Merck's Keytruda Receives EU Approval for First-Line Combination Therapy in HER2-Positive Gastric or GEJ Adenocarcinoma

Intelligent Finance APP learned that Merck (MRK.US) announced on Tuesday that the European Commission has approved its anti-PD-1 drug Keytruda as part of a combination regimen for first-line treatment of gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Therefore, the immunotherapy Keytruda will be used in the region for HER2-positive gastric cancer or GEJ adenocarcinoma treated with chemotherapy and the anticancer drug trastuzumab.

This decision applies to EU member states as well as Iceland, Liechtenstein, Norway, and Northern Ireland, with a panel of experts from the European Medicines Agency (EMA), the EU's pharmaceutical regulatory body, issuing a positive opinion in July.

The approval has been obtained.MSDData from the Phase 3 KEYNOTE-811 trial supported this, in which patients receiving first-line Keytruda + trastuzumab and chemotherapy showed significantly improved progression-free survival (PFS) compared to those receiving trastuzumab + chemotherapy.

However, the trial of 732 patients did not reach another primary endpoint of overall survival (OS), but showed a trend toward improvement.Overall SurvivalAnalysis of the data is currently underway.