A new glioblastoma treatment from Northwest Biotherapeutics improved outcomes for many patients in a phase 3 clinical study, according to a study published in JAMA Oncology. Matt Ewend, MD, in the UNC Department of Neurosurgery and at UNC Lineberger, led the trial site at the N.C. Basnight Cancer Hospital.
Patients with glioblastoma, the most deadly form of brain cancer, desperately need new treatment options, and a new study published in JAMA Oncology suggests that adding a new therapy from Northwest Biotherapeutics to standard therapy significantly increased life expectancy after a phase 3 clinical trial.
Northwest Biotherapeutics, which developed DCVax® personalized immune therapies for solid tumor cancers, reported that both median survival and the “long tail” of extended survival were increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L. The trial met the primary and the secondary endpoints under the Statistical Analysis Plan for the trial.
The trial results were reported today in a featured publication co-authored by more than 70 physicians from leading institutions across the United States, Canada, United Kingdom, and Germany.
Co-authored by Matt Ewend, MD, Van L. Weatherspoon, Jr. Eminent Distinguished Professor of Neurosurgery and member of the UNC Lineberger Comprehensive Cancer Center, the paper titled, “Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination with Extension of Survival Among Patients with Newly Diagnosed and Recurrent Glioblastoma,” was published online this week in the peer-reviewed cancer journal JAMA Oncology. Dr. Ewend is also President of UNC Physicians and Chief Quality and Value Officer at UNC Health.
The company believes this is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma.
The company says that its product, DCVax-L, is a fully personalized immune therapy made from a patient’s own immune cells (dendritic cells) and antigens (biomarkers) from a sample of the patient’s own tumor. A multi-year set of doses is produced in a single manufacturing batch, which takes 8 days. The product is then stored frozen in individual doses, and is “off the shelf” throughout the treatment regimen. The doses are stored centrally and simply taken out of the freezer and delivered to the physician when needed for the patient’s next treatment.
In the phase 3 trial of DCVax®-L, median overall survival for newly diagnosed patients was 19.3 months from randomization (22.4 months from surgery) with DCVax-L vs. 16.5 months from randomization in the controls. Survival at 48 months from randomization was 15.7% with DCVax-L vs. 9.9%, and at 60 months was 13% vs. 5.7%. For recurrent GBM was 13.2 months from relapse vs. 7.8 months. Survival at 24 and 30 months post-recurrence was 20.7% with DCVax-L vs. 9.6%, and 11.1% vs 5.1%, respectively.
Further details can be found at JAMA Oncology or in the Northwest Biotherapeutics press release.