More data for Merck's pembrolizumab
Merck & Co. Inc. (NYSE:MRK) presented data at the American Society of Clinical Oncology meeting from two open-label Phase Ib trials of the pharma's pembrolizumab ( MK-3475), a humanized IgG4 mAb against PD-1 receptor ( PDCD1; PD-1; CD279). In 411 patients with advanced melanoma in the KEYNOTE-001 trial, pembrolizumab led to a one-year overall survival (OS) rate of 69%. Median OS has not yet been reached. Grade 3/4 adverse events occurred in 12% of patients. By year end, Merck plans to start Phase III trials of pembrolizumab in adjuvant melanoma and bladder cancer.
In a separate cohort of patients with previously untreated stage IV programmed cell death 1 ligand 1 ( PD-L1; B7-H1; CD274)-positive-non-small cell lung cancer (NSCLC), pembrolizumab led to an overall response rate (ORR) of 47% and a disease control rate (DCR) of 78% by investigator assessment and an ORR of 26% and a DCR of 64% by RECIST criteria. Interim median progression-free survival was 27 weeks by RECIST criteria and 37 weeks by investigator assessment. In September, Merck plans to start the Phase III KEYNOTE-024 trial of pembrolizumab vs. chemotherapy in previously untreated patients with PD-L1-positive, advanced NSCLC. ...