Oh, Do-Youn
Maqueda, Maria Alsina
Quinn, David I.
O’Dwyer, Peter J.
Chau, Ian
Kim, Sun Young
Duran, Ignacio
Castellano, Daniel
Berlin, Jordan
Mellado, Begona
Williamson, Stephen K.
Lee, Keun-Wook
Marti, Francisca
Mathew, Paul
Saif, Muhammad Wasif
Wang, Ding
Chong, Elizabeth
Hilger-Rolfe, Jacqueline
Dean, James P.
Arkenau, Hendrik-Tobias
Article History
Received: 15 September 2022
Accepted: 18 October 2023
First Online: 3 November 2023
Declarations
:
: The protocol was approved by the institutional review boards or independent ethics committees of all participating institutions. The study was approved by the following institutional review boards or independent ethics committees: Asan Medical Center Institutional Review Board 88; CEIm Hospital Universitario Ramon y Cajal Secretria del Comité; Chesapeake Institutional Review Board; Chonnam National University Hwasun Hospital Institutional Review Board; Dignity Health Bay Area Regional Institutional Review Board; Henry Ford Health System Research Administration; Korea University Guro Hospital Institutional Review Board; London-Surrey Borders Research Ethics Committee; Nebraska Methodist Hospital Institutional Review Board; Norwalk Hospital Institutional Review Board; Penn State Milton S. Hershey Medical Center, Penn State College of Medicine Human Subjects Protection Office; Samsung Medical Center Institutional Review Board 81; Severance Hospital Yonsei University Health System 50–1 Institutional Review Board; Seoul National University Bundang Hospital Institutional Review Board 82; Seoul National University Hospital Institutional Review Board 101; The Catholic University of Korea Seoul St. Mary’s Hospital Institutional Review Board 222; Tufts Medical Center/Tufts University Health Sciences Institutional Review Board; University of Kansas Medical Center Institutional Review Board; University of Pennsylvania Office of Regulatory Affairs; University of Southern California Health Sciences Institutional Review Board; University of Texas Medical Branch Institutional Review Board; Vanderbilt University Institutional Review Board, Wake Forest University Health Sciences Institutional Review Board; and Western Institutional Review Board. All patients were required to confirm their willingness to participate in this study as approved by the institutional review boards or independent ethics committees at each participating study site before any study-specific screening procedures were performed. All patients provided written informed consent for participation in this study as approved by the Institutional Review Board/Research Ethics Board/Independent Ethics Committee before any study-specific screening procedures were performed.Patients were also required to grant permission to use protected health information per the Health Insurance Portability and Accountability Act. In addition, patients were required to consent to and sign all approved amendments per the site institutional review board or independent ethics committee guidelines during the course of the study.The study was conducted in accordance with the Declaration of Helsinki and International Conference on Harmonisation Guidelines for Good Clinical Practice.
: Not applicable.
: D-YO: consulting/advisory role with AstraZeneca, Novartis, Genentech/Roche, Merck Serono, Bayer, Taiho, ASLAN, Halozyme, Zymeworks, Bristol Myers Squibb/Celgene, BeiGene, Basilea, and Turning Point Therapeutics; and research funding from AstraZeneca, Novartis, Array BioPharma, Eli Lilly, Servier, BeiGene, Merck Sharp & Dohme, and Handok; MAM: consulting/advisory role with Merck Sharp & Dohme, Bristol Myers Squibb, Eli Lilly, and Servier; and travel accommodations from Eli Lilly; DIQ: honoraria from and consulting/advisory role with Astellas, Bristol Myers Squibb, Bayer, Pfizer, Merck, EMD Serono, Genentech/Roche, and Seagen; and employment with AbbVie; PJO: consulting/advisory role with Genentech and Array BioPharma; research funding from Pfizer, Genentech, Bristol Myers Squibb, AstraZeneca, GlaxoSmithKline, Five Prime Therapeutics, Forty Seven, Merck, Syndax, bbi-biotech GmbH, Novartis, Celgene, Incyte, Eli Lilly/ImClone, Array BioPharma, H3 Biomedicine, Taiho, Minneamrita, Pharmacyclics LLC, an AbbVie Company, and Mirati; and expert testimony for Bayer and Eli Lilly; IC: honoraria from Eli Lilly and Eisai; consulting/advisory role with Eli Lilly, Bristol Myers Squibb, Merck Sharp & Dohme, Bayer, Roche, Merck-Serono, Five Prime Therapeutics, AstraZeneca, OncXerna, Pierre Fabre, Boehringer Ingelheim, Incyte, and Astellas; and institutional research funding from Eli Lilly, Sanofi Oncology, and Cilag-Janssen; SYK: institutional research funding from F. Hoffman-La Roche; ID: honoraria from Roche-Genentech, Merck Sharp & Dohme, Bristol Myers Squibb, Ipsen, AstraZeneca, and Eusa Pharma; consulting/advisory role with Roche-Genentech, Merck Sharp & Dohme, Bristol Myers Squibb, Novartis, Ipsen, AstraZeneca, Debiopharm, Seagen, and Pharmacyclics, LLC, an AbbVie Company; institutional research funding from Roche and AstraZeneca; and travel accommodations from Ipsen and AstraZeneca; DC: honoraria from and consulting/advisory role with Astellas, Janssen, Roche, Merck, Ipsen, Exelixis, Pfizer, Bristol Myers Squibb, Eisai, and AstraZeneca; JB: consulting/advisory role with Ipsen, Bayer, QED, Eisai, Seagen, Mirati, Clovis, Insmed, and EMD Serono; institutional research funding from AbbVie, Bristol Myers Squibb, Boston Biomedical, I-Mab, Dragonfly, Symphogen, Immunomedics, Eli Lilly, Bayer (Loxo), EMD Serono, Incyte, Karyopharm, Pfizer, Astellas, and Atreca; travel accommodations from EMD Serono and Seagen; and other relationship (data and safety monitoring board) with Novocure, Karyopharm, and Pancreatic Cancer Action Network; BM: research funding from Roche, Bayer, and Janssen; speakers bureau with Roche, Sanofi, Janssen, Astellas, Pfizer, Novartis, Bristol Myers Squibb, and Ipsen; and travel accommodations and expenses from Pfizer and Janssen; SKW: stock or other ownership in Horizon Therapeutics, Merus, and Iovance Biotherapeutics; and institutional research funding from Daiichi Sankyo, Bayer Health, Acceleron Pharma, Sotio, Rogosin Institute, Pharmacyclics LLC, an AbbVie Company, Merck Serono, EMD Serono, Sanofi, Novartis, Nektar, Seagen, Astellas Pharma, Aleon Pharma, Bristol Myers Squibb, and Regeneron; K-WL: honoraria from Bristol Myers Squibb, Eli Lilly, and Genexine; consulting/advisory role with ISU ABXIS, Bayer, Bristol Myers Squibb, and Daiichi Sankyo; and institutional research funding from Ono Pharmaceutical, Merck Sharp & Dohme, AstraZeneca/MedImmune, Merck KGaA, Pfizer, MacroGenics, Green Cross, ABL Bio, Y-Biologics, Daiichi Sankyo, Taiho Pharmaceutical, Five Prime Therapeutics, Oncologie, Pharmacyclics, LLC, an AbbVie Company, LSK.BioPharma, ALX Oncology, Zymeworks, BeiGene, and Genexine; FM: consulting/advisory role and speakers bureau with, and travel accommodations from Servier; PM: reports no conflict of interest; MWS: research funding from Pharmacyclics LLC, an AbbVie Company; DW: consulting/advisory role with Castle Biosciences; EC: employment with and stock ownership in Pharmacyclics LLC, an AbbVie Company; JHR: employment with AbbVie and stock ownership in AbbVie; immediate family member stock ownership in Celgene/Bristol Myers Squibb; JPD: employment with and stock ownership in Pharmacyclics LLC, an AbbVie Company; HTA: employment with HCA Healthcare UK/Sarah Cannon Research Institute; honoraria from BeiGene, Bicycle, LabGenius, CellCentric, iOnctura, Taiho, Servier, and Guardant; consulting/advisory role with iOnctura, Engitix, LabGenius, CellCentric, Daiichi Sankyo, Bicycle, and BeiGene; institutional research funding from Sarah Cannon Research Institute; and speakers bureau with Servier and Guardant.