Biogen Begins CLL Registrational Trial

Biogen Idec has initiated a randomized, controlled, registration trial of an investigational anti-CD23 monoclonal antibody, lumiliximab, for patients with chronic lymphocytic leukemia (CLL). The trial will compare treatment with lumiliximab in combination with fludaribine, cyclophosphamide and rituximab (FCR), to FCR alone in patients with CLL that has relapsed or failed to respond to initial therapy. Lumiliximab was recently granted Fast Track and Orphan Drug designations by the FDA for this indication.

“We are pleased that the FDA has recognized the unmet medical need of patients with chronic lymphocytic leukemia, and we believe that this fast track designation may be an important step towards bringing lumiliximab more rapidly to the market,” said David Parkinson, M.D., senior vice president, oncology research and development, Biogen Idec.

The registration trial will enroll approximately 276 patients worldwide at more than 90 centers. Data from a Phase I/II study on lumiliximab showed that when added to the FCR regimen, lumiliximab demonstrated a 52% complete response (CR) rate in patients who have CLL that was progressing after prior therapy. CR rate is a predictor of progression-free survival in CLL patients.