Celldex begins phase 2 study of glembatumumab vedotin for advanced melanoma

Celldex Therapeutics has begun an open-label phase 2 study of glembatumumab vedotin for treating patients with unresectable stage III or IV melanoma, according to a press release.

Glemabatumumab vedotin (CDX-011), a fully-human monoclonal antibody-drug conjugate (ADC), focuses on glycoprotein NMB (gpNMB), a protein overexpressed in multiple tumor types, according to the release. This includes metastatic melanoma, in which approximately 85% of patients overexpress the protein.

“Based upon initial studies in breast cancer and melanoma, we believe that gpNMB could be a very important target in oncology, especially in melanoma,” Thomas Davis, MD, executive vice president and chief medical officer of Celldex Therapeutics, said in the release “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.”

Ten sites in the United States are expected to be included in the study, with enrollment of approximately 60 patients, the release stated. The patients, who must have received no more than four prior anticancer regimens for advanced disease, will receive glembatumumab vedotin every three weeks until disease progression or intolerance. Follow-up will be through survival.

The evaluation of anticancer activity of glembatumumab vedotin in advanced melanoma as measured by objective response rate will be the primary endpoint. Progression-free survival analyses, response duration, overall survival, and “retrospective investigation of whether the anticancer activity of glembatumumab vedotin is dependent upon the degree of gpNMB expression in tumor tissue or safety” are secondary endpoints.

Previous trials of glembatumumab vedotin include a phase 1/2 study in patients with unrespectable stage II or IV melanoma, a phase 1/2 study in advanced breast cancer, a phase 2 study in advanced breast cancer and a current trial of patients with metastatic triple negative breast cancers that overexpress gpNMB, the release stated.