Ofatumumab, particularly at a dose of 2 g, appears to be well-tolerated, and active as induction followed by maintenance therapy, for patients with previously untreated chronic lymphocytic leukemia (CLL), according to a study published in the American Journal of Hematology.1
Ofatumumab monotherapy demonstrated a 58% response rate in patients with CLL refractory to fludarabine and alemtuzumab. For the present phase 2 study, researchers evaluated the safety, progression-free survival, and response rate of single-agent ofatumumab as frontline therapy.
Investigators enrolled 77 patients with untreated, symptomatic CLL who were aged 65 years or older, or who were ineligible to receive chemotherapy. Participants received either ofatumumab 1 g or 2 g weekly for 8 weeks, followed by maintenance dosing every 2 months, for a total of 24 months.
The best overall response rates in the 1 g and 2 g cohorts were 72% and 89%, respectively, per the 1996 NCI-WG criteria and 54% and 68%, respectively, using the 2008 IWCLL criteria.
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The 24-month estimated progression-free survival rate was 46% in 1 g group and 78% in the 2 g cohort.
Response and progression-free survival were lower for patients with del(17p) and del(11q) CLL.
- Flinn IW, Ruppert AS, Harwin W, et al. A phase II study of two dose levels of ofatumumab induction followed by maintenance therapy in symptomatic, previously untreated chronic lymphocytic leukemia. Am J Hematol. 2016 Jul 22. doi: 10.1002/ajh.24468 [Epub ahead of print]