In a nutshell
This study evaluated the safety and effectiveness of ibrutinib (Imbruvica) plus nivolumab (Opdivo) for relapsed or unresponsive chronic lymphocytic leukemia (CLL). This study concluded that this treatment was well-tolerated and showed promising effectiveness in these patients.
Treatment remains challenging for high-risk patients with relapsed or refractory CLL. One of the goals of developing new treatments is to improve treatment response. This can help reduce the chances of disease relapse and progression (tumor growth or spread). One new treatment combination under investigation is ibrutinib plus nivolumab.
Ibrutinib is a targeted therapy. This type of treatment only targets cancer cells and blocks their growth. Nivolumab is a monoclonal antibody. This type of treatment helps the body’s immune system attack cancer cells. The safety and effectiveness of these agents together for relapsed or unresponsive CLL remain under investigation.
Methods & findings
This study involved 36 patients with relapsed or refractory CLL. Patients previously received an average of 3 prior lines of treatment. All patients received ibrutinib combined with nivolumab. The average follow-up was 19.7 months.
Overall, 22 (61%) of patients responded to treatment. The average duration of response was 19.2 months and the average period the disease remained stable was 19.7 months.
The most common serious and life-threatening side effects were low white blood cell count (53%) and low red blood cell count (25%). Serious pneumonia (14%), rash (6%), and low potassium (8%) were also reported.
The bottom line
This study concluded that this treatment was well-tolerated and showed promising effectiveness for patients with relapsed or unresponsive CLL.
The fine print
The number of patients was small. Larger studies are needed to confirm these results. This was a Phase 1/2 study. Further studies are needed to determine the role of ibrutinib combined with nivolumab for the treatment of relapsed or unresponsive CLL.
Published By :
The Lancet. Haematology
Jan 11, 2019