Celldex Therapeutics Initiates a Phase 2 Study of Glembatumumab Vedotin in Patients with Advanced Melanoma

On Dec 5, 2014

Hampton-based Celldex Therapeutics, Inc. announces that it has initiated an open-label Phase 2 study of glembatumumab vedotin (CDX-011) in patients with unresectable Stage III or IV melanoma. Glembatumumab vedotin is a fully-human monoclonal antibody-drug conjugate (ADC) that targets glycoprotein NMB (gpNMB), a protein overexpressed by multiple tumor types, including metastatic melanoma where approximately 85% of patients overexpress the marker. Overexpression of gpNMB has been shown to promote the invasion and metastasis of cancer and has been associated with poor clinical outcome. The study is expected to include up to 10 sites in the United States and will enroll approximately 60 patients. Glembatumumab vedotin was previously evaluated in a Phase 1/2 study in patients with unresectable stage III or stage IV melanoma, a Phase 1/2 study in advanced breast cancer, a Phase 2 study in advanced breast cancer (the EMERGE study) and is currently being evaluated in patients with metastatic triple negative breast cancers that overexpress gpNMB in the METRIC Study.

“Based upon initial studies in breast cancer and melanoma, we believe gpNMB could be a very important target in oncology, especially in melanoma. Despite significant advances in the field, metastatic melanoma has one of the fastest growing incidence rates and large numbers of patients still require additional treatment options,” said Thomas Davis, MD, Executive Vice President and Chief Medical Officer of Celldex Therapeutics. “In a previous study of patients with metastatic melanoma that did not select for gpNMB expression, we observed an impressive 15% overall response rate and a progression-free survival of 3.9 months in all-comers. Upon further analysis, the data suggested a trend toward prolonged PFS in patients with high gpNMB expression.

Fundamental to this new study and planned future studies of glembatumumab vedotin in additional indications, we will evaluate whether potential clinical benefit is linked to the degree of gpNMB expression.”

Study Overview

This study is a Phase 2, open-label study of glembatumumab vedotin in patients with unresectable stage III or IV melanoma. Eligible patients must have received no more than four prior anticancer regimens, including no more than one prior chemotherapy-containing regimen, for advanced disease. Patients will receive glembatumumab vedotin every 3 weeks until disease progression or intolerance and then be followed for survival. Prior treatments must include ipilimumab and BRAF/MEK targeted agents, as applicable. The primary objective is to evaluate the anticancer activity of glembatumumab vedotin in advanced melanoma as measured by the objective response rate (ORR). Secondary endpoints include analyses of progression-free survival (PFS), duration of response (DOR), overall survival (OS), retrospective investigation of whether the anticancer activity of glembatumumab vedotin is dependent upon the degree of gpNMB expression in tumor tissue and safety.

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