Wang, Danyi
Elenbaas, Brian http://orcid.org/0000-0002-7892-6028
Murugesan, Karthikeyan http://orcid.org/0000-0002-2275-1126
Shah, Kunal
Montesion, Meagan
Gounaris, Ioannis http://orcid.org/0000-0003-2755-6597
Scheuenpflug, Juergen
Locatelli, Giuseppe
Feng, Zheng
Funding for this research was provided by:
Merck KGaA | EMD Serono (CrossRef Funder ID: 10.13039/100004755, CrossRef Funder ID: 10.13039/100004755, CrossRef Funder ID: 10.13039/100004755, CrossRef Funder ID: 10.13039/100004755, CrossRef Funder ID: 10.13039/100004755, CrossRef Funder ID: 10.13039/100004755, CrossRef Funder ID: 10.13039/100004755, CrossRef Funder ID: 10.13039/100004755, CrossRef Funder ID: 10.13039/100004755)
Article History
Received: 25 February 2023
Accepted: 31 August 2023
First Online: 11 October 2023
Competing interests
: D.W., B.E., and Z.F. are employees of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA and own stock in Merck. Ioannis Gounaris is an employee of Merck Serono Ltd., Feltham, UK, an affiliate of Merck KGaA and owns stocks in Merck. J.S. and G.L. are employees of Merck Healthcare KGaA, Darmstadt, Germany. K.M., K.S., and M.M. are employees of Foundation Medicine, Cambridge, MA, USA and stockholders of Roche Pharma AG.
: For Foundation Medicine (FMI) genomic analysis, approval for this study, including a waiver of informed consent and a HIPAA waiver of authorization, was obtained from the WCG Institutional Review Board (IRB; Protocol No. 20152817). The IRB granted a waiver of informed consent under 45 CFR ยง 46.116 based on review and determination that this research meets the following requirements: (i) the research involves no more than minimal risk to the subjects; (ii) the research could not practicably be carried out without the requested waiver; (iii) the waiver will not adversely affect the rights and welfare of the subjects.