DOC1021 Autologous DC Vaccine Hits 88% 12-mo OS in IDH-wt GBM (Phase I)

DOC1021 is an autologous dendritic-cell vaccine loaded with each patient’s tumor lysate plus amplified tumor mRNA and injected near deep cervical nodes with weekly peg-IFN after chemoradiation. In a single-arm adjuvant study of newly diagnosed IDH-wt GBM (n=16; 94% MGMT-unmethylated; 25% subtotal resection; NCT04552886), 12-mo OS was 88% and 5 patients remain alive at 19–30 months; AEs were mainly grade 1–2 flu-like/injection-site reactions with no DLTs, and immune monitoring showed expansion of CD4+/CD8+ central memory T cells and CD8+CD127+ MPECs; among 8 patients observed for early post-vaccine MRI worsening, signal resolved and mOS was not reached vs 15.1 mo in 8 who underwent re-operation—reassuring for pseudo-progression. These outcomes sit above historical anchors for radiochemotherapy (1-yr OS ~66%; mOS 16.0 mo) and approach TTFields+TMZ (mOS 20.9 mo), noting that MGMT-unmethylated cohorts typically see mOS ~12–14 mo.

Note: ASCO presentation with updated data has 4 patients, and not 5 remaining alive.