Real‐world outcomes of avelumab plus axitinib as first‐line therapy in patients with advanced renal cell carcinoma in Japan: A multicenter, retrospective, observational study (J‐DART).

Objectives: In the phase 3 JAVELIN Renal 101 trial in patients with advanced renal cell carcinoma (aRCC), objective response rate (ORR) and progression‐free survival (PFS) were significantly improved in patients treated with first‐line avelumab plus axitinib vs sunitinib. Here we evaluate real‐world outcomes with first‐line avelumab plus axitinib in Japanese patients with aRCC. Methods: In this multicenter, noninterventional, retrospective study, clinical data from patients with aRCC treated with first‐line avelumab plus axitinib between December 2019 and December 2020 in Japan were reviewed. Endpoints included ORR and PFS per investigator assessment, and time to treatment discontinuation (TTD). Results: Data from 48 patients (median age, 69 years) from 12 sites were analyzed. Median follow‐up was 10.4 months (range, 2.6–16.5), and median duration of treatment was 7.4 months (range, 0.5–16.5). International Metastatic RCC Database Consortium risk category was favorable, intermediate, or poor in 16.7%, 54.2%, and 29.2% of patients, respectively. The ORR was 48.8% (95% CI, 33.3%–64.5%), including complete response in 3/43 patients (7.0%). Thirteen patients (27.1%) had disease progression or died, and median PFS was 15.3 months (95% CI, 9.7 months – not estimable). At data cutoff, 24 patients (50.0%) were still receiving avelumab plus axitinib, and median TTD was 15.2 months (95% CI, 7.4 months – not estimable). Three patients (6.3%) received high‐dose corticosteroid treatment for immune‐related adverse events, and 8 (16.7%) received treatment for infusion‐related reactions. Conclusions: We report the first real‐world evidence of the effectiveness and tolerability of first‐line avelumab plus axitinib in Japanese patients with aRCC. Results were comparable with the JAVELIN Renal 101 trial. [ABSTRACT FROM AUTHOR]