OncoMed Begins NSCLC Trial

OncoMed Pharmaceuticals has started a multi-center Phase Ib trial of its first-in-class Wnt-pathway-targeting antibody vantictumab (OMP-18R5) with docetaxel in non-small cell lung cancer (NSCLC). This trial is the second of three Phase Ib trials for vantictumab that OncoMed expects to initiate this year as part of the company’s collaboration with Bayer Pharma AG.

The trial is a dose-escalation study of the anti-CSC antibody vantictumab in combination with docetaxel in patients with second- and third-line advanced NSCLC. Primary objectives of the trial are to evaluate safety of this combination regimen and determine a recommended Phase II dose for vantictumab in combination with docetaxel. Key secondary and exploratory objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics (PD) of vantictumab and the efficacy of this combination. Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of vantictumab.

OncoMed recently initiated a Phase Ib study of vantictumab and paclitaxel in HER2 negative breast cancer. Results for the single-agent, first-in-human Phase Ia trial for vantictumab in solid tumor patients showed that vantictumab is well tolerated with early evidence of single agent activity. Additionally, clinical biomarker data from the Phase Ia trial indicated PD modulation of the Wnt pathway by vantictumab.