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Phase III, Randomized, Placebo-Controlled, Double-Blind Trial of Motesanib (AMG-706) in Combination With Paclitaxel and Carboplatin in East Asian Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer.

Kaoru Kubota, Nippon Medical School; Kaori Hara and Takayuki Asato, Takeda Pharmaceutical, Tokyo; Hiroshige Yoshioka, Kurashiki Central Hospital, Kurashiki; Fumihiro Oshita, Kanagawa Prefectural Ashigarakami Hospital, Matsuda; Toyoaki Hida, Aichi Cancer Center Hospital, Nagoya; Kiyotaka Yoh, National Cancer Center Hospital East, Chiba; Hidetoshi Hayashi, Hiroyasu Kaneda, and Kazuhiko Nakagawa, Kindai University Faculty of Medicine; Hidetoshi Hayashi, Kishiwada Municipal Hospital, Osaka; Terufumi Kato, Kanagawa Cardiovascular and Respiratory Center, Yokohama; Kazuhiko Yamada, Kurume University School of Medicine; Yukito Ichinose, National Kyushu Cancer Center, Fukuoka; Hiroshi Tanaka, Niigata Cancer Center Hospital, Niigata, Japan; Keunchil Park, Samsung Biomedical Research Institute, Seoul; Eun Kyung Cho, Gachon University; Kyung-Hee Lee, Inha University Hospital, Incheon, South Korea; Chih-Bin Lin, Buddhist Tzu-Chi General Hospital, Hualien; James Chih-Hsin Yang, National Taiwan University Hospital; National Taiwan University Cancer Center, Taipei City, Peoples Republic of China.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2017;(32):3662-3670
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Abstract

Purpose This phase III, randomized, placebo-controlled, double-blind study determined whether motesanib improved progression-free survival (PFS) compared with placebo in combination with paclitaxel and carboplatin (P/C) in East Asian patients with stage IV/recurrent nonsquamous non-small-cell lung cancer. Patients and Methods Patients were randomly assigned (1:1) to receive oral motesanib 125 mg or placebo once daily plus paclitaxel 200 mg/m2 IV and carboplatin area under the concentration-time curve 6 mg/mL ⋅ min IV for up to six 3-week cycles. Random assignment was stratified by epidermal growth factor receptor status, region, and weight loss in the 6 months before assignment. The primary end point was PFS, the key secondary end point was overall survival, and other secondary end points were objective response rate, time to tumor response, duration of response, and adverse events (AEs). Results Four hundred one patients were assigned to receive motesanib plus P/C (n = 197) or placebo plus P/C (n = 204). Median PFS was 6.1 v 5.6 months for motesanib versus placebo (stratified log-rank test P = .0825; stratified hazard ratio, 0.81; 95% CI, 0.64 to 1.03; P = .0820); median overall survival was not reached versus 21.6 months ( P = .5514). In secondary analyses, the objective response rate was 60.1% v 41.6% ( P < .001); median time to tumor response, 1.4 v 1.6 months, and median duration of response, 5.3 v 4.1 months. Incidence of grade ≥ 3 AEs (86.7% v 67.6%) and AEs that led to drug discontinuation (32.7% v 14.2%) were higher with motesanib than with placebo. AEs reported more frequently with motesanib were GI disorders, hypertension, and gallbladder related. Conclusion Motesanib plus P/C did not significantly improve PFS versus placebo plus P/C in East Asian patients with stage IV/recurrent nonsquamous non-small-cell lung cancer.

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