Novartis announced that the top-line results from the phase III COMPLEMENT 2 study showed that treatment with Arzerra (ofatumumab) plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival (PFS) in patients with relapsed chronic lymphocytic leukaemia (CLL) (p=0.0036). The safety profile observed in this trial is consistent with other trials of Arzerra and no new safety signals were observed.

"Patients eventually stop responding to current CLL treatments, making the investigation of new options critically important," said Alessandro Riva, MD, global head, Novartis Oncology Development and Medical Affairs. "We're encouraged by these positive topline results from COMPLEMENT 2, which demonstrate continued momentum for our expanding oncology portfolio and we look forward to sharing the full results of this study at an upcoming medical meeting."

CLL, the most commonly diagnosed adult leukaemia in Western countries, accounts for approximately 1 in 4 cases of leukaemia.

COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomized, phase III study, which included 365 patients in 18 countries with relapsed CLL. Patients in the study were randomized 1:1 to treatment with up to six cycles of ofatumumab in combination with fludarabine and cyclophosphamide or up to six cycles with fludarabine and cyclophosphamide alone.

The primary endpoint of the study was PFS was assessed by an Independent Review Committee (IRC) according to the International Workshop for Chronic Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines. Secondary endpoints included overall response, overall survival, patient reported outcomes, time to response, duration of response, time to progression, time to next therapy, safety assessments and quality of life.

Arzerra is not approved for this indication and Novartis will further analyze the data from the COMPLEMENT 2 study and plans to share the results with regulatory agencies to evaluate the potential for future regulatory filings.

Arzerra (ofatumumab) is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Arzerra is also approved for first-line use in Russia, Iceland, Norway, Luxembourg and Brazil.

In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.

Arzerra is marketed under a co-development and collaboration agreement between Genmab and Novartis, as successor in interest to GSK.