Dr. Davids Discusses the Results of Ibrutinib Plus FCR in CLL

Matthew S. Davids, MD, MMSc
Published: Monday, Feb 05, 2018



Matthew S. Davids, MD, MMSc, associate director, Dana-Farber Cancer Institute, Center for Chronic Lymphocytic Leukemia, discusses results of a study combining ibrutinib (Imbruiva) plus fludarabine-cyclophosphamide-rituximab (FCR) in patients with chronic lymphoctic leukemia (CLL).

The combination of ibrutinib and FCR induced negative MRD status in bone marrow for 83% of patients, according to results from preliminary clinical study. In findings presented at the 2017 ASH Annual Meeting, the high rate of minimal residual disease (MRD)-negativity held up across all risk categories of CLL. Thirteen of 35 patients (37%) had complete response in association with MRD-negativity, and the rate of best bone marrow MRD-negativity was higher than any prior regimen for frontline therapy across CLL risk groups, says Davids.

The toxicity with this regimen was consistent with the known toxicities of ibrutinib and FCR chemoimmunotherapy. There are no additional side effects. Davids adds that this regimen may be a valuable addition to the armamentarium for CLL.

Additionally, responses to this regimen deepened over time in both the IGHV-mutated and unmutated patients, says Davids, suggesting that ibrutinib maintenance is beneficial for these patients. An expansion cohort that will explore discontinuation in patients with bone marrow MRD-negativity after 2 years of ibrutinib maintenance is now accruing.


Matthew S. Davids, MD, MMSc, associate director, Dana-Farber Cancer Institute, Center for Chronic Lymphocytic Leukemia, discusses results of a study combining ibrutinib (Imbruiva) plus fludarabine-cyclophosphamide-rituximab (FCR) in patients with chronic lymphoctic leukemia (CLL).

The combination of ibrutinib and FCR induced negative MRD status in bone marrow for 83% of patients, according to results from preliminary clinical study. In findings presented at the 2017 ASH Annual Meeting, the high rate of minimal residual disease (MRD)-negativity held up across all risk categories of CLL. Thirteen of 35 patients (37%) had complete response in association with MRD-negativity, and the rate of best bone marrow MRD-negativity was higher than any prior regimen for frontline therapy across CLL risk groups, says Davids.

The toxicity with this regimen was consistent with the known toxicities of ibrutinib and FCR chemoimmunotherapy. There are no additional side effects. Davids adds that this regimen may be a valuable addition to the armamentarium for CLL.

Additionally, responses to this regimen deepened over time in both the IGHV-mutated and unmutated patients, says Davids, suggesting that ibrutinib maintenance is beneficial for these patients. An expansion cohort that will explore discontinuation in patients with bone marrow MRD-negativity after 2 years of ibrutinib maintenance is now accruing.



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