Following successful Phase 1 clinical trials of a new immunotherapy for patients with recurrent brain cancer, the Toca regimen trial has advanced to a Phase 3 study, which is currently underway. The Toca regimen trial is being conducted at 67 sites across the United States, Canada, Israel and South Korea, including at Atlantic NeuroSurgical Specialists (ANS) Brain Tumor Center, one of three clinical trial sites in New Jersey. In this surgical study, patients are randomized to either standard of care treatment or the Toca regimen. Enrollment is expected to complete in this trial by the end of 2018.
"Toca 5 uses a virus to stimulate a patient's own immune system and attack recurring high-grade gliomas – glioblastoma and anaplastic astrocytoma," said Dr. Yaron Moshel, a board-certified neurosurgeon at ANS. "Data from Phase 1 testing of the Toca regimen showed a favorable safety profile, complete tumor shrinkage, and extended patient longevity compared to other therapies."
Patients randomized to the Toca regimen receive an investigational treatment that involves two discrete steps. During the first step, patients receive Toca 511 (vocimagene amiretrorepvec), a replicating virus that selectively infects cancer cells, at the time of surgery. After a few weeks, they then take cycles of Toca FC (extended-release 5-fluorocytosine), a potent anti-cancer pill that kills cancerous cells and activates immune cells selectively against cancerous ones, leaving healthy cells unharmed.
With the current standard of care, newly diagnosed patients with glioblastomas have a median survival of approximately 14 to 16 months. After recurrence, median survival is typically seven to nine months.