What You Need to Know
Researchers from John Theurer Cancer Center participated in a multicenter study showing that a new cancer vaccine more than doubled the survival of patients with recurrent glioblastoma compared to historical controls. The findings suggest the vaccine has promising efficacy, and support its further evaluation in randomized clinical trials. The data was reported in June 2022 in the online journal Frontiers in Oncology.
Recurrent Glioblastoma (rGBM) has an average survival from recurrence of only 8 months. Effective chemotherapy is limited by the blood-brain barrier (BBB), and immunotherapeutic approaches such as immune checkpoint inhibitors (iCI) have been largely ineffective in this disease.
This study treated 21 patients with recurrent glioblastoma with a vaccine called Sitoiganap, made from the patients’ own tumor tissue, along with the standard anticancer drugs cyclophosphamide, bevacizumab, and checkpoint inhibitors (nivolumab or pembrolizumab), plus GM-CSF. The median time it took for a patient's cancer to progress (progression-free survival) was 9 months and the overall survival from study entry was 20 months from the date the patients entered the study. The treatment was very well tolerated, with few side effects.
About half of the study’s patients were treated at John Theurer Cancer Center.
Sitoiganap is a novel vaccine custom-made from cells from a patient's own tumor as well as certain cells from the brain tumors of other patients participating in the study.
The study offered patients the vaccine on a "Right-to-Try" (RTT) basis. RTT is a new regulatory pathway created in 2018, that allows patients access to investigational medications outside of a traditional clinical trial framework. The advantage to RTT over standard expanded access (EA) protocols lies in the comparative ease of running such protocols. The RTT framework cuts through much of the regulatory red tape that can delay EA protocols.