Gumenyuk, Solomiya
Ogirala, Ajay
Szabo, Steven T.
Koblan, Kenneth
Hopkins, Seth C.
Ufer, Mike https://orcid.org/0000-0002-6637-4406
Funding for this research was provided by:
Sumitomo Pharma America Inc. & Sumitomo Pharma Switzerland GmbH
Article History
Received: 15 June 2025
Accepted: 13 January 2026
First Online: 16 February 2026
Declarations
:
: This work was funded by Sumitomo Pharma America Inc. and Sumitomo Pharma Switzerland GmbH. The funders had no role in study design, data collection, data analysis, data interpretation, manuscript drafting, or the decision to submit the manuscript for publication.
: All authors are current or previous employees of Sumitomo Pharma America Inc. or Sumitomo Pharma Switzerland GmbH who funded this work.
: Available from the corresponding author upon reasonable request.
: All authors reviewed and approved the final version of the manuscript and agreed to be accountable for all aspects of the work. All authors made substantial contributions to the conception of the work as well as to the acquisition, analysis, or interpretation of data. SG: writing, methodology, and data analysis; AO: methodology, data management, and data analysis; STS: conceptualization, and methodology; KK: conceptualization; SCH: conceptualization and methodology; MU: writing, methodology, and data analysis.
: Each of these five studies was done in accordance with regulatory requirements and with the standards of ethics according to the principles outlined in the Declaration of Helsinki and International Council for Harmonization (ICH) guideline for Good Clinical Practice. Approval of the study protocols was obtained from multiple central and local institutional review boards (IRBs). The present work did not require additional ethics approval, since it was based on de-identified data from completed studies and there was no requirement for enrolment of new human subjects.
: In each clinical study, all participants signed an informed consent form prior to any study assessment. Each participant was provided with full and adequate verbal and written information regarding the nature, purpose, and possible risk and benefit of study participation. This included the understanding that a subject was free to discontinue his or her participation at any time. The present work did not require additional consent, since it was based on de-identified data from completed studies.
: Not applicable.
: Not applicable.