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Friday, January 26, 2024 3:53:15 PM
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
“A vaccine to treat glioblastoma
Glioblastoma is the most aggressive primary brain tumor in adults, with more than 10,000 new cases diagnosed in the United States each year. Standard treatment involves surgery, radiation, and chemotherapy; and the median overall survival rate is only 15 to 17 months from diagnosis.
A vaccine to treat glioblastoma called DCVax-L has been in development for several years. Linda Liau, MD, PhD, MBA, and a team of UCLA researchers were the first to investigate whether a patient’s own dendritic cells (a specialized type of immune cell) could be used to create a personalized treatment for the deadly cancer.
“We tested the method with a single patient in 1997, and then moved to a phase 1 safety trial in the early 2000s,” says Dr. Liau, professor and chair of Neurosurgery at UCLA.
A series of phase 2 early efficacy and optimization trials followed, and then an international, multi-site study led by Dr. Liau began in 2007.
The vaccine consists of two components: a patient’s dendritic cells, which are special types of immune cells, and proteins prepared from a patient’s tumor.
To create the vaccine, which is individualized for each patient, medical staff first perform a procedure called leukapheresis, in which a patient’s blood is drawn and their white blood cells are collected. Then, the patient’s tumor is removed and sent to a lab where researchers obtain proteins from the specimen, called tumor lysate. The white blood cells are cultured to differentiate into dendritic cells, and then combined with the tumor lysate to make the vaccine.
Dendritic cells are “antigen-presenting” cells, which means that they are able to process all kinds of foreign invaders in the body and alert the immune system’s T cells to mobilize a broad immune response against those invaders. Glioblastoma is a highly heterogenous disease, meaning there are many different types of cancer cells within a single tumor. Therefore, the dendritic cells — loaded with a patient’s own tumor lysate — allow a patient’s immune system to recognize a wide variety of tumor targets and spur the immune system to respond, according to Dr. Liau.
The phase 3 trial led by Dr. Liau involved 331 study participants at 80 sites around the world from August 2007 to November 2015. During the study, 232 people received standard care and DCVax-L at new diagnosis, while 64 out of 99 people received standard care and a placebo. (Patients in the placebo group received the DCVax-L at recurrence.)
The trial results, published in JAMA Oncology in November 2022, showed that newly diagnosed glioblastoma patients receiving the vaccine had an overall survival of 19.3 months on average, compared to 16.5 months on average among the contemporaneous, matched external control group.
“There is a significant subgroup of patients who lived more than five years, but the challenge is trying to determine which patients it may work for, and for which patients it doesn’t,” Dr. Liau says.
At UCLA, Dr. Liau and other researchers are now testing whether the vaccine would be more effective in combination with a PD-1 checkpoint inhibitor. Checkpoint inhibitors are a type of immunotherapy that work by blocking proteins that stop the immune system from attacking cancer cells. While the vaccine allows T-cells to get inside of the tumor, the checkpoint inhibitors may allow T-cells to be more functional and better attack the tumor cells.
“Because of the heterogeneity of glioblastoma, I don’t think there is going to be one drug or one treatment that is going to be effective for all patients. The future of glioblastoma treatments is going to be these combination approaches,” Dr. Liau says.”
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