Study finds vaccine extends recurrent GBM survival rates by 2 to 3 times

In data presented at The American Society of Clinical Oncology (ASCO) Annual Meeting, cancer researchers found that the brain tumor vaccine HSPPC-96 for treating recurrent gliobastoma (GBM) has a favorable safety profile and extends survival by two to three times more than the current median survival rate. Patients in the study, conducted at University Hospitals Case Medical Center, University of California, San Francisco and Columbia University, were found to have a median survival of 11 months compared to current three to five month survival.

“The findings are very favorable for patients with this deadly form of brain cancer,” said Andrew Sloan, MD, one of the authors of the study presented at ASCO and Director of the Brain Tumor and Neuro-Oncology Center at University Hospitals Case Medical Center. “The vaccine is one of the few immune therapies designed specifically for patients who are not newly diagnosed, and these encouraging results make this a promising therapy for a more extensive Phase 3 trial.”

HSPPC-96 isolates the heat shock protein, which is part of the immune system. The protein from the patient’s tumor is then reinjected into the skin with an adjuvant, or an agent added to a drug to increase its effect.

The vaccine was developed by Andrew Parsa, MD, PhD, principal investigator of the Brain Tumor Research Center at the University of California, San Francisco. He is collaborating with the Lexington, Massachusetts biotech company called Agenus. Columbia University also is part of the ongoing Phase 2 study designed to evaluate overall survival and immunologic response with HSPPC-96 in patients with first or subsequent recurrence of GBM.

All patients underwent surgery prior to vaccine therapy. However, since the vaccine is made from the patient’s own tumor, the surgery had to be performed at one of the participating sites. The vaccine therapy begins within 5 weeks after surgery and consists of four weekly injections, followed by bi-weekly injections for up to 52 weeks.

“The vaccine is made from a patient’s own cells, so it takes into account what is unique about the patient’s particular tumor—it’s the ultimate in ‘personalized medicine’,” said Dr. Sloan who also is the Peter D. Cristal Chair in Neurosurgery and an Associate Professor of Neurological Surgery at Case Western Reserve University School of Medicine.

In addition to this promising research, UH Case Medical Center’s Seidman Cancer Center physician scientists presented a variety of oral and poster presentations at ASCO. Notably, Cynthia Owusu, MD, breast oncologist, is presenting two important abstracts related to the treatment of older women with breast cancer. Importantly, the first study concludes that one in four women, after 6 months, and one in three, after 12 months, display plummeting physical function which shows a clear need to remedy treatment options to help preserve activity of breast cancer patients later in life. UH Case Medical Center abstracts are highlighted below:

Title: Autologous heat shock protein vaccine (HSPPC-96) for patients with recurrent glioblastoma (GBM): Results of a phase II multicenter clinical trial with immunological assessments.

Monday June 6, 8:00 AM to 12:00 PM

Abstract (http://abstract.asco.org/AbstView_102_85010.html) Background: HSPPC-96 is derived from a patient’s individual tumor and contains glycoprotein-96 (gp96) polypeptide associated with cancer-specific antigenic peptides. Methods: This ongoing single-arm multicenter Phase 2 trial is designed to evaluate overall survival (primary objective) and immunologic response (secondary objective) with HSPPC-96 in patients with first or subsequent recurrence of GBM. Prior treatment with radiotherapy and temozolomide was required. All patients underwent a >90% resection of the recurrence. Vaccine therapy was to be initiated within 5 weeks post-surgery and consisted of 25 µg HSPPC-96, given ID weekly x 4, followed by bi-weekly injections for up to 52 weeks. Results: A total of 33 patients at first recurrence (M:F = 25:8) with a median KPS of 80 were entered. A median of 6 injections (range: 1-15) were administered to the ITT population, with a requisite of 4 vaccinations for the evaluable population. The vaccine was well tolerated with no attributed serious adverse events and no related grade 3 or 4 toxicities. Injection site reaction was seen in 12 patients and fatigue was reported in 9 patients. As of Jan. 2011, the median survival (KM estimates) is 324 days for ITT population (37-877) and 333 days for evaluable population (99-877). 11 patients are still alive and being followed, including 4 beyond one year (374d, 419d, 578d, and 877 days, respectively). All patients with immunological endpoints tested to date exhibited a significant innate immune response and all patients demonstrated CD8 T cell IFN gamma production upon restimulation with autologous gp-96; following vaccine administration. Conclusions: HSPPC-96 evokes a specific and innate immune response in patients with recurrent glioma and survival data available to date indicates HSPPC-96 vaccine provides a possible clinical benefit with a favorable safety profile. Collectively these results provide the impetus for Phase 3 testing against currently approved therapies for patients with recurrent glioblastoma.

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