CHMP recommends approval of Keytruda plus Herceptin in HER2-positive gastric or gastroesophageal junction adenocarcinoma
Merck Inc announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] of at least 1)
The recommendation is based on interim results from the Phase III KEYNOTE-811 trial, in which the Keytruda regimen demonstrated a statistically significant improvement in progression-free survival (PFS) and objective response rate (ORR) compared to trastuzumab and chemotherapy alone in patients whose tumors expressed PD-L1 (CPS of at least 1). In the study, more than 80% of patients had tumors that were PD-L1 positive. These PFS results will be presented at an upcoming medical meeting.
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the third quarter of 2023.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.