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Jeremy S. Abramson, MD, MMSc
Jeremy S. Abramson, MD, MMSc
Posted: Tuesday, January 18, 2022
Time-limited therapies consisting of venetoclax and obinutuzumab, with or without ibrutinib, led to improved rates of undetectable measurable residual disease (MRD) in peripheral blood samples of patients with chronic lymphocytic leukemia (CLL) compared with standard chemoimmunotherapy. These results from the GAIA (CLL13) trial were presented by Barbara Eichhorst, MD, of the University Hospital, Cologne, Germany, at the 2021 American Society of Hematology (ASH) Annual Conference & Exposition (Abstract 71).
This trial enrolled 926 patients with treatment-naive CLL who required therapy. Patients were randomly assigned 1:1:1:1 to receive one of four different regimens: (1) chemoimmunotherapy consisting of fludarabine, cyclophosphamide, and rituximab or bendamustine and rituximab; (2) venetoclax plus rituximab; (3) venetoclax plus obinutuzumab; or (4) venetoclax, obinutuzumab, and ibrutinib. Patients’ peripheral blood was assessed at month 15 after treatment initiation, and bone marrow was evaluated 3 months after the end of treatment.
The rate of undetectable MRD in peripheral blood in the intention-to-treat population was 86.5% in the group receiving venetoclax and obinutuzumab, 92.2% in the group receiving venetoclax, obinutuzumab, and ibrutinib, 57.0% in the group receiving venetoclax plus rituximab, and 52.0% in the group receiving chemoimmunotherapy. The bone marrow undetectable MRD rates were 72.5% with venetoclax/obinutuzumab, 77.9% with venetoclax/obinutuzumab/ibrutinib, 43.0% with venetoclax/rituximab, and 37.1% with chemoimmunotherapy.
The most common grades 3 to 5 treatment-emergent adverse events seen in all treatment groups included neutropenia (50.5%), thrombocytopenia (12.2%), tumor-lysis syndrome (7.5%), infusion-related reaction (7.2%), febrile neutropenia (6.5%), and pneumonia (5.3%). Fatal adverse events occurred in six patients in the venetoclax/obinutuzumab group, nine patients in the venetoclax/obinutuzumab/ibrutinib group, seven in the venetoclax/rituximab group, and five in the chemoimmunotherapy group.
Disclosure: For a full list of authors’ disclosures, visit ash.confex.com.
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