Ramucirumab after prior sorafenib in patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein: Japanese subgroup analysis of the REACH-2 trial.

"Conflicts of interest MK has had a consulting/advisory role with Bayer, Bristol-Myers Squibb, Eisai Co., Ltd., MSD, and Ono Pharmaceutical; has received honoraria from Bayer, EA Pharma Co., Ltd., Eisai Co., Ltd., and MSD; and has received research funding from AbbVie Inc., Astellas Pharma Inc., Bristol-Myers Squibb, Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., EA Pharma Co., Ltd., Eisai Co., Ltd., Gilead Sciences, Inc., Medico’s Hirata Inc., Otsuka Pharmaceutical Co., Ltd., Taiho Pharmaceutical, and Takeda Pharmaceutical Company Limited. TO has received research funding from Eli Lilly Japan K.K., AstraZeneca K.K., Baxter, Bristol-Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Novartis Pharma K.K., and Sumitomo Dainippon Pharma Co., Ltd. KM has received honoraria from Eisai Co., Ltd. TY has received honoraria from Eli Lilly, Bayer, and Eisai Co., Ltd. HT, GH, and RY are employees of Eli Lilly Japan K.K. and own stock in Eli Lilly and Company. IO, MM, SSeo, YW, SSato, MF, TA, SN, KO, HF, TK, JF, and AXZ have no conflicts of interest to declare."

"Funding This work was supported by Eli Lilly Japan K.K., manufacturer/licensee of ramucirumab. Eli Lilly and Company was involved in the study design, data collection, data analysis, and preparation of the manuscript."

"Full details of the REACH-2 and REACH study design have been published elsewhere [, ]. REACH-2 is a randomized, double-blind, placebo-controlled, phase 3 study of second-line ramucirumab treatment in patients with HCC and elevated baseline AFP following first-line treatment with sorafenib, conducted in 20 countries. The ethics review board of each site approved the study protocol. The study was conducted in accordance with the Declaration of Helsinki, the Council for International Organizations of Medical Sciences International Ethical Guidelines, Good Clinical Practice guidelines, and applicable local guidelines. All patients provided written informed consent before enrollment. The study was registered at www.clinicaltrials.gov (NCT02435433)."