Merck (known as MSD outside of the US and Canada) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for KEYTRUDA.
CHMP also recommended approval of the anti-programmed death receptor-1 (PD-1) therapy.
It recommended approval of KEYTRUDA along with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for locally advanced metastatic HER2-negative gastroesophageal junction (GEJ) adenocarcinoma in adult patients.
The recommendation is applicable for adults, whose tumours express PD-L1 (Combined Positive Score (CPS) ≥1).
Merck Research Laboratories global clinical development, late-stage oncology senior vice-president and head Dr Marjorie Green said: “This positive CHMP opinion builds on our efforts to treat advanced gastric and GEJ cancer in Europe, including in patients with HER2-negative disease, which accounts for vast majority of gastric cancer cases.
“We look forward to the European Commission’s decision and are excited to potentially provide an immunotherapy regimen to patients in EU with locally advanced unresectable or metastatic HER2-negative gastric or GEJ cancer, whose tumours express PD-L1 with a CPS≥1.”
The latest recommendation is based on data obtained from the Phase III KEYNOTE-859 trial.
This trial, which evaluated KEYTRUDA in combination with chemotherapy, showed an improvement in overall survival versus chemotherapy alone in subjects whose tumours expressed PD-L1 (CPS ≥1).
The European Commission will now review the CHMP recommendation for marketing authorisation in the European Union (EU).
Merck expects a final decision in the fourth quarter of the current year.
If this line of treatment is approved, it will be the second KEYTRUDA indication in advanced gastric or GEJ cancer in Europe.