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FDA Removes Clinical Hold on Early Trials of Cancer Drug Vantictumab
The FDA has removed its partial clinical hold on enrollment in phase I clinical trials of the investigational cancer treatment vantictumab.
The drug is being studied in combination with standard-of-care chemotherapy in three phase Ib studies in patients with advanced non–small-cell lung cancer (NSCLC), advanced human epidermal growth factor receptor 2 (HER2)-negative breast cancer, or advanced pancreatic cancer. Enrollment and dosing of new patients is expected to resume within the next few weeks.
The partial clinical hold occurred on July 1, 2014 after the drug’s developer (OncoMed Pharmaceuticals) voluntarily halted its Wnt pathway programs because of observed mild-to-moderate, bone-related adverse events.
The FDA removed the partial clinical hold to permit enrollment into vantictumab clinical trials following its review of a clinical safety and efficacy data package and revised study protocols submitted by the company. Amendments for the phase Ib combination trials included modified dosing regimens, risk mitigation measures (such as increased monitoring and bone-protection strategies), and modified enrollment criteria.
Vantictumab is a first-in-class antibody that has shown anti-cancer stem cell and anti-tumor activity in patient-derived xenograft tumor models. The drug inhibits a key signaling pathway in cancer, the Wnt pathway. Specifically, vantictumab selectively targets Frizzled receptors, which are activators of Wnt signaling. Although vantictumab was originally identified by binding to Frizzled7, the antibody selectively targets five different Frizzled receptors.
A phase Ia trial of vantictumab in patients with advanced solid tumors is currently nearing completion. Preliminary data from this study were presented in September 2013 at the European Cancer Conference (ECC 2013), held in Amsterdam.
Vantictumab is now being evaluated in combination with standard-of-care chemotherapy in three phase Ib clinical trials in patients with 1) advanced NSCLC (vantictumab + docetaxel); 2) advanced HER2-negative breast cancer (vantictumab + paclitaxel); or 3) advanced pancreatic cancer (vantictumab + gemcitabine + paclitaxel).
Source: OncoMed Pharmaceuticals; August 28, 2014.