Olaptesed pegol: Interim Phase IIa data

Interim data from a pilot group of 9 evaluable patients with relapsed CLL in an open-label, dose-escalation, European Phase IIa trial showed that 1, 2 and 4 mg/kg NOX-A12 in combination with bendamustine and rituximab led to effective and prolonged mobilization of CLL cells into the peripheral blood. The combination led to an ORR of 100%, including a CR rate of 22% and a partial response rate of 78%. The combination was well tolerated with neutropenia, thrombocytopenia and anemia reported as the most common serious adverse events. The first 9 patients in the trial received a single dose of 1, 2 or 4 mg/kg NOX-A12 administered 2 weeks before starting combination treatment with NOX-A12, bendamustine and rituximab. The second part of the trial is evaluating NOX-A12 in combination with bendamustine and rituximab without the single starting dose of NOX-A12. The trial is enrolling 33 relapsed CLL patients. Data were presented at the American Society of Hematology meeting in New Orleans. ...