DCVax-L improves OS in newly diagnosed or recurrent glioblastoma
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The addition of an autologous tumor lysate-loaded dendritic vaccine to standard care extended OS among certain patients with glioblastoma, according to results of a prospective phase 3 trial published in JAMA Oncology.
DCVax-L (Northwest Therapeutics) is a fully personalized immune therapy made from a patient’s own immune cells and antigens obtained from a tumor sample.
Researchers conducted a nonrandomized trial to assess OS among patients with newly diagnosed or recurrent glioblastoma treated with DCVax-L plus standard temozolomide.
Researchers compared outcomes of those patients with contemporaneous matched external control populations from control groups of other formal randomized clinical trials.
OS among patients with newly diagnosed glioblastoma served as the primary endpoint, and OS among those with recurrent disease served as a secondary endpoint.
Researchers enrolled 331 patients in the trial, conducted at 94 sites in four countries from August 2007 to November 2015.
In the enrolled population, the 232 patients assigned DCVax-L received vaccination on days 0, 10 and 20, then in months 2, 4, 8, 12, 18, 24 and 30, plus monthly temozolomide. The other 99 patients received placebo plus temozolomide.
In the external control group, those with newly diagnosed glioblastoma received temozolomide plus placebo, and those with recurrent disease received approved therapies.
Among patients with newly diagnosed glioblastoma, those treated with DCVax-L achieved longer median OS than external controls (19.3 months vs. 16.5 months; HR = 0.8; 98% CI, 0-0.94). A higher percentage of those treated with DCVax-L remained alive at 48 months (15.7% vs. 9.9%) and 60 months (13% vs. 5.7%).
An analysis of patients with newly diagnosed disease who had methylated MGMT showed longer OS among those who received DCVax-L vs. external controls (median, 30.2 months vs. 21.3 months; HR = 0.74; 98% CI, 0.55-1).
Among those with recurrent glioblastoma, those treated with DCVax-L achieved longer median OS from relapse than external controls (13.2 months vs. 7.8 months; HR = 0.58; 98% CI, 0-0.76). A higher percentage of patients who received DCVax-L remained alive at 24 months (20.7% vs. 9.6%) and 30 months (11.1% vs. 5.1%).
Researchers administered more than 2,100 doses of DCVax-L during the trial. They reported five serious adverse events deemed at least potentially related to treatment. These included three cases of intracranial edema, one case of nausea and one case of lymph node infection.
"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,” Linda Powers, CEO of Northwest Biotherapeutics, said in a press release. “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."
References:
- Liau LM, et al. JAMA Oncol. 2022;doi:10.1001/jamaoncol.2022.5370.
- Northwest Biotherapeutics reports positive top-line results from phase 3 trial of DCVax-L for glioblastoma. Available at: https://nwbio.com/northwest-biotherapeutics-reports-positive-top-line-results-from-phase-3-trial-of-dcvax-l-for-glioblastoma/. Posted Nov. 17, 2022. Accessed Nov. 18, 2022.
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Liau LM, et al. JAMA Oncol. 2022;doi:10.1001/jamaoncol.2022.5370.
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