Merck announced first-time data from the pivotal Phase 3 KEYNOTE-590 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-based chemotherapy (cisplatin plus 5-fluorouracil [5-FU]) for the first-line treatment of patients with locally advanced or metastatic esophageal and gastroesophageal junction (GEJ) cancer.

In the study, KEYTRUDA in combination with chemotherapy significantly improved overall survival (OS), reducing the risk of death by 27% [HR=0.73 [95% CI, 0.62-0.86]; p<0.0001], versus chemotherapy in all randomized patients. KEYTRUDA in combination with chemotherapy also significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 35% or more than a third [HR=0.65 [95% CI, 0.55-0.76]; p<0.0001] in all randomized patients. With these results, KEYTRUDA is the first anti-PD-1 therapy in combination with chemotherapy to show superior OS, PFS and objective response rates (ORR) versus chemotherapy, the current standard of care, for these patients regardless of histology or PD-L1 expression status.

“Esophageal cancer is an aggressive disease that is associated with very poor survival, and there is an urgent need for advances for newly diagnosed, previously untreated patients,” said Dr. Ken Kato, chief, department of Head and Neck Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. “In KEYNOTE-590, with a 27% reduction in the risk of death, the results show KEYTRUDA has the potential to change the current treatment paradigm for the first-line treatment of patients with locally advanced and unresectable or metastatic esophageal or esophagogastric junction cancer. Results also showed a median overall survival of 12.4 months for KEYTRUDA versus 9.8 months for chemotherapy.”

“These findings for KEYTRUDA in combination with chemotherapy are particularly impressive considering improvement in overall survival was observed across all patient populations – including those patients with esophageal squamous cell carcinoma, adenocarcinoma and gastroesophageal junction tumors – and regardless of PD-L1 expression,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Our goal is to extend the lives of people living with cancer, and these important findings add to a growing body of survival data for KEYTRUDA in a wide range of cancers.”

These late-breaking data were presented during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on Monday, Sept. 21 (Abstract #LBA51). As announced, data spanning more than 15 types of cancer will be presented from Merck’s broad oncology portfolio and investigational pipeline at the congress.

Merck will be sharing these data with regulatory authorities worldwide. KEYTRUDA is currently approved in the U.S., China and Japan as monotherapy for the second-line treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10). Merck is continuing to study KEYTRUDA across multiple settings and stages of gastrointestinal cancer – including gastric, hepatobiliary, esophageal, pancreatic, colorectal and anal cancers – through its broad clinical program.