BioCentury
ARTICLE | Clinical News

Activase alteplase: Phase III data

June 24, 2013 7:00 AM UTC

The open-label, international Phase III IST-3 trial in 3,035 patients with an acute ischemic stroke showed that 0.9 mg/kg IV alteplase plus standard of care (SOC) given within 6 hours of onset of stroke symptoms missed the primary endpoint of a greater proportion of patients who were alive and independent with an OHS score of 0-2 points at 6 months vs. SOC alone. On secondary endpoints, a significantly greater proportion of patients receiving alteplase plus SOC were alive and independent with an OHS score of 0-2 points at 18 months vs. SOC alone (35% vs. 31.4%, adjusted odds ratio=1.28, 95% CI: 1.03, 1.57, p=0.024). Additionally, alteplase plus SOC significantly improved overall self-reported health at 18 months vs. SOC alone (p=0.002), but there was no significant difference between treatment groups in survival rate at 18 months (34.9% vs. 35.1%, p=0.85). Data were published in The Lancet.

Roche's Genentech Inc. unit markets alteplase in the U.S. as Activase to treat acute ischemic stroke within 3 hours after stroke symptom onset and after exclusion of intracranial hemorrhage, for acute myocardial infarction (MI) and for acute massive pulmonary embolism (PE). Last year, Roche withdrew an sBLA to expand the label for Activase to extend the time window for treatment of acute ischemic stroke to 4.5 hours (see BioCentury, Aug. 6, 2012). Genentech said it has no plans at this time to submit the IST-3 data to FDA to expand the label for Activase. ...