NEW YORK – Merck said on Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has recommended marketing authorization for pembrolizumab (Keytruda) combined with chemotherapy as a first-line treatment for patients with advanced esophageal cancer or HER2-negative gastroesophageal junction, or GEJ, cancers whose tumors express PD-L1.
Specifically, CHMP recommended the pembrolizumab-chemo combination be available to GEJ cancer patients in the EU with a PD-L1 expression combined positive score, or CPS, of at least 10, as well as patients with locally advanced unresectable or metastatic esophageal cancer.
The committee based its decision on the results of the Phase III Keynote-590 trial, which randomized 749 patients with advanced esophageal cancer to receive either the pembrolizumab plus chemotherapy combination or chemotherapy alone. In the entire study population, regardless of PD-L1 expression status or histology, those who received the pembrolizumab combination had a 27 percent reduction in the risk of death and a 35 percent reduction in the risk of disease progression or death compared to those receiving chemo alone. Although the benefit of the pembrolizumab combination was observed in this all-comer population, patients with a PD-L1 CPS of at least 10 derived the greatest degree of overall survival benefit.
Following CHMP's recommendation, the European Commission is expected to issue a final decision during this quarter. The EMA is also reviewing an application for Bristol Myers Squibb's checkpoint inhibitor, nivolumab (Opdivo), plus chemotherapy as a first-line treatment for a similar patient population, but with a PD-L1 CPS cutoff of at least 5.