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BFAST but be smart: bTMB remains an exploratory biomarker in NSCLC

A high tumour mutational burden (≥10 mutations per megabase) is a companion biomarker in the histology-agnostic approval of pembrolizumab for treatment-refractory advanced-stage solid tumours, and continues to be an exploratory predictive biomarker for immune-checkpoint inhibitors in non-small-cell lung cancer. Herein, we discuss recent results from the first phase III trial evaluating blood-based tumour mutational burden in patients with treatment-naive advanced-stage non-small-cell lung cancer.

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Correspondence to Roy S. Herbst.

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Competing interests

R.S.H. is on the board of directors for Immunocore and Junshi Pharmaceuticals; holds stock options in Bolt Biotherapeutics, Checkpoint Therapeutics, and Immunocore; has received fees for consultancy roles from AstraZeneca, Bolt Biotherapeutics, Bristol Myers Squibb, Candel Therapeutics, Checkpoint Therapeutics, Cybrexa Therapeutics, DynamiCure Biotechnology, eFFECTOR Therapeutics, Eli Lilly, EMD Serono, Genentech, Gilead, HiberCell, I-Mab Biopharma, Immune-Onc Therapeutics, Immunocore, Janssen, Johnson and Johnson, Junshi Pharmaceuticals, Loxo Oncology, Merck, Mirati Therapeutics, NextCure, Novartis, Ocean Biomedical, Oncocyte, Oncternal Therapeutics, Pfizer, Regeneron Pharmaceuticals, Revelar Biotherapeutics, Ribbon Therapeutics, Roche, Sanofi, and Xencor; and has received research support from AstraZeneca, Eli Lilly, Genentech/Roche, and Merck. He also holds leadership roles for the American Association for Cancer Research, International Association for the Study of Lung Cancer, Society for Immunotherapy of Cancer, and Southwest Oncology Group. S.Y.K. declares no competing interests.

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Kim, S.Y., Herbst, R.S. BFAST but be smart: bTMB remains an exploratory biomarker in NSCLC. Nat Rev Clin Oncol 20, 3–4 (2023).

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