SafetyAcross 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.|