains limited. <h3>Methods</h3> This was a UK-based multicentre, retrospective noninterventional cohort study. Inclusion criteria were diagnosis of aRCC, A + Ax initiation on or after 1 August 2019, and aged ≥18 years at the date of initiation. Primary endpoints were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and best response at 36 months after initiation. <h3>Results</h3> A total of 130 patients were included. Median age was 67.1 years; 74% (<i>n</i> = 96) were male. OS and PFS rates [95% confidence interval (95% CI)] at 36 months were 53% (45.2% to 62.9%) and 27% (20.3% to 36.0%), respectively. Median OS was not reached; median PFS was 13.5 months (95% CI 10.2-17.7 months). ORR (<i>n</i> = 127) at 36 months was 62% (95% CI 53.8% to 70.6%), including best response of complete response in 5% (<i>n</i> = 6) and partial response in 57% (<i>n</i> = 73). <h3>Conclusions</h3> In this UK-based real-world study of first-line A + Ax treatment in patients with aRCC, OS, PFS, ORR, and best response observed at 36 months were in line with findings from JAVELIN Renal 101 (NCT02684006) and other observational studies, with no newly emerging adverse events.