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ARTICLE | Clinical News

ATIR: Phase II data

December 21, 2015 8:00 AM UTC

Data from 19 evaluable patients with a hematologic malignancy in the open-label, international Phase II CR-AIR-007 trial showed that a single IV infusion of 2x10 6 CD3+ cells/kg ATIR101 following an HSCT from a haploidentical donor significantly improved 6-month transplant-related mortality rate, the primary endpoint, vs. historical controls for HSCT only (15% vs. 37%, p=0.002). There were 3 cases of transplant-related mortality reported within the first 6 months post-HSCT; in all cases cause of death was an infection. ATIR101 plus HSCT also significantly improved OS vs. historical controls for HSCT alone (p=0.0006). The 1-year survival rate for ATIR101 plus HSCT was 75% vs. 20% for historical controls for HSCT alone. Only 1 patient died as a result of disease relapse. No patients developed grade 3/4 acute GvHD and there were 2 cases of grade 2 acute GvHD with delayed onset. The trial enrolled 23 patients. Data were presented at the American Society of Hematology meeting in Orlando. Full primary endpoint data are expected in April 2016. ...