In a nutshell
The study evaluated the treatment benefits of venetoclax (Venclexta) and obinutuzumab (Gazyva) in patients with untreated chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The main finding was that the combination therapy improved outcomes in these patients.
Some background
Most patients with CLL are older than 70 years. They also have several coexisting medical conditions. The combination of chlorambucil (Leukeran) and obinutuzumab was previously proven effective in such patients. Venetoclax also proved to be an optimum treatment for CLL. However, the safety and effectiveness of combining venetoclax with obinutuzumab in older and frail patients with CLL are still unclear.
Methods & findings
A total of 432 patients from 21 countries were included in this study. All patients had newly diagnosed CLL. Patients were randomly assigned to receive either venetoclax combined with obinutuzumab or the combination of chlorambucil and obinutuzumab. Patients were followed up for 28 months on average.
The risk of developing disease progression or death was 65% lower in the venetoclax–obinutuzumab group compared to the chlorambucil–obinutuzumab group. The percentage of patients alive without disease progression after 2 years was 88% in venetoclax–obinutuzumab group compared to 64% in the chlorambucil–obinutuzumab group.
More patients in the venetoclax–obinutuzumab group (76%) had no cancer left in their blood after 3 months of treatment completion compared to the chlorambucil–obinutuzumab group (35%). Also, more patients in the venetoclax–obinutuzumab group (57%) had no cancer left in their bone marrow 3 months after treatment completion compared to the chlorambucil–obinutuzumab group (17%).
Side effects that led patients to stop treatment occurred in 16% of the venetoclax–obinutuzumab group and in 15% of the chlorambucil–obinutuzumab group.
The bottom line
The study concluded that venetoclax–obinutuzumab improved the outcomes of patients with CLL and was well tolerated.
Published By :
Oncology (Williston Park, N.Y.)
Date :
Nov 14, 2019