Impax initiates patent challenge related to Fentora

March 12, 2017

Previously published retrospective analysis has documented that expression of the EGFRvIII oncogene correlates with poor long term survival. In ACT III, the two-year survival rate was 52% and compares very favorably with 6% for the matched EGFRvIII-positive historical cohort. The two-year survival data in ACT III is also consistent with the two prior studies, which each showed 50% survival at two years. In addition, data from ACTIVATE and ACT II have shown that approximately 20% of patients from each study continue treatment with durations of 6-8 years on study.

"These data continue to suggest that rindopepimut is extending survival well beyond what we have seen historically in this EGFRvIII patient population," said Rose Lai, M.D., Assistant Professor of Neurology in the Division of Neuro-Oncology, Department of Neurology, Columbia University Medical Center, and lead investigator on the ACT III study.

"The consistency of data from three separate studies, including a large multicenter trial, is very encouraging and clearly supports our plan to advance clinical development of rindopepimut with ACT IV, a pivotal, randomized, blinded international Phase 3 study," said Thomas Davis, M.D., Chief Medical Officer of Celldex Therapeutics.

Source Celldex Therapeutics, Inc.