BioVex reports positive results from Phase II melanoma trial

Among 43 patients currently evaluable of the 50 patients enrolled, tumors injected with OncoVEX GM-CSF routinely responded, often with local complete responses or palliative benefit. With regard to systemic overall responses required for treatment success, six patients showed complete clinical responses; five of which are ongoing at between four and 27 months post first injection.

The sixth complete response patient presented with a new lesion 15 months after initiating therapy. A further six patients achieved a partial response, five of which are ongoing seven-13 months post first injection and two of which have no disease after surgical resection of residual tumors.

The current rate of objective response stands at 28%. Other patients have shown clinical benefit including prolonged periods of stable disease as well as post treatment responses after being withdrawn from the study for initial progression. Seven patients remain on study with stable disease three to 10 months post initiation of therapy.

The Phase II trial was designed to measure overall objective response, which is defined as a complete response, where disease is completely eliminated, or partial response, where there is a >30% reduction in disease burden. The target efficacy endpoint detailed in the Phase II protocol and agreed with the FDA was to achieve two objective responses or stable disease >two months.

Philip Astley-Sparke, president and CEO of BioVex, said: “OncoVEX GM-CSF is poised to become the first product in its class to enter into a pivotal, Phase III study.”