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news.Data from a phase II study show that immunization with Oxxon Therapeutics' Hi-8 MEL therapeutic vaccine is well tolerated at all doses and shows clinical benefit in patients with advanced non-resectable melanoma.
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The study found that patients receiving any dose of Hi-8 MEL who developed a CD8+ response specific to melan-A (one of seven melanoma-specific epitopes used in the Hi-8 MEL treatment) in the first 16 weeks had a median survival of 86 weeks compared to 37 weeks for immunological non-responders.
Furthermore, high doses of Hi-8 MEL induced melanoma-specific CD8+ T-cell responses in 91% of patients so treated, as measured by tetramer staining. Importantly, higher boosting doses were associated with an increase in the magnitude and duration of responses and the proportion of patients showing such an immune response.
Tumor responses were seen in nearly 20% of patients, including one partial response lasting more than 12 months and seven cases with stable disease lasting more than six months. Seven out of the eight patients showing a tumor response had generated a melanoma-specific CD8+ T-cell response following treatment with Hi-8 MEL.
Two of these patients have seen no disease progression for 18 months and 26 months, respectively, following treatment and continue to receive Hi-8 MEL boost immunizations.
“These data provide a strong indication of the potential of our Hi-8 MEL therapeutic vaccine as a treatment for advanced metastatic melanoma. Our next step is to discuss with regulators the design of further clinical trials,” said Dr Joerg Schneider, vice president and director of research at Oxxon.
The data were reported at the 2006 annual meeting of the American Society of Clinical Oncology (ASCO).