Brain Cancer Vaccine Shows Promise in Phase 2 Trial

Agenus announced results from a Phase 2 trial analysis in patients with newly diagnosed glioblastoma multiforme (GBM) treated with Prophage Series G-100 (HSPPC-96) in combination with current standard of care (radiation and temozolomide).

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Analyses of data collected to date demonstrate a median progression free survival (PFS) of 17.8 months with 63% of the patients progression free at 12 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) with a median PFS of 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. 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.

Based on these findings, Agenus plans to hold an end of Phase 2 meeting with the FDA 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 glioblastoma multiforme.

HSPPC-96 is also being evaluated for overall survival in a large, randomized, Phase 2 trial in combination with Avastin (bevacizumab) in patients with surgically resectable glioblastoma multiforme.

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