Why data from a Phase III clinical trial offers promise for patients with a deadly form of brain cancer.
A Phase III clinical trial has produced promising results for a cancer vaccine targeting patients with a new or recurrent glioblastoma.
The study, which involved 331 patients, wanted to assess whether or not the DCVax-L vaccine could improve the overall survival for patients with a newly diagnosed glioblastoma, and recurrent glioblastoma, compared to therapies used as the standard of care.
Glioblastomas are fast and aggressive growing brain tumours with high mortality rates. Whilst typically treated with surgery, radiotherapy, or chemotherapy, glioblastomas are highly recurrent and less than 5% of patients are given a five-year survival1.
DCVax-L is an immunotherapy that is developed using a type of immune cells known as dendritic cells, which are taken directly from a patient. Developed by Northwest Biotherapeutics, the development involves taking both tumours and blood from the patient, where the dendritic cells are then separated from the patient’s blood and exposed to the tumour cells. This process helps the dendritic cells recognise the biomarkers and proteins related to a patient’s tumour, enabling the immune system to attack the cancer cells more directly.
Results of the study show that patients receiving DCVax-L experienced an improved overall survival time of around three-months compared to patients receiving chemotherapy. Perhaps most significant was that data from the trial show that the five-year survival for patients with a newly diagnosed glioblastoma was more than doubled for those receiving DCVax-L. Trial data show that 13% of patients receiving the vaccine survived the five years, compared to 5.7% receiving existing treatments.
Northwest Biotherapeutics spoke of the importance of the immunotherapy in a press statement, saying that it believes it’s the first time in 20 years that a treatment has shown this type of survival extension in newly diagnosed glioblastoma, and the first time in 30 years that this type of treatment has shown survival extension in recurrent glioblastoma.
Speaking about the results, CEO of Northwest Biotherapeutics Linda Powers said: “We are excited to see the meaningful survival extensions in glioblastoma patients treated with DCVax-L in this trial – particularly in the ‘long tail’ of the survival curve, where we see more than double the survival rates as with existing standard of care. With well over 400 clinical trials for glioblastoma having failed over the last 15 years, it is gratifying to be able to offer new hope to patients who face this devastating disease.”
“It is especially encouraging to see these survival extensions with a treatment that has such a benign safety profile. Over 2,100 doses of DCVax-L were administered during the trial, and we found that the adverse event profile was not meaningfully different than with standard of care alone. DCVax-L is also quite simple for the physician and patient: just an intradermal injection in the upper arm, six times over the course of year one, and then twice a year for maintenance thereafter.”
Professor Ashkan, Professor of Neurosurgery at King’s College Hospital, and European Chief Investigator of the clinical trial, added: “Immunotherapy is a very promising approach for treating cancer, and the final results of this Phase II trial, now unblinded and published, offer fresh hope to patients battling with glioblastoma.
“The vaccine was shown to prolong life, and interestingly so in patients traditionally considered to have poorer prognosis. For example, we see clear benefits in the older patient groups as well as in those patients in whom radical surgery was not possible for technical or other reasons.
“I am optimistic we can build upon this going forward; investigating combination of DCVax-L with other emerging therapies for glioblastomas.”
DDW Volume 24 – Issue 1, Winter 2022/2023
- JAMA Oncol. Published online November 17, 2022. doi:10.1001/jamaoncol.2022.5370