Ethics approval and consent to participate
CELESTIAL was conducted in accordance with the International Conference on Harmonisation Good Clinical Practice guidelines and the Declaration of Helsinki. The protocol was approved by the ethics committee/institutional review board of participating study centres (supplementary file). All patients provided written informed consent. This study adhered to CONSORT guidelines .
Consent for publication
Availability of data and material
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
ABEK: Consulting/advisory: AstraZeneca, Bayer, BMS, Celgene, CytomX, Eisai, Exelixis, Novartis, Roche; grant support: AstraZeneca, Astex; speakers’ bureau fee: Merrimack.
TM: Grant support/consulting: Bayer, BMS, BTG, Eisai, Merck.
ALC: Honorarium: Bayer, Eisai, Merck, Merck Serono, Novartis, Ono Pharma., Roche, IQVIA; consulting/advisory: Bayer, BMS, Eisai, Exelixis, IQVIA, Merck Serono, Novartis, Nucleix, Ono Pharma., Roche; speaker bureau fees: Amgen, Bayer, Novartis, Eisai, Ono Pharma. Yakuhin.
LR: Consulting/advisory: Amgen, ArQule, AstraZeneca, Basilea, Bayer, BMS, Celgene, Eisai, Exelixis, Genenta, Hengrui, Incyte, Ipsen, IQVIA, Lilly, MSD, Nerviano Medical Sciences, Roche, Sanofi, Zymeworks; speakers bureau fee: AbbVie, Amgen, Bayer, Eisai, Gilead, Incyte, Ipsen, Lilly, Merck Serono, Roche, Sanofi; travel fee: Ipsen; research funding: Agios, ARMO BioSciences, AstraZeneca, BeiGene, Eisai, Exelixis, Fibrogen, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Sciences, Roche, Zymeworks.
SS, SM: Employees of Exelixis.
RKK: Consulting/advisory: Agios, AstraZeneca, BMS, Exact Sciences, Genentech/Roche, Gilead, Ipsen, Merck; research funding: Adaptimmune, Agios, AstraZeneca, Bayer, BMS, Celgene, Eli Lily, EMD Serono, Exelixis, MedImmune, Merck, Novartis, Partner Therapeutics, Taiho Pharmaceuticals.
GKAA: Grant support: ActaBiologica, Agios, AstraZeneca, Bayer, Beigene, Berry Genomics, BMS, Casi, Celgene, Exelixis, Genentech/Roche, Halozyme, Incyte, Mabvax, Puma, QED, Sillajen, Yiviva; consulting/advisory: Agios, AstraZeneca, Autem, Bayer, Beigene, Berry Genomics, Celgene, CytomX, Debio, Eisai, Eli Lilly, Flatiron, Genentech/Roche, Gilead, Incyte, Ipsen, LAM, Loxo, Merck, MINA, Polaris, QED, Redhill, Silenseed, Sillajen, Sobi, Therabionics, Twoxar, Vector, Yiviva.
This study was supported by Exelixis, Inc.
ABEK, TM, ALC, LR, SM, RKK, and GKAA contributed to the conception of the manuscript and interpretation of data. SS contributed to the conception and drafting of the manuscript and interpretation of data. All authors provided critical review and revisions, and all authors approved the final version of the manuscript for submission and publication.
Medical writing assistance provided by Alan Saltzman, PhD, and Bryan Thibodeau, PhD (Fishawack Communications, Conshohocken, PA) and funded by Exelixis.
Tim Meyer is part funded by the NIHR UCH Biomedical Research Centre.