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ARTICLE | Clinical News

Bavituximab: Phase II data

February 18, 2013 8:00 AM UTC

Top-line data from an open-label, U.S. and Ukrainian Phase II trial in 70 previously untreated stage IV pancreatic cancer patients showed that first-line treatment with bavituximab plus gemcitabine led to a median OS, the primary endpoint, of 5.6 months vs. 5.2 months for gemcitabine alone. On a secondary endpoint, bavituximab plus gemcitabine led to an ORR of 28% vs. 13% for gemcitabine alone. Peregrine did not disclose p-values and declined to say whether the trial was specifically powered to detect statistical significance. Bavituximab was generally well tolerated with similar adverse events occurring in both treatment arms. The trial enrolled patients with advanced metastatic disease including significant liver involvement and poor performance status associated with rapid disease progression to receive 1,000 mg/m 2 gemcitabine on days 1, 8, and 15 of 28-day cycles with or without weekly 3 mg/kg bavituximab. Peregrine said it is conducting subgroup analyses to help determine next steps for bavituximab in pancreatic cancer. ...