Northwest Biotherapeutics (MD, USA) have announced the publication of interim, blinded survival data from its Phase III clinical trial of DCVax®-L for newly diagnosed glioblastoma. Researchers believe that addition of DCVax-L to standard therapy is feasible and safe in glioblastoma patients and may extend survival.
The interim data have been published in the Journal of Translational Medicine and the trial is currently ongoing while data continue to mature. The company, investigators and patients all remain blinded.
The study included data from patients in both arms of the trial combined: those receiving standard of care plus DCVax-L and those receiving standard of care plus placebo. Administration of DCVax-L involved an intra-dermal injection in the arm, three-times in the first month of treatment, three additional times over the rest of the first year (at months 2, 4 and 8), and twice a year thereafter.
When the patients experienced tumor recurrence, all patients from both arms were allowed to crossover and receive DCVax-L. However, these patients were not unblinded and were not aware of what treatment they had received before tumor recurrence.
Due to the crossover design of the study, almost 90% of the total 331 patients in the trial received DCVax-L treatment. The median survival for the total 331 patients (both trial arms combined) was 23.1 months from surgery. According to the researchers, the median survival for newly diagnosed glioblastoma with the standard of care today is approximately 15–17 months.
In addition to this, the researchers have reported that patients with methylated MGMT gene status (131 patients) demonstrated a median survival of 34.7 months from surgery. With standard of care today, the median survival for these patients has been reported in literature as 21.7 months. Moreover, patients with unmethylated MGMT gene status (162 patients) revealed a median survival of 19.8 months from surgery, whereas the standard of care today for these patients is reported in literature to be 12.7 months.
It was also revealed that the top 100 patients (30%) of the total 331 patients in the trial demonstrated particularly extended survival, with a median survival time of 40.5 months from surgery.
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“These are just interim data, and the data may get either better or worse as they continue to mature,” commented Linda Powers, CEO of Northwest Biotherapeutics. “However, the survival times we are seeing are encouraging, especially in light of how little progress has been made in decades in treatments for glioblastoma.”
“DCVax-L is designed to use nature’s system to mobilize an anti-tumor immune response, targeting the full set of antigens on a patient’s tumor and doing so in a fully personalized way. We believe this approach is key to the clinical results we are seeing,” Powers explained.
“The safety profile of DCVax-L is also quite encouraging, with almost no serious adverse events related to the treatment, no necessity for additional drugs to manage side effects and no hospital in-patient stays as are often required with certain other kinds of immune cell therapies. This safety profile is quite important to patients, and we believe it can also facilitate combining DCVax-L with a variety of other types of treatments,” Powers concluded.
Sources: Liau LM, Ashkan K, Tran DD et al. First results on survival from a large Phase III clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma. J. Transl. Med. doi:10.1186/s12967-018-1507-6 (2018) (Epub ahead of print); www.nwbio.com/nwbio-announces-scientific-publication-interim-survival-data-phase-3-trial-dcvax-l-glioblastoma-brain-cancer/