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news.Celldex Therapeutics has reported that the FDA has granted fast track designation to CDX-110, an investigational immunotherapy that targets the tumor specific molecule EGFRvIII, for the treatment of glioblastoma multiforme.
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In the Activate Phase IIa study, glioblastoma multiforme (GBM) patients treated with CDX-110 showed a median survival time of 30 months, more than a 100% increase in survival, versus the historical control’s median of 14.5 months. The study has demonstrated a median time-to-progression of 13 months (p=0.0001) versus the historical control’s median of 6.4 months. GBM that recurred after treatment with CDX-110 consistently lost EGFRvIII expression with its aggressive growth signal.
In September, Celldex randomized its first patient into ACT III, a definitive Phase II/III randomized study of CDX-110 with radiation and temozolomide in patients with newly-diagnosed GBM. The clinical trial is investigating the anticancer activity, impact on survival, and safety of the addition of CDX-110 vaccine to standard of care, versus standard of care alone.
Thomas Davis, chief medical officer of Celldex Therapeutics, said: “Fast Track status acknowledges CDX-110’s potential to fill an unmet need for glioblastoma patients and gives it priority within the FDA.”