US biotech Agenus has announced encouraging results from a Phase II trial of its brain cancer vaccine.
Things had taken a turn for the worse for Lexington-based Agenus at the start of the month, as it was announced that a late-stage trial with GSK's MAGE-A3 melanoma cancer vaccine – for which it made the adjuvant – had failed to meet its first co-primary endpoint. Hence the encouraging results from this mid-stage trial with Agenus' Prophage Series G-100 (HSPPC-96) cancer vaccine for newly diagnosed glioblastoma multiforme will definitely be welcomed by the company.
In the 46-patient study, the HSPPC-96 immunotherapy used in combination with the current standard of care (radiation and a chemotherapy agent known as temozolomide) showed an almost 18 month median progression free survival. This represented a 160% increase compared to current standard of care alone, which stands at just under 7 months. This new trial data supports the already-positive Phase II data reported back in May.
Andrew T. Parsa, Lead Clinical Investigator and Chair of Neurosurgery at Northwestern Memorial Hospital, said the results were "encouraging and certainly justify a definitive randomized study" and "the patient-specificity and lack of toxicity, combined with patient selection to optimize immunotherapy efficacy, could position this vaccine as a break-through treatment for newly diagnosed GBM patients in the years ahead."
The Prophage Series G vaccines are also being studied in recurrent disease. Based on the Phase II data, Agenus says it now plans to discuss potential Phase III trials with the FDA.
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