PMID- 34973108 OWN - NLM STAT- MEDLINE DCOM- 20220208 LR - 20220221 IS - 1437-7772 (Electronic) IS - 1341-9625 (Print) IS - 1341-9625 (Linking) VI - 27 IP - 2 DP - 2022 Feb TI - Avelumab first-line maintenance plus best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Japanese subgroup analysis. PG - 383-395 LID - 10.1007/s10147-021-02067-8 [doi] AB - BACKGROUND: The phase 3 JAVELIN Bladder 100 trial showed significantly prolonged overall survival (OS) with avelumab as first-line (1L) maintenance therapy + best supportive care (BSC) vs BSC alone in patients with advanced urothelial carcinoma (UC) that had not progressed with 1L platinum-containing chemotherapy. Efficacy and safety were assessed in patients enrolled in Japan. METHODS: Patients with locally advanced or metastatic UC that had not progressed with 4-6 cycles of 1L platinum-containing chemotherapy were randomized to avelumab (10 mg/kg intravenously every 2 weeks) + BSC or BSC alone. The primary endpoint was OS, and secondary endpoints included progression-free survival (PFS) and safety. RESULTS: In Japanese patients (n = 73) randomized to avelumab + BSC (n = 36) or BSC alone (n = 37), median OS was 24.7 months (95% CI, 18.2-not estimable) vs 18.7 months (95% CI, 12.8-33.0), respectively (HR, 0.81 [95% CI, 0.41-1.58]), and median PFS was 5.6 months (95% CI, 1.9-9.4) vs 1.9 months (95% CI, 1.9-3.8), respectively (HR, 0.63 [95% CI, 0.36-1.11]). In the avelumab + BSC and BSC-alone arms, grade >/= 3 treatment-emergent adverse events (AEs) occurred in 50.0% vs 8.1%, including grade >/= 3 treatment-related AEs in 13.9% vs 0%, respectively. Efficacy and safety results in Japanese patients were generally consistent with findings in the overall trial population. CONCLUSION: Avelumab 1L maintenance treatment showed a favorable benefit-risk balance in Japanese patients, supporting avelumab 1L maintenance as a new standard of care in Japanese patients with advanced UC that has not progressed with 1L platinum-containing chemotherapy. TRIAL REGISTRATION: Clinicaltrials.gov NCT02603432. CI - (c) 2021. The Author(s). FAU - Tomita, Yoshihiko AU - Tomita Y AD - Department of Urology and Department of Molecular Oncology, Niigata University Graduate School of Medicine, 1-757 Asahimachi, Chuou-ku, Niigata, 951-8510, Japan. ytomita@med.niigata-u.ac.jp. FAU - Yamamoto, Yoshiaki AU - Yamamoto Y AD - Department of Urology, Graduate School of Medicine, Yamaguchi University, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan. FAU - Tsuchiya, Norihiko AU - Tsuchiya N AD - Department of Urology, Yamagata University Faculty of Medicine, 2-2-2 Iida-Nishi, Yamagata, 990-9585, Japan. FAU - Kanayama, Hiroomi AU - Kanayama H AD - Department of Urology, Tokushima University Graduate School of Biomedical Sciences, 3-18-15, Kuramoto-cho, Tokushima, 770-8503, Japan. FAU - Eto, Masatoshi AU - Eto M AD - Department of Urology, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. FAU - Miyake, Hideaki AU - Miyake H AD - Department of Urology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan. FAU - Powles, Thomas AU - Powles T AD - Experimental Cancer Medicine Centre, Barts Cancer Institute, Queen Mary University of London, St Bartholomew's Hospital, West Smithfield, London, EC1A 7BE, UK. FAU - Yoshida, Mizuki AU - Yoshida M AD - Pfizer R&D Japan, 3-22-7 Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan. FAU - Koide, Yuichiro AU - Koide Y AD - Pfizer R&D Japan, 3-22-7 Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan. FAU - Umeyama, Yoshiko AU - Umeyama Y AD - Pfizer R&D Japan, 3-22-7 Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan. FAU - di Pietro, Alessandra AU - di Pietro A AD - Pfizer srl, Via Anna Maria Mozzoni, 12, 20152, Milan, Italy. FAU - Uemura, Hirotsugu AU - Uemura H AD - Department of Urology, Faculty of Medicine, Kindai University, 377-2 Ohno-Higashi, Osakasayama, Osaka, 589-8511, Japan. LA - eng SI - ClinicalTrials.gov/NCT02603432 PT - Journal Article PT - Randomized Controlled Trial DEP - 20220101 PL - Japan TA - Int J Clin Oncol JT - International journal of clinical oncology JID - 9616295 RN - 0 (Antibodies, Monoclonal, Humanized) RN - KXG2PJ551I (avelumab) SB - IM MH - Antibodies, Monoclonal, Humanized MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - *Carcinoma, Transitional Cell/drug therapy MH - Humans MH - Japan MH - Urinary Bladder MH - *Urinary Bladder Neoplasms/drug therapy PMC - PMC8816770 OTO - NOTNLM OT - Avelumab OT - Immunotherapy OT - Japan OT - Maintenance OT - Urinary bladder neoplasms COIS- Y. Tomita has received honoraria from Astellas Pharma, Bristol Myers Squibb, Chugai Pharma, Novartis, Ono Pharmaceutical, and Pfizer; served in a consulting or advisory role for Novartis, Ono Pharmaceutical, and Taiho Pharmaceutical; and received research funding from Astellas Pharma, AstraZeneca, Chugai Pharma, Eisai, MSD, Novartis, Ono Pharmaceutical, Pfizer, and Takeda. Y. Yamamoto reports no disclosures. N. Tsuchiya has received honoraria from Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Janssen, Merck & Co., MSD, Novartis, Pfizer, Sanofi, and Takeda and received research funding from Pfizer and Takeda. H. Kanayama has received research funding from Astellas Pharma, Fujifilm, Kissei Pharmaceutical, MSD KK, Nihon Medi-Physics, Ono Pharmaceutical, Taiho Pharmaceutical, and Takeda. M. Eto has served in a consulting or advisory role for AstraZeneca, Bristol Myers Squibb, Chugai Pharma, Eisai, Johnson & Johnson, Merck, Olympas, Ono Pharmaceutical, and Pfizer; has provided speakers services for Bristol Myers Squibb, Chugai Pharma, Janssen, MSD, Novartis, Ono Pharmaceutical, Pfizer, and Takeda; and received research funding from Astellas Pharma, Bayer, Kissei Pharmaceutical, Ono Pharmaceutical, Sanofi, and Takeda. H. Miyake has received honoraria and research funding from and served in a consulting or advisory role for Pfizer. T. Powles has received honoraria and research funding from and served in a consulting or advisory role for Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Exelixis, Ipsen, Johnson & Johnson, Merck & Co., MSD, Novartis, Pfizer, Seattle Genetics, and Roche; has received honoraria from and served in a consulting or advisory role for Incyte; and has received travel and accommodation expenses from AstraZeneca, Ipsen, MSD, Pfizer, and Roche. M. Yoshida reports employment at Pfizer R&D Japan. Y. Koide reports employment at Pfizer R&D Japan and owns Pfizer stock. Y. Umeyama reports employment at Pfizer R&D Japan and owns Pfizer stock. A. di Pietro reports employment at Pfizer and owns Pfizer stock. H. Uemura has provided speaker services for Bayer, Bristol Myers Squibb, Janssen, MSD, and Pfizer and has received research funding from Astellas Pharma, AstraZeneca, Daiichi Sankyo, Kissei Pharmaceutical, Ono Pharmaceutical, Sanofi, and Takeda. EDAT- 2022/01/02 06:00 MHDA- 2022/02/09 06:00 PMCR- 2022/01/01 CRDT- 2022/01/01 12:03 PHST- 2021/09/20 00:00 [received] PHST- 2021/10/30 00:00 [accepted] PHST- 2022/01/02 06:00 [pubmed] PHST- 2022/02/09 06:00 [medline] PHST- 2022/01/01 12:03 [entrez] PHST- 2022/01/01 00:00 [pmc-release] AID - 10.1007/s10147-021-02067-8 [pii] AID - 2067 [pii] AID - 10.1007/s10147-021-02067-8 [doi] PST - ppublish SO - Int J Clin Oncol. 2022 Feb;27(2):383-395. doi: 10.1007/s10147-021-02067-8. Epub 2022 Jan 1.