In a recent public statement, Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced that DSMB had recommended to discontinue its Phase 3 ACT IV study of RINTEGA.
DSMB or Data Safety and Monitoring Board conducted a preplanned interim analysis and came up with a conclusion that this study in EGFRvIII-positive glioblastoma patients wouldn’t serve its statistical purpose. It claimed that control arm and RINTEGA arm in such patients was performing equally in such patients; hence, the Phase 3 ACT IV study was of minimum or no significance.
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In this study, RINTEGA managed to perform at par with the standards set by the Phase 2 studies; however, the control arm has outperformed everyone’s expectations. Based on the inputs given by DSMB, Celldex has decided to end the Phase 3 study right away. The expectations of incurring extra cost on this study in the near future are almost next to impossible. All those patients who are on the RINTEGA arm of the ACT IV study will be offered complete access to RINTEGA.
Reports claim that Celldex received the data a few days back and currently reviewing it to reach to any conclusion.
The entire senior management team of the company is disappointed to announce this update. According to Anthony Marucci, Co-Founder, CEO & President, Celldex, it’s disappointing to close this study at such a time when many patients had high hopes from it. Celldex expresses gratitude to all those patients, ACT IV investigators, and families who showed faith in this trial and participated with complete enthusiasm.
He further added that the result of this study was not up to expectations; however, his belief in immunotherapy for the cancer treatment remained intact. Going forward, Celldex will look forward to analyzing the outcome of this study and come up with a new trial that can do justice with everyone’s expectations and hard work. Details of such programs will be announced in the near future.