Looks Like Immunotherapy for Glioblastoma Works After All
From Agenus Press Release: "Agenus Inc. AGEN today announced that 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 +0.61%, news), 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 (AANS) Annual Scientific Meeting in May 2013.
“These additional results from the Phase 2 trial of HSPPC-96 in patients with newly diagnosed GBM are extremely encouraging and certainly justify a definitive randomized study,” said Andrew T. Parsa, MD, PhD, Lead Clinical Investigator and Chair of Neurosurgery at Northwestern Memorial Hospital and Northwestern University Feinberg School of Medicine. “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.”
Based on these findings, Agenus 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.
Phase 2 HSPPC-96 Update in Newly Diagnosed GBM Patients
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 resul
I hate to admit it, but you may be right. There is a problem for IMUC in Agenus' news: the bar has been set higher, meaning IMUCs' results will now have to exceed Agenus' by a large margin for the FDA to get over the political hurdle of "favoring" IMUC. The key to success for all glioma immunotherapies is overall survival; if IMUC produces a "tail" of 38.6% overall survival -- as it did in Phase I -- I believe the FDA will allow the drug to go to market, with appropriate restrictions as to continuing collection of data and use. If the results are like Agenus', the FDA may have no choice but to order a Ph III. One thing is clear: this is a deadly disease with no effective remedy.