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Article History

Received: 10 June 2020

Revised: 26 January 2021

Accepted: 18 February 2021

First Online: 7 April 2021

Ethics approval and consent to participate

: APHINITY was conducted in accordance with the Declaration of Helsinki; all patients provided written informed consent. The protocol was approved by the appropriate institutional review board at each centre. A full list of ethical committees and institutional review boards is listed in the supplementary material.

: Qualified researchers may request access to individual patient-level data through the clinical study data request platform: . Further details on Roche’s criteria for eligible studies are available here: . For further details on Roche’s Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: .

: All authors received support for third-party writing assistance for this manuscript, provided by F. Hoffmann-La Roche Ltd. J.Bi. reports consulting/advisory roles for AbbVie, Genomic Health, Libbs, Lilly, Pfizer, F. Hoffmann-La Roche Ltd, and travel/accommodations/expenses from AstraZeneca and F. Hoffmann-La Roche Ltd. E.C. is an employee of Roche Products Limited and is named on issued patent ‘Uses for and article of manufacture including HER2 dimerisation inhibitor pertuzumab, 13/649591’. C.B. is a freelance pharmaceutical physician/medical advisor with Barton Oncology Ltd and has undertaken paid consultancy work with Roche Products Limited and many other companies and organisations, including (in the last ~5 years) Apeiron Biologics AG, Cancer Research UK Centre for Drug Development, Cancer Targeting Systems Inc, CellCentric Ltd, Certara LP, Innate Pharma SA, Macrophage Pharma Ltd, MorphoSys AG, Mosaic Biomedicals SL, Norgine Pharmaceuticals Ltd, Ona Therapeutics SL, Orion Clinical Services Ltd, Piqur Therapeutics AG, PTEN Research Foundation, SFL Services GmbH, T3 Pharmaceuticals AG, UCB Biopharma SPRL, and the Wellcome Trust Ltd. She is on the advisory board for SFL Services GmbH and owns shares in GlaxoSmithKline. E.R. is an employee of, and holds shares in, F. Hoffmann-La Roche Ltd. M.Pr.’s institution received funding from F. Hoffmann-La Roche Ltd with respect to the APHINITY study. A.S. reports a consulting/advisory role with Eli Lilly, Pfizer, and Novartis; travel/accommodations/expenses from Neopharm and Celgene; and has been on speaker bureaus for Teva, F. Hoffmann-La Roche Ltd, and Pfizer (all unrelated to the APHINITY study). D.F.’s and A.A.’s institution has received research funding to support the conduct of APHINITY from F. Hoffmann-La Roche Ltd/Genentech, Inc.; and research funding from AstraZeneca, Tesaro, Novartis, Pfizer, F. Hoffmann-La Roche Ltd/Genentech, Inc., and Servier, outside the submitted work. D.P. is a member of the APHINITY Joint Study Management Team and has never received any personal fees for the APHINITY study or outside of the APHINITY study from F. Hoffmann-La Roche Ltd. His institution, Institut Jules Bordet, has received both financial and non-financial (e.g., provision of drugs for study) support for the conduct of the APHINITY study. Institut Jules Bordet has received and still receives research grants or non-financial support outside of APHINITY from F. Hoffmann-La Roche Ltd. J.Ba. was an employee of AstraZeneca, served on the Board of Directors of Foghorn, and was a past board member of Varian Medical Systems, Bristol-Myers Squibb, Grail, Aura Biosciences, and Infinity Pharmaceuticals. He had performed consulting and/or advisory work for Grail, PMV Pharma, ApoGen, Juno, Lilly, Seragon, Novartis, and Northern Biologics. He had stock or other ownership interests in PMV Pharma, Grail, Juno, Varian, Foghorn, Aura, Infinity, and ApoGen, as well as Tango and Venthera, for which he is a co-founder. He had previously received honoraria or travel expenses from F. Hoffmann-La Roche Ltd, Novartis, and Lilly. He had also received from F. Hoffmann-La Roche Ltd non-financial support for studies’ drug supplies and conduct. G.V. has received travel grants and remuneration for advisory board meetings from F. Hoffmann-La Roche Ltd. His institution received investigators’ fees for the APHINITY study. L.L.R. has received airfare, taxi fare, and accommodation payments to attend APHINITY Steering Committee meetings since 2012. E.F. has received <$500 airfare and accommodation payments to attend APHINITY Steering Committee meetings. R.D.G.’s institution receives support for his salary from F. Hoffmann-La Roche Ltd, Pfizer, AstraZeneca, Merck, Ipsen, Ferring, Celgene, and Novartis. He has received travel support payments to attend APHINITY Steering Committee meetings from F. Hoffmann-La Roche Ltd. M.Pi. serves on the Scientific Board for Oncolytic. She has received honoraria for consulting roles for AstraZeneca, Camel-IDS, Crescendo Biologics, Debiopharm, G1 Therapeutics, Genentech, Inc., Huya, Immunomedics, Lilly, Menarini, MSD, Novartis, Odonate, Periphagen, Pfizer, F. Hoffmann-La Roche Ltd, and Seattle Genetics, and her institute has received research grants from AstraZeneca, Lilly, MSD, Novartis, Pfizer, Radius, F. Hoffmann-La Roche Ltd/Genentech, Inc., Servier, and Synthon. C.J. has received travel support payments for Steering Committee meetings, consulting fees, and honoraria from F. Hoffmann-La Roche Ltd for the APHINITY study. His institution received investigators’ fees for the APHINITY study. J.A.P. is an employee of Genentech, Inc. and has shares in F. Hoffmann-La Roche Ltd.

: This work was supported by F. Hoffmann-La Roche Ltd, Basel, Switzerland/Genentech, Inc., South San Francisco, CA, USA (no grant number applicable). F. Hoffmann-La Roche Ltd/Genentech, Inc. was involved in the study design, data interpretation, and the decision to submit for publication in conjunction with the authors.

: Not required.