- The primary endpoint of the study (6 or more objective responses in the first 52 patients enrolled) was exceeded. 7 of 62 (11%) patients experienced a confirmed response, and an additional 3 patients also experienced single timepoint responses.
- Median duration of response in this heavily pre-treated patient population was 6.0 months.
- 53% of patients experienced stable disease (with a minimum duration of six weeks).
- A 52% disease control rate (patients without progression for greater than three months) was demonstrated.
- 52% of patients experienced tumor shrinkage.
- Median progression-free survival (PFS) for all patients was 4.4 months.
- Patients who experienced rash in Cycle 1 experienced a 20% confirmed response rate and a more prolonged PFS of 5.5 months [p=0.054; HR=0.52 (0.27, 1.02)].
HAMPTON, N.J., Oct. 09, 2016 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today presented positive results from the Company's Phase 2 study of glembatumumab vedotin in patients with stage III/IV checkpoint inhibitor-refractory, and, if applicable, BRAF/MEK inhibitor-refractory metastatic melanoma (n=62). 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 greater than 80% of patients overexpress the marker. High tumor expression of gpNMB is associated with shorter metastasis-free survival and reduced overall survival. 1 Study results were presented today at the ESMO 2016 Congress in Copenhagen in poster titled " A Phase 2 study of glembatumumab vedotin (GV), an antibody-drug conjugate (ADC) targeting gpNMB, in advanced melanoma." Study Highlights