Merck, known as MSD outside the United States and Canada, 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 (OS) in patients with squamous cell carcinoma or adenocarcinoma who progressed after standard therapy and whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10), with a 31 percent reduction in the risk of death compared to chemotherapy (paclitaxel, docetaxel or irinotecan) (HR=0.69 [95% CI, 0.52-0.93]; p=0.0074). 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 (ITT) 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 (ASCO GI) 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. 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.
said Dr. Takashi Kojima, professor at the Department of Gastroenterology and Gastrointestinal Oncology at the National Cancer Center Hospital East in Kashiwa, Japan.
Esophageal cancer often progresses aggressively, so we are encouraged to see these overall survival results for KEYTRUDA as monotherapy in previously treated patients. Merck is committed to understanding the clinical benefit of KEYTRUDA across a range of gastrointestinal cancers, including esophageal cancer. Along with other new data for KEYTRUDA and from our broad oncology portfolio, we are pleased to share our latest clinical research in gastrointestinal cancers at ASCO GI.
said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
Merck is continuing to study KEYTRUDA across multiple settings and stages of gastrointestinal cancer – including gastric, hepatocellular carcinoma and esophageal – through a broad clinical program comprised of more than 9,000 patients in 65 studies involving KEYTRUDA, including 7,000 patients in 35 Merck-affiliated studies. In esophageal cancer, the Phase 3 trial KEYNOTE-590, evaluating KEYTRUDA in combination with chemotherapy as a first-line treatment, is ongoing.