*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 first-line CLL patients to experience remission powered by V1-4*
VENCLYXTO+O is the only 1-year chemo-free fixed treatment duration therapy in first-line CLL:
CLL-14
Unfit previously untreated CLL2,3
Randomised, open label, phase III trial of VEN+O vs Clb+O (N=432).
The primary endpoint of investigator-assessed PFS was met showing VEN+O superiority vs Clb+O (HR 0.35; 95% CI, 0.23–0.53; P<0.001).2
*Remission is based on CR, ORR and PR. CR is defined in the SmPC as complete remission.
CLL-13
Fit previously untreated CLL4
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Randomised, open-label, phase III trial of VEN+O vs CIT (FCR or BR) (N=466). Two arms of this trial cannot be discussed as unlicensed.
The co-primary endpoints of uMRD rates in PB at month 15 for VEN+O vs CIT arms, and PFS in the relevant arms were met.4
The opportunity to achieve remission and deep response off-treatment…*
CR+CRi was 50% VEN+O vs 23% Clb+O
3 months after completing treatment
(ITT population; secondary endpoint; P<0.001)2
CR+CRi was 57% VEN+O vs 31% CIT
3 months after completing treatment
(secondary endpoint)4
76% VEN+O vs 35% Clb+O
Higher PB MRD negativity 3 months after completing treatment
(ITT population; secondary endpoint; P<0.001)2†
Median follow-up time in the primary analysis was 28 months.
*Remission is based on CR, ORR and PR. CR is defined in the SmPC as complete remission.
†PB MRD negativity = <1 tumour cell per 104 white cells.
87% VEN+O vs 52% CIT
Significantly greater PB MRD negativity 3 months after completing treatment
(co-primary endpoint; P<0.001)4†
Median observation time 38.8 months.
*Remission is based on CR, ORR and PR. CR is defined in the SmPC as complete remission.
†PB MRD negativity = <1 tumour cell per 104 white cells.
More CLL-treatment-free time…
...for patients with coexisting conditions3
The majority of VEN+O patients did not require another CLL treatment 6 years after starting treatment3
...for fit patients4
94% of VEN+O patients did not require another CLL treatment 3 years after starting treatment4
Time to next treatment* for VEN+O vs Clb+O over 6 years (secondary endpoint)1
Time to next treatment for VEN+O vs CIT over 3 years (secondary endpoint)1
Adapted from Al-Sawaf O et al. 2023
*TTnT was defined as the time between the date of randomisation to the date of first intake of new anti-CLL treatment or death prior to initiating new anti-CLL treatment.
†Median follow-up 76.4 months.
Adapted from Eichhorst B et al. 2023
Data cutoff January 2022.
*Median observation time 38.8 months.
Not tested for statistical significance.
Sustained survival off-treatment…
…at 6 years in unfit CLL patients3
Over twice as many VEN+O patients remained progression free vs Clb+O 5 years after completing VEN+O treatment3
…at 3 years in fit CLL patients4
VEN+O demonstrated significantly higher PFS vs CIT (FCR/BR) 2 years after completing VEN+O treatment4
PFS (INV-assessed) of VEN+O vs Clb+O at 6 years1*
PFS (INV-assessed) of VEN+O vs CIT (ITT population; secondary endpoint)4
Adapted from Al-Sawaf O et al. 2023
PFS: primary endpoint.
*In the primary analysis at 28.1 months (ITT population), PFS with VEN+O was superior to Clb+O (HR: 0.35; 95% CI: 0.23-0.53; P<0.001).
†Median follow-up 76.4 months.
Adapted from Eichhorst B et al. 2023
Data cutoff January 2022.
*Median observation time 38.8 months.
Co-primary endpoint of PFS between relevant arms was met.
Over 75% overall survival for VEN+O patients 5 years after completing treatment3
Overall survival in the ITT population at 6 years (secondary)3
Adapted from Al-Sawaf O et al. 2023.
*Median follow-up 76.4 months.
CLL-14
Unfit previously untreated CLL2,3
Randomised, open label, phase III trial of VEN+O vs Clb+O (N=432).
The primary endpoint of investigator-assessed PFS was met showing VEN+O superiority vs Clb+O (HR 0.35; 95% CI, 0.23–0.53; P<0.001).2
The opportunity to achieve remission and deep response off-treatment…*
50% VEN+O vs 23% Clb+O
3 months after completing treatment
(ITT population; secondary endpoint; P<0.001)2
76% VEN+O vs 35% Clb+O
Higher PB MRD negativity 3 months after completing treatment
(ITT population; secondary endpoint; P<0.001)2†
Median follow-up time in the primary analysis was 28 months.
*Remission is based on CR, ORR and PR. CR is defined in the SmPC as complete remission.
†PB MRD negativity = <1 tumour cell per 104 white cells.
More CLL-treatment-free time…
...for patients with coexisting conditions3
The majority of VEN+O patients did not require another CLL treatment 6 years after starting treatment3
Time to next treatment* for VEN+O vs Clb+O over 6 years (secondary endpoint)1
Adapted from Al-Sawaf O et al. 2023
*TTnT was defined as the time between the date of randomisation to the date of first intake of new anti-CLL treatment or death prior to initiating new anti-CLL treatment.
†Median follow-up 76.4 months.
Sustained survival off-treatment…
…at 6 years in unfit CLL patients3
Over twice as many VEN+O patients remained progression free vs Clb+O 5 years after completing VEN+O treatment3
PFS (INV-assessed) of VEN+O vs Clb+O at 6 years1*
Adapted from Al-Sawaf O et al. 2023
PFS: primary endpoint.
*In the primary analysis at 28.1 months (ITT population), PFS with VEN+O was superior to Clb+O (HR: 0.35; 95% CI: 0.23-0.53; P<0.001).
†Median follow-up 76.4 months.
Over 75% overall survival for VEN+O patients 5 years after completing treatment3
Overall survival in the ITT population at 6 years (secondary)3
Adapted from Al-Sawaf O et al. 2023.
*Median follow-up 76.4 months.
CLL-13
Fit previously untreated CLL4
.jpg)
Randomised, open-label, phase III trial of VEN+O vs CIT (FCR or BR) (N=466). Two arms of this trial cannot be discussed as unlicensed.
The co-primary endpoints of uMRD rates in PB at month 15 for VEN+O vs CIT arms, and PFS in the relevant arms were met.4
The opportunity to achieve remission and deep response off-treatment…*
57% VEN+O vs 31% CIT
3 months after completing treatment
(secondary endpoint)4
87% VEN+O vs 52% CIT
Significantly greater PB MRD negativity 3 months after completing treatment
(co-primary endpoint; P<0.001)4†
Median observation time 38.8 months.
*Remission is based on CR, ORR and PR. CR is defined in the SmPC as complete remission.
†PB MRD negativity = <1 tumour cell per 104 white cells.
More CLL-treatment-free time…
...for fit patients4
94% of VEN+O patients did not require another CLL treatment 3 years after starting treatment4
Time to next treatment for VEN+O vs CIT over 3 years (secondary endpoint)1
Adapted from Eichhorst B et al. 2023
Data cutoff January 2022.
*Median observation time 38.8 months.
Not tested for statistical significance.
Sustained survival off-treatment…
…at 3 years in fit CLL patients4
VEN+O demonstrated significantly higher PFS vs CIT (FCR/BR) 2 years after completing VEN+O treatment4
PFS (INV-assessed) of VEN+O vs CIT (ITT population; secondary endpoint)4
Adapted from Eichhorst B et al. 2023
Data cutoff January 2022.
*Median observation time 38.8 months.
Co-primary endpoint of PFS between relevant arms was met.
Give your first-line CLL patients a chance to take back their life with a fixed treatment duration1-5
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.
ADRs=Adverse drug reactions; CIT=Chemoimmunotherapy; Clb+O=Chlorambucil + Obinutuzumab; CR=Complete response; CRi=CR with incomplete marrow recovery; ORR=Overall response rate; PB=Peripheral blood; PD=Disease progression; PR=Partial response; TLS=Tumour lysis syndrome; TTnT=Time to next treatment; MRD=Minimal residual disease; VEN+O=VENCLYXTO + Obinutuzumab; VEN+R=VENCLYXTO + Rituximab.
References
- VENCLYXTO Summary of Product Characteristics.
- Fischer K et al. N Engl J Med. 2019; 380: 2225–36.
- Al-Sawaf O et al. Abstract S145. EHA Congress. 2023.
- Eichhorst B et al. N Engl J Med. 2023; 388: 1739-54.
- Leukaemia Care Living with Leukaemia 2018 Report Available from: 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-230272 (desktop).
UK-VNCCLL-230363 (mobile).
Date of preparation: September 2023.
