Celldex Therapeutics Initiates Accelerated Approval Study of Glembatumumab Vedotin in Patients with Triple Negative Breast Cancer

Celldex Therapeutics

today announced that it has launched a randomized study (METRIC) of Glembatumumab vedotin (CDX-011) in patients with metastatic triple negative breast cancers that over-express glycoprotein NMB (gpNMB). Glembatumumab vedotin is an antibody-drug conjugate that targets and binds to gpNMB, a specific protein that is expressed in breast cancer which promotes the migration, invasion and metastasis of the disease. It is also highly expressed in triple negative breast cancers where it is associated with increased risk of recurrence. Initial sites are now open to screen patients in the United States. Additional sites in the United States and in Canada and Australia will open in early 2014. The study is expected to include up to 100 sites and will enroll approximately 300 patients. "In the Phase 2 EMERGE study, Glembatumumab vedotin elicited impressive response rates that correlated with a survival benefit for patients with metastatic breast cancer that also had high levels of gpNMB on the surface of their tumor cells," said Thomas Davis, M.D., Senior Vice President and Chief Medical Officer of Celldex. "Currently, patients with triple negative breast cancer have very limited treatment options and no targeted interventions.