GenVec nose-dives as it halts pancreatic cancer drug trial on poor results

Another once-promising cancer drug hit the buffers, when USA-based GenVec revealed that, after advice from its independent Data Safety Monitoring, it is discontinuing the Phase III clinical trial of TNFerade in patients with locally-advanced pancreatic cancer based on results of an interim analysis. In afternoon trading yesterday, GenVec stock plunged 72% to $0.80, bringing the firm in danger of delisting from the Nasdaq.

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 said it has determine 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 stated.