De Laurentiis, Michelino http://orcid.org/0000-0001-9009-1572
Caputo, Roberta
Mazza, Manuelita
Mansutti, Mauro
Masetti, Riccardo
Ballatore, Zelmira
Torrisi, Rosalba
Michelotti, Andrea
Zambelli, Alberto
Ferro, Antonella
Generali, Daniele
Vici, Patrizia
Coltelli, Luigi
Fabi, Alessandra
Marchetti, Paolo
Ballestrero, Alberto
Spazzapan, Simon
Frassoldati, Antonio
Sarobba, Maria Giuseppina
Grasso, Donatella
Zamagni, Claudio
Funding for this research was provided by:
Novartis Pharmaceuticals Corporation
Article History
Accepted: 10 August 2022
First Online: 24 September 2022
Declarations
:
: This study was funded by Novartis Pharmaceuticals Corporation.
: Michelino De Laurentiis participated in the advisory board and received grants, consulting fees and honoraria from Novartis, Roche, MSD, Astra Zeneca, Daiichi Sankyo, Seagen, Eli Lilly, and Pfizer. Manuelita Mazza participated in the advisory board and received grants, consulting fees and honoraria from Novartis, Pfizer, Astra Zeneca, Eli Lilly, Gentili, and Roche. Mauro Mansutti participated in the advisory board of Amgen, Astra Zeneca, Eli Lilly, Gentili, MSD Italia, Novartis, Pfizer, Roche; honoraria from Pierre Fabre; reimbursement of travel or accommodation expenses from Eisai, Novartis, Pfizer, Pierre Fabre, Roche. Zelmira Ballatore received honoraria from Ipsen, Novartis, Roche. Rosalba Torrisi received honoraria from Astra Zeneca, Eisai, Pfizer, Eli Lilly, and Gentili. Rita De Sanctis Novartis, Amgen, Kyowa Kirin, and Eisai. Alberto Zambelli participated in the advisory board of Novartis, Pfizer, Astra Zeneka, Daiichi Sankyo, MSD, Eli Lilly; received honoraria from Novartis, Pfizer, Astra Zeneka, Daiichi Sankyo, MSD, Eli Lilly, Exact Sciences. Antonella Ferro received personal fees from Novartis and Eli Lilly. Daniele Generali participated in advisory board for Lilly, Novartis, Pierre Fabre; received honoraria from Novartis, Pfizer, Lilly, Astra Zeneca, ESAI, Istituto Gentili; reimbursement of travel or accommodation expenses from Novartis, Lilly, and Pierre-Febre. Patrizia Vici participated in advisory board for Novartis, Eisai; and received honoraria from Pfizer, Novartis, Gentili, Lilly, EISAI, Roche. Paolo Marchetti received honoraria from Roche, BMS, MSD, Novartis, Pfizer, Pierre Fabre; reimbursement support for congress attendance from BMS, Roche, Pierre Fabre; received grants to institution from Roche, BMS, Pfizer, Incyte, Novartis, Takeda, MSD, Pierre Fabre. Simon Spazzapan participated in the advisory board of Novartis, Astra Zeneca, Daichii, Sankyo and received honoraria from Novartis, Pfizer, Astra Zeneka, Daiichi Sankyo, MSD, Eli Lilly. Antonio Frassoldati participated in the advisory board and received personal fees from Novartis, Astra Zeneca, Pfizer, Lilly, Roche, Daichii, Seagen, Amgen. Maria Giuseppina Sarobba participated in the advisory board of Novartis, Pierre Fabre, MSD, and received honoraria from Novartis, Pfizer, Lilly, Astra Zeneca, MSD, Astellas. Donatella Grasso is employed by Novartis. Claudio Zamagni has received honoraria for consulting or advisory roles from Astra Zeneca, Eisai, Novartis, Pfizer, PharmaMar, Pierre Fabre, and Roche; research funding from AbbVie, Array BioPharma, Astra Zeneca, Celgene, Medivation, Morphotek, Novartis, Pfizer, Roche, and Roche/Genentech; reimbursement for travel, accommodations, or expenses from Celgene, Novartis, Pierre Fabre, and Roche. Roberta Caputo, Riccardo Masetti, Andrea Michelotti, Luigi Coltelli, Alessandra Fabi, and Alberto Ballestrero declared no conflict of interest.
: The data that support the findings of this study are available from Novartis Pharmaceuticals Corporation, but restrictions apply to the availability of these data (https://www.novartisclinicaltrials.com/Trial ConnectWeb/home.nov). However, data are available from the authors upon reasonable request and with permission of Novartis Pharmaceuticals Corporation.
: The study was reviewed and approved by a properly constituted Institutional Review Board/Independent Ethics Committee/ Research Ethics Board before study commencement for each center and was conducted in accordance with the in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Harmonized Tripartite Guidelines for Good Clinical Practice, applicable local regulations, and the ethical principles laid down in the Declaration of Helsinki. All patients provided written informed consent prior to participation in the study.
: Written informed consent was obtained from all patients.
: All authors critically reviewed, provided feedback at each stage of the manuscript, approved the final version and agreed to be accountable for all aspects of the work.
: We thank all patients and investigators involved in the study. Medical writing assistance was provided by Moumita Samanta, PhD from Novartis Pharmaceuticals Corporation, India.