Tumor burden
Decreasing detectable CLL cells in peripheral blood and/or bone marrow
CLL=chronic lymphocytic leukemia; CR=complete remission; MRD=minimal residual disease.
MURANO: In a randomized (1:1), multicenter, actively controlled, open-label, phase 3 trial (MURANO), VEN+R was studied against bendamustine in combination with rituximab (BR) in 389 patients with CLL who had received at least one line of prior therapy. The primary endpoint was progression-free survival. See full study design.1,6
reduction in risk of progression or death vs BR (HR=0.19; 95% CI: 0.12-0.28 [P<0.0001])
After a median follow-up of 23.4 months (range: 0-37.4+ months):
See response rates here (secondary endpoint).
Not tested for statistical significance.
The population with evaluable results (n=233) excludes results missing due to progressive disease (PD), withdrawal (including withdrawal due to toxicity), deaths, MRD status unknown, and other missing samples or assessments.12
Not prespecified or tested for statistical significance.
*From Cycle 1, Day 1 of rituximab, in the absence of disease progression or unacceptable toxicity.1
†Number of events based on earliest event of disease progression or deaths without disease progression due to any cause.1
‡Assessed 3 months after end of combination treatment.1
§The number of patients in the VEN+R arm with undetectable MRD is based on the EoCT MRD status at the clinical cutoff date of May 8, 2017, where 1 patient wasn't categorized as negative due to missing EoCT response visit.
BR=bendamustine + rituximab; CI=confidence interval; EoCT=end of combination treatment; HR=hazard ratio; IRC=Independent Review Committee; ITT=intent to treat; PFS=progression-free survival; VEN+R=VENCLEXTA + rituximab.
In an exploratory post hoc analysis, PFS was assessed among MRD-evaluable VEN+R patients12‡
§The number of patients in the VEN+R arm with undetectable MRD is based on the EoCT MRD status at the clinical cutoff date of May 8, 2017, where 1 patient wasn’t categorized as negative due to missing EoCT response visit.
IIThe end of combination treatment assessment occurred 3 months after the end of combination treatment.1
INV=investigator; uMRD=undetectable minimal residual disease.
VENCLEXTA® and its design are registered trademarks of AbbVie Inc.
GAZYVA® is a registered trademark of Genentech, Inc.
VENCLEXTA Prescribing Information.
VENCLEXTA Prescribing Information.
Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23):2225-2236.
Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23):2225-2236.
GAZYVA Prescribing Information.
GAZYVA Prescribing Information.
Data on file, AbbVie Inc. ABVRRTI69608.
Data on file, AbbVie Inc. ABVRRTI69608.
Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23)(suppl):2225-2236.
Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23)(suppl):2225-2236.
Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax–rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107-1120.
Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax–rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107-1120.
Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax–rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12)(suppl):1107-1120.
Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax–rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12)(suppl):1107-1120.
Data on file, AbbVie Inc. ABVRRTI69609.
Data on file, AbbVie Inc. ABVRRTI69609.
Seymour JF, Kipps TJ, Eichhorst B, et al. Four-year analysis of MURANO study confirms sustained benefit of time-limited venetoclax-rituximab (VenR) in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Presented at: 61st American Society of Hematology Annual Meeting and Exposition; December 7-10, 2019; Orlando, FL.
Seymour JF, Kipps TJ, Eichhorst B, et al. Four-year analysis of MURANO study confirms sustained benefit of time-limited venetoclax-rituximab (VenR) in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Presented at: 61st American Society of Hematology Annual Meeting and Exposition; December 7-10, 2019; Orlando, FL.
Data on file, AbbVie Inc. ABVRRTI72219.
Data on file, AbbVie Inc. ABVRRTI72219.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed January 25, 2023. To view the most recent and complete version of the guidelines, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed January 25, 2023. To view the most recent and complete version of the guidelines, go online to NCCN.org.
Data on file, AbbVie Inc. ABVRRTI71322.
Data on file, AbbVie Inc. ABVRRTI71322.
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Seymour JF, Kipps TJ, Eichhorst B, et al. Four-year analysis of MURANO study confirms sustained benefit of time-limited venetoclax–rituximab (VenR) in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Presented at: 61st American Society of Hematology Annual Meeting and Exposition; December 7-10, 2019; Orlando, FL.
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CRESEMBA Prescribing Information. December 2019.
CRESEMBA Prescribing Information. December 2019.
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https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers#cypEnzymes. Updated November 14, 2017. Accessed March 11, 2021.
Drug development and drug interactions: table of substrates, inhibitors and inducers. US Food and Drug Administration website.
https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers#cypEnzymes. Updated November 14, 2017. Accessed March 11, 2021.
RITUXAN Prescribing Information.
RITUXAN Prescribing Information.
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Al-Sawaf O, Zhang C, Tandon M, et al. Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukemia (CLL14); follow-up results from a multicentre, open-label, randomized, phase 3 trial. Lancet Oncol 2020;21:1188-1200.
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