Announced today were the first presentation of results from KEYNOTE-181, a Phase 3 trial investigating pembrolizumab, an anti-PD-1 therapy, as monotherapy for the second-line treatment of advanced or metastatic oesophageal or oesophagogastric junction carcinoma.
In this study, pembrolizumab 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 tumours 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).
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 favourable, 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.
“The prognosis for patients diagnosed with oesophageal 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 Centre Hospital East in Kashiwa, Japan.
“The significant improvement in overall survival observed with pembrolizumab in patients with squamous cell carcinoma or adenocarcinoma whose tumours 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.”
“Oesophageal cancer often progresses aggressively, so we are encouraged to see these overall survival results for pembrolizumab as monotherapy in previously treated patients,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
Data from KEYNOTE-181 will be submitted to the U.S. Food and Drug Administration (FDA) and other regulatory authorities for review.