Tenecteplase: Phase IIb data

Researchers at the University of Newcastle and colleagues reported data from the double-blind, Australian Phase IIb TAAIS trial in 75 patients showing that tenecteplase met the co-primary endpoints of greater reperfusion at 24 hours on perfusion-weighted MRI (79.3% vs. 55.4%, p=0.004) and greater clinical improvement at 24 hours as measured by NIHSS scores vs. alteplase (8 vs. 3 points, p<0.001). Additionally, a significantly greater proportion of patients receiving tenecteplase had excellent or good recovery at 90 days as measured by an mRS score of 0-2 (72% vs. 44%, p=0.02). Furthermore, a significantly greater proportion of patients receiving high-dose tenecteplase had no clinically significant disability at 90 days vs. alteplase (72% vs. 40%, p=0.02). There were no differences in intracranial bleeding or other serious adverse events between treatment groups.

The trial enrolled patients with a perfusion lesion of at least 20% greater than the infarct core on CT perfusion imaging at baseline and an associated vessel occlusion on CT angiography. Patients received 0.1 or 0.25 mg/kg tenecteplase or 0.9 mg/kg alteplase less than 6 hours after onset of ischemic stroke. Data were published in the New England Journal of Medicine. According to the researchers, tenecteplase has PK advantages over alteplase, which has incomplete and often delayed reperfusion. The researchers said next steps would be to conduct a Phase III trial. However, Roche's Genentech Inc. unit said it has no plans to develop tenecteplase to treat acute ischemic stroke. ...