The FINANCIAL -- Novartis on June 12 announced data from the Phase III COMPLEMENT 2 study showing that treatment with Arzerra (ofatumumab) plus fludarabine and cyclophosphamide significantly improved median progression-free survival (PFS) by 54% compared to treatment with fludarabine and cyclophosphamide alone (28.9 months vs 18.8 months, respectively; p=0.0032) in patients with relapsed chronic lymphocytic leukemia (CLL). Results are being presented at the 20th Congress of the European Hematology Association (EHA) in Vienna.
"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 Hematology, Department of Hematology, 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."
The most commonly diagnosed adult leukemia in Western countries, CLL accounts for approximately 1 in 4 cases of leukemia. Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment, according to Novartis.
In this clinical study, median PFS was improved by 54% in patients receiving Arzerra® (ofatumumab) in combination with fludarabine and cyclophosphamide (n=183) compared to those receiving fludarabine and cyclophosphamide alone (28.9 months vs 18.8 months, respectively; HR 0.67 [95% CI: 0.51, 0.88]; p=0.0032). Additionally, patients receiving ofatumumab in combination with fludarabine and cyclophosphamide had a higher overall response rate (ORR) compared to those receiving fludarabine and cyclophosphamide alone (84% vs 68% of patients, respectively; p=0.0003), with a better complete response (CR) rate (27% vs 7% of patients, respectively), compared to those receiving fludarabine and cyclophosphamide alone (n=182). Median overall survival (OS) was 56.4 months for patients receiving ofatumumab in combination compared to 45.8 months for patients receiving fludarabine and cyclophosphamide alone (HR 0.78 [95% CI: 0.56, 1.09]; p=0.1410). The safety profile observed in this trial was consistent with other trials of ofatumumab and no new safety signals were observed. The most common AEs (>=5%) reported were neutropenia, thrombocytopenia, anemia, nausea, leukopenia, vomiting, pyrexia, rash, fatigue, and pneumonia.
"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."