Real-world Outcomes with Avelumab + axitinib in Patients with Advanced Renal Cell Carcinoma in Japan: Subgroup Analyses from the J-DART2 Study by International Metastatic Renal Cell Carcinoma Database Consortium Risk Classification

Overview

Journal Int J Clin Oncol

Specialty Oncology

Date 2025 Feb 11

PMID 39934514

Authors

Junya Furukawa

Taigo Kato

Toshinari Yamasaki

Keisuke Monji

Toshiaki Tanaka

Norihiko Tsuchiya

Tomoaki Miyagawa

Hiroshi Yaegashi

Tomoyasu Sano

Takashi Karashima

Kazutoshi Fujita

Jun-Ichi Hori

Takayuki Ito

Masahiro Kajita

Yoshihiko Tomita

Nobuo Shinohara

Masatoshi Eto

Mototsugu Oya

Hirotsugu Uemura

Affiliations

Soon will be listed here.

Abstract

Background: Avelumab + axitinib was approved for the treatment of advanced renal cell carcinoma (aRCC) in Japan in December 2019. We report long-term real-world subgroup analyses with first-line avelumab + axitinib in patients with aRCC by International Metastatic RCC Database Consortium (IMDC) risk classification from the J-DART2 study in Japan.

Methods: J-DART2 was a multicenter, noninterventional, retrospective study examining characteristics, treatment patterns, and outcomes in patients with aRCC who started first-line avelumab + axitinib in Japan between December 2019 and October 2022.

Results: Data from 150 patients across 19 sites were analyzed. IMDC risk was favorable in 39 patients (26.0%), intermediate (1 risk factor) in 46 (30.7%), intermediate (2 risk factors) in 36 (24.0%), and poor in 29 (19.3%). Baseline characteristics were generally consistent across IMDC risk subgroups. In subgroups with favorable, intermediate (1 risk factor), intermediate (2 risk factors), and poor risk, median progression-free survival was 31.0, 15.3, 16.4, and 8.1 months; median overall survival (OS) was not reached, but 24-month OS rates were 95.2%, 91.3%, 85.3%, and 57.6%, respectively. Objective response rates were 54.5%, 56.8%, 47.1%, and 54.2%, respectively. High-dose corticosteroid treatment for immune-related adverse events was administered in 5.1%, 8.7%, 8.3%, and 6.9% of patients, respectively.

Conclusion: Subgroup analyses from J-DART2 confirm the long-term real-world effectiveness of first-line avelumab + axitinib across IMDC risk groups in patients with aRCC in Japan. Our findings were consistent with previous analyses by IMDC risk and support the favorable benefit-risk profile of avelumab + axitinib in clinical practice in Japan.

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