Safety

Across both Group 1 and Group 2, rindopepimut plus bevacizumab was very well tolerated (dosing up to 13+ months). There were no unexpected toxicities associated with concomitant bevacizumab administration and there were no treatment-related toxicities resulting in discontinuation of study treatment. Adverse events were consistent with prior studies of rindopepimut.

Phase 2 Frontline Long-term Overall Survival Assessments (ACT III, ACT II and ACTIVATE)

Celldex also announced today the presentation of four- and five-year survival data from the Phase 2 rindopepimut clinical program (3 studies; pooled n=105) in EGFRvIII-positive glioblastoma. 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 all other time points evaluated. 
Phase 2 Frontline Long-term Overall Survival Assessments (ACT III, ACT II and ACTIVATE)
  Median, Years (95% CI) 2-year rate 3-year rate 4-year rate 5-year rate
Phase 2 Rindopepimut Studies, Pooled (n=105) 2.1 (1.8, 2.4) 51% 30% 18% 14%
Matched historical control (n=17)* 1.3 (0.9, 1.7) 6% 6% 0% 0%
*Patients treated at M.D. Anderson contemporaneously to ACTIVATE, matched for major eligibility requirements, including EGFRvIII+ GBM, GTR and no PD through CRT.

The pooled overall long-term survival results continue to be consistent with the ACT III Phase 2 study (18% for 4-years and 14% for 5-years). The Phase 3 registration study, ACT IV, is modeled after the ACT III study.

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