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EMA's CHMP Recommends Keytruda Plus Herceptin, Chemo for HER2-Postive, PD-L1-Positive Gastric Cancer

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended Merck's Keytruda (pembrolizumab) plus Genentech's Herceptin (trastuzumab) and chemotherapy as first-line treatment for advanced gastric or gastroesophageal junction cancer patients whose tumors are HER2- and PD-L1-postive.

CHMP recommended the treatment combination for patients whose tumors express PD-L1 with a combined positive score of at least one. The positive opinion is based on interim results from the Phase III KEYNOTE-811 clinical trial, in which Keytruda, Herceptin, and chemotherapy improved patients' progression-free survival and objective response rates versus Herceptin and chemo alone.

Since 2021, Keytruda plus Herceptin and chemotherapy has had US Food and Drug Administration approval as first-line treatment for advanced HER2-positive gastric or gastroesophageal junction cancer patients regardless of PD-L1 expression. Last month, however, based on updated data from the KEYNOTE-811 trial showing that the benefit of added Keytruda among PD-L1 expressors was driving the overall benefit observed, Merck asked the FDA to update its approval to limit the indication to PD-L1 expressors. The FDA has not yet updated the indication.

Merck plans to present the progression-free survival results at an upcoming medical meeting.

The European Commission will now review CHMP's recommendation and decide whether to authorize the treatment combination for this patient population in Europe during the third quarter of this year.