UK-VNCCLL-230003. Date of Preparation: March 2023.
For your relapsed/refractory adult CLL patients, now is the time to experience remission powered by V1,2
In the MURANO trial the primary endpoint of investigator-assessed PFS in the ITT population was
met, showing VEN+R superiority vs BR (HR: 0.17; 95% CI: 0.11–0.25; P<0.001) at 23.8 months.2
VENCLYXTO+R is the only fixed treatment duration chemo-free therapy that
can offer your first-relapse CLL patients:
Complete remission (CR)*
The primary endpoint of investigator-assessed PFS in the ITT population was met, showing VEN+R superiority vs BR (HR: 0.17; 95% CI: 0.11–0.25; P<0.001) at 23.8 months2
Rate of INV-assessed CR† at 9 months in the ITT population (secondary endpoint, not tested for statistical significance)1,2
Rate of IRC-assessed CR† at 9 months in the ITT population (first of the secondary end points to be tested hierarchically)1,2
*Remission is based on CR, ORR and PR. CR is defined in the SmPC as complete remission.
†CR = CR+CRi.
‡The discrepancy between IRC-and INV-assessed CR rates was due to interpretation of residual adenopathy on CT scans.
*In the primary analysis in the ITT population, INV PFS with VEN+R was superior to BR. (0.17; 95% CI 0.11-0.25; P<0.001).1
†Median follow-up 59 months. Data cut off was 8 May 2020.
Overall survival in the ITT population at 5 years (secondary endpoint, not tested for statistical significance)4
Adapted from Kater AP et al. 2020
*Median follow-up 59 months. Data cut off was 8 May 2020.
Time to next treatment* in the ITT population for VEN+R vs BR over 5 years6
Adapted from Harrup R et al. 2020.
*Defined as time from initiation of BR or VEN+R to next anti-CLL treatment, or death (whichever occurs first).
†1 patient omitted due to invalid date for commencement of follow up therapy.
*Includes neutropenia and decreased neutrophil count
Neutropenia & infections:1
- Grade 3 or 4 neutropenia has been reported in patients treated with VENCLYXTO. Complete blood counts should be monitored throughout the treatment period. Dose interruptions or reductions are recommended for patients with severe neutropenia.
- Serious infections, including sepsis with fatal outcome, have been reported. Monitoring of any signs and symptoms of infection is required. Suspected infections are to receive prompt treatment, including antimicrobials and dose interruption or reduction, and use of growth factors as appropriate.
Dose titration and prophylactic measures effectively mitigated the risk of TLS
Incidence of TLS in patients receiving mitigation measures alongside VENCLYXTO:2,3
*All events were laboratory TLS, (which is defined as the presence of ≥2 events of hyperkalemia, hyperphosphatemia or hypocalcaemia within 24 hours of each other); and occurring in patients who have lymph node(s) ≥5cm or ALC≥25x109/L. Clinical TLS was defined as laboratory TLS event accompanied by increased creatinine/acute renal failure, cardiac dysrhythmia, seizures or death
*MURANO was a multicentre, open-label, Phase III 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 (initiated after the 5-week dose titration schedule); 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.
#Assessed using the International Workshop for Chronic Lymphocytic Leukaemia (IwCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008).
**uMRD = <1 tumour cell per 10,000 white cells. MRD was evaluated in the peripheral blood and/or bone marrow using ASO-PCR and/or flow cytometry.
2L = Second line; ASO-PCR = Allele-specific oligonucleotide polymerase chain reaction; BR = Bendamustine+ rituximab; BTKi = Bruton's tyrosine kinase inhibitor; CI = Confidence interval; CLL = Chronic lymphocytic leukaemia; CR = Complete remission; CRi = CR with incomplete haematologic recovery; EoCT = End of combination therapy; EoT = End of treatment; FTD = Fixed treatment duration; HR = Hazard ratio; INV = Investigator; IRC = Independent review committee; ITT = Intent-to-treat; IV = Intravenous; MRD = Minimal residual disease; nPR = Nodular partial response; ORR = Overall response rate; OS = Overall survival; PFS = Progression free survival; PR = Partial response; R/R = Relapsed/refractory; SmPC = Summary of product characteristics; TLS = Tumour lysis syndrome; uMRD; Undetectable minimal residual disease; VEN+O = VENCLYXTO+obinutuzumab; VEN+R = VENCLYXTO+rituximab.
- VENCLYXTO Summary of Product Characteristics.
- Seymour JF et al. N Engl J Med. 2018; 378(12): 1107–20.
- Fischer K et al. N Engl J Med. 2019; 380: 2225–36.
- Kater AP et al. ASH 2020. Oral presentation 642.
- Kwok M et al. Blood 2016; 128: 2770–3.
- Harrup R et al. Poster 3139. Presented at ASH 2020.
- Leukaemia Care Living with Leukaemia 2018 Report https://media.leukaemiacare.org.uk/wp-content/uploads/Living-with-Leukaemia-2018-Full-Report_compressed.pdf (accessed May 2022).
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
Adverse events should also be reported to AbbVie on [email protected]
UK-VNCCLL-220190. Date of preparation: May 2022.