Document is current

Article History

Received: 7 May 2025

Accepted: 6 October 2025

First Online: 8 December 2025

Declarations

:

: The trial was conducted in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki. All patients provided written informed consent.IEC/IRB approval was obtained for the study in all applicable locations. This includes both national and local approvals in each of the relevant countries.

: AOD, DS, MC, RZUD, NVM, AdS, SM, MW, MS, VT, YH, VTK, ASB are employees of Johnson & Johnson Innovative Medicine. AOD is a minor shareholder in Anumana, a software as a medical device company. BDG is an advisory board member for Elly Health, Inc. NA reports institutional research funding from Arnivas, Astellas, AstraZeneca, Bavarian Nordic, Bayer, Bristol Meyers Squibb, Calithera, Celldex, Clovis, CRISPR Therapeutics, Eisai, Eli Lilly, EMD Serono, Exelixis, Genentech, Gilead, Glaxo Smith Kline, Immunomedics, Janssen, Lava, Medivation, Merck, Nektar, Neoleukin, New Link Genetics, Novartis, Oric, Pfizer, Prometheus, Rexahn, Roche, Sanofi, Seattle Genetics, Takeda, and Tracon. AA reports the following relationships: Consultant — Aculeus Therapeutics, Astellas, Janssen, Novartis; Speakers Bureau — Astellas, Janssen, Novartis, Amgen, Ipsen, Bristol Myers Squibb; Merck Serono, Bayer; Honoraria — Aculeus Therapeutics, Amgen, Arvinas, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi Sankyo, Ipsen, Janssen, Merck Serono, Merck Sharpe Dohme, Novartis, Noxopharm, Pfizer, Sanofi, Telix, Tolmarl Scientific Advisory Board — Amgen, Arvinas, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi Sankyo, Ipsen, Janssen, Merck Serono, Merck Sharpe Dohme, Novartis, Noxopharm, Pfizer, Sanofi, Telix, Tolmar; Travel + Accommodation - Amgen, Astellas, Bayer, Hinova, Janssen, Merck Serono, Novartis, Pfizer, Tolmar; Research Funding — Aptevo Therapeutics (institutional), Astellas (investigator), Astellas (institutional), Astra Zeneca (institutional), Astra Zeneca (investigator), Bayer (institutional), Bayer (institutional), Bionomics (institutional), Bristol Myers Squibb (institutional), Eli Lilly (institutional), Exelixis (institutional), Gilead Sciences (institutional), Glaxo Smith Kline (institutional), Hinova (institutional), Ipsen (institutional), Janssen (institutional), MedImmune (institutional), Merck Serono (investigator), Merck Serono (institutional), Merck Sharpe Dohme (institutional), Novartis (institutional), Pfizer (institutional), Sanofi Aventis (institutional), SYNthorx (institutional); Steering Committee Member- Astra Zeneca, Arvinas, Astellas, Exelixis, Janssen, Pfizer, Merck Sharpe Dohme