Document is current

Article History

Received: 27 November 2024

Accepted: 15 January 2025

First Online: 13 March 2025

Declarations

:

: Jianming Xu reports no conflicts of interest. Ken Kato has received consulting fees from AstraZeneca, Bayer, BeiGene, Bristol Myers Squibb, Janssen, Merck Bio, Merck & Co., Novartis, Ono Pharmaceutical, and Roche; 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. Richard Hubner has received honoraria from Eisai and has participated on data safety monitoring boards or advisory boards for BeiGene, Ipsen, and Novartis. Sook Ryun Park has received research grants from ImmuneOncia Therapeutics, Incyte, Ono Pharma Korea; has received consulting fees from BeiGene and Pfizer Pharmaceuticals; and has received honoraria from MSD. Takashi Kojima has received grants from Amgen, BeiGene, Bristol Myers Squibb, Chugai Pharmaceutical, EPS Corporation, Merck Biopharma, Merck Sharp & Dohme K.K., Ono Pharmaceutical, Parexel, Shionogi & Co., and Taiho Pharmaceutical; has received honoraria from Bristol Myers Squibb, Covidien Japan, Merck Sharp & Dohme K.K., Oncolys BioPharma, Ono Pharmaceutical, and Taiho Pharmaceutical; and has participated on data safety monitoring boards or advisory boards for Astellas Pharma, Bristol Myers Squibb, Merck Biopharma, Merck Sharp & Dohme K.K., and Oncolys BioPharma. Ryu Ishihara has received honoraria from AI Medical Service, AstraZeneca, Daiichi Sankyo, FUJIFILM Medical, Miyarisan Pharmaceutical, Merck Sharp & Dohme, Olympus, and Ono Pharmaceutical. Lucjan Wyrwicz has received honoraria from AstraZeneca, BeiGene, Bristol Myers Squibb, Merck Sharp & Dohme, Roche, and Servier Laboratories; has acted as a committee member for Bristol Myers Squibb and Servier Laboratories; and owns stocks in BeiGene. Eric Van Cutsem reports participation in advisory boards for AbbVie, Agenus, ALX, Amgen, Arcus Biosciences, Astellas, AstraZeneca, Bayer, BeiGene, Bexon Clinical, BioNtech, Boehringer Ingelheim, Bristol Myers Squibb, Canfour, Daiichi Sankyo, Debiopharm, Elmedix, Eisai, Galapagos, GSK, Hookipa Biotech, Incyte, Ipsen, Lilly, Merck Sharp & Dohme, Merck KGaA, Mirati, Novartis, Nordic, Pierre Fabre, Pfizer, Roche, Seattle Genetics, Servier, Simcere, Takeda, Taiho Pharmaceutical, and Terumo. Paula Jimenez-Fonseca has participated in presentations, educational events, and/or advisory boards for Astellas, AstraZeneca, BeiGene, Bristol Myers Squibb, Esteve, Merck Sharp & Dohme, Novartis, Nutricia, Pfizer, Rovi, Takeda, and Viatris. Hongqian Wu, Lei Wang, Sebastian Yan, Jingwen Shi, and Alysha Kadva are employees of BeiGene, Ltd. and own stocks in BeiGene. Harry H. Yoon reports speaker fees from BeiGene; writing engagements with BeiGene; expert testimony fees from MJH Life Sciences; advisory roles for Amgen, Astellas, AstraZeneca, BeiGene, Bristol Myers Squibb, Elevation Oncology, Macrogenics, Merck Sharp & Dohme, Novartis, OncXerna, and Zymeworks; research grants from Amgen, BeiGene, Bristol Myers Squibb, CARsgen Therapeutics, Macrogenics, and Merck; and support for travel from Astellas, BeiGene, Elevation Oncology, and PRIME.

: RATIONALE-306 was conducted in compliance with Good Clinical Practice guidelines, the principles of the Declaration of Helsinki and its later amendments, as well as local regulations, and was approved by the relevant institutional review board/independent ethics committee for each study site. Written informed consent was obtained from all patients before study participation, and safety was monitored by an independent data monitoring committee. A complete list of ethics committees by site number is available in the Supplementary Materials.