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J Clin Oncol ; 38(31): 3626-3637, 2020 11 01.
Article in English | MEDLINE | ID: mdl-32795224

ABSTRACT

PURPOSE: The development of highly effective targeted agents for chronic lymphocytic leukemia offers the potential for fixed-duration combinations that achieve deep remissions without cytotoxic chemotherapy. PATIENTS AND METHODS: This phase II study tested a combination regimen of obinutuzumab, ibrutinib, and venetoclax for a total of 14 cycles in both patients with treatment-naïve (n = 25) and relapsed or refractory (n = 25) chronic lymphocytic leukemia to determine the response to therapy and safety. RESULTS: The primary end point was the rate of complete remission with undetectable minimal residual disease by flow cytometry in both the blood and bone marrow 2 months after completion of treatment, which was 28% in both groups. The overall response rate at that time was 84% in treatment-naïve patients and 88% in relapsed or refractory patients. At that time, 67% of treatment-naïve patients and 50% of relapsed or refractory patients had undetectable minimal residual disease in both the blood and marrow. At a median follow-up of 24.2 months in treatment-naïve patients and 21.5 months in relapsed or refractory patients, the median progression-free and overall survival times were not yet reached, with only 1 patient experiencing progression and 1 death. Neutropenia and thrombocytopenia were the most frequent adverse events, followed by hypertension. Grade 3 or 4 neutropenia was experienced by 66% of patients, with more events in the relapsed or refractory cohort. There was only 1 episode of neutropenic fever. A favorable impact on both perceived and objective cognitive performance during treatment was observed. CONCLUSION: The combination regimen of obinutuzumab, ibrutinib, and venetoclax offers time-limited treatment that results in deep remissions and is now being studied in phase III cooperative group trials.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Cognition/drug effects , Killer Cells, Natural , Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy , Adenine/administration & dosage , Adenine/analogs & derivatives , Adult , Aged , Antibodies, Monoclonal, Humanized/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Bridged Bicyclo Compounds, Heterocyclic/administration & dosage , CD4 Lymphocyte Count , Female , Follow-Up Studies , Humans , Hypertension/chemically induced , Hyponatremia/chemically induced , Leukemia, Lymphocytic, Chronic, B-Cell/blood , Male , Middle Aged , Neoplasm, Residual , Neutropenia/chemically induced , Piperidines/administration & dosage , Progression-Free Survival , Quality of Life , Remission Induction , Retreatment , Sulfonamides/administration & dosage , Survival Rate , Thrombocytopenia/chemically induced , Young Adult
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