Celldex Therapeutics said today it is ending its Phase III ACT IV study of its immunotherapy candidate Rintega® (rindopepimut) in patients with newly diagnosed EGFRvIII-positive glioblastoma, at the recommendation of the trial’s independent Data Safety and Monitoring Board (DSMB).
The DSMB concluded, based on a preplanned interim analysis, that continuation of the study in patients with newly diagnosed EGFRvIII-positive glioblastoma will not reach statistical significance for overall survival in patients with minimal residual disease, Celldex said.
Rintega is designed to target the tumor specific oncogene EGFRvIII (also known as EGFRv3), a functional and permanently activated mutation of the epidermal growth factor receptor (EGFR).
Celldex said Rintega’s performance in ACT IV has been consistent with past Phase II studies, “but the control arm has significantly outperformed expectations.” The company said it received the negative data Friday following the close of financial markets and is reviewing the results.
“We are extremely disappointed for patients that the ACT IV study was not successful,” Celldex Co-founder, President and CEO Anthony Marucci said in a statement. “While this is certainly not the desired outcome, we remain steadfast believers in the power of immunotherapy to transform the future of cancer treatment.”
Celldex said it does not anticipate incurring “substantial” additional costs related to Rintega “at this time.”
All patients on the Rintega arm of the ACT IV study, prior Phase II studies, and existing compassionate use recipients will be offered ongoing access to Rintega on a compassionate use basis, Celldex said.
Celldex continues to lead seven ongoing clinical trials across five product candidates. The company said it expected to report data from a number of these studies over the next 3 to 18 months, including a registration study in triple-negative breast cancer and several Phase I and II cancer immunotherapy combination trials.