In a nutshell
This study aimed to investigate the use of ofatumumab maintenance treatment in patients with relapsed chronic lymphocytic leukemia. This study concluded that this treatment significantly prolonged progression-free survival in these patients and was well tolerated.
Some background
Ofatumumab (Arzerra) is a monoclonal antibody (immunotherapy) that can be used to treat chronic lymphocytic leukemia (CLL) in adults who have not improved after other treatments. It can be used as a maintenance therapy. Maintenance therapy is used after the end of another treatment to keep the cancer from coming back.
It was not known if ofatumumab maintenance is safe and effective in patients that were treated for relapsed CLL.
Methods & findings
This study involved 480 patients with CLL in complete or partial remission after a second- or third-line treatment. 240 patients received ofatumumab and 240 patients did not receive ofatumumab (observation group). Patients were followed for an average of 40.9 months.
The average progression-free survival (PFS) was 34.2 for the ofatumumab group compared to 16.9 for the observation group. Patients in the ofatumumab maintenance group were 45% more likely to have a longer PFS compared to the observation group. The average time to the next treatment for the ofatumumab group was 37.4 months. This was compared to 27.6 months for the observation group. The rate of overall survival was similar in both groups.
Severe to life-threatening side effects occurred in 62% of the ofatumumab group compared to 51% of the observation group. Neutropenia (low level of white blood cells) was experienced by 23% of the ofatumumab group compared to 10% of the observation group. Pneumonia (lung infection) was experienced by 13% of the ofatumumab group compared to 12% of the observation group. Neutropenia with fever was experienced by 6% of the ofatumumab group compared to 4% of the observation group.
The bottom line
This study concluded that ofatumumab maintenance significantly prolonged progression-free survival in patients with relapsed CLL and was well tolerated.
The fine print
This study was funded by GlaxoSmithKline and Novartis, the manufacturers of ofatumumab.
Published By :
Blood cancer journal
Date :
Dec 04, 2019