Background: Surgical resection is the only curative treatment option for gastric cancer. Despite widespread adoption of multimodality perioperative treatment strategies, 5-year overall survival rates remain low. In patients with advanced gastric or gastroesophageal junction adenocarcinoma, pembrolizumab has demonstrated promising efficacy and manageable safety as monotherapy in previously treated patients and as first-line therapy in combination with cisplatin and 5-fluorouracil. Combining chemotherapy with pembrolizumab in the neoadjuvant/adjuvant setting may benefit patients with locally advanced, resectable disease. Aim: To describe the design and rationale for the global, multicenter, randomized, double-blind, Phase III KEYNOTE-585 study to evaluate the efficacy and safety of pembrolizumab plus chemotherapy compared with placebo plus chemotherapy as neoadjuvant/adjuvant treatment for localized gastric or gastroesophageal junction adenocarcinoma. ClinicalTrials.gov: NCT0322142.
Bibliographical noteFunding Information:
Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Y-J Bang has served in a consulting or advisory role for Samyang and BeiGene and has received research funding from AstraZeneca/MedImmune, Novartis, Genentech/Roche, MSD, Merck Serono, Bayer, GlaxoSmithKline, Bristol-Myers Squibb, Pfizer, Lilly, Boehringer Ingelheim, Macrogenics, Takeda, Boston Biomedical, Five Prime Therapeutics, CKD, Ono, Taiho, BeiGene, Curis Pharma and Greencross Biotherapeutics. EV Cutsem has served in a consulting or advisory role for Bayer, Lilly, Roche and Servier, and has received research funding from Amgen, Bayer, Boehringer, Celgene, Lilly, MSD, Merck, Novartis, Ipsen, Roche, Sanofi and Servier. C Fuchs has served in a leadership role for CytomX and has served in a consulting or advisory role for Eli Lilly, En-trinsic Health, Genentech, Merck, Sanofi, Five Prime Therapeutics, Merrimack, Bayer, Agios, Taiho, Kew, Unum Therapeutics and Bain Capital. A Ohtsu has received research funding from Bristol-Myers Squibb and reports employment of an immediate family member with Celgene. J Tabernero has served in a consulting or advisory role for Amgen, Bayer, Boehringer Ingelheim, Celgene, Chugai, Genentech, Lilly, MSD, Merck Serono, Novartis, Pfizer, Roche, Sanofi, Symphogen, Taiho and Takeda. D Ilson has served in a consulting or advisory role for Pieris, AstraZeneca, Astellas, Bristol-Myers Squibb, Pfizer, Bayer, Lilly, Roche, Oncolys and Merck. WJ Hyung reports stock ownership in Hutom, has served in a consulting or advisory role for Ethicon, and has received research funding from Medtronics. V Strong reports no conflicts of interest. TO Goetze has served in a consulting or advisory role for MSD, Lilly, Shire, Celgene, Bayer and Bristol-Myers Squibb, has served on a speaker’s bureau for Lilly, and has received reimbursement for travel, accommodation or expenses from Bristol-Myers Squibb and Lilly. T Yoshikawa has received honoraria from Chugai Pharma, Yakult, Taiho Pharmaceutical, Abbott Nutrition, Takeda, Daiichi Sankyo, Ajinomoto, Ono Pharmaceutical, Nihonkayaku, Johnson & Johnson, Medtronic, Olympus and Lilly, has served in a consulting or advisory role for Novartis, MSD Oncology, and Chugai Pharma, and has received research funding from Novartis, Chugai Pharma, Taiho Pharmaceutical and Yakult. L Tang reports no conflicts of interest. PMT Hwang, N Webb and D Adelberg are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Kenilworth, NJ, USA. MT Hwang also reports stock ownership for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Kenilworth, NJ, USA. K Shitara has received honoraria from Novartis, AbbVie and Yakult, has served in a consulting or advisory role from Astellas Pharma, Lilly, Bristol-Myers Squibb, Takeda, Pfizer and Ono Pharmaceutical, and has received research funding from Lilly, Ono Pharmaceutical, Dainippon Sumoitomo Pharma, Daiichi Sankyo, Taiho Pharmaceutical, Chugai Pharma and MSD. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Medical writing and/or editorial assistance was provided by M Sweetlove, and SS Shaevitz, of the ApotheCom pembrolizumab team (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
All Science Journal Classification (ASJC) codes
- Cancer Research