Merck announced the first presentation of results from KEYNOTE-181, a Phase 3 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma. In this pivotal study, KEYTRUDA met a primary endpoint by significantly improving overall survival in patients with squamous cell carcinoma or adenocarcinoma who progressed after standard therapy and whose tumors expressed PD-L1. This represents the first time an anti-PD-1 therapy has demonstrated a survival benefit for this patient population. The primary endpoint of OS was also evaluated in patients with squamous cell histology and in the entire intention-to-treat study population. While directionally favorable, statistical significance for OS was not met in these two patient groups. These results, as well as other study findings, are being presented at the 2019 Gastrointestinal Cancers Symposium in San Francisco in an oral presentation on Thursday, Jan. 17. "The prognosis for patients diagnosed with esophageal cancer is poor, and for those who experience disease progression, there is no established standard of care, underscoring the need for improved therapies in the second-line setting," said Dr. Takashi Kojima, professor at the Department of Gastroenterology and Gastrointestinal Oncology at the National Cancer Center Hospital East in Kashiwa, Japan. "The significant improvement in overall survival observed with KEYTRUDA in patients with squamous cell carcinoma or adenocarcinoma whose tumors expressed PD-L1 with a CPS of 10 or greater represents an important scientific advancement and has the potential to benefit patients who currently have limited treatment options."
