Tumour mutational burden in treatment-resistant tumours – Authors' reply

Aurelien Marabelle; Fan Jin; Kevin Norwood; Deepti Aurora-Garg

doi:10.1016/S1470-2045(20)30697-5

Tumour mutational burden in treatment-resistant tumours – Authors' reply

Aurelien Marabelle, Fan Jin, Kevin Norwood, Deepti Aurora-Garg

Research output: Contribution to journal › Letter › peer-review

3 Citations (Scopus)

Original language	English
Pages (from-to)	e552
Journal	The Lancet Oncology
Volume	21
Issue number	12
DOIs	https://doi.org/10.1016/S1470-2045(20)30697-5
Publication status	Published - 1 Dec 2020

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title = "Tumour mutational burden in treatment-resistant tumours – Authors' reply",

author = "Aurelien Marabelle and Fan Jin and Kevin Norwood and Deepti Aurora-Garg",

note = "Funding Information: AM reports research funding to their institution during the conduct of this study from Merck Sharp & Dohme (MSD); research grants to their institution for other clinical trials or pre-clinical studies from MSD, Bristol-Myers Squibb, AstraZeneca, Roche/Genentech, Pfizer, and Sanofi; a research grant from MSD Avenir Foundation (France); honoraria for serving as a scientific advisory board member for MSD, AstraZeneca, Roche/Genentech, and Pfizer; honoraria for serving as a symposium scientific committee member or speaker for Bristol-Myers Squibb and Roche/Genentech; travel expenses from MSD, Bristol-Myers Squibb, AstraZeneca, and Roche/Genentech; additional research funding or study drug supply from MSD, Bristol-Myers Squibb, AstraZeneca, and Roche/Genentech; and consulting fees from Sanofi. FJ, KN, and DA-G are employees of MSD (a subsidiary of Merck & Co; Kenilworth, NJ, USA). Funding Information: First, Nie and colleagues suggest that we should have used a cancer-specific threshold to define high tissue tumour mutational burden (tTMB-high) in our study. However, the tTMB-high cutpoint of 10 mutations per megabase was supported by the consensus recommendation of the Friends of Cancer Research TMB Harmonization Project (a consortium of industry, academia, and the US Food and Drug Administration). The cutpoint of 10 mutations per megabase had previously been established as the tTMB cutoff that enriches for response to immunotherapy (including when tTMB is assessed with the FoundationOne Cdx assay; Foundation Medicine, Cambridge, MA, USA) and aligned with efforts to use a standardised cutoff across clinical trials. 2,3 As such, the selection of 10 mutations per megabase relied on a consensus with scientific and clinical guidance and has now been prospectively validated in the KEYNOTE-158 study. ",

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AU - Marabelle, Aurelien

AU - Jin, Fan

AU - Norwood, Kevin

AU - Aurora-Garg, Deepti

N1 - Funding Information: AM reports research funding to their institution during the conduct of this study from Merck Sharp & Dohme (MSD); research grants to their institution for other clinical trials or pre-clinical studies from MSD, Bristol-Myers Squibb, AstraZeneca, Roche/Genentech, Pfizer, and Sanofi; a research grant from MSD Avenir Foundation (France); honoraria for serving as a scientific advisory board member for MSD, AstraZeneca, Roche/Genentech, and Pfizer; honoraria for serving as a symposium scientific committee member or speaker for Bristol-Myers Squibb and Roche/Genentech; travel expenses from MSD, Bristol-Myers Squibb, AstraZeneca, and Roche/Genentech; additional research funding or study drug supply from MSD, Bristol-Myers Squibb, AstraZeneca, and Roche/Genentech; and consulting fees from Sanofi. FJ, KN, and DA-G are employees of MSD (a subsidiary of Merck & Co; Kenilworth, NJ, USA). Funding Information: First, Nie and colleagues suggest that we should have used a cancer-specific threshold to define high tissue tumour mutational burden (tTMB-high) in our study. However, the tTMB-high cutpoint of 10 mutations per megabase was supported by the consensus recommendation of the Friends of Cancer Research TMB Harmonization Project (a consortium of industry, academia, and the US Food and Drug Administration). The cutpoint of 10 mutations per megabase had previously been established as the tTMB cutoff that enriches for response to immunotherapy (including when tTMB is assessed with the FoundationOne Cdx assay; Foundation Medicine, Cambridge, MA, USA) and aligned with efforts to use a standardised cutoff across clinical trials. 2,3 As such, the selection of 10 mutations per megabase relied on a consensus with scientific and clinical guidance and has now been prospectively validated in the KEYNOTE-158 study.

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Tumour mutational burden in treatment-resistant tumours – Authors' reply

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