Emergent Presents Positive Interim Phase 2 Data Evaluating Otlertuzumab

(RTTNews) - Emergent BioSolutions Inc. (EBS) announced positive interim results from a Phase 2 study evaluating the combination of otlertuzumab or TRU-016 and bendamustine versus bendamustine alone in people with relapsed chronic lymphocytic leukemia or CLL (Study 16201).

Overall response rate was the primary endpoint of the study. Data show that otlertuzumab in combination with bendamustine produced a higher response rate than bendamustine alone by International Workshop on CLL or IWCLL and National Cancer Institute or NCI response criteria.

Overall incidence of adverse events, severe and serious adverse events were generally similar in both arms of the study.

The company noted that the Phase 2 data were presented at the American Society of Hematology annual meeting in New Orleans, Louisiana.

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 or NHL, diffuse large B-cell lymphoma or DLBCL and other cancers of the blood. Otlertuzumab is built on Emergent's ADAPTIRTM (modular protein technology) platform, for the treatment of CLL.