Acknowledgements
The authors thank the patients, their families, investigators, nurses, and site staff at participating centers; Lucia Trandafir at Bayer for support in the set-up and running of these trials; and Josh Weng (statistician consultant) and Jin Li (statistical analyst) for support in the statistical analyses.
Medical writing support in the preparation of this article was provided by Sara Black, ISMPP CMPP™, of OPEN Health Communications (London, UK), with financial support from Bayer. Editorial assistance in the preparation of this manuscript was provided by Lila Adnane (Bayer Healthcare).
Funding
This work was supported by Bayer HealthCare.
Competing Interests
HSR: Grants to institution from Astellas, AstraZeneca, Ayala, Boehringer Ingelheim, Daiichi, Gilead, Lilly, Macrogenics, Merck, Novartis, Pfizer, Polyphor, Roche, Seattle Genetics, and Sermonix; honoraria from Mylan, NAPO, Puma, and Samsung.
CVP: Research grant from Bayer for a study outside of the one associated with this manuscript; royalties from UpToDate; board member (unpaid) of Cancer and Bone Society, an independent organization that promotes international collaborations within the cancer and bone field in both clinical and basic research.
PN: Research funding from Kom op Tegen Kanker; consulting fees from AstraZeneca, Lilly, Novartis, Pfizer, and Roche; consulting or advisory roles for Lilly, Novartis, Pfizer, and Roche.
ID: No conflicts to disclose.
SCL: Research grants from ACT Genomics, Eisai, Pfizer, and Taiho; consulting/advisory roles for, and payment/honoraria from, AstraZeneca, Daiichi-Sankyo, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, and Roche; travel/meeting attendance support from Pfizer and Roche.
MC: Payment and/or honoraria from Amgen, Gilead, GSK, Merck Sharp & Dohme, Novartis, Pfizer, and Seagen (to institution) and from Lilly, Pierre Fabre, and Sanofi (to self).
YKC: No conflicts to disclose.
EVA: No conflicts to disclose.
BN: No conflicts to disclose.
EB: Consulting fees from Daiichi-Sankyo, Pfizer, and Sandoz; payment and/or honoraria from Eli Lilly, Pfizer, and Seagen; travel/meeting attendance support from Pfizer and Sandoz; consultancy/advisory role for Daiichi-Sankyo.
JMS: Employee of Bayer; stock ownership in Bayer AG; leadership and/or committee roles in Pharmaceutical Industry Working Group on Estimands in Oncology, Society for Clinical Biostatistics Subcommittee for Statistics in Regulatory Affairs, and American Statistical Association.
RL: Employee of Bayer.
DU: Employee of Bayer.
VW: Employee of Bayer.
REC: Consulting fees from Sanofi; payment/honoraria from Amgen and Beigene; patent for MAF gene test and stock options with Inbiomotion; consultancy/advisory role for AstraZeneca.
Author Contributions
All authors contributed to the conception or design of the work and the acquisition, analysis, or interpretation of the data. HSR, JMS, DU, and REC drafted the article, with medical writing support from Sara Black at OPEN Health. All authors critically reviewed the manuscript for important intellectual content and approved the version to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Data Availability
Availability of the data underlying this publication will be determined later according to Bayer’s commitment to the EFPIA/PhRMA “Principles for responsible clinical trial data sharing”. This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified scientific and medical researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the United States (US) and European Union (EU) as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal. Data access will be granted to anonymized patient-level data, protocols and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded.
Ethical Approval
The study protocols and all protocol amendments were reviewed and approved by each study site’s independent ethics committee or institutional review board. The studies were conducted in accordance with all local legal and regulatory requirements and with the principles in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice.
Consent to Participate
All patients signed an informed consent form before participation.
Consent to Publish
Not applicable.