Note to Affiliates: VEN + LDAC is not approved in the EU. These are optional pages for affiliates with this combination in label. Localize use of the VENCLYXTO or VENCLEXTA brand names in accordance with your local label.
[VENCLYXTO] in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
VIALE-C evaluated [VENCLYXTO] plus low-dose cytarabine (VEN+LDAC), an alternative to combination with hypomethylating agents (VEN+HMAs). The primary endpoint (statistically significant improvement in overall survival) was not met, therefore, secondary endpoints are descriptive only. VIALE-C was a randomised (2:1), double-blind, placebo-controlled, Phase 3 study that evaluated the efficacy and safety of VEN+LDAC in patients with newly diagnosed AML who were ineligible for intensive chemotherapy.1,2
[VENCLYXTO] + LOW-DOSE CYTARABINE
test
VIALE-C: A PHASE 3 TRIAL COMPARING [VENCLYXTO] PLUS LDAC VERSUS LDAC ALONE IN FIRST-LINE AML TREATMENT1,2
A randomised, double-blind, placebo-controlled study that evaluated the efficacy and safety in patients ineligible for intensive chemotherapy1,2
SELECT INCLUSION CRITERIA2
KEY ELIGIBILITY:
| • | ≥18 years and confirmed AML by World Health Organization criteria, previously untreated |
| • | ECOG status of 0 to 2 for patients ≥75 years of age or 0 to 3 for patients ≥18 to 74 years of age |
| • | ≥75 years of age or ≥18 to 74 years of age with comorbidities that make them ineligible for standard induction regimens |
SELECT EXCLUSION CRITERIA2
KEY INELIGIBILITY:
| • | Prior therapy for AML (except hydroxyurea prior to and during the first cycle of study treatment) |
| • | Any previous exposure to cytarabine for any indication |
| • | Known CNS involvement with AML |
EFFICACY AND SAFETY WERE EVALUATED IN NEWLY DIAGNOSED PATIENTS WITH AML1,2
Treatment was continued until disease progression or unacceptable toxicity was observed1
A BROAD RANGE OF PATIENT SUBGROUPS WERE STUDIED1,2
Baseline demographic and disease characteristics were similar between the treatment arms1,2
Overall survival outcomes
Primary endpoint not met1,2
| • | At the time of primary analysis for overall survival, the median overall survival in the [VENCLYXTO] plus LDAC group was 7.2 months (95% CI: 5.6-10.1) vs 4.1 months for LDAC alone (95% CI: 3.1-8.8) (HR=0.75 [95% CI: 0.52-1.07, respectively; P=0.114])1,2 |
MEDIAN OVERALL SURVIVAL (NOT STATISTICALLY SIGNIFICANT)1,2
REMISSION OUTCOMES
The primary endpoint for VIALE-C was not met; therefore, secondary endpoints are descriptive only.
Increased remission rates with [VENCLYXTO] plus LDAC vs LDAC alone1,2
CR+CRi* RATES2
| • | The CR+CRh rate in the VEN+LDAC arm was 47% (95% CI: 39%, 55%) and in the placebo+LDAC arm was 15% (95% CI: 7.3%, 25%) with a median duration of CR+CRh of 11.1 months with VEN+LDAC treatment and 6.2 months with placebo+LDAC treatment.1 |
TIME TO REMISSION
Patients treated with [VENCLYXTO] plus LDAC achieved remission in a median of 1.0 month1
MEDIAN TIME TO FIRST RESPONSE (CR or CRh)
CR+CRi BY CYCLE 22
CR+CRi AFTER CYCLE 22‡
| • | The primary endpoint for VIALE-C was not met; therefore, secondary endpoints are descriptive only.
|
DURATION OF REMISSION (CR)
Patients receiving [VENCLYXTO] plus LDAC achieved remissions that lasted a median of 11.1 months vs 8.3 months for LDAC alone1
MEDIAN DURATION AND RANGE OF RESPONSE (CR)
| • | The CR rate for patients receiving [VENCLYXTO] plus LDAC was 27% (95% CI: 20%, 35%) compared to 7.4% (95% CI: 2.4%, 16%) for patients receiving LDAC alone1 |
| • | The primary endpoint for VIALE-C was not met; therefore, secondary endpoints are descriptive only. |
DURATION OF REMISSION (CR+CRh)
Patients receiving [VENCLYXTO] plus LDAC achieved remissions that lasted a median of 11.1 months vs LDAC alone1
MEDIAN DURATION OF RESPONSE (CR+CRh)
| • | The CR+CRh rate for patients receiving [VENCLYXTO] plus LDAC was 47% (95% CI: 39%, 55%) compared to 15% (95% CI: 7.3%, 25%) for patients receiving LDAC alone1 |
| • | Event-free survival in patients treated with [VENCLYXTO] plus LDAC was longer than LDAC alone (4.7 months vs 2 months, respectively)2 |
| • | The primary endpoint for VIALE-C was not met; therefore, secondary endpoints are descriptive only. |
Continue treatment until disease progression or unacceptable toxicity1
*CRi=complete remission with incomplete blood count recovery defined in all criteria as CR except for residual neutropaenia <103/μL or thrombocytopaenia <105/μL. If all criteria for CR are met except for RBC transfusion independence, CRi criteria are met.2
†This P value is descriptive.
‡The rate of CR+CRi after Cycle 2 was calculated by subtracting the rate of CR+CRi by Cycle 2 from the total CR+CRi rate.
TRANSFUSION-FREE PERIODS
37% of patients treated with [VENCLYXTO] plus LDAC achieved independence from both RBC and platelet transfusions2
TRANSFUSION INDEPENDENCE* RATES
| • | 33% (37/111) of patients treated with [VENCLYXTO] + LDAC who were dependent on RBC and platelets transfusions at baseline became independent, vs 13% (7/55) of LDAC alone1 |
| • | 50% (16/32) of patients treated with [VENCLYXTO] + LDAC who were independent of RBC and platelets transfusions at baseline remained independent, vs 31% (4/13) of LDAC alone1 |
| • | The primary endpoint for VIALE-C was not met; therefore, secondary endpoints are descriptive only.
|
*Transfusion independence was defined as a period of at least 56 consecutive days with no transfusion after the first dose of study drug and on or before the last dose of the study drug plus 30 days.1
†This P value is descriptive.
AML=acute myeloid leukaemia; BCL-2=B-cell lymphoma 2; CNS=central nervous system; CR=complete remission; CRh=complete remission with partial haematological recovery; CRi=complete remission with incomplete haematological recovery; CI=confidence interval; ECOG=Eastern Cooperative Oncology Group; FLT=fms-like tyrosine kinase; HMA=hypomethylating agent; HR=hazard ratio; IDH=isocitrate dehydrogenase; LDAC=low-dose cytarabine; NPM=nucleophosmin; NR=not reported; PO=by mouth; RBC=red blood cell; SC=subcutaneous; TP53=tumour protein p53; VEN=VENCLYXTO.
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References: 1. VENCLEXTA Prescribing Information. North Chicago, IL: AbbVie Inc. 2. Wei AH, Montesinos P, Ivanov V, et al. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial. Blood. 2020;135(24):2137-2145. doi:10.1182/blood.2020004856
ALL-VNCAML-220066 October 2023