COMPLEMENT 2 study showed that treatment with Arzerra (ofatumumab) plus fludarabine and cyclophosphamide significantly improved median progression-free survival in CLL patients- Novartis
Novartis 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.
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. 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.
Comment: Arzerra is not approved in combination with fludarabine and cyclophosphamide for relapsed CLL.
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