FDA approves extension of label for Keytruda for the first-line treatment of patients with stage III NSCLC

Merck Inc. announced that the FDA has approved an expanded label for Keytruda Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (tumor proportion score [TPS] greater than 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

The approval is based on results from the Phase III KEYNOTE-042 trial, in which overall survival (OS) was sequentially tested as part of a pre-specified analysis plan. In the trial, Keytruda monotherapy demonstrated a statistically significant improvement in OS compared with chemotherapy alone in patients whose tumors expressed PD-L1 with a TPS ?50%, with a TPS ?20%, and then in the entire study population (TPS greater than 1%).