Vantictumab: Phase Ib ongoing

OncoMed said FDA lifted a partial hold on the company’s open-label, dose-escalation, U.S. Phase Ib trials evaluating vantictumab in combination with other therapies. In June, OncoMed announced the hold after the company halted the trial due to mild to moderate bone-related adverse events (see BioCentury, June 16). According to OncoMed, FDA lifted the partial hold following a review of safety and efficacy data and revised study protocols submitted by the company with modified dosing regimens, risk mitigation measures and modified enrollment criteria. OncoMed said FDA’s partial hold of Fzd8-Fc ( OMP-54F28), which also targets the Wnt pathway, is still in place.

Vantictumab is in Phase Ib trials in combination with Abraxane nab-paclitaxel and gemcitabine to treat previously untreated stage IV pancreatic cancer; in combination with paclitaxel to treat locally advanced or metastatic HER2-negative breast cancer; and in combination with docetaxel as second- and third-line treatment of advanced non-small cell lung cancer (NSCLC). Fzd8-Fc, a Wnt signaling antagonist, is in Phase Ib trials in combination with carboplatin and paclitaxel to treat recurrent platinum-sensitive ovarian cancer; in combination with Abraxane and gemcitabine to treat previously untreated pancreatic cancer; and in combination with Nexavar sorafenib as first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC). ...