KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated...in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Merck...announced that the European Commission (EC) has approved KEYTRUDA, 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] ≥1).

First-line pembro plus trastuzumab and chemo significantly improved PFS, and improved ORR with durable responses vs pbo plus trastuzumab and chemo in pts with unresectable, HER2+ mG/GEJ adenocarcinoma, specifically in pts with PD-L1 CPS ≥1. These data support use of this regimen as a standard option for HER2+ and PD-L1-positive tumors.

Compared with placebo, pembrolizumab significantly improved progression-free survival when combined with first-line trastuzumab and chemotherapy for metastatic HER2-positive gastro-oesophageal cancer, specifically in patients with tumours with a PD-L1 combined positive score of 1 or more.

First-line pembro plus trastuzumab and chemo provided superior PFS, and improved ORR with durable responses vs pbo plus trastuzumab and chemo in pts with unresectable, HER2+ mG/GEJ adenocarcinoma, notably in pts with PD-L1 CPS ≥1. These efficacy and safety data continue to support use of this regimen in the first-line setting.

Merck...announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, 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] ≥1)...The recommendation is based on interim results from the Phase 3 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 ≥1).