Strong interim survival trend (12.0 vs 7.9 months) emerging in ongoing bevacizumab naive randomized cohort; 5.6 month median OS (48% > 6 months) in bevacizumab refractory single-arm cohort; robust anti-tumor immune responses were generated among heavily pre-treated patients with recurrent tumors and these responses correlate with improved outcome
Rindopepimut demonstrates ability to significantly shrink recurrent and refractory glioblastomas
Long-term survival update also provided for three Phase 2 frontline studies; EGFRvIII patients continue to exceed expectations with 14% 5-year survival vs 0% historical controlHAMPTON, N.J., Nov. 24, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported interim data from its ongoing, exploratory Phase 2 ReACT study of rindopepimut in recurrent glioblastoma. Rindopepimut is an immunotherapeutic vaccine that targets the tumor specific oncogene EGFRvIII(v3). Patients with EGFRvIII-positive glioblastoma typically have a worse prognosis than the overall glioblastoma population, including poor long term survival. The ReACT results demonstrate promising signs of clinical activity in advanced patient populations, including patients both naïve and refractory to bevacizumab (Avastin ®). An update on long-term survival for the three completed Phase 2 frontline studies in EGFRvIII-positive glioblastoma was also presented and results continue to exceed outcomes seen in contemporary controls. A webcast/conference call will be held at 8:30 am ET on Monday, November 25 th, to discuss the results (details provided below). The data were presented in an oral session by David A. Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Center and Associate Professor of Medicine, Harvard Medical School and the lead investigator of the ReACT study, at the 4th Quadrennial Meeting of the World Federation of Neuro-Oncology held in conjunction with the 18th Annual Meeting of the Society for Neuro-Oncology (SNO). "Patients who have grown right though Avastin are resistant to all of our available therapies," said David Reardon, M.D. "The potent immune response generated by rindopepimut and preliminary signs of anti-tumor activity in the Avastin refractory patients in the ReACT study are very exciting. The additional signal of an improved survival outcome in Avastin naïve patients further supports the potential activity of rindopepimut. I look forward to the final results of this study and hope they confirm what we have seen so far."