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.
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.
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.
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.
International journal of clinical oncology. 2022 Jan 01 [Epub ahead of print]
Yoshihiko Tomita, Yoshiaki Yamamoto, Norihiko Tsuchiya, Hiroomi Kanayama, Masatoshi Eto, Hideaki Miyake, Thomas Powles, Mizuki Yoshida, Yuichiro Koide, Yoshiko Umeyama, Alessandra di Pietro, Hirotsugu Uemura
Department of Urology and Department of Molecular Oncology, Niigata University Graduate School of Medicine, 1-757 Asahimachi, Chuou-ku, Niigata, 951-8510, Japan. ., Department of Urology, Graduate School of Medicine, Yamaguchi University, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan., Department of Urology, Yamagata University Faculty of Medicine, 2-2-2 Iida-Nishi, Yamagata, 990-9585, Japan., Department of Urology, Tokushima University Graduate School of Biomedical Sciences, 3-18-15, Kuramoto-cho, Tokushima, 770-8503, Japan., Department of Urology, Kyushu University Graduate School of Medical Sciences, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan., Department of Urology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan., Experimental Cancer Medicine Centre, Barts Cancer Institute, Queen Mary University of London, St Bartholomew's Hospital, West Smithfield, London, EC1A 7BE, UK., Pfizer R&D Japan, 3-22-7 Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan., Pfizer srl, Via Anna Maria Mozzoni, 12, 20152, Milan, Italy., Department of Urology, Faculty of Medicine, Kindai University, 377-2 Ohno-Higashi, Osakasayama, Osaka, 589-8511, Japan.