A combination of autologous tumour lysate–loaded dendritic cell vaccine (DCVax-L) plus standard-of-care (SOC) temozolomide (Temodar) prolonged the overall survival (OS) of patients with newly diagnosed or recurrent glioblastoma. These findings from the phase III trial were recently published in JAMA Oncology.
Glioblastomas are highly heterogeneous and aggressive tumours of the brain with poor prognosis. With a need for new treatment options, a phase III trial has investigated the efficacy of personalized active immunotherapy.
The prospective, nonrandomized, phase III study enrolled 303 (median age, 56 years and 61.0% men) participants with newly diagnosed glioblastoma. The patients were non-randomly assigned to receive either the initial DCVax-L treatment (n=232) or placebo (n=99) plus SOC. Due to recurrence, 64 out of 99 patients crossed over to the DCVax-L arm. The study was compared to a contemporaneous matched external control population (ECP) treated with SOC.
The median OS was prolonged with DCVax-L to 19.3 months from randomization and 22.4 months from surgery as compared to 16.5 months from randomization in the control group. The survival rate was also increased in the experimental group (15.7% at 48 months and 13.0% at 60 months) versus 9.9% and 5.7%, respectively, in the control group. Taken together, the DCVax-L treatment reduced the risk of death by 20%, the benefit of which increased over time. Only five serious adverse effects were observed across all the delivered doses of DCVax-L, elucidating the safety of DCVax-L treatment.
Treating glioblastoma patients with DCVax-L plus SOC resulted in extended OS compared with external controls.
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