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Apr 10, 2024
Glioblastoma or Glioblastoma Multiforme (GBM) represents the most common primary tumor of the central nervous system (CNS). Despite advancements in diagnostic approaches and the development of new therapies, the prognosis for glioblastoma patients remains notably poor, with limited improvement observed.
At AACR 2024, Diakonos Oncology announced promising interim analysis of the Phase 1 (NCT04552886) open-label trial of its dendritic cell vaccine (DOC1021) showing substantially increased survival of glioblastoma multiforme (GBM) patients well beyond the expected median overall survival (mOS) of 12.7 months for patients receiving the standard of care (SOC).
Findings from the ongoing analysis show that 12/16 newly diagnosed GBM patients remain alive with no attributable serious adverse events at an average of 12.9 months of follow-up. The current 12-month overall survival of 88% for unmethylated GBM patients compares favorably to the fifty-three percent 12-month historical survival of unmethylated GBM patients treated with standard of care.
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Moreover, Diakonos’ trial has garnered praise for its inclusive trial design. 56% of enrolled patients, who would have likely been excluded from other GBM clinical trials due to factors like pre-treatment progression, subtotal resection status, or advanced age, participated. Despite facing challenging prognoses, these patients experienced a statistically significant improvement in expected overall survival, with an increase of 7.7 months compared to similar patients.
DOC1021 has received Fast Track and Orphan Drug Designations from the US FDA. The company expects to begin Phase II trials of DOC1021 for GBM patients within the next year and is conducting two other clinical development programs in pancreatic cancer and angiosarcoma.
For more information on Glioblastoma Multiforme, refer to DelveInsight’s report:
Glioblastoma Multiforme Market Insight, Epidemiology and Market Forecast -2032
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