The JAVELIN Bladder 100 phase 3 trial showed that avelumab first-line maintenance + best supportive care significantly prolonged overall survival and progression-free survival versus best supportive care alone in patients with advanced urothelial carcinoma who were progression-free following first-line platinum-based chemotherapy. We report findings from J-AVENUE (NCT05431777), a real-world study of avelumab first-line maintenance therapy in Japan.
Medical charts of patients with advanced urothelial carcinoma without disease progression following first-line platinum-based chemotherapy, who received avelumab maintenance between February and November 2021, were reviewed. Patients were followed until June 2022. The primary endpoint was patient characteristics; secondary endpoints included time to treatment failure and progression-free survival.
In 79 patients analyzed, median age was 72 years (range, 44-86). Primary tumor site was upper tract in 45.6% and bladder in 54.4%. The most common first-line chemotherapy regimen was cisplatin + gemcitabine (63.3%). Median number of chemotherapy cycles received was four. Best response to chemotherapy was complete response in 10.1%, partial response in 58.2%, and stable disease in 31.6%. Median treatment-free interval before avelumab was 4.9 weeks. With avelumab first-line maintenance therapy, the disease control rate was 58.2%, median time to treatment failure was 4.6 months (95% CI, 3.3-6.4), and median progression-free survival was 6.1 months (95% CI, 3.6-9.7).
Findings from J-AVENUE show the effectiveness of avelumab first-line maintenance in patients with advanced urothelial carcinoma in Japan in clinical practice, with similar progression-free survival to JAVELIN Bladder 100 and previous real-world studies, supporting its use as a standard of care.
International journal of urology : official journal of the Japanese Urological Association. 2024 May 09 [Epub ahead of print]
Eiji Kikuchi, Nozomi Hayakawa, Masashi Nakayama, Masahiro Uno, Hiroomi Nakatsu, Chiyoe Kitagawa, Hideaki Miyake, Takeshi Yamada, Kazutoshi Fujita, Hideaki Shimoyama, Kiyoaki Nishihara, Mizuki Kobayashi, Motonobu Nakamura, Kiyohide Fujimoto, Takeshi Sano, Naotaka Nishiyama, Takayuki Ito, Masahiro Kajita, Takashi Kobayashi, Hiroshi Kitamura
Department of Urology, St. Marianna University School of Medicine, Kanagawa, Japan., Department of Urology, Osaka International Cancer Institute, Osaka, Japan., Department of Urology, Ogaki Municipal Hospital, Gifu, Japan., Department of Urology, Asahi General Hospital, Chiba, Japan., Department of Medical Oncology, National Hospital Organization Nagoya Medical Center, Aichi, Japan., Department of Urology, Hamamatsu University School of Medicine, Shizuoka, Japan., Department of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan., Department of Urology, Kindai University Faculty of Medicine, Osaka, Japan., Department of Urology, Showa University Fujigaoka Hospital, Kanagawa, Japan., Department of Urology, Kurume University School of Medicine, Fukuoka, Japan., Department of Urology, Akita University Hospital, Akita, Japan., Department of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan., Department of Urology, Nara Medical University Hospital, Nara, Japan., Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan., Department of Urology, Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama, Toyama, Japan., Medical Department, Merck Biopharma Co., Ltd. (an affiliate of Merck KGaA), Tokyo, Japan., Oncology Medical Affairs, Merck Biopharma Co., Ltd. (an affiliate of Merck KGaA), Tokyo, Japan.