GenVec, Inc. is discontinuing its Phase 3 clinical trial of TNFerade(TM) in patients with locally advanced pancreatic cancer based on results of an interim analysis. This interim analysis of overall survival, conducted after the 184th death (two-thirds of total expected events), was designed to determine whether the study should continue.
GenVec has determined, after conferring with its independent Data Safety Monitoring Board, that the PACT trial would not meet the goal of demonstrating persuasive evidence of clinical effectiveness that could form the basis for regulatory approval in the population chosen for study. This randomized, controlled trial compared treatment with TNFerade (in combination with standard of care (SOC)) to SOC alone in patients with locally advanced pancreatic cancer.
These interim data demonstrated an approximately 8% lower risk of death in the TNFerade plus SOC arm relative to the SOC alone (hazard ratio= 0.921; 95% Confidence Interval [0.678 -1.252]). Accordingly, these data strongly suggest the trial will not achieve the statistical significance required to form the basis for approval of a biological license application in the population chosen for study, thereby warranting discontinuing the trial.
The Company is in the process of notifying the investigators and regulatory agencies of the discontinuation of the PACT trial.
"We are disappointed that the PACT trial did not provide sufficient evidence of the clinical effectiveness of TNFerade to warrant completion of the trial," said Mark Thornton, M.D., Ph.D., Senior Vice President of Product Development at GenVec. "We will, of course, continue to follow the patients currently enrolled in the trial and are conducting additional analyses of the data from the trial and expect that the results will be presented in the future at an appropriate scientific meeting."
"We are very disappointed with the data, particularly given the lack of adequate treatments for pancreatic cancer. For this reason, among others, including the significant resources committed by the Company to this program over the past several years, we will continue to analyze the data from PACT in order to assess the future strategic value of TNFerade to the Company. We acknowledge and thank the patients and investigators who participated in this trial," said Paul H. Fischer, Ph.D., President and Chief Executive Officer at GenVec. "As our shareholders know, in addition to TNFerade our research and development pipeline consists of a number of funded vaccine programs based on our industry-leading technology. At this time, we will continue to focus on those programs and supporting our collaboration with Novartis to develop treatments for hearing loss," he added.