A major phase III clinical trial has found that DCVax®-L, an immunotherapy vaccine, can prolong the lives of patients diagnosed with new or recurrent glioblastomas. Glioblastomas are the most aggressive form of brain tumors in adults. The study – conducted locally by Yaron Moshel, MD, PhD, and Robert Aiken, MD – determined that adding DCVax-L to standard chemotherapy prolonged patients’ lives by nearly three additional months compared to chemotherapy alone. Dr. Moshel, a neurosurgeon specializing in brain tumors, and Dr. Aiken, a neuro-oncologist, are co-directors of the Gerald J. Glasser Brain Tumor Center.
What is DCVax-L?
DCVax-L is a type of immunotherapy known as a dendritic cell vaccine. Developed by Northwest Biotherapeutics, DCVax-L is a personalized vaccine made from each patient’s own dendritic cells. These cells help the immune system recognize and attack cancer cells.
How is the vaccine made?
Brain tumor cells that were removed during surgery are prepared and then presented to the patient’s dendritic cells in order to stimulate an immune reaction. Dendritic cells are specialized immune cells normally found throughout the body and present foreign antigens to the rest of the immune system. In the study, dendritic cells were isolated from the patient’s bloodstream and then exposed to the tumor cells in the lab. Through this process, the dendritic cells learn to recognize the specific markers and proteins associated with the patient’s tumor cells.
The “educated” dendritic cells are then injected back into the patient. They recruit and “teach” T-cells – which are anti-cancer immune cells – to travel to the tumor site and attack the cancerous cells.
How is the vaccine administered?
The vaccine consists of six injections in the upper arm in the first year and then twice a year for maintenance thereafter. It is non-invasive for the patient and easy for doctors to administer.
Who participated in the trial?
The trial involved 331 patients ranging from 18 to 70 years old. Nearly two-thirds – or 232 randomized patients – received DCVax-L plus temozolomide chemotherapy. The remaining 99 received the placebo – temozolomide chemotherapy alone.
What were the trial results?
Peer review of the phase III clinical trial found:
- DCVax-L + temozolomide chemotherapy offered patients an average of nearly three months of additional survival compared to standard chemotherapy alone.
- DCVax-L doubled the five-year survival rate for patients with a newly diagnosed glioblastoma, with 13% being alive five years later compared to 5.7% in the control group receiving the existing standard of care.
- For patients with recurrent glioblastoma, the 30-month survival rate doubled, with 11.1% being alive after 30 months compared to 5.1% in the control group.
- DCVax-L also benefited elderly patients and those who typically have poorer survival rates when diagnosed with a glioblastoma.
What is the status of the trial now?
The trial is now closed. DCVax-L is currently being vetted for possible US Food and Drug Administration approval.