Obinutuzumab bests Rituxan in CLL trial

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit said obinutuzumab ( GA101) plus chlorambucil chemotherapy met the primary endpoint of improving progression-free survival (PFS) vs. Rituxan rituximab plus chlorambucil in Stage 2 of the Phase III CLL11 (BO21004) trial to treat previously untreated chronic lymphocytic leukemia (CLL). Genentech previously reported data from Stage 1a of the trial showing obinutuzumab plus chlorambucil chemotherapy met the primary endpoint of improving median PFS vs. chlorambucil alone (see BioCentury, June 10).

Earlier this month, FDA accepted and granted Priority Review to a BLA for obinutuzumab to treat previously untreated CLL, for which the product has breakthrough therapy designation from FDA. The PDUFA date is Dec. 20. Roche and Genentech submitted an MAA to EMA for the glycoengineered humanized mAb against CD20 in April. Obinutuzumab also is in Phase III testing for non-Hodgkin's lymphoma (NHL) and diffuse large B cell lymphoma (DLBCL). ...