Independent DSMB Recommends Continuation Of Celldex's Phase 3 Study Of RINTEGA

(RTTNews) - Celldex Therapeutics, Inc. (CLDX) announced that an independent Data Safety and Monitoring Board or DSMB recommended continuation of the Phase 3 ACT IV study of RINTEGA in patients with newly diagnosed glioblastoma.

The company noted that the ACT IV study is a randomized, double-blind, placebo controlled study of rindopepimut plus GM-CSF added to standard of care temozolomide in patients with newly diagnosed, surgically resected, EGFRvIII-positive glioblastoma. 745 patients were enrolled into ACT IV to reach the required 374 patients with minimal residual disease needed for analysis of the primary overall survival endpoint. All patients, including those with disease that exceed this threshold, will be included in a secondary analysis of overall survival as well as analyses of progression-free survival, safety and tolerability, and quality of life.

The timing of the overall survival primary endpoint data is event-driven. Interim analyses assessing safety, futility and efficacy conducted by an independent DSMB were prespecified at 50 percent and 75 percent of events.

As previously announced, the second interim analysis is expected to occur in late 2015/early 2016, Celldex stated.