DCVax-L improves OS in newly diagnosed or recurrent glioblastoma

November 18, 2022

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Source:

Liau LM, et al. JAMA Oncol. 2022; doi:10.1001/jamaoncol.2022.5370.


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Adding an autologous tumor lysate-loaded dendritic vaccine to standard care improved OS among selected patients with glioblastoma, according to results from a prospective phase 3 trial published in JAMA Oncology.

DCVax-L (Northwest Therapeutics) is a fully personalized immunotherapy made from the patient’s own immune cells and antigens obtained from a tumor sample.



An image of a brain mri



Investigators conducted a nonrandomized trial to evaluate OS among patients with newly diagnosed or recurrent glioblastoma treated with DCVax-L plus standard temozolomide.

The researchers compared the results of these patients with matched external control groups from control groups of other formal randomized clinical trials.

OS among patients with newly diagnosed glioblastoma was the primary endpoint, and OS among those with recurrent disease was a secondary endpoint.

Researchers enrolled 331 patients in the study, which was conducted at 94 sites in four countries from August 2007 to November 2015.

In the population enrolled, 232 patients received DCVax-L vaccination at days 0, 10, and 20, then at 2, 4, 8, 12, 18, 24, and 30 months, plus monthly temozolomide. The remaining 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 the approved treatment.

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 proportion of those receiving DCVax-L remained alive at 48 months (15.7% vs. 9.9%) and 60 months (13% vs. 5.7%).

Analysis of patients with newly diagnosed disease who had methylated MGMT showed longer OS among those treated with DCVax-L vs. external control (median, 30.2 months vs. 21.3 months; HR = 0.74; 98% CI, 0.55–1).

Among those with recurrent glioblastoma, those receiving 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 proportion of patients treated with 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 study. They reported five serious side effects that were considered at least possibly 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 meaningful survival prolongation in glioblastoma patients treated with DCVax-L in this study – particularly in the ‘long tail’ of the survival curve, where we see more than double the survival rate as with the current 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 past 15 years, it is gratifying to be able to offer new hope to patients facing this devastating disease.” It is particularly encouraging to see these survival extensions with a treatment that has such a benign safety profile.”

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