Melanoma treatment PV-10 shows promise in phase 2 trial

Source: Dermatology Times, October 2014

A phase 2 trial of PV-10, a formulation of rose bengal, demonstrated effectiveness in the treatment of locally advanced cutaneous melanoma.

Provectus Biopharmaceuticals recently released results of a study analyzing its investigational agent PV-10 for intralesional treatment of melanoma.

The study suggests PV-10 elicits a high rate of response in injected tumors through its ablative effect. Also, the durability of response and the bystander response in uninjected tumors implicate an immunologic mechanism secondary to ablation.

The multicenter phase 2 trial, led by Sanjiv S. Agarwala, M.D., chief of medical oncology and hematology at St. Luke’s University Hospital, Bethlehem, Pennsylvania, involved 80 patients with melanoma who had had a median of six previous interventions. They received PV-10 up to four times a week in up to 20 cutaneous and subcutaneous lesions over a 16-week period, with a 52-week follow-up. Best overall response rate was assessed by RECIST (response evaluation criteria in solid tumors) standards in up to 10 injected target lesions. Secondary endpoints included assessment of duration of response, best overall response rate of untreated bystander lesions, overall survival and adverse events.

The researchers found a 71 percent overall response rate in the group of 28 patients who received PV-10 in all of their lesions. In these patients and in those with uninjected disease limited to bystanders, complete response was achieved in 232 of the 363 injected lesions. Of these, 121 lesions required a single injection, 84 required two injections, 22 required three and five required four injections. Ten of 28 uninjected bystander lesions also achieved complete response.

“The results of this study provide evidence of a safe and effective intralesional treatment for patients with melanoma metastatic to cutaneous and subcutaneous sites, with a pronounced local and, in addition, systemic effect,” Dr. Agarwala tells Dermatology Times. “It also has the potential to be combined with recently approved systemic immunotherapies that will be the focus of future clinical trials.”

The study results were presented at the European Society for Medical Oncology Congress, held recently in Madrid.

 

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