The trial is OncoMed's fourth Phase 1b trial of demcizumab, and the second portion of this protocol would represent the first Phase 2 trial of demcizumab. Previous Phase 1b trials combining demcizumab with chemotherapy regimens have been initiated in patients with first-line pancreatic cancer (with gemcitabine and Abraxane™), first- or second-line colorectal cancer (with FOLFIRI chemotherapy) and first-line non-small cell lung cancer (with carboplatin and pemetrexed chemotherapy). The Phase 1b trials in pancreatic cancer and non-small cell lung cancer are currently enrolling patients.
"We believe ovarian cancer is another important cancer indication for the demcizumab clinical program and an area of high unmet medical need," said Dr. Jakob Dupont, Chief Medical Officer of OncoMed. "We have observed strong preclinical efficacy of demcizumab and paclitaxel in patient-derived ovarian cancer xenograft models, as well as early evidence of activity of demcizumab in ovarian cancer in the Phase 1a single-agent study of demcizumab."
Paul Hastings, Chairman and Chief Executive Officer of OncoMed, emphasized, "The ovarian cancer trial provides the earliest opportunity to advance a demcizumab program to Phase 2. As such it will represent a significant advance for this unpartnered anti-cancer stem cell asset."
About DemcizumabDemcizumab (OMP-21M18) is a humanized monoclonal antibody that inhibits Delta-Like Ligand 4 (DLL4) in the Notch signaling pathway. Two Phase 1b combination trials of demcizumab are ongoing. The first trial is in combination with standard-of care gemcitabine and Abraxane™ in first-line advanced pancreatic cancer patients, and the second trial is in combination with standard of care carboplatin and pemetrexed (Alimta™) in first-line advanced non-small cell lung cancer (NSCLC) patients. Data from the demcizumab NSCLC Phase 1b trial were presented at the EORTC-AACR-NCI Molecular Targets and Cancer Therapeutics Meeting in Dublin, Ireland in November 2012. In addition, a Phase 1b/2 trial of demcizumab and paclitaxel in patients with platinum-resistant ovarian cancer has been initiated. OncoMed has worldwide rights to this program.