Final results in KEYNOTE-010 study of Keytruda (pembrolizumab) in non-small cell lung cancer published in The Lancet- Merck Inc

Merck Inc has announced results from the pivotal KEYNOTE-010 study of Keytruda (pembrolizumab) in patients with advanced non-small cell lung cancer (NSCLC). In the Phase II/III study, the drug significantly improved overall survival compared to chemotherapy in patients with any level of PD-L1 expression, as defined by a tumor proportion score (TPS) of 1 percent or more. In the total study population, Keytruda resulted in a 29 percent improvement in OS for the 2 mg/kg dose and a 39 percent improvement in OS for the 10 mg/kg dose, compared to docetaxel. The estimated 1-year OS rates for Keytruda were 43.2 percent and 52.3 percent, respectively, compared to 34.6 percent for docetaxel. Median OS for Keytruda were 10.4 months and 12.7 months, respectively, compared to 8.5 months for docetaxel.

Among patients with higher levels of PD-L1 expression Keytruda improved OS by 46 percent for the 2 mg/kg dose and by 50 percent for the 10 mg/kg dose, compared to docetaxel. Median OS for Keytruda (2 mg/kg and 10 mg/kg, respectively) was 14.9 months and 17.3 months, compared to 8.2 months for docetaxel. The results were published in The Lancet and will be presented at the European Society for Medical Oncology (ESMO) Asia 2015 Congress.