DSMB recommends discontinuation of Phase III study of Rintega (rindopepimut) in brain cancer- Celldex Therapeutics

Celldex Therapeutics announced that the independent Data Safety and Monitoring Board (DSMB) has determined, based on a preplanned interim analysis, that continuation of the Phase III ACT IV study of Rintega (rindopepimut) in patients with newly diagnosed EGFRvIII-positive glioblastoma will not reach statistical significance for overall survival in patients with minimal residual disease, the primary endpoint of the study, as both the RINTEGA arm and the control arm are performing on par with each other.

In the ACT IV study, Rintega has performed consistently with prior Phase II studies but the control arm has significantly outperformed expectations (Hazard ratio = 0.99; median OS: Rintega 20.4 months vs. control 21.1 months). Based on this recommendation, Celldex is discontinuing the study and 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 first received the data after market close on Friday, March 4th and is in the process of reviewing the results.