Results from a Phase III Trial Analyzing Obinutuzumab (GA101) in CLL

September 17, 2013
Valentin Goede, MD

Valentin Goede, MD, Department I of Internal Medicine and Center of Integrated Oncology Cologne-Bonn, University of Cologne, Germany, discusses the findings of the phase III CLL11 trial.

Valentin Goede, MD, Department I of Internal Medicine and Center of Integrated Oncology Cologne-Bonn, University of Cologne, Germany, discusses the findings of the phase III CLL11 trial.

The CLL11 trial evaluated obinutuzumab (GA101) plus chlorambucil or rituximab plus chlorambucil versus chlorambucil alone in patients with chronic lymphocytic leukemia (CLL) and comorbidities.

Researchers found that the combination of obinutuzumab and chlorambucil prolonged progression-free survival significantly compared with chlorambucil alone. The most important piece of this finding, Goede notes, is the hazard ratio (0.14), which signifies an 86% reduction in risk of progressing with CLL in these patients. The trial also found that the hazard ratio for rituximab and chlorambucil compared with chlorambucil alone was 0.32.

Goede says that obinutuzumab and rituximab cannot be compared head-to-head with these data alone.

Clinical Pearls

  • In the CLL111 trial, obinutuzumab and chlorambucil prolonged PFS compared with chlorambucil alone
  • The combination demonstrated an 86% reduction in risk of progressing