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.
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).
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.
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.
International journal of urology : official journal of the Japanese Urological Association. 2023 Dec 18 [Epub ahead of print]
Taigo Kato, Yuzo Nakano, Fumiya Hongo, Hidenori Katano, Tomoaki Miyagawa, Kosuke Ueda, Haruhito Azuma, Masahiro Nozawa, Nobuyuki Hinata, Junichi Hori, Taiyo Otoshi, Nobuaki Shimizu, Mana Aizawa, Shingo Osada, Akiko Matsui, Mototsugu Oya, Masatoshi Eto, Yoshihiko Tomita, Nobuo Shinohara, Hirotsugu Uemura
Department of Urology, Osaka University Graduate School of Medicine, Suita, Japan., Department of Urology, Kobe University Graduate School of Medicine, Kobe, Japan., Department of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan., Department of Urology, Iwamizawa Municipal General Hospital, Iwamizawa, Japan., Department of Urology, Jichi Medical University Saitama Medical Center, Saitama, Japan., Department of Urology, Kurume University School of Medicine, Kurume, Japan., Department of Urology, Osaka Medical and Pharmaceutical University, Takatsuki, Japan., Department of Urology, Kindai University Faculty of Medicine, Osakasayama, Japan., Department of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan., Department of Renal and Urologic Surgery, Asahikawa Medical University, Asahikawa, Japan., Department of Urology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan., Department of Urology, Gunma Prefectural Cancer Center, Ota, Japan., Biometrics and Data Management, Pfizer R&D Japan, Tokyo, Japan., Oncology Medical Affairs, Pfizer Japan, Inc., Tokyo, Japan., Department of Urology, Keio University School of Medicine, Tokyo, Japan., Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan., Departments of Urology and Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan., Department of Urology, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.