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ARTICLE | Clinical News

CV-301: Phase II data

June 17, 2013 7:00 AM UTC

An open-label, U.S. Phase II trial in 74 patients with resected mCRC showed that CV-301 alone led to a 2-year recurrence-free survival rate, the primary endpoint, of 47% vs. 55% for CV-301 plus GM-CSF (p=0.48). At a median follow-up of 35.7 months, there were 2 deaths in patients receiving CV-301 alone and 5 deaths in patients receiving CV-301 plus GM-CSF. Bavarian Nordic said that OS was significantly longer in CV-301-treated patients compared to a group of contemporary control patients who were matched for clinical features and had similar surgery and chemotherapy (p<0.0001). CV-301 was well tolerated with injection-site reactions, fever, fatigue and muscle soreness reported as the most common side effects. The trial enrolled patients who were disease free after surgical resection of metastatic colon cancer and who received chemotherapy followed by treatment with CV-301 alone or in combination with GM-CSF. Bavarian Nordic said the data support a pivotal trial of CV-301 in this patient population. Data were published in the Annals of Surgery. ...