Avelumab is a human anti-PD-L1 IgG1 monoclonal antibody that has shown antitumor activity in early phase studies in advanced/metastatic gastric/gastroesophageal junction cancer, including as first-line maintenance therapy. Here, we describe the design of JAVELIN Gastric 100 (NCT02625610), an open-label, Phase III trial. A total of 499 patients with locally advanced/metastatic HER2- gastric/gastroesophageal junction cancer adenocarcinoma, who had achieved at least stable disease following 12 weeks of first-line oxaliplatin/fluoropyrimidine chemotherapy, have been randomized 1:1 to receive avelumab maintenance therapy or continue chemotherapy. The primary objective is to demonstrate superior overall survival in all randomized patients or in the PD-L1+ population. Secondary objectives are to demonstrate superiority for progression-free survival and objective response rate, compare quality of life measures, and determine safety.
Bibliographical noteFunding Information:
The JAVELIN Gastric 100 trial discussed in this manuscript is sponsored by Merck KGaA and is part of an alliance between Merck KGaA and Pfizer (New York, NY, USA). M Moehler has acted in a consultant/advisory role and has provided speaker services for Amgen, Bayer, Merck & Co, Merck KGaA and Roche, and has received travel expenses from Amgen, Merck KGaA and Pfizer. M-H Ryu has acted in a consultant/advisory role for and received honoraria from Bayer, Bristol-Myers Squibb, DAE HWA Pharmaceutical, Eli Lilly, Novartis, Ono Pharmaceutical, Pfizer, Roche, Sanofi and Taiho, and has received research grants from Novartis. K-W Lee’s institution has received research grants from AstraZeneca, Merck & Co, Ono Pharmaceutical, Roche and Taiho Pharmaceutical. R Wong has received travel expenses from AstraZeneca. HC Chung has acted in a consultant/advisory role for Bristol-Myers Squibb, Celltrion Healthcare, Eli Lilly, Merck & Co, Merck KGaA, Quintiles and Taiho, has provided speaker services for Eli Lilly, Foundation Medicine and Merck KGaA, and has received research grants from Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck & Co, Merck KGaA, Ono Pharmaceutical and Taiho Pharmaceutical. A Tsuji has received honoraria from Bristol-Myers Squibb, Chugai Pharma, Daiichi Sankyo, Merck KGaA, Taiho Pharmaceutical and Takeda, and has provided speaker services for Chugai Pharma, Merck KGaA, Taiho Pharmaceutical and Takeda. AS Muntean has received travel expenses from Janssen, Merck KGaA and Roche. GM Vaccaro has acted in a consultant/advisory role for Genentech and Taiho Pharmaceutical, and has received research funding from Celgene. N Boku has received honoraria from Chugai Pharma, Eli Lilly, Merck KGaA, Ono Pharmaceutical, Shionogi Pharma, Taiho Pharmaceutical and Yakult Honsha, and his institution has received research grants from Bristol-Myers Squibb, Ono Pharmaceutical and Taiho Pharmaceutical. M Sharma, H Xiong and I Conti are employees of EMD Serono, a company of Merck KGaA, Darmstadt, Germany. J Taieb has acted in a consultant/advisory role for Amgen, Baxalta, Celgene, Eli Lilly, Merck KGaA, Roche/Genentech, and Servier, and has provided speaker services for Amgen, Baxalta, Eli Lilly, Merck KGaA, Roche/Genentech, Sanofi, and Servier. Y-J Bang has acted in a consultant/advisory role for Merck KGaA, and his institution has received research grants from Merck KGaA. M Dvorkin, HS Cos¸kun, A Poltoratsky, CJ Yen, S Le Sourd, L Overton, ZA Wainberg and M Patel have no competing interests. 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 support was provided by Clinical Thinking and funded by Merck KGaA and Pfizer.
All Science Journal Classification (ASJC) codes
- Cancer Research