(ChemotherapyAdvisor) – ImmunoPulse DNA IL-12 electroporation immunotherapy might induce regression or stabilization of previously-untreated distant metastatic melanoma, according to preliminary interim results from a multi-center, single-arm phase 2 safety and efficacy clinical trial reported at the 6th World Meeting of Interdisciplinary Melanoma Skin Cancer Centres & 8th EADO Congress in Barcelona, Spain.
“Analysis of the safety data for the subjects analyzed confirms that intratumoral administration of DNA IL-12 with electroporation is safe and well-tolerated,” reported principal investigator Adil Daud, MD, co-director of melanoma research at the University of California, San Francisco (UCSF) School of Medicine. “No related adverse events reported were greater than grade 2, and were generally limited to transient pain related to electroporation treatment.”
Electroporation, also known as electropermeabilization, involves the application of an external electric field to increase the permeability of tumor cells’ plasma membranes, allowing increased delivery of antitumor agents into cancer cells. Immunopulse DNA IL-12 electroporation immunotherapy is under development by biopharmaceutical firm OncoSec Medical.
Analysis of 13 phase 2 patients supported “key findings from a phase 1 trial suggesting that ImmunoPulse is able to induce regression or stabilization of distant untreated metastases following a single cycle of treatment,” Dr. Daud said.
“Ninety-five percent of treated lesions demonstrated response at day 39 (5% progressive disease, 14% stable disease, 42% partial response, 39% complete response),” the authors reported. Only 2 of 13 participants were evaluable at day 180; one patient had confirmed stable disease and the other had “confirmed complete response of all treated and untreated lesions,” they reported.
The multi-center study is enrolling up to 25 patients with stage 3 or 4 cutaneous and in-transit metastatic melanoma by the end of 2012. The study’s protocol required a preliminary interim analysis to be completed after 50% of the study’s enrollment goal was met. Long-term follow-up will allow assessment of the durability of responses, Dr. Duad said.
“One treatment cycle will consist of three treatments applied to up to four lesions on days 1, 5 and 8 with a maximum dose of 1.5 mg DNA IL-12 per treatment cycle,” Dr. Duad said. “At 12 months, patients will be moved to the follow-up phase of the study and will be followed for up to 5 years for safety.”