Celldex Brain Cancer Vaccine Disappoints, Phase III Trial To Be Discontinued

(RTTNews) - Celldex Therapeutics Inc. (CLDX) said that the independent Data Safety and Monitoring Board or DSMB has determined that continuation of the Phase 3 ACT IV study of RINTEGA or 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. Based on this recommendation, The company is discontinuing the study and does not anticipate incurring substantial additional costs related to RINTEGA at this time.

"We are extremely disappointed for patients that the ACT IV study was not successful," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics.

In the ACT IV study, RINTEGA has performed consistently with prior Phase 2 studies but the control arm has significantly outperformed expectations (Hazard ratio = 0.99; median OS: RINTEGA 20.4 months vs. control 21.1 months).

All patients on the RINTEGA arm of the ACT IV study, prior Phase 2 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.

Celldex said it currently has seven company-led clinical trials across five product candidates ongoing. The Company expects to report data from a number of these studies over the next three to 18 months, including a registration study in triple negative breast cancer and a number of Phase 1 and 2 cancer immunotherapy combination trials.