Postel-Vinay, Sophie http://orcid.org/0000-0001-5562-1857
Coves, Juan
Texier, Matthieu
Aldea, Mihaela http://orcid.org/0000-0001-7685-051X
Gazzah, Anas
Dómine, Manuel
Planchard, David
De Las Peñas, Ramon
Sala Gonzalez, Ma Angeles
Viteri, Santiago
Perez, Javier
Ortega, Ana Laura http://orcid.org/0000-0002-5727-3371
Moran, Teresa
Camps, Carlos
Lopez-Martin, Ana
Provencio, Mariano
Soria, Jean-Charles
Besse, Benjamin
Massuti, Bartomeu
Rosell, Rafael http://orcid.org/0000-0003-0817-3400
Funding for this research was provided by:
AstraZeneca funded the trial and provided the drug Gustave Roussy sponsored this academic trial
AstraZeneca, academic trial
AZ, academic trial
Article History
Received: 29 April 2023
Revised: 2 November 2023
Accepted: 21 November 2023
First Online: 14 December 2023
Competing interests
: SPV and AG: Principal/sub-Investigator of Clinical Trials for Abbvie, Adaptimmune, Aduro Biotech, Agios Pharmaceuticals, Amgen, Argen-X Bvba, Arno Therapeutics, Astex Pharmaceuticals, Astra Zeneca Ab, Aveo, Basilea Pharmaceutica International Ltd, Bayer Healthcare Ag, Bbb Technologies Bv, Beigene, Blueprint Medicines, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Ca, Celgene Corporation, Chugai Pharmaceutical Co, Cullinan-Apollo, Daiichi Sankyo, Debiopharm, Eisai, Eisai Limited, Eli Lilly, Exelixis, Forma Tharapeutics, Gamamabs, Genentech, GlaxoSmithKline, H3 Biomedicine, Hoffmann La Roche Ag, Imcheck Therapeutics, Innate Pharma, Institut De Recherche Pierre Fabre, Iris Servier, Janssen Cilag, Janssen Research Foundation, Kyowa Kirin Pharm. Dev, Lilly France, Loxo Oncology, Lytix Biopharma As, Medimmune, Menarini Ricerche, Merck Sharp & Dohme Chibret, Merrimack Pharmaceuticals, Merus, Millennium Pharmaceuticals, Molecular Partners Ag, Nanobiotix, Nektar Therapeutics, Novartis Pharma, Octimet Oncology Nv, Oncoethix, Oncopeptides, Orion Pharma, Oxford Therapeutics, Ose Pharma, Pfizer, Pharma Mar, PEP-therapy, Pierre Fabre, Medicament, Roche, Sanofi Aventis, Sotio A.S, Syros Pharmaceuticals, Taiho Pharma, Tesaro, Xencor. SPV: Preclinical research funding: IMCore Hoffman La-Roche; AstraZeneca for work unrelated to this manuscript; Advisory board: Daiichi-Sankyo, Amgen. MA Travel: Sandoz ; Recherche grant : Sandoz ; Advisory : Viatris. DP: Consulting, advisory role or lectures: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer CME, Roche, Samsung; Honoraria: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer CME, Roche, Samsung; Clinical trials research as principal or co-investigator (Institutional financial interests): AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Pfizer, Roche, Medimmun, Sanofi-Aventis, Taiho Pharma, Novocure, Daiichi Sankyo; Travel, Accommodation, Expenses: AstraZeneca, Roche, Novartis, prIME Oncology, Pfizer. MD: MD: Consultant or Advisory Role: Astra-Zeneca, Boehringer Ingelheim, Janssen Cilag, MSD, Pfizer, Roche, Sanofi, Takeda. Speaking: Astra-Zeneca, BMS, MSD, Pfizer, Roche, Takeda. MP<b>:</b> MP: Consulting, advisory role or lectures: AstraZeneca, Bristol-Myers Squibb (BMS), Merck, Novartis, Pfizer, Travel, Accommodation, Expenses: AstraZeneca, Roche, Novartis,BMS. ALM<b>:</b> No conflicts of interest related to this study. Other conflicts of interest: - Consultant or advisory board: Amgen, Boehringer. Speaking: BMS, MSD, Pierre Fabre, Astra Zeneca. TM<b>:</b> Dr. Moran declares consulting/advisory role fees from Roche, Bristol Myers, Boeringher, Astra Zeneca, Lilly, and Research funding from Kyowa Kirin and Janssen, all of them unrelated with the present project. JCS is a full time-employee at Amgen since August 2021. He owns stock at Gritstone Bio, Relay Therapeutics and Amgen. BB<b>:</b> Contracted / supported research grants: Abbvie, Amgen, AstraZeneca, BeiGene, Blueprint Medicines, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Cristal Therapeutics, Daiichi-Sankyo, Eli Lilly, GSK, Ignyta, IPSEN, Inivata, Janssen, Merck KGaA, MSD, Nektar, Onxeo, OSE immunotherapeutics, Pfizer, Pharma Mar, Roche-Genentech, Sanofi, Servier, Spectrum Pharmaceuticals, Takeda, Tiziana Pharma, Tolero Pharmaceuticals JCS: Personal fees outside of this work: Astex, AstraZeneca, Bayer, Blend Therapeutics, Boehringer-Ingelheim, Clovis, Eli Lilly, Gammamabs, Merus, Mission Therapeutics, Pfizer, Pharmamar, Pierre Fabre, Roche, Sanofi, Servier, Symphogen, Tarveda; Gritstone; AstraZeneca All other authors declare no conflicts of interest.
: PIPSeN was granted central approval by the French Regulatory Authority ANSM under the reference 150127A12, on 10 April 2015, and Ethics Committee CPP Ile de France 8 on 10 Feb 2015. In Spain, PIPSeN was approved by the Agencia Española del Medicamento y Productos Sanitarios under the reference MUH/AEC, and the EC of Hospital Germans Trias i Pujol. Each enrolled patient provided informed consent as described in the manuscript and InternalRef removed.