Phase III trial of DCVax-L meets both endpoints in glioblastoma.- Northwest Biotherapeutics
Northwest Biotherapeutics reported that in its Phase III clinical trial both median survival and the "long tail" of extended survival were increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax-L.
The trial has met both the primary and the secondary endpoint under the Statistical Analysis Plan for the trial. The Company believes this is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma.
In the Phase III trial of DCVax-L, median Overall Survival (mOS) for newly diagnosed GBM patients (n=232) was 19.3 months from randomization (22.4 months from surgery) with DCVax-L vs. 16.5 months from randomization in the controls (HR=0.80, p=0.002). Survival at 48 months from randomization was 15.7% vs. 9.9%, and at 60 months was 13% vs. 5.7%. For recurrent GBM (n=64), mOS was 13.2 months from relapse vs. 7.8 months (HR = 0.58, p<0.001). survival at 24 and 30 months post-recurrence was 20.7% vs. 9.6%, and 11.1% vs 5.1%, respectively. in newly diagnosed gbm patients with methylated mgmt, mos was 30.2 months from randomization (33 months from surgery) with dcvax-l (n="90)" vs. 21.3 months in controls (n="199)" (hr="0.74," p="0.027)." from a safety perspective, out of more than 2,100 doses of dcvax-l administered during the phase iii trial, there were only 5 serious adverse events that were deemed at least possibly related to the treatment. there were 3 cases of intracranial edema, 1 case of nausea and 1 case of lymph node infection. ></0.001).>
The trial results were reported in a featured publication co-authored by more than 70 physicians from leading institutions across the U.S., Canada, U.K. and Germany, in the peer reviewed cancer journal JAMA Oncology.
See: "Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent GlioblastomaA Phase 3 Prospective Externally Controlled Cohort Trial." Linda M. Liau et al. JAMA Oncol. Published online November 17, 2022. doi:10.1001/jamaoncol.2022.5370
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