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Celldex Therapeutics' Rindopepimut Demonstrates Promising Clinical Activity In Patients With EGFRvIII-positive Recurrent Glioblastoma At SNO

14 out of 18 (78%) patients with measurable disease on the rindopepimut arm experienced any tumor shrinkage versus 9 out of 16 (56%) patients on the control arm. Assessments of response were conducted by study investigators according to RANO criteria. Cases with greater than a 25% reduction in area of measurable disease were also reviewed by an expert panel blinded to treatment assignment.

Preliminary Analysis of Objective Response Bevacizumab-Naïve Recurrent GBM
  Rindo + Bev Control + Bev
ORR (confirmed CR/PR) 1,2 3/19 (16%)** 2/16 (13%)**
Any response ( > 50% shrinkage) including those not sustained at subsequent assessment 1    
 By Investigator review 7/19 (37%) 3/16 (19%)
 By Expert Panel review 6/19 (32%) 4/16 (25%)
 By Either review 9/19 (47%) 4/16 (25%)
**Two additional patients in the rindopepimut arm and 1 in the control arm have experienced greater than 50% shrinkage by either investigator or expert panel review and are pending follow up for confirmation of response. 1Response-evaluable patient subset with measurable disease. 2All concordant between investigator and expert panel review

70% of patients in the rindopepimut arm had stable disease or better for greater than 2 months versus 55% in the control arm. Further emphasizing the benefit in disease control, only 5% of patients treated with rindopepimut required an increase in steroids versus 35% of patients on the control arm.

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