Brain cancer is a horrific disease with an equally dreadful prognosis that kills about 67% of patients within five years of diagnosis. Glioblastoma multiforme (GBM) is the most common primary malignant brain tumor, comprising about 52% of all primary brain tumors, according to the American Association of Neurological Surgeons.
Today's standard of care is surgery, then radiation and chemotherapy. Still, the outlook isn't good, with about 90% of glioblastoma patients succumbing to the disease within five years.
Northwest Biotherapeutics (OTCQB:NWBO) is trying to do something about these poignant statistics, developing its DCVax personalized immune therapies for solid tumors.
Data from an ongoing phase 3 trial evaluating DCVax-L in newly diagnosed glioblastoma patients was recently published in the peer-reviewed Journal of Translational Medicine, giving shares a nice lift on Tuesday morning.
DCVax-L involves only a series of simple intra-dermal injections (like a flu shot).
The data remains blinded while the trial continues. The interim data was an aggregate from patients in both the standard of care arm plus placebo (1/3 of enrollment) and those receiving standard of care plus DCVax-L (2/3 of enrollment). Where patients experienced tumor recurrence, they were allowed to switch to the standard of care plus DCVax-L arm, but the data remained blinded as to which arm the patient was in to begin with. Because of this crossover component, almost 90% of the 331 patients in the study have received DCVax-L therapy.
For the 331 patients in both arms of the study, the median survival rate so far has totaled 23.1 months from the date of surgery. That compares to a median survival for standard of care today in the range of 15-17 months.
Looking at particular subsets, there are indications of a meaningful benefit to Northwest's treatment. For the 131 patients with methylated MGMT gene status, the median survival was 34.7 months, compared to other research today showing a median survival of 21.7 months for patients receiving today's standard of care. MGMT data was unavailable for 38 patients.
For the 162 patients with unmethylated MGMT status, median survival to date is 19.8 months, compared to literature showing just 12.7 months.
A look at the top 100 patients delivered particularly interesting data, namely a median survival of 40.5 months from surgery. At this point, though, with the data blinded, scientists can't provide a breakdown as to the minutiae.
With any vaccine, the long-term data is what is critical and that is where Northwest is getting in the lengthy trial. So far, 223 patients were at least 30 months post-surgery and 182 were at least 36 months post-surgery, with 24.2% of these patients still alive.
Shares of NWBO have gained 23.9% in Tuesday action to 28.5 cents and have traded as high as 33.5 cents during the first 2-1/2 hours of the day, marking the highest level since March 20.
