The FINANCIAL — Phase III data published in The Lancet showed that treatment with Arzerra (ofatumumab) plus chlorambucil, a chemotherapy, resulted in a statistically significant improvement in progression free survival (PFS) versus chlorambucil alone in treatment-naïve patients with chronic lymphocytic leukemia (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, according to Novartis.
“Finding effective treatments with clinically acceptable safety profiles for elderly patients with CLL and for those with co-existent chronic and potentially life-threatening conditions continues to be a challenge,” said Prof. Peter Hillmen, St. James’s University Hospital, Leeds, United Kingdom and lead study author. “The results published in The Lancet reinforce our understanding that the combination of ofatumumab plus chlorambucil provides this patient population a treatment option that improves clinical health outcomes in CLL.”
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[6]. 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. 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.
“The results presented in The Lancet demonstrate that the addition of Arzerra to chlorambucil resulted in a significant improvement in progression free survival, with an acceptable safety profile,” said Alessandro Riva, M.D., Global Head, Novartis Oncology Development and Medical Affairs. “We are excited that Arzerra is now part of the Novartis Oncology portfolio of products, and look forward to building upon the body of evidence that supports the clinical benefit of Arzerra for appropriate patients with CLL.”
These Phase III data formed the basis for regulatory approvals in the United States (US) and European Union (EU) in 2014, as well as the recent inclusion of Arzerra plus chlorambucil in the National Comprehensive Cancer Network (NCCN) treatment guidelines.
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