Merck and Co Inc (MRK)

[DewDiligence]

FDA_approves_Keytruda/chemo_ in_1L-metastatic_or locally_recurrent_TNBC_with_PD-L1>=10%—the first indication for Keytruda in any form of breast cancer:

https://www.businesswire.com/news/home/20201113005691/en/FDA-Approves-Merck%E2%80%99s-KEYTRUDA%C2%AE-pembrolizumab-in-Combination-With-Chemotherapy-for-Patients-With-Locally-Recurrent-Unresectable-or-Metastatic-Triple%E2%80%91Negative-Breast-Cancer-Whose-Tumors-Express-PD-L1-CPS-%E2%89%A510

This approval is based on the KEYNOTE-355 study, where the HR for PFS (Keytruda/chemo vs chemo alone) was 0.65 in the subgroup of patients with PD-L1>=10% (#msg-153786469). PFS was not statsig for the subgroup of patients with PD-L1>=1% or in the entire ITT population of the trial.