Merck known as MSD outside the United States and Canada, announced that the Phase 3 KEYNOTE-181 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma has met a primary endpoint of overall survival (OS) in patients whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10). In this pivotal study, treatment with KEYTRUDA resulted in a statistically significant improvement in OS compared to chemotherapy (paclitaxel, docetaxel or irinotecan) in patients with CPS ≥10, regardless of histology. 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. Per the statistical analysis plan, the key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR) were not formally tested, as OS was not reached in the full ITT study population. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities worldwide.
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“In this pivotal trial, KEYTRUDA resulted in a statistically significant and clinically meaningful improvement over standard chemotherapy in overall survival for patients with advanced esophageal or esophagogastric junction carcinoma whose tumors express PD-L1 with a CPS of 10 or greater. This marks the sixth tumor type where KEYTRUDA has demonstrated a survival benefit, and represents the first time an anti-PD-1 therapy has achieved overall survival for this patient population,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We are encouraged by these results of KEYTRUDA as monotherapy in previously-treated patients, and look forward to continuing our research efforts in this significant area of unmet need with our ongoing Phase 3 trial, KEYNOTE-590, evaluating KEYTRUDA in combination with chemotherapy as a first-line treatment for patients with esophageal carcinoma.”