Note to affiliates: This update to the venetoclax CLL AbbVie Pro site includes a homepage headline, updated CLL14 6-year and MURANO 7-year data sets, and other streamlined content updates. The CLL14 6-year and MURANO 7-year data have been updated based on the EHA 2023 abstracts. For countries that cannot use these data sets, please follow local regulations and MRLO guidance, and revert to CLL14 5-year and MURANO 5-year published data from the product label.
Primary analysis in ITT population for VEN+O vs O+Clb1:
INV-assessed PFS†: Reduced risk of progression or death (HR=0.35; 95% CI: 0.23–0.53 [P<0.0001]).
| • | Median follow-up of 28 months |
Additional analyses:
6-year PFS estimate (INV-assessed)2‡: 53% vs 22% (HR=0.40; 95% CI: 0.31–0.52) after 5 years off treatment.
| • | Median PFS of 76.2 months with VEN+O vs 36.4 months with O+Clb |
INV-assessed complete remission (CR/CRi)1: 50% vs 23% (P<0.0001).
| • | ORR: 85% (95% CI: 79.2–89.2) vs 71% (95% CI: 64.8–77.2 [P=0.0007]) |
Primary analysis in ITT population for VEN+R vs BR:
INV-assessed PFS†: Reduced risk of progression or death (HR=0.17; 95% CI: 0.11–0.25 [P<0.0001]).
| • | Median follow-up of 23.8 months |
Additional analyses:
7-year PFS estimate (INV-assessed)3‡: 23% (95% CI: 16.1–29.9) vs NE after ~5 years off treatment.
| • | Median PFS of 54.7 months with VEN+R (95% CI: 52.3–59.9) vs 17.0 months with BR (95% CI: 15.5–21.7) |
INV-assessed complete remission (CR/CRi)1‡: 27% vs 8%.
| • | ORR: 93% (95% CI: 88.8–96.4) vs 68% (95% CI: 60.6–74.2) |
*See full dosing information for VEN+O and for VEN+R in the dosing and administration section.
†Primary endpoint.
‡Results are descriptive only.
1L=first line; CLL=chronic lymphocytic leukaemia; VEN+O=VENCLYXTO + obinutuzumab; ITT=intent to treat; O+Clb=obinutuzumab + chlorambucil; INV=investigator; PFS=progression-free survival; HR=hazard ratio; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete bone marrow recovery; ORR=overall response rate; 2L+=second line + later lines of therapy; VEN+R=VENCLYXTO + rituximab; BR=bendamustine + rituximab; NE=not evaluable.
THE USE OF VENCLYXTO BEFORE BTKi IN CLL PATIENTS IS SUPPORTED BY REAL-WORLD EVIDENCE1*
| • | Multicentre, international, retrospective cohort study across 31 centres (n=326); 188 patients (58%) who initially received VENCLYXTO were treated with a subsequent line of therapy (including BTKi, n=74; 44 BTKi-naive patients, 30 BTKi-exposed patients) |
| • | Median follow-up of 7.7 months (1–48 months) in patients subsequently treated with a BTKi |
Post VENCLYXTO efficacy: ORR and PFS with BTKi†‡
ORR: BTKi-NAIVE PATIENTS (N=44)
PFS: BTKi-NAIVE PATIENTS (N=44)
Median follow-up in BTKi-naive patients treated with BTKi after VENCLYXTO: 10.5 months.
In BTKi-exposed patients (n=30)
ORR with BTKi was:
| • | 50% in prior BTKi-resistant patients (n=20) |
| • | 70% in prior BTKi-intolerant patients (n=10) |
mPFS with BTKi was:
| • | 4 months in prior BTKi-resistant patients (n=20) |
| • | Not reached in prior BTKi-intolerant patients (n=10) |
Discontinuation rate due to AEs was 14.3% for BTKi-naive patients and 8.3% for BTKi-exposed patients.
This retrospective cohort study investigated CLL patients who had discontinued VENCLYXTO (monotherapy, 73%); 4% of patients were treatment-naive, and 96% were relapsed/refractory. Coprimary endpoints were ORR and PFS of treatment following VENCLYXTO discontinuation. Responses were defined by modified International Workshop on CLL criteria, and PFS as time from post-VENCLYXTO therapy to CLL progression of disease, death, or last follow-up.
*Data represent a subset of patients who received BTKi following VENCLYXTO (n=74).
†Patient cohorts were BTKi exposure (naive/resistant/intolerant), PI3K, and cellular therapies.
‡BTKi included ibrutinib, acalabrutinib, and noncovalent BTKi.
BTKi=Bruton's tyrosine kinase inhibitor; PR-L=partial response with lymphocytosis; mPFS=median progression-free survival; AE=adverse event; PI3K=phosphoinositide 3-kinase.
Real-world evidence is collected outside of controlled clinical trials and has inherent limitations,
including a lesser ability to control for confounding factors.
Results are descriptive and not tested for statistical significance.
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References: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. 2. AI Sawaf O, Robrecht S, Zhang C, et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized CLL14 study. HemaSphere. 2023;7(S3):1-3. 3. Kater A, Harrup R, Kipps TJ, et al. Final 7-year follow up and retreatment substudy analysis of MURANO: venetoclax-rituximab (VENR)-treated patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Abstract presented at the European Hematology Association Congress 2023; June 8-11, 2023; Frankfurt, Germany. 4. Mato AR, Roeker LE, Jacobs R, et al. Assessment of the efficacy of therapies following venetoclax discontinuation in CLL reveals BTK inhibition as an effective strategy. Clin Cancer Res. 2020;26(14):3589-3596.
ALL-VNCCLL-220060 May 2024