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news.Novartis announced that the top-line results from the Phase III COMPLEMENT II study showed that treatment with Arzerra (ofatumumab) plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival (PFS) in patients with relapsed chronic lymphocytic leukemia (CLL) (p=0.0036).
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The safety profile observed in this trial is consistent with other trials of Arzerra and no new safety signals were observed.
"Patients eventually stop responding to current CLL treatments, making the investigation of new options critically important," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs.
"We’re encouraged by these positive topline results from COMPLEMENT 2, which demonstrate continued momentum for our expanding oncology portfolio and we look forward to sharing the full results of this study at an upcoming medical meeting."
CLL, the most commonly diagnosed adult leukemia in Western countries, accounts for approximately 1 in 4 cases of leukemia[1],[2].
COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomized, Phase III study, which included 365 patients in 18 countries with relapsed CLL.
Patients in the study were randomized 1:1 to treatment with up to six cycles of ofatumumab in combination with fludarabine and cyclophosphamide or up to six cycles with fludarabine and cyclophosphamide alone.
The primary endpoint of the study was PFS was assessed by an Independent Review Committee (IRC) according to the International Workshop for Chronic Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines.
Secondary endpoints included overall response, overall survival, patient reported outcomes, time to response, duration of response, time to progression, time to next therapy, safety assessments and quality of life.
Arzerra is not approved for this indication and Novartis will further analyze the data from the COMPLEMENT 2 study and plans to share the results with regulatory agencies to evaluate the potential for future regulatory filings.