NEW YORK – Imugene on Monday said it has struck a deal with Merck to study Keytruda (pembrolizumab) in combination with HER-Vaxx in HER2-positive gastric cancer patients.
Under the terms of their agreement, Sydney, Australia-based Imugene will sponsor the trial, and Merck will supply Keytruda for the nextHERIZON trial. The companies didn't detail the financial terms of the deal, but Imugene said that the agreement will be in effect for at least two years, when the study is slated for completion.
NextHERIZON is an open-label, signal-generating, Phase II trial evaluating the combination of Imugene's B-cell activating immunotherapy HER-Vaxx with Merck's PD-1 inhibitor Keytruda in patients with metastatic HER2-overexpressing gastric or gastroesophageal junction adenocarcinomas. Patients eligible for the study must have progressed on Genentech's Herceptin (trastuzumab).
Researchers are primarily interested in the combination's safety as well as in patients' responses to treatment. Secondary endpoints in the trial are duration of response, progression-free survival, and overall survival. Patients will also be evaluated for biomarkers of response.
HER-Vaxx has already demonstrated tolerability and promising efficacy by itself in metastatic HER2-positive gastric cancer patients. The aim in the nextHERIZON trial is to explore if Keytruda can bolster HER-Vaxx's efficacy in relapsed or refractory gastric cancer patients.
"This collaboration with MSD is significant for our company as it provides the opportunity to optimize and enhance our formulations and utility in an additional setting in an effort to improve outcomes for more patients," Imugene CEO and Managing Director Leslie Chong said in a statement.