Shots:

• The accelerated approval is based on KEYNOTE-158 study assessing Keytruda (200mg- q3w). In a study- 1-050 patients were included in the efficacy analysis population in which TMB was analyzed in the subset of 790 patients with sufficient tissue for testing based on protocol-specified testing requirements- out of 790- 102 had tumors identified as TMB-H- defined as TMB ≥10 mut/Mb
• Results: In patients whose tumors were TMB-H- ORR (29%); CR (4%); PR (25%); after a median follow-up time of 11.1 mos. mDOR (not reached). In a pre-specified analysis of patients with TMB ≥13 mut/Mb: ORR (37%); CR (3%); PR (34%)- In an exploratory analysis in 32 patients whose cancer had TMB ≥10 mut/Mb & <13 mut/Mb- the ORR (13%); median duration of exposure (4.9mos.)
• The FDA also approved FoundationOne CDx test as the companion diagnostic to identify patients with solid tumors that are TMB-H (≥10 mutations/ megabase) who may benefit from immunotherapy treatment with Keytruda monotherapy

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Ref: Buinesswire | Image: Merck