EC Oks Merck's Keytruda Plus Chemotherapy For Treatment Of Certain Patients With Esophageal Cancer

(RTTNews) - The European Commission has approved Keytruda, Merck & Co Inc.'s (MRK) anti-PD-1 therapy, in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1.

The approval allows marketing of the Keytruda combination in all 27 European Union member states plus Iceland, Lichtenstein, Norway and Northern Ireland.

The approval was based on results from the Phase 3 KEYNOTE-590 trial, in which Keytruda plus 5-fluorouracil or 5-FU and cisplatin demonstrated statistically significant improvements in overall survival and progression-free survival compared with 5-FU and cisplatin alone in all pre-specified study populations.

Esophageal cancer begins in the inner layer of the esophagus and grows outward.

Merck said it is continuing to study Keytruda across multiple settings and stages of gastrointestinal cancer through its broad clinical program, including studies in esophageal, gastric, hepatobiliary, pancreatic, colorectal and anal cancers.