Pembrolizumab showed superior overall survival benefit compared with chemotherapy in previously treated patients with advanced non-small cell lung cancer (NSCLC) whose tumors express programmed death-ligand 1 (PD-L1), findings from the KEYNOTE-010 announced in a press release by Merck have shown.1
For the pivotal phase 2/3 trial, researchers enrolled 1,034 patients with NSCLC who experienced disease progression following platinum-containing systemic therapy and whose tumors expressed PD-L1. Patients were randomly assigned to receive pembrolizumab 2 mg/kg or 10 mg/kg every 3 weeks or docetaxel 75 mg/m2 every 3 weeks.
Results showed that both the approved 2 mg/kg dose and the investigational 10 mg/kg dose were associated with longer survival compared with docetaxel. The 2 pembrolizumab doses demonstrated similar efficacy.
Pembrolizumab treatment at both doses was also associated with superior progression-free survival vs docetaxel in patients whose tumors had PD-L1 expression tumor proportion scores 50% or higher; however, there was no significant difference in progression-free survival between pembrolizumab and docetaxel in PD-L1-positive patients.
In regard to tolerability, the safety profile of pembrolizumab was similar to that observed in previously reported studies that evaluated the immunotherapy in patients with advanced NSCLC.
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“The results from this trial provide part of a growing body of evidence supporting the potential of Keytruda [pembrolizumab] in the treatment of non-small-cell lung cancer,” said Dr. Roger Perlmutter, president, Merck Research Laboratories.
Pembrolizumab is approved at a dose of 2 mg/kg for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 with disease progression on or after platinum-containing chemotherapy. It is also approved for certain patients with unresectable or metastatic melanoma.
- Merck’s Keytruda shows superior overall survival compared to chemotherapy in patients with previously treated advanced non-small cell lung cancer whose tumors express PD-L1 [news release]. Kenilworth, NJ: Merck; October 26, 2015. http://www.mercknewsroom.com/news-release/prescription-medicine-news/mercks-keytruda-pembrolizumab-shows-superior-overall-surviva. Accessed October 27, 2015.