Celldex Therapeutics, Inc. (NASDAQ:CLDX) has recently presented at the European Society for Medical Oncology (ESMO) Congress 2016 the encouraging results from the Phase 2 clinical trial evaluating glembatumumab vedotin, a monoclonal antibody drug conjugate (ADC) targeting glycoprotein NMB (gpNMB) for the treatment of patients suffering from stage III/IV checkpoint inhibitor-refractory and— if applicable— BRAF/MEK inhibitor-refractory metastatic melanoma.
Thomas Davis, M.D., Celldex Therapeutics Chief Medical Officer (CMO) and Executive Vice President (EVP), believes that glembatumumab vedotin is a potential treatment for refractory metastatic melanoma, citing the results of the Phase 2 clinical trial.
Clinical Trial Results
The Phase 2 clinical trial has exceeded its primary endpoint of achieving at least six objective responses out of the first 52 patients, having seven objective responses. Three more patients have also exhibited single time point responses.
Meanwhile, 53% of the subjects have experienced a stable disease with a minimum six-week duration while 52% of them have experienced a shrinking of tumor. The median progression-free survival (PFS) is 4.40 months.
The safety profile of glembatumumab vedotin has been established as well, remaining consistent with previous clinical trials evaluating its safety. The most adverse occurrences observed by far include neuropathy, neutropenia, and rash.
“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,” noted Patrick Ott, M.D., Ph.D., Dana-Farber Cancer Institute Clinical Director of Melanoma Center and Center for Immuno-Oncology, who is strongly encouraged by the latest positive results.
Earlier this year, Celldex Therapeutics has announced its plans to include a second cohort of patients for glembatumumab vedotin as a combination therapy with varlilumab.
Varlilumab is a monoclonal agonist antibody binding and activating CD27, a co-stimulatory molecule in the immune activation cascade.
Presently, the enrollment for the said clinical trial evaluating glembatumumab vedotin with varlilumab is ongoing. Once completed, the company is considering initiating a new part of the clinical development program to evaluate glembatumumab vedotin and checkpoint combination.
Late Tuesday morning, Celldex Therapeutics is trading at $4.02.