The SurVaxM vaccine appears to be safe and may be a novel immunotherapy that can benefit newly diagnosed patients with glioblastoma brain tumors.
The SurVaxM vaccine appears to be safe and may be a novel immunotherapy that can benefit newly diagnosed patients with glioblastoma brain tumors. The vaccine therapy was developed at Roswell Park Cancer Institute and it is now moving up the development pipeline.
It will be tested in a multisite clinical trial involving 50 patients. Investigators will assess the effectiveness of the SurVaxM vaccine in combination with standard chemotherapy as treatment for this highly lethal cancer. The primary endpoint for the study is progression-free survival (PFS).
Patients will receive the first priming dose of the vaccine 7 to 14 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase. Following that phase, patients will receive the vaccine and every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. All 50 patients in the single-arm, phase II study are receiving the vaccine in combination with temozolomide (Temodar), the standard chemotherapy for glioblastoma.
“Our first clinical study established that this vaccine appears to have low toxicity, that it generated the tumor-specific immune response we were looking for and that some patients seemed to benefit from it,” said principal study investigator Robert Fenstermaker, MD, who is Chair of the Department of Neurosurgery, Director of the Neuro-Oncology Program, and Professor of Neurosurgery and Oncology at the Roswell Park Cancer Institute in Buffalo. “While it was a small study, 7 of the 8 patients who received all doses of the vaccine, all of whom had failed standard therapy, survived longer than a year, some much longer. In a disease where few survive beyond eight months, that’s an important signal.”1
Though relatively rare, glioblastoma is the most common and aggressive type of primary brain tumor. The SurVaxM vaccine, developed by Robert Fenstermaker, MD, and Michael Ciesielski, PhD, targets survivin, a cell-survival protein that’s present in the vast majority of cancers, including glioblastoma. A peptide mimic, the vaccine is engineered to treat survivin-expressing cancer cells as foreigners, inciting a specific immune response. Preclinical studies suggest that the approach may be worthy of additional study in melanoma, ovarian, and prostate tumors and perhaps in other survivin-expressing cancers.
“We’ll be looking to see if patients who receive the vaccine in addition to standard therapy do better than patients who receive standard therapy alone,” said Michael Ciesielski, who is an Assistant Professor in the Department of Neurosurgery at Roswell Park. “In glioblastoma, a patient’s immune system is healthiest early in the course of the disease, right after they’ve had surgery. So we’re particularly excited about the opportunity to be giving the vaccine up front, in patients who are most likely to benefit.”