CVac: Additional Phase II data

Additional data from the open-label, international Phase II CAN-003 trial in 56 evaluable epithelial ovarian cancer patients showed that CVac significantly improved estimated median PFS, the primary efficacy endpoint, in patients in complete remission after second-line therapy (n=20) vs. the observation (no intervention) control arm (>12.91 vs. 4.94 months, HR=0.32, p=0.04). CVac did not improve median PFS in patients in complete remission after first-line therapy (n=36) vs. the observation arm (HR=1.18, p=0.69). Patients received CVac every 4 weeks for 24 weeks followed by booster injections every 8 weeks until week 48. Data were presented at the American Society of Clinical Oncology meeting in Chicago. Prima expects OS data from CAN-003 to mature in 4Q14.

CVac is in the Phase II CANVAS (CAN-004-B) trial in 210 patients with epithelial ovarian cancer in complete remission following second-line, platinum-based chemotherapy. Prima suspended the Phase II/III CANVAS trial last September and amended it to be a Phase II trial. The trial was evaluating CVac as maintenance treatment of epithelial ovarian, primary peritoneal or fallopian tube cancer patients in complete remission. The company is not enrolling additional first-remission patients into the amended CANVAS trial and the 76 patients with first-remission ovarian cancer already enrolled will be analyzed separately from the second-remission cohort. The suspension came after data from CAN-003 showed no observed difference between the CVac and observation arms in estimated median PFS (see BioCentury, Oct. 22, 2012 & Sept. 23, 2013). ...