By RTT News, September 17, 2013, 07:50:00 AM EDT
(RTTNews.com) - Agenus Inc. ( AGEN ) announced that a recent analysis from a Phase 2 trial in patients with newly diagnosed glioblastoma multiforme or GBM treated with Prophage Series G-100 (HSPPC-96) in combination with the current standard of care (radiation and temozolomide) showed an almost 18 month median progression free survival or PFS, which represents a 160% increase versus current standard of care alone.
This analysis confirms continuation of the positive trends from the Phase 2 HSPPC-96 newly diagnosed GBM trial first reported at the 81st American Association of Neurological Surgeons or AANS Annual Scientific Meeting in May 2013.
The company noted that, based on these findings, it plans to hold an end of Phase 2 meeting with the US Food and Drug Administration to discuss a Phase 3 trial that could potentially lead to marketing approval of the HSPPC-96 vaccine as a treatment for patients with newly diagnosed GBM.
The Phase 2 trial of HSPPC-96 in patients with newly diagnosed GBM includes 46 patients treated at eight centers across the US. Patients were treated with radiation and temozolomide as the standard of care in addition to HSPPC-96 vaccination. Analyses of data collected to date show a median PFS of 17.8 months with 63% of the patients progression free at twelve months and 20% progression free at 24 months. These results indicate considerable improvement when compared to patients treated with the standard of care (radiation plus temozolomide), which is 6.9 months.
Median overall survival (OS), the primary endpoint of the trial, is 23.3 months and remains durable in patients treated with HSPPC-96. In this study, the 12 month survival rate is 85% with 50% of patients still alive and being followed, with many surviving beyond the 24 month study period. For the standard of care alone, median OS survival rate is 14.6 months.
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