Phase 2 Study of Novel Vaccine Underway in Newly Diagnosed Glioblastoma

Patients with newly diagnosed glioblastoma are now being accepted at two institutions to enter a phase 2 study to assess the efficacy of the SurVaxM vaccine in combination with standard chemotherapy. Patients will begin enrollment at the Roswell Park Cancer Institute and the Cleveland Clinic.

The SurVaxM vaccine, developed by Robert Fenstermaker and Michael Ciesielski, targets survivin, a cell-survival protein that’s present in most cancers, including glioblastoma. The vaccine is engineered incite an immune response to survivin-expressing cancer cells.

A phase 1 study demonstrated that the vaccine has tremendous potential.

"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," principal investigator Robert Fenstermaker, professor, Neurosurgery and Oncology at Roswell Park said.

“While it was a small study, seven of the eight 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," Fenstermaker added.1

In the single-arm phase 2 study, 50 patients will receive the vaccine in combination with Temodar (temozolomide), the standard chemotherapy for glioblastoma. The vaccine will be given in four doses over the first eight weeks of treatment, and once every 12 weeks from that point on.

Newly diagnosed patients likely have the best chance to benefit from the vaccine.

“In glioblastoma, a patient’s immune system is healthiest early in the course of the disease, right after they’ve had surgery," Ciesielski, assistant professor, Department of Neurosurgery at Roswell Park. So we’re particularly excited about the opportunity to be giving the vaccine up front, in patients who are most likely to benefit.&quot

Glioblastoma and Vaccines

Glioblastoma is a very aggressive disease and long-term survival remains low. The current standard of care is surgery followed by radiation and chemotherapy (Temodar). Median survival on this regimen is about 1.5 years.

There are numerous vaccines in development for glioblastoma, including the Northwest Biotherapeutics DCVax-L (phase 3), Celldex’s rindopepimut (phase 3), Immunocellular’s ICT-107 (phase 2), Agenus’ heat shock protein vaccine (phase 2), and many others.2

To learn more about the study, visit https://www.roswellpark.org/clinical-trials/list/2579


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