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Celldex Posts Positive 3-Year Survival Data from Phase 2 Rindopepimut Program

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Celldex Therapeutics, Inc. (NASDAQ: CLDX) announced today the presentation of three-year survival data from the Phase 2 rindopepimut clinical program in EGFRvIII-positive glioblastoma—a more aggressive form of glioblastoma typically associated with reduced long-term survival in comparison to the glioblastoma population as a whole. Across three Phase 2 studies of rindopepimut, survival data remains consistent and suggests a substantial and continuing survival benefit in comparison to independent control datasets (see chart below) at the median and at three years. In the multi-center Phase 2 ACT III study, the median overall survival is 24.6 months from diagnosis (21.8 months from study entry) and overall survival is 26% at three years. In the Phase 2 ACT II study, the median overall survival is 24.4 months from diagnosis (20.5 months from study entry) and overall survival is 23% at three years. In the Phase 2 ACTIVATE study, the median overall survival is 24.6 months from diagnosis (20.4 months from study entry) and overall survival is 33% at three years.

Rindopepimut Overall Survival (OS) Across Three Phase 2 Studies in EGFRvIII-Positive Glioblastoma vs Independent Control Datasets Rindopepimut Phase 2 Studies (all data from study entry)       Median     OS 3 years (months) ACT III (n=65)     21.8     26% ACT II (n=22)     20.5     23% ACTIVATE (n=18)     20.4     33% Independent Control Datasets (all data from study entry) MD Anderson EGFRvIII-positive patients matched^1 to ACTIVATE patient population (n=17)     12.2^2     6%

(contemporary with ACTIVATE) Radiation Therapy Oncology Group (RTOG) 0525 study - all EGFRvIII-positive patients (n=142)     15.1     18%

(contemporary with ACT III) RTOG 0525 study - all EGFRvIII-positive patients treated with standard dose temozolomide (n=62)     14.2     7%

(contemporary with ACT III) RTOG 0525 study - EGFRvIII-positive patients matched^1 to ACT III/IV patient population (n=29)     16     13%

(contemporary with ACT III)

^1Controls are closely matched to rindopepimut patient criteria including gross total resection of patient tumor and ~3 months without disease progression at time of study entry; ^2In order to provide comparable timeframes across datasets, data have been estimated assuming study entry at three months from diagnosis.

Posted-In: News FDA

 

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