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.
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VENCLYXTO in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL).
VENCLYXTO in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
VENCLYXTO monotherapy is indicated for the treatment of CLL:
- 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, or
- in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
VENCLYXTO-based regimens now proven in two phase 3 clinical trials, opening treatment possibilities for more patients with CLL
DEEP RESPONSE*
- CR/CRi (INV): 50% (VEN+O) vs 23% (O+Clb) (P<0.0001)1
- MRD NEGATIVITY (PB): 76% with VEN+O (95% Cl: 69–81) vs 35% with O+Clb (95% Cl: 29–42) (ITT population)1,2
- CR/CRi (INV): 27% (VEN+R) vs 8% (BR)1
- MRD negativity (PB): 62% with VEN+R (95% Cl: 55.2–69.2) vs 13% with BR (95% Cl: 8.9–18.9) (not tested for statistical significance)
*Secondary endpoint. Deep response as indicated by CR or MRD negativity.
SUSTAINED† OFF‐TREATMENT
PFS OUTCOMES1
- PFS 2‑year estimates (1° EP): 88% (VEN+O) vs 64% (O+Clb) 1 year after all patients were off treatment (HR=0.35; 95% Cl: 0.23–0.53 [P<0.0001]) (medians not reached)1
- PFS 3‑year estimates: 82% (VEN+O) vs 50% (O+Clb) after 2 years off‑treament with VEN (HR=0.31; 95% Cl: 0.22–0.44, median NR in VEN+O and 35.6 months with O+Clb)1
- PFS 2‑year estimates (1° EP): VEN+R significantly prolonged PFS vs BR (HR=0.17; 95% Cl: 0.11–0.25 [P<0.0001])1
- PFS 4‑year estimates: 57% (VEN+R) vs 5% (BR) after 2 years off‑treatment with VEN3
- OS 4‑year estimates: 85% (VEN+R) vs 67% (BR) (descriptive endpoint, not tested for statistical significance)3
†Sustained off‑treatment response based on 2‑year (CLL14) and 4‑year (MURANO) updated efficacy analyses.1,3
FIXED TREATMENT DURATION
- In 1L CLL: VEN+O fixed treatment duration 1 year1‡
- In 2L+ CLL: VEN+R fixed treatment duration ~2 years1§
‡Treatment complete after twelve 28-day cycles.1
§Treatment complete after 5‑week dose-titration period and twenty‑four 28‑day cycles.1
MANAGEABLE SAFETY
- Most common ARs (≥20%): Neutropaenia, diarrhoea, and upper respiratory tract infection1
- The most frequently reported serious ARs (≥2%): Pneumonia, sepsis, febrile neutropaenia, and TLS. Serious infections including events of sepsis with fatal outcome have been reported1
- TLS mitigated with implementation of the current TLS prophylaxis and monitoring protocol1,2
Use VENCLYXTO at the earliest indicated opportunity in your patients with CLL1,3
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; TP53=tumor protein 53; CR=complete remission; CRi=complete remission with incomplete marrow recovery; INV=investigator; VEN+O=VENCLYXTO + obinutuzumab; MRD=minimal residual disease; PB=peripheral blood; ITT=intent to treat; 1° EP=primary endpoint; NR=not reached; AR=adverse reaction.
[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. <Current SmPC.> 2. 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. 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. 4. 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. 5. 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. 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.
GR-VNCCLL-200048 -JAN2021