Adding an autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) to standard care improves overall survival (OS) in patients with glioblastoma, according to results of a phase 3 trial published in JAMA Oncology.

The trial (ClinicalTrials.gov Identifier: NCT00045968) enrolled 331 patients with newly diagnosed glioblastoma and a life expectancy of at least 8 weeks. The patients had a median age of 56 years (range, 19-73).

Patients underwent surgery and collection of tumor tissue for manufacturing of DCVax-L. After receiving chemoradiation for 6 weeks, patients were randomly assigned to receive DCVax-L or placebo, each in combination with adjuvant temozolomide. Crossover or continuation of DCVax-L after recurrence was allowed. 


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There were 232 patients initially assigned to the DCVax-L arm, 99 initially assigned to the placebo arm, and 64 who crossed over from the placebo arm to the vaccine arm.

Because so many patients crossed over to the placebo arm, OS evaluations made use of data from matched external control patients (ECPs) from randomized controlled trials. There were 1366 ECPs with newly diagnosed glioblastoma and 640 ECPs with a first recurrence of glioblastoma.

The primary endpoint was OS in the patients with newly diagnosed glioblastoma. In this group, the median OS was 19.3 months for patients initially assigned to DCVax-L and 16.5 months for the ECPs (hazard ratio [HR], 0.80; P =.002). 

The 48-month OS rate was 15.7% in the DCVax-L arm and 9.9% for ECPs. The 60-month OS rates were 13.0% and 5.7%, respectively.

A secondary endpoint was OS among patients with disease recurrence. In this group, the median OS was 13.2 months for patients who crossed over from the placebo arm to the vaccine arm and 7.8 months among the ECPs (HR, 0.58; P <.001). 

The 24-month OS rates after recurrence were 20.7% with DCVax-L and 9.6% for ECPs. At 30 months post-recurrence, OS rates were 11.1% and 5.1%, respectively.

There were 5 serious adverse events considered potentially related to DCVax-L. These were grade 3 nausea (n=1), grade 3 lymph node infection (n=1), grade 2 intracranial edema (n=1), and grade 3 intracranial edema (n=2). 

Disclosures: This research was supported by Northwest Biotherapeutics, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Liau LM, Ashkan K, Brem S, et al. Association of autologous tumor lysate-loaded dendritic cell vaccination with extension of survival among patients with newly diagnosed and recurrent glioblastoma: A phase 3 prospective externally controlled cohort trial. JAMA Oncol. Published online November 17, 2022. doi:10.1001/jamaoncol.2022.5370