TY - JOUR
T1 - A subanalysis of Japanese patients in a randomized, double-blind, placebo-controlled, phase 3 trial of nivolumab for patients with advanced gastric or gastro-esophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2)
AU - Kato, Ken
AU - Satoh, Taroh
AU - Muro, Kei
AU - Yoshikawa, Takaki
AU - Tamura, Takao
AU - Hamamoto, Yasuo
AU - Chin, Keisho
AU - Minashi, Keiko
AU - Tsuda, Masahiro
AU - Yamaguchi, Kensei
AU - Machida, Nozomu
AU - Esaki, Taito
AU - Goto, Masahiro
AU - Komatsu, Yoshito
AU - Nakajima, Takako Eguchi
AU - Sugimoto, Naotoshi
AU - Yoshida, Kazuhiro
AU - Oki, Eiji
AU - Nishina, Tomohiro
AU - Tsuji, Akihito
AU - Fujii, Hirofumi
AU - Kunieda, Kenji
AU - Saitoh, Soh
AU - Omuro, Yasushi
AU - Azuma, Mizutomo
AU - Iwamoto, Yasuo
AU - Taku, Keisei
AU - Fushida, Sachio
AU - Chen, Li Tzong
AU - Kang, Yoon Koo
AU - Boku, Narikazu
N1 - Funding Information:
Acknowledgements 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’ detailed directions, collating author comments, copyediting, fact checking, and referencing, was provided by Annirudha Chillar, MD, PhD, of Cactus Communications, and funded by Ono Pharmaceutical Co., Ltd., Osaka, Japan, and Bristol-Myers Squibb, Princeton, NJ, USA.
Publisher Copyright:
© 2018, The Author(s).
PY - 2019/3/15
Y1 - 2019/3/15
N2 - Background: Nivolumab, an anti-programmed death-1 agent, showed survival benefits in Asian patients, including Japanese, with gastric/gastro-esophageal junction (G/GEJ) cancer. We report the analysis of the Japanese subpopulation from ATTRACTION-2 that evaluated nivolumab versus placebo in unresectable advanced or recurrent G/GEJ cancer after ≥ 2 chemotherapy regimens. Methods: Data from the Japanese subpopulation in the randomized, double-blind, placebo-controlled, phase 3 trial were analyzed (data cutoff, February 25, 2017). Primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS) and objective response rate (ORR). Results: Among the overall study population of 493 patients, 226 (nivolumab 152; placebo 74) were enrolled from 28 sites in Japan. In the Japanese subset, median OS was longer with nivolumab versus placebo (5.4 months, 95% CI 4.6–7.4 versus 3.6 months, 95% CI 2.8–5.0). The risk of death was lower in the nivolumab versus placebo group (hazard ratio 0.58, 95% CI 0.42–0.78; p = 0.0002). Incidences of serious adverse events were 23% (35/152) and 25% (18/72) in the nivolumab and placebo groups, respectively. In the Japanese ITT population, 22% of nivolumab-treated and 28% of placebo-treated patients received prior ramucirumab treatment. Overall, clinical activity of nivolumab was observed regardless of prior ramucirumab use. In the nivolumab group, ORR and PFS were numerically higher in patients with prior ramucirumab use than in those without. Conclusions: In the Japanese subpopulation, patients receiving nivolumab had longer OS, similar to the overall population, with a manageable safety profile. The interaction between nivolumab and ramucirumab will be clarified in ongoing clinical trials.
AB - Background: Nivolumab, an anti-programmed death-1 agent, showed survival benefits in Asian patients, including Japanese, with gastric/gastro-esophageal junction (G/GEJ) cancer. We report the analysis of the Japanese subpopulation from ATTRACTION-2 that evaluated nivolumab versus placebo in unresectable advanced or recurrent G/GEJ cancer after ≥ 2 chemotherapy regimens. Methods: Data from the Japanese subpopulation in the randomized, double-blind, placebo-controlled, phase 3 trial were analyzed (data cutoff, February 25, 2017). Primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS) and objective response rate (ORR). Results: Among the overall study population of 493 patients, 226 (nivolumab 152; placebo 74) were enrolled from 28 sites in Japan. In the Japanese subset, median OS was longer with nivolumab versus placebo (5.4 months, 95% CI 4.6–7.4 versus 3.6 months, 95% CI 2.8–5.0). The risk of death was lower in the nivolumab versus placebo group (hazard ratio 0.58, 95% CI 0.42–0.78; p = 0.0002). Incidences of serious adverse events were 23% (35/152) and 25% (18/72) in the nivolumab and placebo groups, respectively. In the Japanese ITT population, 22% of nivolumab-treated and 28% of placebo-treated patients received prior ramucirumab treatment. Overall, clinical activity of nivolumab was observed regardless of prior ramucirumab use. In the nivolumab group, ORR and PFS were numerically higher in patients with prior ramucirumab use than in those without. Conclusions: In the Japanese subpopulation, patients receiving nivolumab had longer OS, similar to the overall population, with a manageable safety profile. The interaction between nivolumab and ramucirumab will be clarified in ongoing clinical trials.
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U2 - 10.1007/s10120-018-0899-6
DO - 10.1007/s10120-018-0899-6
M3 - Article
C2 - 30506519
AN - SCOPUS:85057801395
SN - 1436-3291
VL - 22
SP - 344
EP - 354
JO - Gastric Cancer
JF - Gastric Cancer
IS - 2
ER -
