Otlertuzumab: Interim Phase Ib/II data

Interim data from 60 evaluable patients with relapsed CLL who failed 1-3 prior treatments in the Phase II portion of the open-label, U.S. Phase Ib/II Study 16201 showed that 20 mg/kg IV otlertuzumab given weekly for two 28-day cycles followed by every 14 days for four 28-day cycles plus 70 mg/kg IV bendamustine led to an ORR of 69% with a complete response (CR) rate of 14% and a partial response (PR) rate of 55% vs. an ORR of 32% with a CR rate of 3% and a PR rate of 29% for bendamustine alone according to 2008 International Workshop on CLL (IWCLL) response criteria. According to 1996 National Cancer Institute (NCI) Working Group response criteria (n=65 evaluable patients), otlertuzumab plus bendamustine led to an ORR of 81% with a CR rate of 22% and a PR rate of 59% vs. an ORR of 64% with a CR rate of 9% and a PR rate of 54% for bendamustine alone. The most common grade 3/4 adverse events included neutropenia, thrombocytopenia, infections and anemia. Data were presented at the American Society of Hematology meeting in New Orleans. ...