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.

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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.


  1. 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. Accessed October 27, 2015.