Merck updates timeline for Keytruda label extensions

Merck & Co. Inc. (NYSE:MRK) submitted an sBLA for Keytruda pembrolizumab to treat advanced squamous and non-squamous non-small cell lung cancer (NSCLC) and said it plans to submit an sBLA for the drug as first-line treatment for melanoma mid-year. The company reported data from Keytruda trials for these indications at the American Association for Cancer Research meeting in Philadephia. The humanized IgG4 mAb against programmed cell death 1 ( PDCD1; PD-1; CD279) is approved to treat advanced melanoma in patients previously treated with Yervoy ipilimumab from Bristol-Myers Squibb Co. (NYSE:BMY).

Merck reported data from the Phase Ib KEYNOTE-001 trial in which Keytruda-treated NSCLC patients with ≥50% tumor cells positive for PD-L1 expression had an overall response rate (ORR) of 45.4%, compared to 16.5% of patients with1-49% tumor cells positive and 10.7% of patients with <1% tumor cells positive for PD-L1 expression. Merck said the findings showed that tumor PD-L1 expression may be a relevant biomarker to identify NSCLC patients who are more likely to benefit from anti-PD-1 therapy. ...