Posted by Michael Wonder on 31 Oct 2018
FDA approves Merck’s Keytruda (pembrolizumab) in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer
30 October 2018 - First anti-PD-1 approved for first-line treatment of squamous non-small cell lung cancer regardless of PD-L1 expression.
Merck today announced that the U.S. FDA has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer based on results from the KEYNOTE-407 trial.
In the pivotal Phase 3 trial of patients regardless of tumour PD-L1 expression status, KEYTRUDA in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) significantly improved overall survival, reducing the risk of death by 36% compared to chemotherapy alone (HR=0.64 [95% CI, 0.49, 0.85]; p=0.0017).
