First-Line Tislelizumab Plus Chemotherapy for Advanced Gastric Cancer with Programmed Death-Ligand 1 Expression ≥ 1%: A Retrospective Analysis of RATIONALE-305

Conflict of Interest

Markus Moehler reports consulting or advisory roles for Bayer, Merck Sharp & Dohme, Merck Serono, Amgen, Taiho Pharmaceutical, Pfizer, Roche, Lilly, Servier, BeiGene, Bristol Myers Squibb, AstraZeneca, Astellas, Dragonfly, Novartis; reports honoraria from Amgen, Genentech/F. Hoffmann-La Roche Ltd, Merck Serono, Merck Sharp & Dohme, Bristol Myers Squibb, AstraZeneca/MedImmune, Servier, Pierre Fabre, Sanofi, Falk Foundation, Transcenta, Daiichi Sankyo, Astellas, and Nordic; and has received grant or research funding from Amgen, Leap Therapeutics, Merck Serono, and Merck Sharp & Dohme; and reports other renumeration from Amgen, Merck Serono, F. Hoffmann-La Roche Ltd, Bayer, ASCO, German Cancer Society, Merck Sharp & Dohme, ESMO, BeiGene, and EORTC. Do-Youn Oh has received honoraria from AstraZeneca, Novartis, Array Biopharma, Lilly, Servier, BeiGene, Merck Sharp & Dohme, and Handok, and has participated on data safety monitoring boards or advisory boards for AstraZeneca, Novartis, Genentech/F. Hoffmann-La Roche Ltd, Merck Serono, Bayer, Taiho Pharmaceutical, Aslan, Halozyme, Zymeworks, Celgene, Basilea, BeiGene, Yunan, Arcus Biosciences, Turning Point Therapeutics, IQVIA, and Merck Sharp & Dohme. Ken Kato has received consulting fees from AstraZeneca, Bayer, BeiGene, Bristol Myers Squibb, Janssen, Merck Bio, Merck & Co., Novartis, Ono Pharmaceutical, and F. Hoffmann-La Roche Ltd; has received payment for expert testimony from Bristol Myers Squibb and Ono Pharmaceutical; and has participated on data safety monitoring boards or advisory boards for Bristol Myers Squibb, Chugai, Merck & Co., and Ono Pharmaceutical. Tobias Arkenau has received consulting fees from Further and EDX Medical; has received honoraria from Servier; and owns stock or stock options in Ellipses Pharma and Careforme. Josep Tabernero owns stocks in Oniria Therapeutics; has received honoraria from Imedex/HMP, Medscape Education, MJH Life Sciences, and PeerView Institute for Medical Education and Physicians Education; and has received consulting fees from Array Biopharma, AstraZeneca, Bayer, Boehringer Ingelheim, Cardiff Oncology, Chugai, Daiichi Sankyo, Genentech/F. Hoffmann-La Roche Ltd, HalioDX SAS, Hutchison MediPharma International, Ikena Oncology, Inspirna Inc, IQVIA, Lilly, Menarini, Merck Serono, Merus, Merck Sharp & Dohme, Mirati, Neophore, Novartis, Ona Therapeutics, Orion Biotechnology, Peptomyc, Pfizer, Pierre Fabre, Samsung Bioepis, Sanofi, Scandion Oncology, Scorpion Therapeutics, Seattle Genetics, Servier, Sotio Biotech, Taiho Pharmaceutical, TheraMyc, and Tolremo Therapeutics. Keun-Wook Lee has received grants or contracts for conducting clinical trials from BeiGene, AstraZeneca, Ono Pharmaceutical, Merck Sharp & Dohme, Merck KGaA, F. Hoffmann-La Roche Ltd, Pfizer, Leap Therapeutics, ALX Oncology, Zymeworks, Astellas, Macrogenics, Amgen, Seagen, Bolt Therapeutics, Trishula Therapeutics, Oncologie, Pharmacyclics, MedPacto, Green Cross Corp, ABLBIO, Y-BIOLOGICS, Daiichi Sankyo, Taiho Pharmaceutical, InventisBio, Elevar Therapeutics, Metafines, Idience, Genome & Company, and Exelixis. Hidekazu Hirano has received institutional research grants from PPD, Daiichi Sankyo, Nippon Boehringer Ingelheim, Novartis, BeiGene, Taiho Pharmaceutical, Amgen, ALX Oncology, and Bristol Myers Squibb, and reports speaker honorarium from FUJIFILM Toyama Chemical, Chugai Pharmaceutical, Bristol Myers Squibb, Taiho Pharmaceutical, Novartis, Teijin Pharma, and Ono Pharmaceutical. Sun Young Rha has received grants from Amgen, Astellas, AstraZeneca, Arcus, Daiichi Sankyo, Eisai, Merck & Co., F. Hoffmann-La Roche Ltd, Gilead, Zymeworks, Indivumed, Merck Sharp & Dohme, Ono Pharmaceutical/Bristol Myers Squibb, ABL Bio, Taiho Pharmaceutical, Lilly, SN Bioscience, Boehringer Ingelheim, and YH Corp; consulting fees from Amgen, ABL Bio, Astellas, AstraZeneca, Daiichi Sankyo, Eisai, Indivumed Therapeutics, LG BioChem, Merck Sharp & Dohme, and Ono Pharmaceutical/Bristol Myers Squibb; and honoraria from Merck Sharp & Dohme, Amgen, Ono Pharmaceutical, Bristol Myers Squibb, Eisai, and Daiichi Sankyo. David Spigel reports grants from Genentech/F. Hoffmann-La Roche Ltd, Novartis, Celgene, Bristol Myers Squibb, Lilly, AstraZeneca, University of Texas SW Medical Center – Simmons Cancer Center, Merck, G1 Therapeutics, Neon Therapeutics, Nektar, Celldex, Clovis Oncology, Daiichi Sankyo, Astellas Pharma, GRAIL, Transgene, Aeglea Biotherapeutics, Ipsen, BIND Therapeutics, Eisai, ImClone Systems, Janssen, MedImmune, Agios, GlaxoSmithKline, Tesaro, Cyteir Therapeutics, Novocure, Elevation Oncology, Calithera Biosciences, Arcus Biosciences, Arrys Therapeutics, Bayer, BeiGene, Blueprint Medicine, Boehringer Ingelheim, Hutchinson MediPharma, Incyte, Kronos Bio, Loxo Oncology, MacroGenics, Molecular Templates, Pure Tech Health, Razor Genomics, Repare Therapeutics, Rgenix, Tizona Therapeutics, Verastem, BioNTech, AbbVie, Amgen, Anheart Therapeutics, Ascendis Pharma, Endeavor BioMedicines, Erasca, Faeth Therapeutics, Fujifilm, Gilead, Jazz Pharmaceuticals, Lyell Immunopharma, Millennium, Moderna Therapeutics, Monte Rosa Therapeutics, Peloton Therapeutics, Shenzhen Chipscreen Biosciences, Stemline Therapeutics, Synthekine, Taiho Pharmaceutical, Tango Therapeutics, Tarveda Therapeutics, Zai Lab, Apollomics, Strata Oncology, and Asher Biotherapeutics; and has received consulting fees from Genentech/F. Hoffmann-La Roche Ltd, Novartis, Bristol Myers Squibb, AstraZeneca, GlaxoSmithKline, Molecular Templates, Jazz Pharmaceuticals, Sanofi-Aventis, Regeneron, Lilly, BeiGene, Ipsen, Monte Rosa Therapeutics, AbbVie, Lyell Immunopharma, and Novocure. Kensei Yamaguchi has received honoraria from Lilly Japan, Astellas, Bristol Myers Squibb, Merck Serono, Chugai, Ono Pharmaceutical, and Daiichi Sankyo. Lucjan Wyrwicz has received honoraria from AstraZeneca, BeiGene, Bristol Myers Squibb, Merck Sharp & Dohme, F. Hoffmann-La Roche Ltd, and Servier Laboratories; has acted as a committee member for Bristol Myers Squibb and Servier Laboratories; and owns stocks with BeiGene. Umut Disel reports no conflicts of interest. Roberto A. Pazo-Cid has received honoraria from F. Hoffmann-La Roche Ltd, Astellas, Bristol Myers Squibb, Ipsen, Celgene, and Eisai; has received support for attending meetings and/or travel from F. Hoffmann-La Roche Ltd, Servier, Lilly, and Bristol Myers Squibb; and has participated on data safety monitoring boards or advisory boards from AstraZeneca, F. Hoffmann-La Roche Ltd, and Ipsen. Lorenzo Fornaro reports consulting fees from Merck Sharp & Dohme, AstraZeneca, Incyte, Taiho Pharmaceutical, Servier, Daiichi Sankyo, and Lilly; payment or honoraria from Incyte, Bristol Myers Squibb, and Lilly; and leadership or fiduciary role in a board or committee for Merck Sharp & Dohme, Bristol Myers Squibb, AstraZeneca, Incyte, BeiGene, Astellas, Daiichi Sankyo, and F. Hoffmann-La Roche Ltd. Yaling Xu, Tao Sheng, Silu Yang, and Alysha Kadva report employment by BeiGene. Tao Sheng reports stock ownership in BeiGene. Marcia Cruz-Correa has received grants or contracts from BeiGene, AbbVie, Genentech/F. Hoffmann-La Roche Ltd, Taiho Pharmaceutical, Seagen, Bristol Myers Squibb, Merck & Co., Pfizer, Janssen, Mirati, Tempus, Huyabio, Regeneron, and Delfi; has received patents from Johns Hopkins University; and owns stock options in the Pan American Center for Oncology Trials. Rui-Hua Xu reports no conflicts of interest.

Ethical Approval

RATIONALE-305 was conducted in compliance with Good Clinical Practice guidelines and the principles of the Declaration of Helsinki and its later amendments, and was approved by the relevant institutional review board/independent ethics committee for each study site. Written informed consent was obtained before study participation. Full ethics committee information is available in the supplemental materials.

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