OncoMed halts phase I studies of cancer drugs, but aims to reinitiate
- OncoMed, which develops cancer drugs that target cancer stem cells (CMCs), has voluntarily halted two phase I clinical trials of vantictumab and F2d8-Fc.
- Several participating clinical sites reported mild to- oderate, bone-related adverse events.
- OncoMed plans to resubmit protocols to FDA with modifications and reinitiate clinical trials.
OncoMed halted clinical trials after 13% of vanctitumab- and 5% of F2d8-Fc—treated patients experienced bone-related adverse events. There were 63 patients overall. OncoMed will resubmit protocols to FDA for phase Ib combination trials. The modifications will broadly focus on dosing, limiting risk and enrollment criteria. Specific strategies include lower and less frequent dosing, increased oversight and bone-protection strategies.
OncoMed represents a novel approach to developing cancer therapeutics. Targeting cancer stem cells (CSCs) instead of targeting cancerous cells that have already started multiplying could significantly shift the way cancer is treated.