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EU's CHMP Recommends Upfront Keytruda, Chemo for HER2-Negative, PD-L1-Expressing Gastric Cancer

NEW YORK – Merck said on Friday that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for certain HER2-negative gastric cancer patients whose tumors express PD-L1.

The EMA recommended the immunotherapy-chemo combination be available to advanced gastric or gastroesophageal cancer patients in Europe if their tumors do not express HER2 but do express PD-L1 in at least one percent of cells.

The recommendation is based on the results of the Phase III KEYNOTE-859 clinical trial, in which Keytruda plus chemotherapy improved patients' overall survival versus chemotherapy alone. The trial enrolled allcomers, but CHMP's recommendation focused on the results observed specifically among the 80 percent of patients in the study whose tumors met the threshold for PD-L1 positivity.

The European Commission will now review CHMP's recommendation and decide whether to approve the treatment, likely during the fourth quarter of this year.

In the US, meanwhile, Merck filed an application with the US Food and Drug Administration in April seeking approval for first-line Keytruda plus chemo in this gastric cancer patient population regardless of patients' PD-L1 expression status. The FDA is expected to decide on that approval in December.

Keytruda plus chemotherapy and Genentech's Herceptin (trastuzumab) is approved in both the US and EU for gastric cancer patients whose tumors express HER2. For that indication, Merck initially netted accelerated approval in a PD-L1-agnostic patient population but recently said it was asking the FDA to limit the label to PD-L1-expressing cancers based on updated data.