Brain cancer vaccine to move into phase III
pharmafile | November 24, 2010 | News story | Research and Development, Sales and Marketing | Celldex, Pfizer, brain cancer, glioblastoma
Celldex will press ahead with large-scale trials of its vaccine treatment for brain cancer after encouraging phase II results.
The US biotech company says the studies of rindopepimut (CDX-110) in patients with newly diagnosed glioblastoma multiforme (GBM) show a significant extension in progression free survival.
The results are very encouraging for Celldex, which suffered a major setback in September when Pfizer withdrew from a co-development and marketing deal.
The new data showed 66% of patients were progression-free at 8.5 months from diagnosis or 5.5 months from start of vaccination, a statistically significant increase over a predetermined progression-free rate (PFR) estimate of 53 per cent. This compares to studies of patients on current standard of care (consisting of radiation and temozolomide) which showed between 29% and 45% of patients progression-free at 8.5 months post-diagnosis.
Rindopepimut is an immunotherapeutic vaccine that targets epidermal growth factor receptor variant III (EGFRvIII). Glioblastoma multiforme is one of the most hard to treat and aggressive cancers, and new treatments are needed to improve survival in patients.
“These data suggest that rindopepimut is extending survival well beyond what we have seen historically in this patient population,” said Rose Lai, M.D., assistant professor of neurology, Columbia University Medical Center, and lead investigator on the ACT III study. “The consistency of data from three separate studies is impressive and clearly supports the plan to conduct a controlled pivotal study in GBM.”
The company says it will now begin an international, placebo-controlled phase III trial in the second half of 2011.
Andrew McConaghie
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