Genmab announces preliminary top-line results for Arzerra in front line CLL
Genmab A/S announced top-line results from the Phase II study of Arzerra™ (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients.
A total of 61 patients were treated in the study. Treatment response was assessed using the 1996 National Cancer Institute Guidelines. The complete remission rate was 32% in patients who received 500 mg of ofatumumab (n=31) and 50% in patients who received 1000 mg of ofatumumab (n=30). The overall response rate was 77% in the 500 mg treatment group and 73% in the 1000 mg treatment group.
There were no unexpected safety findings reported during treatment and within 30 days after last infusion. The most common adverse event reported was neutropenia at 48%. Other common adverse events (greater that 15 percent) were nausea, leukopenia, rash, vomiting, pyrexia, headache and thrombocytopenia. The number of patients, who experienced adverse events, including serious adverse events, was similar between the two dose groups. One death was reported and was judged by the investigator as unrelated to ofatumumab.
Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available. The CD20 molecule is a key target in CLL therapy because it is expressed on most B-cells in CLL patients. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.
Other news from the department research and development
Most read news
More news from our other portals
See the theme worlds for related content
Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
Last viewed contents
Groundbreaking microscopy technique: Nanochannels light the way towards new medicine - The innovation has also taken a step out into society through the start-up company Envue Technologies
Cell-based fish from the bioreactor - Alternative to fishing –
NLS Pharma acquires a portfolio of strategic patents - Critical step in the novel development of a potential non-amphetaminic stimulant for ADHD
EPO for the Brain - Engineered Moss produces human hormone without doping activity
ProtAffin AG granted patent in EU for CellJammer discovery technology - Novel technology enables development of a new class of biopharmaceuticals
CSIC researchers find the role of a protein in the regulation of synapse formation - The work raises the need for a balance between the Pinkman protein and the sHSPs proteins during the development of the nervous system for its correct formation
Affymetrix Selected to Genotype More Than 9,000 Framingham Heart Study Samples - SHARE Project to Help Identify Genetic Variants Associated With Heart, Lung, Blood and Sleep Disorders
New app calculates corona infection risk in rooms - Size of aerosol droplets that virus carriers release strongly influences infectivity
Northern_Norway_Pharmaceutical_Trust
