Date: 2015-06-12
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 20th Congress of the European Hematology Association (EHA) in Vienna, Austria.
Company: Novartis (Switzerland) Genmab (Denmark)
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: chronic lymphocytic leukemia
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: COMPLEMENT 2 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[4]. 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. (NCT00824265 )
Latest
news: * On June 12, 2015, 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. Results are being presented at the 20th Congress of the European Hematology Association (EHA) in Vienna. * 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.
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.
