USA-based Agenus (Nasdaq: AGEN) says that a Phase II multicenter trial of its autologous heat shock protein-peptide vaccine (HSPPC-96; vitespen) for recurrent glioblastoma multiforme (GBM) patients showed improved survival compared to a contemporary cohort controlled for age, KPS and extent of resection.
"Based on the current data, we plan to move forward with a randomized trial evaluating the efficacy of HSPPC-96 with bevacizumab in recurrent GBM patients undergoing surgical resection," said Andrew Parsa, Associate Professor in the Department of Neurological Surgery at the University of California, San Francisco (UCSF) and lead investigator for the trial, who presented an abstract of the study at the Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Miami, Florida. "I believe the combination of bevacizumab with HSPPC-96 holds significant promise for surgically resected recurrent GBM patients who are faced with limited treatment options," he added.
Over 40 patients were treated and the population evaluated for efficacy had a median Karnofsky performance status (KPS) of 80 and median age of 53. HSPPC-96 treated patients lived significantly longer than 86 consecutive patients not enrolled in the HSPPC-96 clinical trial, but treated with alternative therapies during the study period. Like the HSPPC-96 treated patients, the control patients also underwent >90% resection of recurrent GBM and had a KPS>70. The median overall survival for these patients was only 32.8 weeks with a six-month survival of 68% compared to a median survival of 47.6 weeks and 93% six month survival rate for the vaccine treated group (p<0.01). The vaccine was well tolerated, with no related grade 3 or grade 4 toxicities.
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