Agenus Inc Plans To Move Forward With Randomized Trial Evaluating Efficacy Of HSPPC-96 In Glioblastoma Patients

Agenus Inc. AGEN today announced that an abstract entitled, "A Phase 2 multicenter trial of autologous heat shock protein-peptide vaccine (HSPPC-96; vitespen) for recurrent glioblastoma multiforme (GBM) patients shows improved survival compared to a contemporary cohort controlled for age, KPS and extent of resection," was presented by Dr. Andrew Parsa, Professor, Department of Neurological Surgery, University of California San Francisco, during Plenary Session II at the 80th American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Miami, Florida. "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 T. Parsa, MD, Ph.D., Associate Professor in the Department of Neurological Surgery at the University of California, San Francisco (UCSF) and lead investigator for the trial. "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." 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 percent 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 percent compared to a median survival of 47.6 weeks and 93 percent 6 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. The survival data available to date indicate that the HSPPC-96 vaccine may help patients treated with the therapy live longer, and suggest a possible clinical benefit. In addition, the researchers note that the HSPPC-96 results are superior to similar surgical populations identified in the literature as well as a contemporary cohort controlled for age, KPS and extent of resection. Results provide the impetus for further testing against presently approved therapies for recurrent GBM patients.