Efficacy of venetoclax in relapsed chronic lymphocytic leukemia is influenced by disease and response variables
Open accessAbstract
To define the efficacy of venetoclax with extended follow-up and identify clinical or biological treatment effect modifiers, updated data for previously treated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) enrolled in 4 early-phase trials were pooled. Rates of response, complete remission (CR/CRi), and undetectable minimal residual disease (U-MRD) were analyzed for all patients (n = 436) and for those patients who were planned to receive 400 mg/day monotherapy (n = 347). Univariate and multiple regression analyses were performed to identify the pretreatment factors associated with response rates and duration of response (DoR). Objective responses were documented in 75% of all patients, including 22% CR/CRi. Overall, 27% and 16% of the patients achieved U-MRD in blood and marrow, respectively. Estimated median progression-free survival (PFS), DoR, and time to progression were 30.2, 38.4, and 36.9 months, respectively. Similar efficacy outcomes were observed within the 400 mg/day monotherapy subset. For those who achieved CR/CRi, the 3-year PFS estimate was 83%. DoR was superior for patients achieving CR/CRi or U-MRD in landmark analyses. In multiple regression analyses, bulky lymphadenopathy (≥5 cm) and refractoriness to B-cell receptor inhibitor (BCRi) therapy were significantly associated with lower CR rate and shorter DoR. Fewer prior therapies were associated with higher CR rate, but not DoR. Chromosome 17p deletion and/or TP53 mutat…
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Refractoriness to cBTKi has been independently associated with a lower CR rate and shorter duration of response in multiple regression analyses of early-phase venetoclax studies.
“Refractoriness to cBTKi has been independently associated with a lower CR rate and shorter duration of response in multiple regression analyses of early-phase venetoclax studies (60).”
From Resistance Mechanisms and Approach to Chronic Lymphocytic Leukemia after BTK Inhibitor Therapy (2025) · cites this paper as [60]
Of 21 patients evaluated for mutations, BTK or PLCG2 mutations were present in 17 (81%), with VAF ranging widely from 1.2% to 98.8%.
“Of 21 patients evaluated for mutations, BTK or PLCG2mutations were present in 17 (81%), with VAF ranging widely from 1.2%to 98.8%(60).”
From Resistance Mechanisms and Approach to Chronic Lymphocytic Leukemia after BTK Inhibitor Therapy (2025) · cites this paper as [60]
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Jones, J. A., Mato, A. R., Wierda, W. G., Davids, M. S., Choi, M., Cheson, B. D., Furman, R. R., Lamanna, N., Barr, P. M., Zhou, L., et al. (2018) · The Lancet Oncology · doi:10.1016/s1470-2045(17)30909-9 · Cited by 383 · see citing works
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Mhibik, M., Gaglione, E. M., Eik, D., Herrick, J., Le, J., Ahn, I. E., Chiu, C., Wielgos-Bonvallet, M., Hiemstra, I. H., Breij, E. C. W., et al. (2023) · Blood Advances · doi:10.1182/bloodadvances.2022009517 · Cited by 43 · see citing works
Resistance Mechanisms and Approach to Chronic Lymphocytic Leukemia after BTK Inhibitor Therapy
Gruessner, C., Wiestner, A., & Sun, C. (2025) · Leukemia & Lymphoma · doi:10.1080/10428194.2025.2466101 · Cited by 6 · see citing works
“Refractoriness to cBtKi has been independently associated with a lower cR rate and shorter duration of response in multiple regression analyses of early-phase venetoclax studies [59].”
Influential
- Authors
- Roberts, A. W., Ma, S., Kipps, T. J., Coutre, S. E., Davids, M. S., Eichhorst, B., Hallek, M., Byrd, J. C., Humphrey, K., Zhou, L., Chyla, B., Nielsen, J., Potluri, J., Kim, S. Y., Verdugo, M., Stilgenbauer, S., Wierda, W. G., & Seymour, J. F.
- Affiliations
- The Royal Melbourne Hospital (AU)
- Northwestern University (US)
- University of California San Diego (US)
- Stanford Medicine (US)
- Harvard University (US)
- Department I of Internal Medicine and
- University of Cologne (DE)
- The Ohio State University (US)
- F. Hoffmann-La Roche AG (CH)
- AbbVie (United States) (US)
- Universität Ulm (DE)
- The University of Texas MD Anderson Cancer Center (US)
- ORCID
- Venue
- Blood
- Publisher
- American Society of Hematology
- Published
- 2019-07-11
- Volume
- 134
- Issue
- 2
- Pages
- 111-122
- ISSN
- 0006-4971 (ISSN-L)
- 1528-0020
- PMC
- PMC6624969
- OpenAlex
- W2940785776
- Cited by
- 178
- References
- 1
- Citations by year
- 2026: 9 · 2025: 10 · 2024: 18 · 2023: 22 · 2022: 30 · 2021: 46 · 2020: 35 · 2019: 8
- FWCI
- 16.31
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Blood (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
- Funders
- National Health and Medical Research Council
- Topics
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Acute Lymphoblastic Leukemia research
- Keywords
- venetoclax, relapsed chronic lymphocytic leukemia, small lymphocytic lymphoma, treatment effect modifiers, complete remission, duration of response, progression-free survival, 17p deletion, TP53 mutation, NOTCH1 mutation, depth of response, prognostic factors
- MeSH terms
- Progression-Free Survival, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Female, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Sulfonamides, Leukemia, Lymphocytic, Chronic, B-Cell, Bridged Bicyclo Compounds, Heterocyclic, Kaplan-Meier Estimate
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