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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