publication date: Jan. 18, 2019

Clinical Roundup

Keytruda reduced risk of death vs. chemo in esophageal carcinoma

Merck announced the first presentation of results from KEYNOTE-181, a phase III trial investigating Keytruda, an 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 (Combined Positive Score ≥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 study population. While directionally favorable, statistical significance for OS was not met in these two patient groups.

Data from KEYNOTE-181 will be submitted to FDA and other regulatory authorities for review.

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 III trial KEYNOTE-590, evaluating Keytruda in combination with chemotherapy as a first-line treatment, is ongoing.

KEYNOTE-181 is a randomized, open-label, phase III trial (ClinicalTrials.gov, NCT02564263) investigating Keytruda monotherapy compared to chemotherapy in more than 600 patients with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus, or Siewert … Continue reading Keytruda reduced risk of death vs. chemo in esophageal carcinoma

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