The Committee for Medicinal Products for Human Use of the European Medicines Agency as adopted a positive opinion recommending approval of Keytruda 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 adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10).
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the second quarter of 2021.
Keytruda is sponsored by Merck.
The positive CHMP opinion is based on results from the pivotal phase III KEYNOTE-590 trial, in which Keytruda plus 5-fluorouracil (5-FU) and cisplatin demonstrated significant improvements in overall survival and progression-free survival compared with 5-FU and cisplatin alone in patients regardless of histology or PD-L1 expression status.
Keytruda plus 5-FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; p<0.0001) versus 5-FU and cisplatin alone.
