Emergent BioSolutions announced positive interim results from a Phase 2 study evaluating the combination of otlertuzumab (TRU-016) and bendamustine vs. bendamustine alone in patients with relapsed chronic lymphocytic leukemia (CLL) (Study 16201).
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.
In a multicenter, open-label, randomized, combination study, 65 patients with relapsed CLL who had 1–3 prior treatments were enrolled and randomized to either otlertuzumab 20mg/kg plus bendamustine 70mg/m2 or bendamustine 70mg/m2 alone. The primary endpoint was overall response rate.
Results from this study demonstrated that evaluable patients to date based on International Workshop on CLL (IWCLL) criteria for the combination of otlertuzumab and bendamustine (n=29) showed the overall response rate (ORR) was 69% with a complete response (CR) rate of 14%. For bendamustine alone (n=31), the ORR was 32% with a CR rate of 3%. The NCI response rates for the combination of otlertuzumab and bendamustine (n=32) were 81% ORR and 22% CR compared to 64% ORR and 9% CR for bendamustine alone (n=33).
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