Date: 2015-04-27
Type of information: Initiation of preclinical development
phase: 3
Announcement: results
Company: Novartis (Switzerland)
Product: ofatumumab (Arzerra™)
Action
mechanism: monoclonal antibody. Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. The drug has been developed under a co-development and commercialization agreement between Genmab and GSK. In April 2014, Novartis has agreed to acquire GSK oncology products including ofatumumab.
Disease: relapsed chronic lymphocytic leukemia (CLL)
Therapeutic area: Cancer - Oncology
Country: Brazil, Bulgaria, Canada, Germany, Greece, India, Italy, Mexico, The Netherlands, Poland, Romania, Russian Federation, Spain, Taiwan, Thailand, Ukraine, UK, USA
Trial
details: The purpose of this phase 3, open label, randomized study is to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL). (NCT00824265)
Latest
news: * On April 27, 2015, Novartis announced that the top-line results from the Phase III COMPLEMENT 2 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). The safety profile observed in this trial is consistent with other trials of Arzerra and no new safety signals were observed.
COMPLEMENT 2 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. 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.
