The following is a press release from Celldex Therapeutics announcing positive survival data from their Rindopepimut Phase 2 Brain Cancer Vaccine Study and plans to initiate a Phase 3 trial. Accelerate Brain Cancer Cure funded Duke University's early work on the vaccine.
Celldex Therapeutics Reports Positive Mature Survival Data from Rindopepimut Phase 2 Brain Cancer Study at SNO 2011
-- Randomized International Phase 3 Trial to Initiate in 2011 --
NEEDHAM, Mass., Nov 21, 2011 (BUSINESS WIRE) -- Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced the presentation of mature overall survival (OS) data for ACT III, a multi-center, single arm, Phase 2 clinical trial of rindopepimut (CDX-110) in patients with newly diagnosed EGFRvIII-positive glioblastoma (GB). The data showed a final median OS of 24.6 months from diagnosis, which is significantly better than 15.2 months for a historical cohort of patients selected to match ACT III eligibility criteria. The median OS data obtained from the 31 centers participating in the ACT III study are very consistent with two previous smaller studies with rindopepimut in GB (ACTIVATE and ACT II) conducted at M.D. Anderson and Duke University which showed 24.6 and 24.4 month median OS, respectively. These data were described in an oral presentation at the 16th Annual Meeting of The Society for Neuro-Oncology (SNO) in Orange County, CA by the lead investigator on the study, Dr. Rose Lai.
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.
Rindopepimut is an investigational immunotherapeutic vaccine that targets the tumor-specific molecule epidermal growth factor receptor variant III (EGFRvIII). EGFRvIII is a mutated form of the epidermal growth factor receptor (EGFR) that is only expressed in cancer cells and not in normal tissue and is a transforming oncogene that can directly contribute to cancer cell growth. Expression of EGFRvIII is linked to poor long term survival regardless of other factors such as extent of resection and age. EGFRvIII has been expressed in 31% of GB tumors when assessed using the Celldex PCR assay.
About Celldex Therapeutics, Inc.
Celldex Therapeutics is the first antibody-based combination immunotherapy company. Celldex has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy (PTI) Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators used in optimal combinations to create novel disease-specific drug candidates. For more information, please visit http://www.celldextherapeutics.com.