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. 2023 Jan;23(1):57-67.
doi: 10.1016/j.clml.2022.09.007. Epub 2022 Oct 7.

Outcomes for Patients With Chronic Lymphocytic Leukemia (CLL) Previously Treated With Both a Covalent BTK and BCL2 Inhibitor in the United States: A Real-World Database Study

Anthony R Mato  1 , Lisa M Hess  2 , Yongmei Chen  2 , Paolo B Abada  2 , Heiko Konig  2 , John M Pagel  3 , Richard A Walgren  2
Affiliations
Free article

Outcomes for Patients With Chronic Lymphocytic Leukemia (CLL) Previously Treated With Both a Covalent BTK and BCL2 Inhibitor in the United States: A Real-World Database Study

Anthony R Mato et al. Clin Lymphoma Myeloma Leuk. 2023 Jan.
Free article

Abstract

Purpose: This study describes the treatment patterns and outcomes of patients with CLL/SLL in a de-identified real-world oncology electronic health records database.

Methods: Adult patients with CLL/SLL were eligible if they had received cBTKi therapy, both a cBTKi and a BCL2i, or all 4 drug classes (cBTKi, BCL2i, rituximab, and chemotherapy) at any time during the first 5 lines of therapy. Time-to-event outcomes were evaluated using Kaplan Meier method. No statistical comparisons were conducted; all analyses were descriptive and conducted using SAS Enterprise.

Results: A total of 9578 patients were eligible: 52.0% (n = 4983) received at least one cBTKi, 6.1% (n = 581) received both a cBTKi and BCL2i, and 2.3% (n = 218) received all four therapies (cBTKi, BCL2i, rituximab, and chemotherapy). Of those who discontinued these treatments, only 39.5% (n = 1 206/3 577), 59.7% (n = 228/382), and 55.0% (n = 82/149) received subsequent therapy (post-cBTKi, post-cBTKi/post-BCL2i, and post-all 4 therapies, respectively). Median time from treatment discontinuation of these therapies to the discontinuation of subsequent therapy or death was 9.5 months (all patients who discontinued the cBTKi) 5.6 months (those who discontinued both a cBTKi and BCL2i) and 3.9 months (patients who discontinued all four therapies). The median duration of the next treatment among those who received additional therapy was post-cBTKi treatment duration = 4.1 months; post-cBTKi/post-BCL2i treatment duration = 5.5 months; and median duration of the immediate next therapy after discontinuation of all 4 therapies = 5.1 months.

Conclusions: The poor outcomes observed across cohorts in this study demonstrate the need for effective treatments that can improve outcomes in patients with CLL/SLL.

Keywords: B-cell malignancies; Covalent BTK inhibitor; Observational; Retrospective; Venetoclax.

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Conflict of interest statement

Conflict of Interest ARM serves as a consultant and/or receives institutional research funding from Acerta/AstraZeneca, Johnson and Johnson, AbbVie, Janssen, Genmab, TG Therapeutics, Nutrix, Genentech, Adaptive Biotechnologies, LOXO Oncology, Pharmacyclics, BeiGene and Sunesis. LMH, YC, PBA, HK and RAW are employees of Eli Lilly and Company. JMP is an employee of Loxo Oncology, a wholly owned subsidiary of Eli Lilly and Company.

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