Break free from chemotherapy and continuous oral treatment in CLL. VENCLEXTA (venetoclax tablets) offers the only chemo-free, oral-based regimens with a fixed duration of 1 year in previously untreated CLL with VEN+G.1
The CLL14 trial evaluated PFS with VEN+G, a fixed-duration treatment regimen
1L=first-line; ALC=absolute lymphocyte count; CIRS=Cumulative Illness Rating Scale; CLcr=creatinine clearance; CLL=chronic lymphocytic leukemia; CR=complete remission; CRi=complete remission with incomplete bone marrow recovery; FDA=US Food and Drug Administration; GClb=GAZYVA + chlorambucil; INV=investigator; IRC=Independent Review Committee; IV=intravenous; MRD=minimal residual disease; ORR=overall response rate; PFS=progression-free survival; TLS=tumor lysis syndrome; VEN+G=VENCLEXTA + GAZYVA.
Characteristic | VEN+G (N=216) | GClb (N=216) |
---|---|---|
Age, years; median (range) |
72 (43-89) | 71 (41-89) |
Age ≥70, % | 62 | 59 |
Male, % |
68 | 66 |
Binet stage, % |
||
Binet stage A | 21 | 20 |
Binet stage B | 36 | 37 |
Binet stage C | 43 | 43 |
Median CIRS score (range) |
9 (0-23) | 8 (1-28) |
CLcr <70 mL/min, % |
60 | 55 |
CLL subsets, % |
||
17p deletion | 9 | 7 |
TP53 mutation | 9 | 6 |
11q deletion | 18 | 20 |
lgVH unmutated | 56 | 57 |
lgVH mutated | 35 | 38 |
High TLS risk category, %† |
22 | 20 |
Lymph nodes ≥10 cm | 5 | 5 |
Lymph nodes ≥5 cm to <10 cm and ALC ≥25 x 109/L | 14 | 12 |
Medium TLS risk, % |
64 | 68 |
Low TLS risk, % |
13 | 12 |
ECOG performance status, % |
||
0 | 41 | 48 |
1 | 46 | 40 |
2 | 13 | 12 |
Baseline ALC (x 109/L); median |
56 | 58 |
*Patients with missing results not included.
†TLS risk category was chosen based on lymph node size, ALC, and investigator discretion.1,5
ALC=absolute lymphocyte count; ECOG=Eastern Cooperative Oncology Group; GClb=GAZYVA + chlorambucil; IgVH=immunoglobulin heavy-chain variable gene; TLS=tumor lysis syndrome.
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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Owen C, Christofides A, Johnson N, Lawrence T, MacDonald D, Ward C. Use of minimal residual disease assessment in the treatment of chronic lymphocytic leukemia [published online ahead of print May 16, 2017]. Leuk Lymphoma. 2017;58(12):2777-2785.
Thompson PA, Wierda WG. Eliminating minimal residual disease as a therapeutic end point: working toward cure for patients with CLL. Blood. 2016;127(3):279-286.
Thompson PA, Wierda WG. Eliminating minimal residual disease as a therapeutic end point: working toward cure for patients with CLL. Blood. 2016;127(3):279-286.
US Food and Drug Administration. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment. Guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hematologic-malignancies-regulatory-considerations-use-minimal-residual-disease-development-drug-and. January 2020. Accessed February 28, 2020.
US Food and Drug Administration. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment. Guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hematologic-malignancies-regulatory-considerations-use-minimal-residual-disease-development-drug-and. January 2020. Accessed February 28, 2020.
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.
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Ruddy K, Mayer E, Partridge A. Patient adherence and persistence with oral anticancer treatment. CA Cancer J Clin. 2009;59(1):56-66.
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CRESEMBA Prescribing Information. December 2019.
CRESEMBA Prescribing Information. December 2019.
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.
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.
Souers AJ, Leverson JD, Doghaert ER, et al. ABT-199, a potent and selective BCL-2 inhibitor, achieves antitumor activity while sparing platelets. Nat Med. 2013;19(2):202-203.
Souers AJ, Leverson JD, Doghaert ER, et al. ABT-199, a potent and selective BCL-2 inhibitor, achieves antitumor activity while sparing platelets. Nat Med. 2013;19(2):202-203.
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.
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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