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.
VENCLYXTO in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).1
VENCLYXTO in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.1
VENCLYXTO monotherapy is indicated for the treatment of CLL:1
| • | in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B‑cell receptor pathway inhibitor, or1 |
| • | in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B‑cell receptor pathway inhibitor.1 |
Note to affiliates: For countries that cannot yet promote CLL14 6-year and MURANO 7-year data, please change to 5-year data from the SmPC.
USE VENCLYXTO AT THE FIRST INDICATED OPPORTUNITY IN YOUR PATIENTS
WITH CLL1
DEEP RESPONSE*
| • | uMRD at EoT (PB)†: 76% (95% CI: 69–81) vs 35% (95% CI: 29–42) (P<0.0001) |
| • | INV-assessed complete remission (CR/CRi): 50% vs 23% (P<0.0001) |
| • | uMRD at EoCT (PB)†‡: 62% (95% CI: 55.2–69.2) vs 13% (95% CI: 8.9–18.9) |
| • | INV-assessed complete remission (CR/CRi)‡: 27% vs 8% |
SUSTAINED§ EFFICACY WITH PROLONGED TIME OFF TREATMENT
| • | Primary analysis (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 |
| • | 6-year PFS estimate (INV-assessed)2‡: 53% vs 22% (HR=0.40; 95% CI: 0.31–0.52) after at least 5 years off treatment |
| - | Median PFS of 76.2 months with VEN+O vs 36.4 months with O+Clb2 |
| • | 6-year TTNT rate: 65% vs 37% (HR=0.44; 95% CI: 0.33–0.58) after 5 years off treatment2 |
| • | 6-year OS rate‡: 79% vs 69% (HR=0.69; 0.48–1.01)2 |
| • | Primary analysis (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 |
| • | 7-year PFS estimate (INV-assessed)3‡: 23% (95% CI: 16.1–29.9) vs NE after ~5 years off treatment |
| • | Median TTNT: 63 months vs 24 months (HR=0.30) after ~5 years off treatment3 |
| • | 7-year OS estimate‡: 70% (95% CI: 62.8–76.5) vs 51% (95% CI: 43.3–58.7) (HR=0.53)3 |
MANAGEABLE SAFETY
| • | Most common ARs (≥20%): neutropaenia, diarrhoea, and upper respiratory tract infection |
| • | The most frequently reported serious ARs (≥2%): pneumonia, sepsis, febrile neutropaenia, and TLS, including fatal events and renal failure requiring dialysis, have occurred. Serious infections including events of sepsis with fatal outcome have been reported |
| • | 16% of patients discontinued treatment due to ARs in both the CLL14 and MURANO studies |
*Deep response as measured by uMRD or CR.
†MRD was evaluated using ASO-PCR (CLL14 and MURANO) and/or flow cytometry (MURANO). In PB, the cutoff for an undetectable (negative) status was <1 CLL cell per 104 leukocytes.
‡Results are descriptive.1-3
§Sustained off-treatment response based on 6- and 7-year updated efficacy analyses.2,3
uMRD=undetectable minimal residual disease; EoT=end of treatment; PB=peripheral blood; EoCT=end of combination treatment; TTNT=time to next anti-leukaemic treatment; OS=overall survival; TTNT=time to next anti-leukaemic treatment; AR=adverse reaction; TLS=tumour lysis syndrome; MRD=minimal residual disease; ASO-PCR=allele-specific oligonucleotide polymerase chain reaction.
ACHIEVING uMRD* IS IMPORTANT AND MAY BE ASSOCIATED WITH IMPROVED OUTCOMES4,5
REPRESENTATION OF HYPOTHETICAL SCENARIOS OF LEUKAEMIA CELL BURDEN CHANGES IN RESPONSE
TO TREATMENT6
Figure adapted from: Böttcher S, et al. 2013.
*uMRD=undetectable minimal residual disease.
VENCLYXTO REGIMENS ARE CHEMO-FREE, FIXED-DURATION REGIMENS THAT CAN BE COMPLETED IN 1 OR 2 YEARS1*
TARGET STOP DATE
VENCLYXTO-based regimens give patients a target treatment-completion date
TIME OFF TREATMENT
Patients have the possibility of time off treatment after completing their regimen
LIMITED TREATMENT EXPOSURE
No additional drug exposure after treatment is completed
FIXED COST
VENCLYXTO offers an option with a defined treatment timetable, which may reduce financial burden
*1-year VEN+O regimen or approximate 2-year VEN+R regimen following 5-week dose-titration schedule.
[Placeholder for safety balance required by local regulations]
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References: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. 2. Al-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. 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. 5. Hallek M, Cheson BD, Catovsky D, et al. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood. 2018;131(25):2745-2760. 6. Böttcher S, Hallek M, Ritgen M, Kneba M. The role of minimal residual disease measurements in the therapy for CLL: is it ready for prime time? Hematol Oncol Clin North Am. 2013;27(2):267-288.
ALL-VNCCLL-220060 May 2024