Schwartzberg, Lee
Navari, Rudolph M.
Ruddy, Kathryn J.
LeBlanc, Thomas W.
Clark-Snow, Rebecca
Wickham, Rita
Kloth, Dwight
Binder, Gary
Bailey, William L.
Turini, Marco
Potluri, Ravi
Liu, Xing
Papademetriou, Eros http://orcid.org/0000-0002-9932-566X
Roeland, Eric J.
Funding for this research was provided by:
Helsinn
Article History
Received: 10 March 2023
Accepted: 13 October 2023
First Online: 25 October 2023
Declarations
:
: The protocol for this phase IIIB study (NCT03403712) was approved by ethical review committees at each institution and all patients gave written informed consent. The study was performed in accordance with the principles outlined in the Declaration of Helsinki as amended by the World Medical Association in Fortaleza in 2013, the International Conference on Harmonization (ICH) Good Clinical Practice guidelines, and all local laws and regulations of the countries in which the study was conducted.
: All participants gave their informed consent to participate in the study.
: Not applicable.
: Mr. Binder, Mr. Bailey, and Mr. Turini were employees of Helsinn at the time the study was conducted. Dr. Roeland reports a consulting/advisory role for Napo, AIM Specialty Health, Oragenics, BASF, Immuneering, Vector Oncology, Asahi Kasei, Heron, Pfizer/EMD Serono, and Mitobridge. Dr. LeBlanc reports personal fees for consulting or advisory boards from AbbVie, Agios/Servier, Astellas, BlueNote, BMS/Celgene, Flatiron, Genentech, GSK, and Pfizer; royalties from UpToDate; speakers bureau fees from Agios/Servier, AbbVie, and BMS/Celgene; grants and/or research contracts from the American Cancer Society, AstraZeneca, BMS, Jazz Pharmaceuticals, the NINR / NIH, and Seattle Genetics. Dr. Wickham reports honoraria from Insys Therapeutics, and scientific advisory board fees from Helsinn. Mr. Potluri, Mr. Papademetriou, and Ms. Liu were employees of Putnam PHMR at the time of the study and received payment for conducting the analyses. Dr. Schwartzberg reports consulting fees from Pfizer, Myriad, Genentech, Odonate, Amgen, Spectrum, Napo, Lilly, BMS, Helsinn, Bayer, BeyondSpring, AstraZeneca, Seagen, Sanofi, Coherus; speakers bureau fees from Coherus, Puma, Merck, Seagen, and Pfizer. Drs. Navari, Ruddy, Kloth, and Ms. Clark-Snow report no conflicts of interest.