Ofatumumab/Bendamustine Combo Shows Promise in Leukemia Patients
95% response rate in phase II trial (May 1)
Results have been reported from a phase II study of ofatumumab (Arzerra; Genmab) in combination with bendamustine in patients with untreated or relapsed chronic lymphocytic leukemia (CLL).
A total of 97 patients were treated in the study, and 87% of the patients completed the full course of six cycles of therapy. The study population comprised 44 patients with untreated CLL and 53 patients with relapsed CLL. In patients with untreated CLL, the overall response rate (ORR) was 95%, with a complete response (CR) rate of 43%. The ORR in patients with relapsed CLL was 74%, with a CR rate of 11%.
The most common adverse effects of treatment with ofatumumab and bendamustine (> 20% of patients) were neutropenia, nausea, rash, pyrexia, and thrombocytopenia.
Ofatumumab is a human monoclonal antibody that targets an epitope on the CD20 molecule.
Arzerra (ofatumumab) is approved in the U.S. for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab. The drug is not approved for the treatment of untreated CLL.
Source: Genmab; May 1, 2013.