@article{811d6ec39f5944ac8ba6abd5c0067c58,
title = "A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data",
abstract = "Background: Nivolumab showed improvement in overall survival (OS) in ATTRACTION-2, the first phase 3 study in patients with gastric/gastroesophageal junction (G/GEJ) cancer treated with ≥ 2 chemotherapy regimens. The 2-year follow-up results of ATTRACTION-2 are presented herein. Methods: ATTRACTION-2 was a randomized, double-blind, placebo-controlled, phase 3 trial (49 sites; Japan, South Korea, and Taiwan). The median (min–max) follow-up period was 27.3 (24.1–36.3) months. The primary endpoint was OS. A subanalysis of OS was performed based on best overall response and tumor-programmed death ligand-1 (PD-L1) expression status. Results: Overall, 493 of 601 screened patients were randomized (2:1) to receive nivolumab (330) or placebo (163). OS (median [95% confidence interval; CI]) was significantly longer in the nivolumab group (5.26 [4.60–6.37] vs 4.14 [3.42–4.86] months in placebo group) at the 2-year follow-up (hazard ratio [95% CI], 0.62 [0.51–0.76]; P < 0.0001). A higher OS rate was observed in the nivolumab vs placebo group at 1 (27.3% vs 11.6%) and 2 years (10.6% vs 3.2%). The OS benefit was observed regardless of tumor PD-L1 expression. Among patients with a complete or partial response (CR or PR) in the nivolumab group, the median OS (95% CI) was 26.6 (21.65—not applicable) months; the OS rates at 1 and 2 years were 87.1% and 61.3%, respectively. No new safety signals were identified. Conclusions: Nivolumab treatment resulted in clinically meaningful long-term improvements in OS in patients with previously treated G/GEJ cancer. The long-term survival benefit of nivolumab was most evident in patients with a CR or PR.",
keywords = "Gastric cancer, Gastroesophageal junction cancer, Long-term, Nivolumab, Placebo",
author = "Chen, {Li Tzong} and Taroh Satoh and Ryu, {Min Hee} and Yee Chao and Ken Kato and Chung, {Hyun Cheol} and Chen, {Jen Shi} and Kei Muro and Kang, {Won Ki} and Yeh, {Kun Huei} and Takaki Yoshikawa and Oh, {Sang Cheul} and Bai, {Li Yuan} and Takao Tamura and Lee, {Keun Wook} and Yasuo Hamamoto and Kim, {Jong Gwang} and Keisho Chin and Oh, {Do Youn} and Keiko Minashi and Cho, {Jae Yong} and Masahiro Tsuda and Hiroki Sameshima and Kang, {Yoon Koo} and Narikazu Boku",
note = "Funding Information: We thank the patients, their families, and the investigators. Editorial support, in the form of medical writing, assembling tables and creating high-resolution images based on authors{\textquoteright} detailed directions, collating author comments, copyediting, fact checking, and referencing, was provided by Annirudha Chillar, MD, PhD, of Cactus Communications, and was funded by Ono Pharmaceutical Co., Ltd., Osaka, Japan, and Bristol-Myers Squibb, Princeton, NJ, USA. Funding Information: L-TC reports personal fees from Ono Pharmaceutical Co., Ltd.,; grants and personal fees from Bristol-Myers Squibb for the work under consideration for publication; grants from the Ministry of Science and Technology (Taiwan), Ministry of Health and Welfare (Taiwan), Pfizer (study funding), OBI (preclinical testing), and Polaris (translational research funding); personal fees from AstraZeneca (honorarium), Eli Lilly (honorarium), Five Prime (honorarium), Ipsen, Shire (honorarium), Ono Pharmaceutical Co., Ltd. (honorarium), and MSD (honorarium); personal fees and non-financial support from PharmaEngine (honorarium and study medication); grants, personal fees, and non-financial support (study medication, funding support, and honorarium) from Novartis, Syncore, and TTY; grants and personal fees (honorarium and translation funding) from Bristol-Myers Squibb; and grants and non-financial support (study medication and funding) from Celgene, outside the submitted work. Dr. Satoh reports grants and personal fees from ONO pharmaceutical CO.,LTD., grants and personal fees from Bristol-Myers-Squib, during the conduct of the study; grants and personal fees from Yakult Honsha, grants and personal fees from Chugai-Pharmaceutical, grants and personal fees from Elli-Lilly, grants and personal fees from Merck-Serono, grants and personal fees from Takeda Pharmaceutical, grants and personal fees from Taiho Pharmaceutical, grants and personal fees from MSD, outside the submitted work. M-HR reports honorarium and advisory board fees from Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb, MSD, Eli Lilly, Taiho Pharmaceutical, Novartis, and Daehwa Pharmaceutical, outside the submitted work. YC, WKK, S-CO, L-YB, YH, JGK, KC, and JYC report grants from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication. KK reports research funding from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication, and research funding from Merck & Co., Shionogi & Co., Ltd., Ono Pharmaceutical Co., Ltd., MSD, Merck Serono, and BeiGene, outside the submitted work. HCC reports grants from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication; grants (research support) from Eli Lilly, GlaxoSmithKline, MSD, Merck Serono, Bristol-Myers Squibb, Ono Pharmaceutical Co., Ltd., and Taiho Pharmaceutical; personal fees (honoraria) from Merck Serono, Eli Lilly, Foundation Medicine, and Roche; and personal fees (consultation) from Taiho Pharmaceutical, Celltrion, MSD, Eli Lilly, Quintiles, Bristol-Myers Squibb, and Merck Serono, outside the submitted work. J-SC reports grants and personal fees (consultation) from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication. KM reports grants from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication; grants and personal fees from Ono Pharmaceutical Co., Ltd., and Sanofi; grants from MSD, Daiichi Sankyo, Parexel International, Shionogi Pharmaceutical, Sumitomo Dainippon Pharma, Pfizer, Mediscience Planning, Solasia Pharma, and Merck Serono; and personal fees from Eli Lilly, Chugai Pharmaceutical, Takeda Pharmaceutical, Taiho Pharmaceutical, Bristol-Myers Squibb, and Bayer, outside the submitted work. K-HY reports personal fees from Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb, for the work under consideration for publication, and personal fees (honoraria) from Boehringer Ingelheim, Takeda Pharmaceutical, MSD, Eli Lilly, and Amgen, outside the submitted work. TY reports grants from Ono Pharmaceutical Co., Ltd., and Bristol-Myers Squibb for the work under consideration for publication; grants and personal fees (honoraria) from Chugai and Taiho Pharmaceutical; personal fees (honoraria) from Bristol-Myers Squibb, Yakult, Nihon Kayaku, Olympus, Daiichi Sankyo, MSD, and Terumo; and personal fees (honoraria and advisory role) from Ono Pharmaceutical Co., Ltd., Eli Lilly (Japan), Johnson and Johnson, and Covidien, outside the submitted work. TT reports grants from Ono Pharmaceutical Co., Ltd., and Bristol-Myers Squibb for the work under consideration for publication; grants from MDS Pharmaceutical, Merck Serono Co., Ltd., and Chugai Pharmaceutical Co, Ltd.; and grants and personal fees from Daiichi Sankyo Ltd., Takeda Pharmaceutical, and Taiho Pharmaceutical, outside the submitted work. K-WL reports grants from Ono Pharmaceutical Co., Ltd., Merck Sharp & Dohme Corp., AstraZeneca/MedImmune, Merck KGaA, Pfizer, Macrogenics, Green Cross Corp, Five Prime Therapeutics, Pharmacyclics, LSK BioPharma, ALX Oncology, Zymeworks, BeiGene, Genexine, ASLAN Pharmaceuticals, and Array BioPharma to his institution for conducting clinical trials, and personal fees (honoraria) from Bristol-Myers Squibb, Eli Lilly, and Genexine, outside the submitted work. D-YO reports grants from AstraZeneca outside the submitted work. KM reports research funding from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication. MT reports grants from Ono Pharmaceutical Co., Ltd., outside the submitted work. HS reports personal fees and employment with Ono Pharmaceutical Co., Ltd., outside the submitted work. Y-KK reports grants from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication, and personal fees from Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb, Daehwa Pharmaceutical, Blueprint, Merck, and Astellas, outside the submitted work. NB reports grants and personal fees from Ono Pharmaceutical Co., Ltd., and personal fees from Bristol-Myers Squibb for the work under consideration for publication; grants and personal fees from Taiho Pharmaceutical and personal fees from Chugai and Eli Lilly, outside the submitted work. Publisher Copyright: {\textcopyright} 2019, The Author(s).",
year = "2020",
month = may,
day = "1",
doi = "10.1007/s10120-019-01034-7",
language = "English",
volume = "23",
pages = "510--519",
journal = "Gastric Cancer",
issn = "1436-3291",
publisher = "Springer Japan",
number = "3",
}
