Bauer, Sebastian http://orcid.org/0000-0001-5949-8120
Demetri, George D.
Halilovic, Ensar
Dummer, Reinhard
Meille, Christophe
Tan, Daniel S. W.
Guerreiro, Nelson
Jullion, Astrid
Ferretti, Stephane
Jeay, Sebastien
Van Bree, Laurence
Hourcade-Potelleret, Florence
Wuerthner, Jens U.
Fabre, Claire
Cassier, Philippe A. http://orcid.org/0000-0003-3857-1688
Funding for this research was provided by:
Novartis
Article History
Received: 23 November 2020
Revised: 26 March 2021
Accepted: 17 May 2021
First Online: 17 June 2021
Ethics approval and consent to participate
: The study protocol and all amendments were reviewed by the Independent Ethics Committee or Institutional Review Board for each centre. The study was conducted according to the ethical principles of the Declaration of Helsinki. All animal experiments were performed according to procedures covered by permit number BS-1975 issued by the Cantonal Veterinary Office, Basel, Switzerland, and in strict adherence to the Federal Animal Protection Act and the Federal Animal Protection Code.
: Not applicable.
: Novartis will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be re-identified. Phase 1 studies, by their nature, present a high risk of patient re-identification; therefore, patient individual results for phase 1 studies cannot be shared. In addition, clinical data, in some cases, have been collected subject to contractual or consent provisions that prohibit transfer to third parties. Such restrictions may preclude granting access under these provisions. Where co-development agreements or other legal restrictions prevent companies from sharing particular data, companies will work with qualified requestors to provide summary information where possible.
: S.B. has received honoraria from Novartis, Pfizer, Bayer, PharmaMar and GlaxoSmithKline; served in advisory or consultancy roles for Blueprint Medicines, Bayer, Lilly, Deciphera, Exelixis, Janssen-Cilag, Plexxikon and Nanobiotix; received institutional research funding from Blueprint Medicines, Novartis, and Incyte; and received travel and accommodation funding from PharmaMar. G.D. reports grants, non-financial support and personal fees from Novartis during the conduct of the study. Outside of this work, the following disclosures are reported: grants and personal fees from Bayer, personal fees from Pfizer, personal fees and non-financial support from Roche/Genentech, grants and personal fees from Epizyme, grants and personal fees from LOXO Oncology, grants, personal fees, and non-financial support from AbbVie, grants, personal fees, and non-financial support from GlaxoSmithKline, grants and personal fees from Janssen, personal fees and non-financial support from PharmaMar, personal fees from ZioPharm, grants, personal fees and non-financial support from Daiichi-Sankyo, grants and personal fees from Adaptimmune, personal fees from Ignyta, personal fees from Mirati, personal fees from EMD Serono, personal fees from Sanofi, personal fees and non-financial support from ICON PLC, personal fees and non-financial support from WCG/ARSENAL, personal fees from Polaris Pharmaceuticals, personal fees from MJ Hennessey/OncLive, personal fees from Medscape, grants and non-financial support from the Dr. Miriam and Sheldon G. Adelson Medical Research Foundation, personal fees and “minor equity” from G1 Therapeutics, minor equity, personal fees, non-financial support, and other from CARIS Life Sciences, minor equity from Bessor Pharmaceuticals, minor equity from ERASCA Pharmaceuticals, minor equity and personal fees from RELAY Therapeutics, minor equity and personal fees from Caprion/HistoGeneX, minor equity, personal fees, non-financial support, and other from Blueprint Medicines (where he serves as a member of the Board of Directors), personal fees and member of the Board of Directors (until Oct 2019) of Merrimack Pharmaceuticals, and personal fees, minor equity as a member of the Board of Directors of Translate BIO, all outside the submitted work. S.J. was an employee of Novartis Oncology at the time the study was performed. S.J. is now an employee of Idorsia Pharmaceuticals Ltd. In addition, S.J. has patents WO/2015/097622 and WO/2014/020502 issued. R.D. has intermittent, project focused consulting and/or advisory relationships with Novartis, Merck Sharp & Dhome (MSD), Bristol-Myers Squibb (BMS), Roche, Amgen, Takeda, Pierre Fabre, Sun Pharma, Sanofi, Catalym, Second Genome outside the submitted work. N.G. was an employee of Novartis Pharma AG at the time the study was performed, and owning shares of Novartis Pharma AG. N.G. is now an employee of F. Hoffmann-La Roche AG. D.T. is a senior consultant at the National Cancer Centre Singapore. D.T. has consulting and/or advisory relationships with Novartis, Bayer, Boehringer Ingelheim, Celgene, Astra-Zeneca, Eli-lilly, LOXO, Pfizer, Takeda and Merrimack; Honoraria from Boehringer Ingelheim, Merck, Roche and Pfizer; Research Grants from Novartis, Bayer, Astra-Zeneca, GlaxoSmithKline, outside the submitted work. A.J. is an employee of Novartis Pharma AG owning shares of Novartis Pharma AG. C.M. is an employee of Novartis Pharma AG owning shares of Novartis Pharma AG. S.F. is an employee of Novartis Pharma AG owning shares of Novartis Pharma AG. L.V.B. is an employee of Novartis Pharma AG owning shares of Novartis Pharma AG. E.H. is an employee of Novartis Pharma AG owning shares of Novartis AG. F.H.P. is an employee of Novartis Pharma AG owning shares of Novartis AG. C.F. is an employee of Novartis Pharma AG owning shares of Novartis Pharma AG. J.W. was an employee of Novartis Oncology at the time the study was performed and is holding shares of Novartis Pharma AG. J.W. is now an employee of ADCT Therapeutics SA. P.C.: Honoraria: Amgen, Astra-Zeneca, Blueprint, EMD Serono, Roche/Genentech, Novartis; Travel accommodation: Astra-Zeneca, BMS, EMD Serono, MSD, Novartis; Research support to institution: Abbvie, Bayer, Blueprint, BMS, GSK, Janssen, Lilly, Loxo, Novartis, Roche/Genentech, Taiho. P.C. is a member of the Editorial Board of the British Journal of Cancer.
: The study was sponsored by Novartis Pharma AG. Open Access funding enabled and organized by Projekt DEAL.