*Remission is based on CR, ORR and PR. CR is defined in the SmPC as complete remission.
UK-VNCCLL-220184 | May 2022
UK-VNCCLL-230003. Date of Preparation: March 2023.
Now could be the time for your relapsed/refractory CLL patients to experience remission powered by V1-3*
VENCLYXTO+R is the only chemo-free fixed treatment duration therapy in R/R CLL:
Murano
Previously treated CLL2
Randomised, multicentre, open-label, phase III trial of VEN+R vs BR (N=389)
*Remission is based on CR, ORR and PR. CR is defined in the SmPC as complete remission.
The opportunity to achieve remission*
26.8% VEN+R vs 8.2% BR
Higher rates of INV-assessed CR†
in patients at 9 months
(ITT population; secondary endpoint, not tested for statistical significance)2
In the INV-assessment
• 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
• PR was 63% in the VEN+R arm vs 53% in the BR arm
8.2% VEN+R vs 3.6% BR
Higher rates of IRC-assessed CR†
in patients at 9 months
(ITT population; secondary endpoint, tested hierarchically)2‡
In the IRC-assessment
• ORR was 92% (95% CI: 87.6-95.6) in the VEN+R arm vs 72% (95% CI: 65.5-78.5) in the BR arm
• PR was 82% in the VEN+R arm vs 68% in the BR arm
*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.
More CLL-treatment-free time…
Time to next treatment* in the ITT population of VEN+R vs BR over 7 years3*
Adapted from Kater AP et al. 2023
*TTnT was defined as the time from initiation of BR or VEN+R to next anti-CLL treatment, or death (whichever occurs first).
†Stratified HR is presented, unstratified HR=0.32.
Median follow-up was 86.8 months for VEN+R and 84.4 months for BR.
Sustained survival off-treatment…
PFS (INV-assessed) in the ITT population of VEN+R vs BR at 7 years3*
Adapted from Kater AP et al. 2023
*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).2
†Stratified HR is presented, unstratified HR is 0.25.
Median follow-up was 86.8 months for VEN+R and 84.4 months for BR.
Overall survival in the ITT population at 7 years (secondary endpoint), not tested for statistical significance3
Adapted from Kater AP et al. 2023
*Stratified HR is presented, unstratified HR is 0.54.
Median follow-up was 86.8 months for VEN+R and 84.4 months for BR.
Give your first-relapse CLL patients a chance to take back their life with a fixed treatment duration1-4
Safety Profile1
The safety profile of VENCLYXTO has been evaluated in 758 patients with CLL across 5 clinical trials (one phase I (M12-715), two phase II (M13-982 and M14-032) & two Phase III (MURANO & CLL-14) with VEN-mono, VEN+R or as VEN+O.1
You are strongly advised to read the prescribing information and summary of product characteristics prior to prescribing.
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; FTD = Fixed treatment duration; HR = Hazard ratio; INV = Investigator; IRC = Independent review committee; ITT = Intent-to-treat; IV = Intravenous; MRD = Minimal residual disease; 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.
References
- VENCLYXTO Summary of Product Characteristics.
- Seymour JF et al. N Engl J Med. 2018; 378(12): 1107-20.
- Kater AP et al. EHA 2023. S201 (oral)
- Leukaemia Care Living with Leukaemia 2018 Report. Available at: https://media.leukaemiacare.org.uk/wp-content/uploads/Living-with-Leukaemia-2018-Full-Report-Web-Version.pdf (accessed September 2023).
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-230273 (desktop).
UK-VNCCLL-230364 (mobile).
Date of preparation: September 2023.
