Document is current

Article History

Received: 18 April 2019

Accepted: 22 May 2019

First Online: 1 June 2019

Compliance with ethical standards

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: Mark Rosenthal has nothing to disclose. Richard Curry has part-time employment as medical director for Bexion Pharmaceuticals with potential stock options. David A. Reardon has participated in advisory boards for AbbVie, Advantagene, Agenus, Bristol-Myers Squibb, Celldex, EMD Serono, Genentech/Roche, Inovio, Merck, Merck KGaA, Monteris, Novocure, Oncorus, Oxigene, Regeneron, Stemline, and Taiho Oncology, Inc; the Dana Farber Cancer Institute received financial compensation for research from Acerta Pharmaceuticals, Agenus, Celldex, EMD Serono, Incyte, Inovio, Midatech, Omniox, and Tragara. Erik Rasmussen is an employee of and stockholder in Amgen Inc. Vijay V. Upreti is an employee of and stockholder in Amgen Inc. and is the Clinical Pharmacology Oncology Therapeutic Area Head at Amgen Inc. Michael A. Damore is a stockholder in Amgen Inc. and was an employee of Amgen Inc. at the time that the study was conducted. Haby A. Henary is an employee of Amgen Inc. John S. Hill is a stockholder in Amgen Inc., an author on a US patent awarded to Amgen related to this work, and was an employee of Amgen Inc. at the time that the study was conceived and initiated. Timothy Cloughesy has consulted for Roche/Genentech, VBL, Merck, Bristol-Myers Squibb, Agios, Boston Biomedical, Tocagen, Deciphera, VBI, Celegene, Puma, and Lilly, and he is a stock option holder for Notable Labs and a board member for Global Coalition for Adaptive Research, a 501(c)3 nonprofit organization.

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

: All patients provided written informed consent.

: There is a plan to share data. This may include de-identified individual patient data for variables necessary to address the specific research question in an approved data-sharing request; also related data dictionaries, study protocol, statistical analysis plan, informed consent form, and/or clinical study report. Data sharing requests relating to data in this manuscript will be considered after the publication date and (1) this product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or (2) clinical development discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for these data. Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. A committee of internal advisors reviews requests. If not approved, requests may be further arbitrated by a Data Sharing Independent Review Panel. Requests that pose a potential conflict of interest or an actual or potential competitive risk may be declined at Amgen’s sole discretion and without further arbitration. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the following: .