Emergent Gets Positive Results in CLL Trial

Emergent BioSolutions has posted positive interim results from a Phase II study of the combination of otlertuzumab (TRU-016) and bendamustine versus bendamustine alone in people with relapsed chronic lymphocytic leukemia (CLL). Overall response rate was the primary endpoint of the study.

 

The combination of treatments produced a higher response rate than bendamustine alone by International Workshop on CLL (IWCLL) and National Cancer Institute (NCI) response criteria. Overall incidence of adverse events, severe and serious adverse events were generally similar in both arms of the study. The Phase II data were presented at the American Society of Hematology annual meeting in New Orleans.

 

Otlertuzumab is a humanized anti-CD37 mono-specific protein therapeutic that targets the CD37 signaling pathway involved in B-cell malignancies such as CLL, non-Hodgkin’s lymphoma (NHL), diffuse large B-cell lymphoma (DLBCL) and other cancers of the blood. Otlertuzumab is built on Emergent’s ADAPTIR (modular protein technology) platform, for the treatment of CLL.

 

The Phase II multicenter, open-label, randomized, combination study, involved 65 patients with relapsed CLL who had one to three prior treatments; they were randomized into two dosing schemes.