The approved dose for the anti–PD-1 agent is 2 mg/kg every three weeks.
In a phase 2/3 KEYNOTE-010 study, Keytruda (2 mg/kg or 10 mg/kg every three weeks) demonstrated superior overall survival (OS) compared to chemotherapy in previously-treated patients.
In the study, both doses of the drug significantly improved OS compared with docetaxel. Keytruda resulted in a 29% improvement for the 2 mg/kg dose and a 39% improvement for the 10 mg/kg dose.
Median OS for was 10.4 months and 12.7 months, respectively, compared to 8.5 months for docetaxel.
Merck Research Laboratories senior vice president and therapeutic area head, oncology late-stage development Roger Dansey said: “This approval provides an important new treatment regimen for patients in Europe with advanced lung cancer, one of the most common and challenging cancers.
“In the KEYNOTE-010 trial, patients with advanced lung cancer who had failed prior regimens experienced improved overall survival when treated with Keytruda as compared with those treated with traditional chemotherapy.”
Keytruda increases the ability of the body’s immune system to help identify and fight tumor cells.
It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which could affect both tumor cells and healthy cells.
Image: KEYTRUDA (pembrolizumab) Injection 100 mg. Photo: courtesy of 2009-2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.