JAVEMACS: a real-world study of avelumab maintenance therapy for advanced urothelial carcinoma in Japan

<h3>Background</h3> Avelumab maintenance therapy was approved in Japan in February 2021 for patients with unresectable locally advanced or metastatic urothelial carcinoma (la/mUC) without disease progression after platinum-based chemotherapy (PBC). We report the primary analysis from the JAVEMACS chart review study of avelumab maintenance therapy in Japan. <h3>Materials and methods</h3> This multicenter, retrospective study collected data from medical charts of patients with la/mUC who received avelumab maintenance after first-line (1L) PBC. <h3>Results</h3> Between February 2021 and December 2023, 350 patients received avelumab maintenance; median age was 73 years and most were male (74.0%). Prior 1L PBC was cisplatin–gemcitabine in 56.0% and carboplatin–gemcitabine in 33.1%; 28.6% were cisplatin eligible and 52.9% were cisplatin ineligible/platinum eligible. At data cut-off (June 2024), 67 patients (19.1%) were still receiving avelumab. Among 283 patients who discontinued avelumab, 200 (70.7%) received second-line (2L) treatment. In the overall population, median overall survival (OS) from avelumab initiation was 31.8 months [95% confidence interval (CI) 24.6 months-not estimable (NE)]. In subgroups who received 2L enfortumab vedotin (EV) (<i>n</i> = 133), PBC (<i>n</i> = 41), or pembrolizumab (<i>n</i> = 17), median OS from the start of 2L treatment was 17.8 months (95% CI 11.9 months-NE), 15.1 months (95% CI 11.6 months-NE), and 15.6 months (95% CI 8.6-21.3 months), respectively. Limitations include the study's retrospective nature. <h3>Conclusions</h3> Results from JAVEMACS confirm the effectiveness of avelumab maintenance in real-world clinical practice in Japan, supporting its recommendation for patients with la/mUC without disease progression following 1L PBC. This treatment sequence followed by 2L EV appeared to be associated with encouraging long-term outcomes in this real-world population.

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Journal
ESMO Real World Data and Digital Oncology
Published
2025-11-21
DOI
https://doi.org/10.1016/j.esmorw.2025.100646
Primary Topic
Bladder and Urothelial Cancer Treatments
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article
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article

JAVEMACS: a real-world study of avelumab maintenance therapy for advanced urothelial carcinoma in Japan

Toru Negishi, K. Nishihara, Naotaka Nishiyama, Michihiko Kobayashi et al.
ESMO Real World Data and Digital Oncology
Bladder and Urothelial Cancer Treatments
article

JAVEMACS: a real-world study of avelumab maintenance therapy for advanced urothelial carcinoma in Japan

Toru Negishi, K. Nishihara, Naotaka Nishiyama, Michihiko Kobayashi, Shingo Hatakeyama, Kiyohide Fujimoto, Masaomi Ikeda, Kan Yonemori, Nozomi Hayakawa, Sei Naito, Masahiro Shono, Tadashi Kobayashi, Takuto Hara, Suguru Shirotake, Rikiya Taoka, Natsuko Miura, Junya Furukawa, Junji Yatsuda, Fumitaka Shimizu, K. Fujita, Takashige Abe, Daiki Ikarashi, Masashi Nakayama, Naoya Masumori, Atsuko Fujihara, Tohru Nakagawa, Kaoru Murakami, Hiroshi Kitamura, Yukihiro Endo, Eiryo Kikuchi
article en

Abstract

<h3>Background</h3> Avelumab maintenance therapy was approved in Japan in February 2021 for patients with unresectable locally advanced or metastatic urothelial carcinoma (la/mUC) without disease progression after platinum-based chemotherapy (PBC). We report the primary analysis from the JAVEMACS chart review study of avelumab maintenance therapy in Japan. <h3>Materials and methods</h3> This multicenter, retrospective study collected data from medical charts of patients with la/mUC who received avelumab maintenance after first-line (1L) PBC. <h3>Results</h3> Between February 2021 and December 2023, 350 patients received avelumab maintenance; median age was 73 years and most were male (74.0%). Prior 1L PBC was cisplatin–gemcitabine in 56.0% and carboplatin–gemcitabine in 33.1%; 28.6% were cisplatin eligible and 52.9% were cisplatin ineligible/platinum eligible. At data cut-off (June 2024), 67 patients (19.1%) were still receiving avelumab. Among 283 patients who discontinued avelumab, 200 (70.7%) received second-line (2L) treatment. In the overall population, median overall survival (OS) from avelumab initiation was 31.8 months [95% confidence interval (CI) 24.6 months-not estimable (NE)]. In subgroups who received 2L enfortumab vedotin (EV) (<i>n</i> = 133), PBC (<i>n</i> = 41), or pembrolizumab (<i>n</i> = 17), median OS from the start of 2L treatment was 17.8 months (95% CI 11.9 months-NE), 15.1 months (95% CI 11.6 months-NE), and 15.6 months (95% CI 8.6-21.3 months), respectively. Limitations include the study's retrospective nature. <h3>Conclusions</h3> Results from JAVEMACS confirm the effectiveness of avelumab maintenance in real-world clinical practice in Japan, supporting its recommendation for patients with la/mUC without disease progression following 1L PBC. This treatment sequence followed by 2L EV appeared to be associated with encouraging long-term outcomes in this real-world population.

ESMO Real World Data and Digital OncologyVol. 10
Kurume University (JP), Yamagata University (JP), Sapporo Medical University (JP), Hirosaki University (JP), St. Marianna University School of Medicine (JP), Merck KGaA, Darmstadt (Germany) (DE), Iwate Medical University (JP), Kagawa University (JP), Akita University (JP), Hokkaido University (JP), Kyoto University (JP), Juntendo University (JP), Kyoto Prefectural University of Medicine (JP), National Hospital Organization Kyushu Cancer Center (JP), Merck Biopharma Co., Ltd. (Japan) (JP), National Cancer Center Hospital East (JP), Osaka International Cancer Institute (JP), Nippon Medical School Hospital (JP), University of Toyama (JP), Ehime University (JP), Kitasato University (JP), Nara Medical University (JP), Kobe University (JP), Saitama Medical University (JP), Teikyo University (JP), Kindai University (JP), Tokushima University (JP), Kumamoto University (JP)
Bristol-Myers Squibb, Pfizer, AstraZeneca, American Society of Clinical Oncology, Merck KGaA, Kissei, Nipro, Eisai, Astellas Pharma, Ono Pharmaceutical, Chugai Pharmaceutical
Openalex Percentile: Top 46%
Bladder and Urothelial Cancer Treatments
DOIOpen Access PDFOpenAlex
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