Brain Cancer Therapeutic Vaccine Candidate Reports ‘Promising’ Interim Results

The researchers of a multi-year brain cancer study have published very positive results. 

The purpose of this study is to see if boosting the patient's immune response to cancer cells can prevent further tumor recurrence.

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This ongoing phase 3 clinical trial’s interim survival data suggest that glioblastoma patients are living twice as long on standard therapy with the addition of immunotherapy  DCVax-L autologous dendritic cell vaccine.

The longest cancer survivors have lived for more than 7 years after surgery, reported these researchers.

DCVax-L vaccine works by taking dendritic cells, from the patients' bodies and then combining them with a sample of their own tumor.

When the vaccine is injected back into the same patient, the body's entire immune system recognizes the cancer to attack.

The current, standard glioblastoma therapy includes removing the tumor, followed by radiotherapy and chemotherapy with Temodal / temozolomide.

Glioblastoma is the most aggressive of brain tumors in adults. It is difficult to treat and patients live on average for only 15 to 17 months after surgery.

The primary endpoint of this study was progression-free survival (PFS), and the secondary endpoint was overall survival (OS). 

This study reported for the intent-to-treat (ITT) population, median OS (mOS) was 23.1 months from surgery.

Because of the cross-over trial design, nearly 90 percent of the ITT population received DCVax-L.

For patients with methylated MGMT, mOS was 34.7 months from surgery, with a 3-year survival of 46.4 percent.

Another positive finding is that only 2.1 percent of ITT patients had a grade 3 or 4 adverse event that was deemed at least possibly related to the vaccine.

Overall adverse events with DCVax were comparable to standard therapy alone.

Although enrollment was completed in 2015, this trial is still ongoing and will remain blinded until sufficient events of disease progression and/or death have occurred to more fully elucidate the tail of the survival curve.

Patients were eligible for this study if they were 18–70 years of age and had newly diagnosed glioblastoma, as determined through central pathology review. We conducted this study at over 80 sites in 4 countries: the US, Canada, Germany, and the UK.

Northwest Biotherapeutics, Inc. was the trial sponsor and had a role in the design and conduct of the study. Two researchers disclosed potential conflicts of interest. The Principal Investigator is Linda Liau, MD, Ph.D., MBA.