Glembatumumab Vedotin Induces Promising DCR in Uveal Melanoma

Excerpt:

“According to results from the phase II NCI9855 study, presented at the 2017 World Congress of Melanoma, glembatumumab vedotin (CDX-011) induced a 61% disease control rate (DCR) in patients with metastatic uveal melanoma, despite a low a low objective response rate (ORR) of 6%.

“There were no complete responses, 2 (6%) partial responses, and 17 patients (55%) with stable disease. Twelve patients (39%) experienced disease progression.”

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Glembatumumab Vedotin Induces 61% DCR in Uveal Melanoma

Excerpt:

“Glembatumumab vedotin (CDX-011) induced a disease control rate (DCR) of 61% in patients with metastatic uveal melanoma, despite a low a low objective response rate (ORR) of 6%, according to results from the the phase II NCI9855 study.

“There were no complete responses, 2 (6%) partial responses, and 17 patients (55%) with stable disease. Twelve patients (39%) experienced disease progression.”

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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 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.”