Anticipated METRIC Results Could Lead to First Targeted Agent Approved in TNBC

Excerpt:

“Findings from a highly anticipated, randomized, phase II trial could possibly pave the path for the FDA approval of the first targeted therapy for patients with triple-negative breast cancer (TNBC), explains Linda T. Vahdat, MD.

“The METRIC study is exploring the efficacy and safety of glembatumumab vedotin (CDX-011) versus standard capecitabine in this subset of patients, particularly in those with high levels of glycoprotein NMB (gpNMB) expression (NCT01997333).

“The antibody-drug conjugate is a novel approach designed to target a very difficult-to-treat patient population, whose sole approved treatment option is standard chemotherapy, Vahdat stresses.”

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Celldex Reports Positive Phase II EMERGE Trial of Glembatumumab Vedotin to Treat Breast Cancer

“Celldex Therapeutics has reported positive data from the Phase II EMERGE trial of glembatumumab vedotin, an antibody-drug conjugate, in patients with metastatic breast cancer.

“Data from this trial supported the initiation of the ongoing, pivotal Phase II METRIC trial in patients with triple negative breast cancers that over-express glycoprotein NMB (gpNMB).

“Glembatumumab vedotin targets and binds to gpNMB, a protein expressed by multiple tumor types, including breast cancer.

“A total of 124 patients with advanced, heavily pre-treated breast cancer were enrolled in the randomized, multi-center, controlled EMERGE trial and they were randomized (2:1) to receive glembatumumab vedotin or ‘Investigator’s Choice’ (IC) single agent, approved chemotherapy.”