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Novartis: Data Shows Arzerra, Chlorambucil Improved Median PFS In CLL Patients

Novartis AG (NVS) said that last stage data published in The Lancet showed that treatment with Arzerra or ofatumumab plus chlorambucil, a chemotherapy, resulted in a statistically significant improvement in progression free survival or PFS versus chlorambucil alone in treatment-naïve patients with chronic lymphocytic leukemia or CLL for whom fludarabine-based therapy was considered inappropriate, mainly due to advanced age or the presence of comorbidities.

CLL, the most commonly diagnosed adult leukemia in Western countries, accounts for approximately 1 in 4 cases of all leukemia. The average age at the time of diagnosis is approximately 71 years, and the majority of patients with CLL have at least one comorbidity such as hypertension, diabetes, heart disease or COPD.

The primary endpoint of the study was PFS according to the International Workshop for Chronic Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines. In this clinical study, median PFS was improved by 71% in the group receiving ofatumumab plus chlorambucil compared to the chlorambucil alone group (22.4 months vs 13.1 months, respectively; HR 0.57 [95% CI 0.45, 0.72]; p<0.0001). Improvement in PFS was observed in most subgroups irrespective of age, gender, disease stage and prognostic factors.

Improvement in PFS was observed in most subgroups irrespective of age, gender, disease stage and prognostic factors. More patients in the group receiving ofatumumab plus chlorambucil (50%) experienced adverse events (AEs) of grade 3 or greater compared to chlorambucil alone (43%), with neutropenia being the most common adverse event (26% vs. 14%). Grade 3/4 infusion-related reactions (IRRs) were reported in 10% of patients receiving ofatumumab plus chlorambucil leading to drug withdrawal in 3% of patients and hospitalization in 2% of patients. No fatal IRRs were reported.

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