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Merck Secures Initial European Approval for Keytruda Plus Chemotherapy in PD-L1-Positive HER2-Negative Gastric Cancer

NextEdge Admin

10 Jan 2024

2 min 6 sec

The European Commission granted approval to Merck’s immune checkpoint inhibitor, Keytruda (pembrolizumab), in combination with chemotherapy for newly diagnosed gastric or gastroesophageal cancer patients. This approval specifically applies to patients whose tumors are HER2-negative and express PD-L1 with a combined positive score of at least one.

The decision follows the recommendation by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) several months ago, which was based on findings from the Phase III KEYNOTE-859 clinical trial. The study revealed that the Keytruda-containing regimen extended overall survival compared to chemotherapy alone, irrespective of PD-L1 expression. However, the CHMP specifically recommended approval for Keytruda-chemo in PD-L1-expressing gastric cancer, considering that 80 percent of the study participants fell into this category.

Notably, the addition of Keytruda to chemotherapy in the KEYNOTE-859 trial resulted in a 22 percent reduction in the risk of death across the entire population and a 26 percent reduction in the risk of death in the PD-L1-expressing subgroup. Recognizing the broader benefit observed with Keytruda-chemo, the US Food and Drug Administration had approved the first-line combination for HER2-negative gastric cancer patients in the PD-L1-agnostic population just last month.

Furthermore, the European Commission also granted approval for Keytruda-chemo as a first-line treatment for patients with biliary tract cancer.