Northwest Biotherapeutics, which is developing DCVax personalized immune therapies for solid tumor cancers, yesterday (November 17) reported that both median and long tail survival were increased in both newly diagnosed and recurrent glioblastoma.
The brain tumor cancer patients were treated with DCVax-L and in its phase 3 clinical trial met both the primary and secondary endpoints.
The trial results were reported today in a featured publication co-authored by more than 70 physicians from leading institutions across the U.S., Canada, U.K. and Germany, in the peer reviewed cancer journal JAMA Oncology, entitled Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma.
Newly diagnosed glioblastoma
Northwest Biotherapeutics believes this is the first time in nearly 20 years that a phase 3 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 3 trial of any type of treatment has shown such survival extension in recurrent glioblastoma.
Linda Powers, CEO of Northwest Biotherapeutics, 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” Powers continued.
“More than 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, 6 times over the course of year 1, and then twice a year for maintenance thereafter.”
Glioblastoma – most lethal brain cancer
Glioblastoma is the most common and most lethal form of primary brain cancer. Standard of care (SOC) treatments have been virtually unchanged for nearly 20 years. With SOC treatments, patients typically survive for only about 15-17 months from diagnosis, with the tumor recurring at about 6-8 months from diagnosis and the patients typically surviving for about 7-9 months after recurrence. Five-year survival from diagnosis is only about 5%.
In the phase 3 trial of DCVax-L, median Overall Survival (mOS) for 232 newly diagnosed GBM patients was 19.3 months from randomization (22.4 months from surgery) with DCVax-L versus 16.5 months from randomization in the controls. Survival at 48 months from randomization was 15.7% versus 9.9%, and at 60 months was 13% versus 5.7%. For recurrent GBM in 64 patients, mOS was 13.2 months from relapse versus 7.8 months. Survival at 24 and 30 months post-recurrence was 20.7% vs. 9.6%, and 11.1% vs 5.1%, respectively. In 90 newly diagnosed GBM patients with methylated MGMT, mOS was 30.2 months from randomization (33 months from surgery) with DCVax-L versus 21.3 months in controls.
From a safety perspective, out of more than 2,100 doses of DCVax-L administered during the phase 3 trial, there were only 5 serious adverse events that were deemed at least possibly related to the treatment. There were three cases of intracranial edema, one case of nausea and one case of lymph node infection.
About Northwest Biotherapeutics’ personalized immune therapy
Northwest Biotherapeutics’ 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.
Marnix Bosch, senior author on the publication, concluded: “This DCVax-L trial, at 94 hospitals in four countries, involved the teamwork of a large number of dedicated investigators. Publication of the results in the prestigious, peer-reviewed journal JAMA Oncology honors this teamwork and demonstrates how the field can move forward with novel therapies and innovative clinical trial designs.”
Northwest Biotherapeutics is currently working on preparations for applications for regulatory approval of DCVax-L for glioblastoma.