Ofatumumab.
Ofatumumab is a fully human anti-CD20 monoclonal antibody that induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity in CD20-expressing B lymphocytes. Ofatumumab is highly potent in lysing B cells, and this appears to stem from its binding site on the short extracellular loop of the target CD20 protein and its slow release from the target molecule. In a pivotal, noncomparative study in patients with fludarabine- and alemtuzumab-refractory chronic lymphocytic leukaemia (CLL), ofatumumab induced objective responses in 58% (99% CI 40, 74) of patients, which met a prespecified superiority criterion. The median duration of response was 7.1 months. The median progression-free survival was 5.7 months and the median overall survival was 13.7 months. In patients with fludarabine- and alemtuzumab-refractory CLL, infections and neutropenia were the most frequent treatment-related adverse events (all grades) that occurred during ofatumumab treatment; infections that commenced during treatment led to death in five patients (8%).
Sanford
Mark
M
Adis, a Wolters Kluwer Business, Auckland, New Zealand. demail@adis.co.nz
McCormack
Paul L
PL
D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; C527517:ofatumumab