Enrollment for OncoMed’s Vantictumab Breast Cancer Trial Resumes

Enrollment for OncoMed’s Vantictumab Breast Cancer Trial Resumes
OncoMed breast cancer trialOncoMed Pharmaceuticals has been given the green light to continue recruiting patients for its Phase 1b clinical trial of vantictumab (OMP-18R5) to treat breast cancer patients. The Food and Drug Administration had placed a partial clinical hold on enrollment for the trial following OncoMed's voluntary halt due to concerns over adverse effects. "We are pleased by the FDA's action to allow the resumption of enrollment in the vantictumab clinical trials," said Jakob Dupont, MD, Chief Medical Officer of OncoMed, in a news release from the company. "Patient safety is our top priority." Patients were experiencing on-target mild-to-moderate bone-related adverse events while using vantictumab. This is likely a result of vantictumab being in the class of Wnt pathway inhibitors. While inhibiting the Wnt pathway has been shown to fight cancer stem cell and tumor activity in patient-derived xenograft tumor models, the Wnt pathway is also vital to normal bone development and maintains bone health throughout life. Inhibiting the Wnt pathway--in this case, inhibiting Frizzled7, an activator of Wnt signaling--may have negative effects on bone health. To mitigate these risks, OncoMed modified dosing regimens, increased bone monitoring and protection, and modified enrollment criteria for the study. "The revised
Subscribe or to access all post and page content.

Leave a Comment

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.