An Open-Label Phase 2 Study Of Ofatumumab
Chen CI, Snitzler S, Wang T, et al.
Key Points:
- Investigators present an interim analysis of initial 19 of 31 planned pts in a Phase II trial of ofatumumab and afuresertib in relapsed/refractory CLL patients (at least one prior fludarabine-containing regimen with disease progression).
- 4 pts (21%) developed Gr 3-4 neutropenia, 2 pts (10.5%) developed Gr 3-4 thrombocytopenia, no bleeding.
- Most common grade 3-4 toxicities: dyspepsia (53%), diarrhea (37%), nausea (21%), infusion reactions (ofatumumab)(63%)
- 5 (26%) pts developed non-infectious pneumonitis, with 3 hospitalization
- Two pts had exacerbation of preexisting atrial arrhythmias with weekly ofatumumab infusions
- PR: 42%, SD: 58%, no CR
- 5 pts (26%) progressed and 1 patient died after cycle 1 on therapy due to progressive CLL, at median follow-up of 6.8 mos.
Implications:
- Interim phase 2 study results suggests activity and tolerability of a combination of ofatumumab plus oral AKT inhibitor in relapsed, refractory CLL
Additional Comments:
-
Need more mature data, a very short follow up time.
- Cannot comment on duration of response.
View the original abstract on the ASH website.
