Document is current

Article History

Received: 24 March 2025

Accepted: 21 May 2025

First Online: 21 June 2025

Declarations

:

: Divyan Chopra, Nadia Karim, Cynthia Obiozor, and Björn Stollenwerk are employees of and stockholders in Amgen. Hoora Moradian is an employee of Cytel that received consultancy fees from Amgen. Zhiyi Lan was employed by Cytel, Inc., at the time of study conduct. Jürgen Wolf received advisory board and lecture fees from AbbVie, Amgen, AstraZeneca, BeiGene, Blueprint, Bristol Myers Squibb (BMS), Boehringer Ingelheim, Chugai, Daiichi Sankyo, Ellipses Pharma, Genmab, Janssen, Lilly, Loxo, Merck, Murati, Merck Sharp & Dohme (MSD), Novartis, Novalent, Pfizer, Pierre-Fabre, Regeneron, Roche, Seattle Genetics, Takeda, and Turning Point as well as research support from AstraZeneca, BMS, Janssen Pharmaceutica, Novartis, and Pfizer. David M. Waterhouse has served in a consulting or advisory role for BMS, AZTherapies, AbbVie, Amgen, McGivenny Global, Janssen Oncology, Seattle Genetics, Exelixis, Eisai, EMD Serono, Merck, Pfizer, Mirati Therapeutics, Regeneron/Sanofi, Fresenius KBI, Lilly, Sanofi, Astellas Pharma, Gilead Sciences, Takeda, Daiichi Sankyo, Novartis, Bayer, AVEO; has participated in speakers’ bureaus for BMS, Janssen Oncology, Merck, AstraZeneca, Amgen, and EMD Serono; has received travel, accommodations, expenses from BMS. Enriqueta Felip has received consulting fees from AbbVie, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, F. Hoffmann-La Roche, Gilead, GlaxoSmithKline, Iteos Therapeutics, Janssen, Johnson & Johnson, MSD, Novartis, Pierre-Fabre, Pfizer, Regeneron, and Turning Point; has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Amgen, AstraZeneca, BMS, Daiichi Sankyo, Eli Lilly, F. Hoffmann-La Roche, Genentech, Gilead, Janssen, Johnson & Johnson, Medical Trends, Medscape, Merck Serono, MSD, Novartis, Peervoice, Pfizer, and Regeneron; has received support for attending meetings and/or travel from AstraZeneca, Janssen, and Roche; is an independent member of the board of Grifols.

: Zhiyi Lan was employed by Cytel, Inc. at the time of study conduct. Zhiyi’s current affiliation is IQVIA Inc., CA, USA.

: This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.The CodeBreak 200 trial used in the study was conducted in accordance with the International Council for Harmonisation Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. The protocol and amendments were approved by the institutional review board at each participating site and regulatory authorities of participating countries. The protocol for the KRYSTAL-12 trial states that the study will be conducted in accordance with International Ethical Guidelines for Biomedical Research Involving Human Patients (Council for International Organizations of Medical Sciences 2002), Guidelines for Good Clinical Practice (GCP) (International Council for Harmonisation [ICH] 1996), ICH E6 (R2) and concepts that have their origin in the Declaration of Helsinki (World Medical Association 1996, 2008 & 2013), the study will be conducted under a protocol reviewed and approved by an institutional review board/ethics committee.