Arzerra improved median progression-free survival by 54% in patients with relapsed chronic lymphocytic leukaemia

Novartis has presented promising data from the Phase III COMPLEMENT 2 study of Arzerra® (ofatumumab) in patients with replapsed chronic lymphocytic leukaemia (CLL) at the 20th Congress of the European Haematology Association (EHA).

The most commonly diagnosed adult leukaemia in Western countries, CLL accounts for approximately one in four cases of leukaemia. Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment.

Data from the study show that treatment with Arzerra plus fludarabine and cyclophosphamide significantly improved median progression-free survival (PFS) by 54% compared to treatment with fludarabine and cyclophosphamide alone.

“There are limited treatment options for patients who have stopped responding to current CLL treatments, which happens in many patients with this disease over time,” said Tadeusz Robak, Professor of Haematology, Department of Haematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland. “These data showed that the addition of ofatumumab to fludarabine and cyclophosphamide extended the amount of time before a patient’s CLL progressed, and further add to the body of evidence supporting the potential use of ofatumumab for these patients.”

Patients receiving Arzerra plus existing CLL treatments also had a higher overall response rate 

Additional data from the study show that patients receiving the Arzerra regimen had a higher overall response rate (ORR) compared to those receiving fludarabine and cyclophosphamide alone. Median overall survival (OS) was 56.4 months for patients receiving the Arzerra regimen compared to 45.8 months for patients receiving fludarabine and cyclophosphamide alone.

“The results from the COMPLEMENT 2 study validate the benefit of Arzerra treatment in combination with fludarabine and cyclophosphamide in certain patients with CLL,” said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. “We look forward to sharing the data with regulatory authorities.”