Gazyva obinutuzumab: Additional Phase III data

Additional data from Stage 2 of the open-label, international Phase III CLL11 (BO21004) trial in 663 previously untreated CLL patients showed that Gazyva plus chlorambucil chemotherapy led to a median PFS, the primary endpoint, of 26.7 months vs. 15.2 months for Rituxan rituximab plus chlorambucil (HR=0.39, 95% CI: 0.31, 0.49, p<0.0001). On secondary endpoints, Gazyva plus chlorambucil led to an ORR of 78% vs. 65% for Rituxan rituximab plus chlorambucil and a complete response rate of 21% vs. 7% for the control arm. Median OS has not yet been reached in either treatment arm. Additionally, 29.4% of patients in the Gazyva arm achieved MRD, defined as no detectable disease in the blood at the end of treatment, vs. 2.5% of patients in the Rituxan arm.

Roche's Genentech Inc. unit previously reported interim data from Stage 2 of the trial showing that Gazyva plus chlorambucil met the primary endpoint of improving PFS vs. Rituxan plus chlorambucil (see BioCentury, July 29). Genentech also previously reported data from Stage 1a of the trial showing that Gazyva plus chlorambucil met the primary endpoint of improving median PFS vs. chlorambucil alone (23 vs. 10.9 months, p<0.0001) (see BioCentury, May 20). Stage 1a of the 3-arm trial evaluated Gazyva plus chlorambucil compared to chlorambucil alone, while Stage 2 evaluated Gazyva plus chlorambucil compared to Rituxan plus chlorambucil. Stage 1 also included a Stage 1b pre-planned futility analysis to evaluate the likelihood that Gazyva plus chlorambucil would significantly improve PFS vs. Rituxan plus chlorambucil in Stage 2. In January, Genentech said an assessment by an independent DSMB concluded that Stage 2 of the trial should continue until its final analysis (see BioCentury, Feb. 4). ...