@article{80241b569d224231b9c15f34fb2387cf,
title = "Impact of tumor mutational burden on checkpoint inhibitor drug eligibility and outcomes across racial groups",
abstract = "The FDA approval of immune checkpoint inhibitors for cancers with tumor mutation burden (TMB) of at least 10 mut/Mb is postulated to reduce healthcare disparities by broadly expanding treatment eligibility. In a cohort of 39,400 patients with available genomic and race data, black and Asian patients were less likely to have TMB-high cancers in multiple types of malignancies based on the currently approved cut-off. Decreasing TMB thresholds preferentially increased the eligibility of minority patients for immune checkpoint inhibitors while retaining predictive value of treatment benefit in a cohort of immune checkpoint inhibitor treated patients. This study highlights differing distributions of TMB-high cancers between racial groups and provides guidance in developing more rational eligibility criteria for immune checkpoint inhibitors.",
keywords = "Immunotherapy, Tumor biomarkers",
author = "David Hsieh and Magdalena Espinoza and Cristina Valero and Chul Ahn and Morris, {Luc G.T.}",
note = "Funding Information: 1Division of Hematology and Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA 2Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA 3Division of Digestive and Liver Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA 4Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA 5Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, USA Acknowledgements This work was supported by a Cancer Prevention and Research Institute of Texas career award RP200549 (to DH) and an NIH grant R01DE027738 (to LGTM). Both authors declare no conflicts of interest. LGTM is an inventor on a provisional patent application (62/569,053) filed by MSKCC, relating to the use of TMB in cancer immunotherapy. All other authors declare no competing interests. Both authors wrote the paper and approve the final version of the paper. The results reported here are in part based on data generated by the TCGA Research Network: https://www.cancer.gov/tcga. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2021",
month = nov,
day = "18",
doi = "10.1136/jitc-2021-003683",
language = "English (US)",
volume = "9",
journal = "Journal for ImmunoTherapy of Cancer",
issn = "2051-1426",
publisher = "BioMed Central",
number = "11",
}