Ofatumumab works for elderly CLL patients with poor performance status, comorbidities
Ofatumumab alone is safe and effective for treatment-naïve elderly adults with chronic lymphocytic leukaemia (CLL), regardless of comorbidities, a recent study has shown.
The phase II investigation included 34 elderly CLL patients (median age, 73 years; 20 females) who had poor performance status, as determined by the Eastern Cooperative Oncology Group (ECOG) criteria, and comorbidities. Intravenous ofatumumab was given weekly for the first month and then monthly for the following 11 months.
Two patients discontinued within the first month and were excluded from subsequent analyses. Of the remaining 32 participants, 23 had documented treatment response, resulting in an overall response rate (ORR) of 72 percent. Six (19 percent) had complete response, and 17 (53 percent) showed partial response.
Higher ofatumumab doses appeared to be more effective. Nineteen of 24 patients who received the 2,000-mg dose were documented to have responded to the drug, yielding a response rate of 79 percent. In comparison, only four of eight patients who were given the 1,000-mg dose responded, with a corresponding rate of 50 percent.
After a median follow-up of 48 months, disease progression was reported in 65 percent of the sample. The resulting median progression-free survival (PFS) time was 21 months. This varied according to treatment response. PFS was better in those who achieved complete than partial or less response (26 vs 16 months; p=0.009).
In terms of safety, grade 1 and 2 infusion-related adverse events occurred in 56 percent of the participants, and one had a grade 3 reaction. Similarly, grade 1 and 2 infectious side effects were reported, though only one reached grade 3 severity. No grade 4 adverse events were reported.