Offering was announced longback Bottom line is - Results are excellent and Agenus plans to hold an end of Phase 2 meeting with the FDA and most likely FDA might agree to give marketing approval of the HSPPC-96 vaccine as a treatment for patients with newly diagnosed GBM.
Agenus (AGEN) has extraordinary news. A recent analysis from a Phase 2 trial in patients with newly diagnosed glioblastoma multiforme (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 (PFS), which represents a 160% increase versus current standard of care alone. The results confirm 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 (AANS) Annual Scientific Meeting in May 2013.
According to Andrew T. Parsa, MD, PhD, Lead Clinical Investigator and Chair of Neurosurgery at Northwestern Memorial Hospital and Northwestern University Feinberg School of Medicine, the results are extremely encouraging and justify a definitive randomized study. The patient-specificity and lack of toxicity, combined with patient selection to optimize immunotherapy efficacy, could position this vaccine as a breakthrough treatment for newly diagnosed GBM patients in the years ahead.
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 GBM.
The Phase 2 trial includes 46 patients treated with radiation and temozolomide as the standard of care in addition to HSPPC-96 vaccination. Data analysis demonstrates 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 score a considerable improvement when compared to patients treated with the standard of care (radiation plus temozolomide), which is 6.9 months.
The primary endpoint of the trial - Median overall survival (OS) - is 23.3 months and remained durable in patients treated with HSPPC-96. The 12 months survival rate is 85% with 50% of patients still al