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.”


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

The gist: A potential new treatment for metastatic melanoma is being tested in volunteer patients in a clinical trial. The drug is called glembatumumab vedotin (CDX-011). It is a targeted therapy that aims for a protein called gpNMB, which is often found in melanoma tumor cells at higher levels than in healthy cells. The trial will test whether people with higher cpNMB levels in their tumors respond better to CDX-011 treatment. Participation information can be found on the trial website.

“Celldex Therapeutics, Inc. (CLDX) today announced 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.”