The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of Keytruda ( Pembrolizumab ), the anti-PD-1 therapy, for the treatment of locally advanced or metastatic non-small cell lung cancer ( NSCLC ) in adults whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen.
Data supporting the CHMP positive opinion were based on findings from two studies, KEYNOTE-010, a pivotal study assessing overall survival and KEYNOTE-001, which assessed overall response rates ( ORR ).
The CHMP recommended approval of Keytruda monotherapy at a dose of 2 mg/kg every three weeks, which is also the FDA-approved dose for metastatic NSCLC in the United States.
KEYNOTE-010 is an open-label, randomized phase 2/3 trial assessing overall survival with two doses of Keytruda ( 2 mg/kg or 10 mg/kg every three weeks ) compared to Docetaxel ( 75 mg/m2 every three weeks ), a standard of care chemotherapy, in patients with any level of PD-L1 expression ( as defined by a tumor proportion score [ TPS ] of 1% or more ).
KEYNOTE-001 is a multicenter, open-label multi-cohort, activity-estimating study evaluating overall response rate of Keytruda ( 2 mg/kg or 10 mg/kg every three weeks ).
Pembrolizumab is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.
Pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
In the European Union Keytruda is indicated for the treatment of patients with unresectable or metastatic melanoma.
In the United States, Keytruda is also indicated for the treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after Platinum-containing chemotherapy.
Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established.
Keytruda is administered at a dose of 2 mg/kg as an intravenous infusion over 30 minutes every three weeks for the approved indications. ( Xagena )
Source: Merck, 2016