Pretty much the same abstract as was at BNOS 2022:
BRITISH NEURO-ONCOLOGY SOCIETY ANNUALMEETING2022 Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination in Patients with Newly Diagnosed and Recurrent Glioblastoma:
Survival Results from a Phase 3 Trial Top Scoring Oral (20 mins) Mr. KeyoumarsAshkan 1 , Prof. Dr. Linda M. Liau 2, Dr. Marnix L. Bosch 3 1. Neurosurgical Department, King’s College Hospital Foundation Trust, London, UK, 2. University of California, Los Angeles, USA, 3. Northwest Biotherapeutics, Inc, USA Aims Investigate whether adding autologous tumor lysate-loaded dendritic cell vaccine (DCVax®-L) to SOC extends GBMsurvival. Method Newly diagnosed glioblastoma patients were randomized 2:1 to either DCVax-L or placebo. Under a crossover design, all patients could receive DCVax-L following tumor recurrence (everyone remained blinded to prerecurrence treatment). Patients thus received DCVax-L at new diagnosis (nGBM) or at recurrence (rGBM) following crossover from placebo. The primary and secondary endpoints compare overall survival (OS) in these cohorts with independently selected, contemporaneous, matched external controls. Four sets of analyses were conducted to ensure rigorous matching, reduce/eliminate known and unknown potential biases, and confirm the robustness of the survival results. Results 331 patients were enrolled. With the crossover, 89% received DCVax-L. Median OS (mOS) for nGBM patients (n=232) was 19.3 months from randomization (22.4 months from surgery) with DCVax-L vs. 16.5 months (HR=0.80, p=0.002). Survival at 60 months was 13% vs. <5.7%. For rGBM (n=64), mOS was 13.2 months from relapse vs. 7.8 months (HR = 0.58, p<0.001). Survival at 30 months post-recurrence was 11.1% vs 5.1%. In nGBM patients with methylated MGMT (n=90), mOS was 30.2 months from randomization (33 months from surgery) withDCVax-Lvs. 21.3months(HR=0.74,p=0.027). The treatment was well tolerated with only 5 serious adverse events deemed at least possibly related to the vaccine. Conclusion
A clinically meaningful and statistically significant survival extension was seen in both nGBM and rGBM patients treated with DCVax-L and SOC compared with contemporaneous, matched external controls who received SOC alone.
