VENCLYXTO® offers patients with CLL a chance to
BREAK FREE with longer progression-free survival1*†
NOW APPROVED in 1L CLL: VENCLYXTO + obinutuzumab
NOW APPROVED in 1L CLL: VENCLYXTO + obinutuzumab
In 2L+ CLL:
VENCLYXTO + rituximab
*Reduced risk of progression or death vs O+Clb (HR=0.35; 95% CI: 0.23–0.53 [P<0.0001]). Median follow‑up of 28 months. Median PFS not reached in either arm.
†Reduced risk of progression or death vs BR (HR=0.17; 95% CI: 0.11–0.25 [P<0.0001]). Median follow‑up of 23.8 months. Median PFS not reached with VEN+R vs 17 months (15.5–21.6) with BR.
2L+ CLL: VENCLYXTO + rituximab
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MURANO trial was designed to allow patients to complete VENCLYXTO + rituximab treatment in ~2 years1*
MURANO evaluated VENCLYXTO + rituximab vs a standard CIT regimen (bendamustine + rituximab)
*MURANO was a multicenter, open‑label, phase 3 trial. Treatment complete after 5‑week dose‑titration period and twenty‑four 28‑day cycles.
†VENCLYXTO 400 mg daily after initial dose‑titration period in the absence of disease progression or unacceptable toxicity.
‡Rituximab dosing: 375 mg/m2 IV Day 1, Cycle 1; 500 mg/m2 IV Cycles 2–6. Each cycle was 28 days.
§Bendamustine dosing: 70 mg/m2 IV Days 1 and 2, Cycles 1–6. Each cycle was 28 days.
||Starting Cycle 1, Day 1 of rituximab.
Click here for the full dosing information.
Select inclusion criteria2
- Previously treated with at least 1 prior therapy (including at least 1 chemotherapy-containing regimen)
- Patients treated with prior bendamustine, provided the duration of response was ≥2 years
Primary endpoint1,2
INV-assessed PFS¶
Select secondary endpoints1,2
IRC-assessed PFS
INV- and IRC-assessed ORR, CR, CRi, nPR, and PR (ORR=CR+CRi+nPR+PR)
Overall survival
MRD negativity rates at end of combination treatment#
¶Assessed using the International Workshop for Chronic Lymphocytic Leukemia (iwCLL) updated National Cancer Institute–sponsored Working Group (NCI-WG) guidelines (2008).1
#MRD was evaluated in the peripheral blood and/or bone marrow using allele-specific oligonucleotide polymerase chain reaction (ASO-PCR) and/or flow cytometry. The cutoff for a negative (undetectable) status was <1 CLL cell per 104 leukocytes.1
CLL=chronic lymphocytic leukemia; 1L=first line; 2L+=second line + later lines of therapy; O+Clb=obinutuzumab + chlorambucil; HR=hazard ratio; CI=confidence interval; PFS=progression-free survival; BR=bendamustine + rituximab; VEN+R=VENCLYXTO + rituximab; CIT=chemoimmunotherapy; IV=intravenous; INV=investigator; IRC=independent review committee; ORR=overall response rate; CR=complete remission; CRi=complete remission with incomplete marrow recovery; nPR=nodular partial remission; PR=partial response; MRD=minimal residual disease.
VENCLYXTO + rituximab induced deep responses* in many patients1
Clinically meaningful rate of complete remission†
INV-assessed complete remission (CR+CRi) was 27% in the VEN+R arm vs 8% in the BR arm.
- INV-assessed ORR was 93% (95% CI: 88.8–96.4) in the VEN+R arm vs 68% (95% CI: 60.6–74.2) in the BR arm†
- INV-assessed PR was 63% in the VEN+R arm vs 53% in the BR arm
- INV-assessed nPR was 3% in the VEN+R arm vs 6% in the BR arm
- IRC assessment confirmed the benefit of VEN+R. The findings were generally consistent with INV assessment
*Deep response as indicated by CR or MRD negativity.
†Results are descriptive; statistical significance not tested.
High rates of MRD negativity in the VEN+R arm‡
- Rates of MRD negativity in peripheral blood at the end of combination treatment were 4 times higher in the VEN+R arm (62% [95% CI: 55.2–69.2]) than in the BR arm (13% [95% CI: 8.9–18.9])
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- Rates of MRD negativity in bone marrow at the end of combination treatment were 16% (95% CI: 10.7–21.3) in the VEN+R arm and 1% (95% CI: 0.1–3.7) in the BR arm
‡MRD results are descriptive; statistical significance not tested. The cutoff for a negative (undetectable) status was <1 CLL cell per 104 leukocytes (secondary endpoint).
The PFS benefit of VENCLYXTO + rituximab vs BR was sustained at 4‑year follow‑up1,3
INV-assessed PFS in the ITT population (primary analysis)1
- 1-year PFS estimate: 93% (95% CI: 89.1–96.4) with VEN+R vs 73% (95% CI: 65.9–79.1) with BR
- 2-year PFS estimate: 85% (95% CI: 79.1–90.6) with VEN+R vs 36% (95% CI: 28.5–44.0) with BR
Median follow-up of 23.8 months (range: 0–37.4 months; VEN+R: n=194, BR: n=195) (HR=0.17; 95% CI: 0.11–0.25 [P<0.0001]). Median PFS was not reached with VEN+R vs 17 months (95% CI: 15.5–21.6) with BR.
Use VENCLYXTO at the earliest indicated opportunity in your patients with 2L+ CLL3
ITT=intent to treat.
VENCLYXTO + rituximab PFS benefit was consistent across subgroups of interest1*
Data cutoff: 8 May 2017.
*The INV-assessed PFS subgroup analysis was not powered to show statistical significance in subpopulations.
†Unstratified hazard ratio is displayed on the x-axis with logarithmic scale. The size of each square is proportional to the amount of data available.
‡Defined as number of prior lines of therapy.
TP53=tumor protein 53; IgVH=immunoglobulin heavy‑chain variable gene.
Overall survival (OS): VENCLYXTO + rituximab reduced the risk of death compared with BR1,3
In the primary analysis (ITT population; median follow-up 23.8 months), the HR for VEN+R vs BR was 0.48 (95% CI: 0.25–0.90). Median OS was not reached for either treatment group1
At 4-year median follow-up: 79% (81/103) of BR patients received a novel targeted anti-CLL agent after disease progression*
At 4-year median follow-up:
- The estimated 4-year OS rates were 85.3% in the VEN+R arm and 66.8% in the BR arm
The continued PFS and OS benefit observed over time supports using VENCLYXTO-based fixed treatment duration regimens
*81/103 (79%) BR patients received a novel targeted anti-CLL agent after PD (Bruton’s tyrosine kinase inhibitors [n=60], PI3K inhibitors [n=9], VENCLYXTO [n=10], or investigational medicinal products [n=2]).
PD=progressive disease; PI3K=phosphoinositide 3‑kinase.
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References: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. <Current SmPC.> 2. 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. 3. Seymour JF, Kipps TJ, Eichhorst B, et al. Time‑limited venetoclax‑rituximab in relapsed/refractory chronic lymphocytic leukaemia: first presentation of 4‑year data from the MURANO study. Presented at: XVIII International Workshop on CLL (iwCLL); September 20‑23, 2019; Edinburgh, Scotland. Poster #2266.
GR-VNCCLL-200048 -JAN2021