Melanoma drug trial results 'encouraging'

Knoxville, Tenn. - A phase 2 trial of PV-10, a drug to treat metastatic melanoma, showed promising results in response rates and progression-free survival of the disease.

Provectus Pharmaceuticals released top-line final data from the phase 2 clinical trial of its cancer drug, PV-10, BusinessWire reports. The new data reportedly corroborated previously presented preliminary data.

Key final data from the 80 patients in the phase 2 study include:

• An objective response rate (OR) of 50 percent in patients’ target lesions (25 percent complete response, 25 percent partial response);

• 70 percent disease control in these lesions (combined complete, partial and stable response patients);

• Stage 3 patients experienced a substantially higher response rate (58 percent OR, 81 percent disease control) compared to stage 4 patients (22 and 33 percent, respectively;

• Stage 3 patients also experienced significantly greater mean progression-free survival of at least 9.6 months, compared with 3.1 months for stage IV patients. Median progression-free survival for stage 3 patients was not reached during the 12-month study interval.

Higher response rates were noted among patients who continued in the study for at least eight weeks.

The trial results were presented by principal investigator Sanjiv Agarwala, M.D., at the Interdisciplinary Global Conference on Developing New Treatments for Melanoma, held recently in Munich. Dr. Agarwala is chief of medical oncology and hematology, St. Luke’s Hospital and Health Network, Bethlehem, Pa.

In a news release from Provectus, Dr. Agarwala said, “This is very encouraging, as we anticipate phase 3, where this same stage 3 population will have the potential to receive additional benefit under a PV-10 treatment schedule that is well beyond that allowed in this study.”

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