GSK and Genmab Receive EU Authorization for Arzerra™ (ofatumumab) as First-Line Treatment for Chronic Lymphocytic Leukemia (CLL) in Combination with Chlorambucil or Bendamustine for Patients Ineligible for Fludarabine-based Therapy

On July 3, 2014 GlaxoSmithKline and Genmab reported that the European Commission (EC) has granted marketing authorization for a new indication for the use of Arzerra (ofatumumab), a human monoclonal antibody against CD20, in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy (Press release Genmab, JUL 3, 2014, View Source [SID:1234500611]).

“Today’s decision by the European Commission for the first-line use of Arzerra offers a new treatment option for appropriate CLL patients and enables physicians flexibility in their choice of adjunct chemotherapy – chlorambucil or bendamustine,” said Dr. Paolo Paoletti, President of Oncology, GSK.

“We are very pleased to receive this decision that Arzerra is approved in the EU in the front-line setting in combination with two different alkylating chemotherapies. This is another important milestone and we look forward to a successful launch under this new indication of the drug in Europe in the coming months. We hope to receive additional approvals in frontline across the globe in the future,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The EC authorization of the first-line indication for Arzerra (ofatumumab) is based on results from two trials:

A randomized, Phase III open-label, parallel-arm, multicenter, pivotal study (OMB110911, COMPLEMENT 1) evaluating the combination of ofatumumab and chlorambucil (N=221) versus chlorambucil alone (N=226) in CLL patients for whom fludarabine-based treatment is considered inappropriate. In this study, treatment with ofatumumab and chlorambucil demonstrated a statistically significant, 71 per cent improvement in median progression-free survival (PFS) compared to chlorambucil alone (22.4 months versus 13.1 months, respectively) (HR=0.57 [95 per cent CI, 0.45, 0.72] p<0.001). A single-arm, multicenter, Phase II study (OMB115991) evaluating ofatumumab in combination with bendamustine in 44 patients with previously untreated CLL for whom fludarabine-based treatment was considered inappropriate. Results of this study demonstrated that ofatumumab in combination with bendamustine provided an overall response rate (ORR) of 95 per cent [95 per cent CI, 85, 99] and a complete response rate (CR) of 43 per cent.