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Blood Adv. 2019 May 28;3(10):1568-1573. doi: 10.1182/bloodadvances.2019000180.

A retrospective comparison of venetoclax alone or in combination with an anti-CD20 monoclonal antibody in R/R CLL.

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Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Cancer and Haematology Centre, Oxford University Hospitals, NHS Foundation Trust, Oxford, United Kingdom.
Aptitude Health, Chicago, IL.
Department of Medicine, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY.
Department of Hematology and Medical Oncology, Taussig Cancer Center, Cleveland Clinic, Cleveland, OH.
Department of Medicine, Duke University Cancer Center, Durham, NC.
Department of Medicine, Wilmot Cancer Institute, University of Rochester, Rochester, NY.
Department of Medicine, Norris Cotton Cancer Center, Dartmouth University, Lebanon, NH.
Department of Medicine, Lombardi Cancer Center, Georgetown University, Washington, DC.
Department of Medicine, Medical College of Wisconsin Cancer Center, Milwaukee, WI.
Department of Hematology/Oncology, Weill Cornell Medical Center, New York, NY.
Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Department of Medicine, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ.
Department of Medicine, University of North Carolina Cancer Center, Chapel Hill, NC.
Department of Medicine, Cancer Center, Tufts Medical Center, Boston, MA.
Department of Medicine, Fred Hutchinson Cancer Center, University of Washington, Seattle, WA.
Levine Cancer Institute, Carolinas Medical Center, Charlotte, NC.
Swedish Cancer Center, Seattle, WA.
Cancer Research UK & UCL Cancer Trials Centre, University College London, London, United Kingdom; and.
Nottingham University Hospitals, NHS Foundation Trust, Nottingham, United Kingdom.


Venetoclax (VEN) is approved for relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) as monotherapy (VENmono) or in combination with rituximab. Whether VEN plus anti-CD20 (VENcombo) is superior to VENmono is unknown. We conducted a multicenter, retrospective cohort analysis comparing 321 CLL patients treated with VENmono vs VENcombo across the United States and the United Kingdom. We examined demographics, baseline characteristics, dosing, adverse events, response rates, and outcomes. The primary endpoints were progression-free survival (PFS) and overall survival (OS), estimated by Kaplan-Meier method, in patients treated with VENmono vs VENcombo. Univariate and bivariate analyses were performed with COX regression. Three hundred twenty-one CLL patients were included (3 median prior treatments, 78% prior ibrutinib). The overall response rates (ORRs) were similar (VENmono, 81% ORR, 34% complete remission [CR] vs VENcombo, 84% ORR, 32% CR). With a median follow-up of 13.4 months, no differences in PFS and OS were observed between the groups. In unadjusted analyses, the hazard ratios (HRs) for PFS and OS for VENmono vs VENcombo were HR 1.0 (95% confidence interval [CI], 0.6-1.8; P = .7) and HR 1.2 (95% CI, 0.6-2.3; P = .5), respectively. When adjusting for differences between the cohorts, the addition of an anti-CD20 antibody in combination with VEN did not impact PFS (HR, 1.0; 95% CI, 0.5-2.0; P = .9) or OS (HR, 1.1; 95% CI, 0.4-2.6; P = .8). We demonstrate comparable efficacy between VENmono and VENcombo in a heavily pretreated, high-risk, retrospective cohort, in terms of both response data and survival outcomes. Prospective studies are needed to validate these findings.

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