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In ten hard-to-treat cancer types, 29 in 100 people whose tumours carried at least 10 mutations per million DNA letters responded to pembrolizumab, against 6 in 100 below that line.
KEYNOTE-158 was a multi-cohort, open-label, non-randomised phase 2 study of pembrolizumab 200 mg every three weeks in previously treated advanced anal, biliary, cervical, endometrial, mesothelioma, neuroendocrine, salivary, small-cell lung, thyroid and vulvar cancers, at 81 sites in 21 countries. Tissue tumour mutational burden was measured with FoundationOne CDx and the prespecified high cut-off was at least 10 mutations per megabase.
Of 1,050 patients enrolled at least 26 weeks before the June 2019 cut-off, 790 (75 per cent) were evaluable for TMB. 102 (13 per cent) were TMB-high and 688 were not. Objective responses occurred in 30 of 102 (29 per cent, 95 per cent confidence interval 21 to 39) of the high group and 43 of 688 (6 per cent, 5 to 8) of the rest. Grade 3 to 5 treatment-related adverse events occurred in 15 per cent of the high group. This analysis underpins the tumour-agnostic approval of pembrolizumab for TMB-high solid tumours.
It is the evidence for one cut-off across many cancers. It was gathered in ten selected cancer types, and later analyses question whether the line sits in the same place for every tumour.
Shares Tumour mutational burden testing, Tumour-agnostic (tissue-agnostic) approval, Tumour mutational burden (TMB) and the tag precision.
Shares Tumour mutational burden testing and the tag precision.
Shares FoundationOne CDx / Liquid CDx, Tumour mutational burden (TMB), Pembrolizumab and the tag precision.
Shares FoundationOne CDx / Liquid CDx and the tag precision.
Shares Tumour-agnostic (tissue-agnostic) approval and the tag precision.
Shares Tumour mutational burden testing, FoundationOne CDx / Liquid CDx, Tumour mutational burden (TMB) and the tag precision.
Shares FoundationOne CDx / Liquid CDx and the tag precision.
Shares The Lancet Oncology and the tag precision.
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