Chicago, Ill., March 7, 2016 – The following is a statement by Elizabeth M. Wilson, president and CEO, American Brain Tumor Association, on the decision by Celldex Therapeutics Inc. to discontinue a late-stage study of its brain cancer vaccine RINTEGA®.
The announcement comes after the independent Data Safety and Monitoring Board (DSMB) determined, based on a preplanned interim analysis, that continuation of the Phase 3 ACT IV study of RINTEGA in patients with newly diagnosed EGFRvIII-positive glioblastoma (GBM) will not reach statistical significance for overall survival in patients as both the RINTEGA arm and the control arm are performing on par with each other.
“Today’s announcement to halt the phase III study of RINTEGA is a disheartening setback in the quest to develop a successful immunotherapy for highly aggressive GBMs for which there are few treatment options and an unacceptably low five-year survival rate. While disappointed in this outcome, we remain focused on funding innovative research and advocating for new funding opportunities that will yield safe and effective treatment options that will improve, extend and, ultimately, save the lives of those impacted by this devastating diagnosis.”
Founded in 1973, the American Brain Tumor Association was first and is now the only national organization committed to funding brain tumor research and providing education and information on all tumor types and for all age groups. For more information, visit http://www.abta.org or call 800-886-ABTA (2282).
# # #