ACKNOWLEDGMENTS
RP, TG
ONCOLOGY, EMD
This study was sponsored by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. We thank all of the patients and their families, and the investigators and staff at all clinical sites, for their participation in the trial. The authors acknowledge Tori Gordon, BSc, of Ashfield MedComms, an Inizio Company, for medical writing support for the development of this manuscript under the direction of the authors, which was funded by Takeda Pharmaceuticals U.S.A., Inc., and complied with the Good Publication Practice 3 ethical guidelines (Battisti WP, et al. Ann Intern Med 2015. 163: 461–4). R. Popat and W. Townsend acknowledge support from the National Institute for Health Research University College London Hospitals Biomedical Research Centre.
LIG, SM, IP, YS and FB were involved in the conception and design of the study. LIG, RK, JBK, RP, HAB, SF, MRP, GG, DES, FIC, JR, JPO, PLZ, SPI, WT, HM, IP, SW, SK, YY, JZ, KS, YS, CC, and FB made substantial contributions to the acquisition, analysis and interpretation of data. All authors drafted the work or revised it critically for important intellectual content. All authors approved of the final version to be published and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
LIG is on the Data Safety and Monitoring Board (DSMB) for Janssen and is a consultant for Ono Pharmaceuticals. RK received research support from Takeda. RP received honoraria and consultancy fees from Takeda, Janssen, BMS, GSK and Roche. HAB is employed by Sarah Cannon and HCA Healthcare; owns stocks/shares at HCA Healthcare; holds a non-compensated consulting position for AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, GRAIL, Incyte, Novartis, TG Therapeutics, Vincerx Pharma; and reports grants or funds paid to their institution from AbbVie, Agios, ARMO Biosciences, Array BioPharma, AstraZeneca, Bayer, BeiGene, BioAtla, BioMed Valley Discoveries, Boehringer Ingelheim, Bristol-Myers Squibb, CALGB, CicloMed, eFFECTOR Therapeutics, Lilly, EMD Serono, Roche/Genentech, GlaxoSmithKline, Harpoon Therapeutics, Hengrui Therapeutics, Incyte, Janssen, Jounce Therapeutics, Kymab, Macrogenics, MedImmune, Merck, Millennium, Moderna, Pfizer, Revolution Medicine, Foundation Medicine, SeaGen, Tesaro, TG Therapeutics, Verastem, Vertex Pharmaceuticals, Xbiotech, Zymeworks, Arch Oncology, Arvinas, Coordination Pharmaceuticals, NGM Biopharmaceuticals, Gossamer Bio, Ryvu Therapeutics, and BioTheryX. SM received honoraria from Karyopharm, GSK, BMS, Janssen and Oncopeptides. MRP reports leadership at ION Pharma; honoraria from Pfizer, Pharmacyclics, Bayer, Janssen, Genentech, and Adaptive Biotechnologies; consulting/advisory role at Pharmacyclics, Janssen, Pfizer, and EMD Serono; and speakers’ bureaus at Exelixis, Genentech, Roche, Taiho Pharmaceutical, and Celgene. GG reports participation in advisory boards for Roche, IQVIA, Kite-Gilead, Italfarmaco, Takeda, Ideogen, and Genmab; support for attending meetings from Roche, and Sandoz; and training activities for Roche, Takeda, Clinigen, Ideogen, Beigene, and Incyte; and individual scientific consultancy for Takeda. DES reports honoraria from AbbVie, AstraZeneca, Beigene, Janssen, Lily, Roche, and Takeda; consulting fees from AbbVie, ASTEX, AstraZeneca, Beigene, Janssen, and Kyowa Kirin; and financial support for conference/travel from AbbVie, Novartis, and Roche. FIC reports participation in advisory council/committees for Eli-Lilly, Bristol Meyers Squibb, MSD, Roche, Merck-Serono, Astra-Zeneca, OncXerna, Pierre Fabre, Boehringer Ingelheim, Incyte, Astella, GSK, Sotio, Eisai, Daiichi-Sankyo, Taiho, Servier; honoraria from Eli-Lilly, Eisai, Servier, Roche; and grants or funds from Eli-Lilly, Janssen-Cilag. JPO reports participation in advisory council/committees for Janssen, Takeda, and Roche; and grants/funds from Takeda. PLZ reports participation in advisory council/committees for Takeda, MSD, AbbVie, BMS, and ADC Therapeutics; and honoraria from Takeda, MSD, BMS, Gilead, Novartis, Kyowa Kirin, Sanofi, Incyte, Roche, Eusapharma, Janssen, Incyte, and AstraZeneca. SPI reports honoraria from Curebio, MD Education, and Target Oncology; consulting fees from Seagen, Yingli, Legend, and Securabio; and grants/funds from Merck, Seagen, CRISPRx, Legend, Myeloid, Innate, Rhizen, Spectrum, Affimed, Takeda, Yingli, and Ono. WT reports participation in advisory council/committees for Roche, Incyte, and Takeda; honoraria and consulting fees from Roche, Incyte, Takeda, Gilead, and BMS. SK reports employment and ownership of stocks/shares at Labcorp Drug Development. KS reports ownership of stock at AstraZeneca and Teva Pharmaceuticals. HM, IP, SW, SK, YY, JZ, KS and YS are all employees of Takeda; IP and SW also report the ownership of stocks/shares at Takeda. CC reports honoraria and consulting fees from Takeda and Regeneron; and honoraria from BMS, AstraZeneca, Gilead, and Novartis. FB reports participation in advisory council/committees, honoraria, consulting fees, and grants or funds from Roche, Genentech, AbbVie, Janssen, Lilly, AstraZeneca, Novartis, Kite, BMS, Takeda, TG therapeutics, BeiGene, Advantage, Allogene, LAVA therapeutics, Enterome. SF, JBK, and JR report no conflicts of interest.
All patients provided written informed consent. The study was conducted in accordance with the protocol, the ethical principles that have their origin in the Declaration of Helsinki, in accordance with the International Conference on Harmonization Good Clinical Practice standards, and applicable regulatory requirements. Relevant institutional review boards or ethics committees approved all aspects of the study, and all authors had access to primary clinical trial data. This trial is registered at ClinicalTrials.gov (NCT02000934).
This study was funded by Takeda Development Center Americas, Inc. (TDCA), Lexington, MA, USA.