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Positive Results Reported for Leukemia Drug Obinutuzumab (Gazyva) in Phase III Study

Survival increased versus rituximab (November 7)

Positive results have been reported from the second stage of the phase III CLL11 trial, which compared obinutuzumab (Gazyva, Roche) in combination with chlorambucil versus rituximab (Rituxan/ MabThera, Genentech/Biogen IDEC) and chlorambucil in patients with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. Patients in the obinutuzumab arm lived nearly a year longer without their disease worsening (i.e., progression-free survival [PFS]).

For patients in the obinutuzumab arm, the median PFS was 26.7 months compared with 15.2 months for those in the rituximab arm (hazard ratio [HR], 0.39; P

The new data have been accepted for presentation at the 55th Annual Meeting of the American Society of Hematology (ASH), to be held Dec. 7–10 in New Orleans.

Additional data comparing treatment with obinutuzumab or rituximab, both administered with chlorambucil, showed higher complete response rates (21% vs.7%, respectively) and a ten-fold increase in the percentage of people achieving minimal residual disease (MRD) negativity (29.4% vs. 2.5%), which was defined as no detectable disease in the blood at the end of the treatment course.

In addition to the stage 2 data being presented at the ASH meeting, an updated analysis from the first stage of the CLL11 trial, which compared obinutuzumab and chlorambucil with chlorambucil alone, will be presented. This analysis showed that patients treated with obinutuzumab in combination with chlorambucil lived longer (i.e. overall survival) compared with those treated with chlorambucil alone (HR, 0.41; P = 0.002).

On November 1, Gazyva (obinutuzumab) in combination with chlorambucil became the first drug with a “breakthrough therapy” designation to receive FDA approval.

Source: Roche; November 7, 2013.

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