Positive EU CHMP opinion for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for HER2-negative advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma expressing PD-L1.- Merck Inc.,
Merck Inc., known as MSD outside of the United States and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] greater than 1).
“This positive CHMP opinion builds on our efforts to treat advanced gastric and gastroesophageal junction cancer in Europe, including in patients with HER2-negative disease, which accounts for the vast majority of gastric cancer cases,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “We look forward to the European Commission’s decision and are excited to potentially provide an immunotherapy regimen to patients in the EU with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction cancer, whose tumors express PD-L1 with a combined positive score greater than 1.”
The recommendation is based on results from the Phase III KEYNOTE-859 trial in which Keytruda in combination with chemotherapy demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in patients whose tumors expressed PD-L1 (CPS ?1). In the study, approximately 80% of patients had tumors which expressed PD-L1 (CPS greater than 1). The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and a final decision is expected in the fourth quarter of 2023.
If approved, this will be the second indication for Keytruda in advanced gastric or GEJ cancer in Europe. In August 2023,Keytruda in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy was approved for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in adults whose tumors express PD-L1 (CPS greater than 1) in the EU.
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