Advertisement Celldex reports positive Phase II EMERGE trial of glembatumumab vedotin to treat breast cancer - Pharmaceutical Business review
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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.

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.