Phase 2 Study Of Single-agent Glembatumumab Vedotin In Patients With Checkpoint-Refractory Metastatic Melanoma Meets Primary Overall Response Endpoint And Demonstrates Clinically Meaningful Duration Of Response

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
  • 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)].

"While immune checkpoint inhibitors and BRAF targeted therapy have dramatically changed outcomes for many patients with metastatic melanoma, patients who either do not respond or progress through these treatments are faced with very limited treatment options," said Patrick Ott, M.D., Ph.D., Clinical Director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute and an investigator in the study. "The single-agent activity observed in this study and the corresponding duration of response is highly encouraging. I am hopeful that pursuing combination studies of glembatumumab vedotin, including with checkpoint inhibition, could help us bring benefit to an even larger number of melanoma and other cancer patients."

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