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.
The trial’s primary endpoint was overall response rate, while secondary endpoints included duration of response, progression-free survival, overall survival, safety, and pharmacokinetic and pharmacodynamic analyses.
During the trial, gpNMB expression levels were evaluated via central immunohistochemistry on archived tumor tissue.
Celldex Therapeutics executive vice-president and chief medical officer Thomas Davis said: "We designed the EMERGE study to thoroughly explore this hypothesis and observed impressive response rates and prolonged survival in patients that over-expressed gpNMB on the surface of their tumor cells.
"We believe gpNMB could be an important marker in breast cancer and that glembatumumab vedotin holds significant potential as a possible targeted therapy for women facing this disease."
Results from the trial showed that glembatumumab was well tolerated in patients with treatment-refractory breast cancer.
The most common treatment-related adverse events observed in the trial were nausea, rash, fatigue, neuropathy, alopecia and neutropenia.