Celldex Therapeutics, Inc. (NASDAQ:CLDX) gains that it recorded a week ago in response to its update of positive data from a Phase II clinical study evaluating antibody medication conjugate glembatumumab vedotin, has been washed away. The results were showcased at the European Society for Medical Oncology event in Copenhagen. Despite this report, the stock failed to retain its gains.
As per the report, the objective response rate was 11% (n=7/62) while the median response duration was 6 months (heavily pretreated population). In addition, the disease control rate was 52% as was the proportion of subjects experiencing tumor shrinkage. Median PFS came at 4.4 months. Celldex has amended the study protocol to add a second cohort of subjects who will be cured with a combination of varlilumab and glembatumumab vedotin. After enrollment is closed, a new arm will be discovered evaluating a combination of an immune checkpoint inhibitor and glembatumumab vedotin.
The management view
Patrick Ott, M.D., Ph.D., an investigator in the trial said that while BRAF targeted therapy and immune checkpoint inhibitors have considerably changed results for many subjects with metastatic melanoma, people who either do not progress or respond through these treatments have very limited treatment alternatives. The single-agent activity seen in this trial and the related duration of response is extremely promising. He expects that pursuing combination trials of glembatumumab vedotin, along with checkpoint inhibition, could drive in benefit to melanoma and cancer patients.
Thomas Davis, M.D., the Chief Medical Officer of Celldex, said that it is evident depending on these study data that refractory metastatic melanoma acts as responsive target sign for glembatumumab vedotin. gpNMB is highly stated in melanoma with tissue samples on trial testing positive, and nearly 80% of tumors showing 100% expression in epithelial cells. The team is motivated by the data they have recorded to date in this progressive, checkpoint refractory set up. Also, they consider leveraging the immune system via combination therapy is an important next step for subjects in in this indication.
This trial was a Phase II, open-label trial of glembatumumab vedotin in subjects with unresectable stage III or stage IV melanoma. The median count of prior therapies was 3. All subjects had advanced after checkpoint therapy, and nearly all patients received both ipilimumab and PD-1/PDL-1 therapy.