For newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy1
VENCLYXTO is the first approved BCL-2 inhibitor for the treatment of AML1
VENCLYXTO plus azacitidine demonstrated a 5.1-month increase in median overall survival vs AZA alone1*
VENCLYXTO plus low-dose cytarabine showed a 3.1-month increase in median overall survival vs LDAC alone1†
VENCLYXTO plus azacitidine demonstrated a 5.1-month increase in median overall survival vs AZA alone1*
VENCLYXTO plus low-dose cytarabine showed a 3.1-month increase in median overall survival vs LDAC alone1†
*VIALE-A was a randomized (2:1), double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus AZA in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus AZA was 14.7 months (95% CI: 11.9-18.7) vs 9.6 months for AZA alone (95% CI: 7.4-12.7) (HR=0.66 [95% CI: 0.52-0.85; P<0.001]).1
†VIALE-C was a randomized (2:1), double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus LDAC in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus LDAC 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; P=0.114]).1
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
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BCL-2=B-cell lymphoma 2; AZA=azacitidine; LDAC=low-dose cytarabine; CI=confidence interval; HR=hazard ratio.
For newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy1
VENCLYXTO is the first approved BCL-2 inhibitor for the treatment of AML1
VENCLYXTO plus azacitidine demonstrated a 5.1-month increase in median overall survival vs AZA alone1*
VENCLYXTO plus low-dose cytarabine showed a 3.1-month increase in median overall survival vs LDAC alone1†
VENCLYXTO plus azacitidine demonstrated a 5.1-month increase in median overall survival vs AZA alone1*
VENCLYXTO plus low-dose cytarabine showed a 3.1-month increase in median overall survival vs LDAC alone1†
*VIALE-A was a randomized (2:1), double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus AZA in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus AZA was 14.7 months (95% CI: 11.9-18.7) vs 9.6 months for AZA alone (95% CI: 7.4-12.7) (HR=0.66 [95% CI: 0.52-0.85; P<0.001]).1
†VIALE-C was a randomized (2:1), double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus LDAC in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus LDAC 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; P=0.114]).1
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
▼
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
▼
BCL-2=B-cell lymphoma 2; AZA=azacitidine; LDAC=low-dose cytarabine; CI=confidence interval; HR=hazard ratio.
Significantly extend overall survival* in first-line treatment with VENCLYXTO plus azacitidine versus azacitidine alone1
*VIALE-A was a randomized (2:1), double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus AZA in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus AZA was 14.7 months (95% CI: 11.9-18.7) vs 9.6 months for AZA alone (95% CI: 7.4-12.7; HR=0.66; P<0.001).1
Maximize overall survival vs AZA alone
- 5.1-month increase in median overall survival vs AZA alone (14.7 months vs 9.6 months, respectively [95% CI: 0.52-0.85; P<0.001])1
Maintain remission for longer
- More than DOUBLE the remission rate vs AZA alone (66% CR+CRi vs 28%, respectively; P<0.001)1,2
- Increased remission rates across mutational subgroups vs AZA alone1,2
- Longer remission rates among patients who achieved CR+CRi vs AZA alone (17.5 months vs 13.4 months, respectively)1
Minimize transfusion dependence
- RBC and platelet transfusion independence achieved in ≥60% of patients1
mOS=median overall survival; CR=complete remission; CRi=complete remission with incomplete hematological recovery; RBC=red blood cell.
VIALE-A: a phase 3 trial comparing VENCLYXTO plus AZA vs AZA alone in first-line AML treatment
A randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety in patients ineligible for intensive chemotherapy1,2
AML=Acute myeloid leukemia; VEN=VENCLYXTO; PO=by mouth; SC/IV=subcutaneous/intravenous; ECOG=Eastern Cooperative Oncology Group.
Efficacy and safety were evaluated in newly diagnosed patients with AML
Treatment was continued until disease progression or unacceptable toxicity was observed1
*The dual primary efficacy endpoints of the study were overall survival, measured from the date of randomization to death from any cause, and composite complete remission rate (CR+CRi).1
CR=complete remission; CRi=complete remission with incomplete haematological recovery; FLT=fms-like tyrosine kinase; IDH=isocitrate dehydrogenase; MRD=minimal residual disease.
A broad range of patient subgroups were studied
Baseline demographic and disease characteristics were similar between the treatment arms2
MDS=myelodysplastic syndrome; CMML=chronic myelomonocytic leukemia; ECOG=Eastern Cooperative Oncology Group; TP53=tumor protein p53; NPM=nucleophosmin; MRC=myelodysplasia-related changes.
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VENCLYXTO plus AZA significantly extended median overall survival vs AZA alone in hard-to-treat patient populations*
VENCLYXTO plus AZA demonstrated a 5.1-month increase in median overall survival vs AZA alone (14.7 months vs 9.6 months, respectively [95% CI: 0.52–0.85])1
MEDIAN OVERALL SURVIVAL
*”Hard-to-treat patient populations” refers to those patients who are ineligible for intensive chemotherapy.
†Hazard ratio estimate (VENCLYXTO plus AZA vs AZA alone) is based on Cox proportional hazards model stratified by age (18-<75, ≥75) and cytogenetics (intermediate risk, poor risk) as assigned at randomization; P value based on log-rank test stratified by the same factors.1
VENCLYXTO plus AZA demonstrated a 50% increase in median overall survival vs AZA alone1
The increased overall survival seen with VENCLYXTO plus AZA in the overall patient population was consistent across patient subgroups1
FOREST PLOT OF OVERALL SURVIVAL
‡Overall survival in FLT3 and IDH1/2 subgroups were prespecified secondary endpoints. Overall survival in FLT3 did not meet statistical significance and does not support conclusions on efficacy. Other biomarker subgroups (TP53 and NPM1) and cytogenetic risk were prespecified exploratory endpoints.1
§ECOG status does not correlate with eligibility.
Statistically significant remissions (CR+CRi) were achieved
VENCLYXTO plus AZA more than DOUBLED the remission rate vs AZA alone1,2
CR+CRi* RATES
VENCLYXTO plus AZA almost TRIPLED the MRD response† rate in patients who achieved remission (CR+CRi) vs AZA alone1
*CR=absolute neutrophil count (ANC) >1000/microliter, platelets >100,000/microliter, RBC transfusion independence, and bone marrow with <5% blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi=CR with incomplete blood count recovery (ANC ≤1000/microliter or platelets ≤100,000/microliter).1,2
†CR+CRi MRD response rate is defined as the percentage of patients achieving a CR or CRi and demonstrating an MRD response of <10-3 blasts in bone marrow as determined by a standardized, central multicolor flow cytometry assay.1
Almost one quarter of patients who achieved remission (CR+CRi) with VENCLYXTO plus AZA had an MRD response (23% vs 8% for AZA alone)1
Greater CR+CRi improvement was seen across genomic risk and mutation subgroups in hard-to-treat patients‡
More than half of patients achieved remission with VENCLYXTO plus AZA across mutation subgroups1,2
COMPOSITE REMISSION RATES (CR+CRi) BY MUTATION
VENCLYXTO plus AZA increased remission rates across mutation subgroups vs AZA alone by1,2:
‡”Hard-to-treat patient populations” refers to those patients who are ineligible for intensive chemotherapy.
§Fisher’s exact test.
The majority of remissions were demonstrated early and were durable*
Patients treated with VENCLYXTO plus AZA achieved remission in a median of 1.3 months, with a number of patients responding after Cycle 2 of treatment1
Patients who were treated with VENCLYXTO plus AZA and achieved CR+CRi had longer remissions that lasted a median of 17.5 months vs AZA alone1
*A longer median duration of response vs AZA alone.1
†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.
‡Median duration of response is from Kaplan-Meier estimate and was defined as time from first response of CR or CRi to the first date of confirmed morphologic relapse, confirmed progressive disease, or death due to disease progression, whichever occurred earlier.1
NR=not reported.
VENCLYXTO plus AZA offered more transfusion-free periods and maintained quality of life
Transfusion independence* was achieved in ≥60% of patients receiving VENCLYXTO plus AZA1
- Of the patients who were RBC transfusion dependent at baseline and treated with VENCLYXTO plus AZA, 49% became transfusion independent
- Of the patients who were platelet transfusion dependent at baseline and treated with VENCLYXTO plus AZA, 50% became transfusion independent
*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, or before relapse or disease progression, or before the initiation of posttreatment therapy, whichever is earlier.1
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References: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. <Current SmPC.> 2. DiNardo CD, Jonas BA, Pullarkat V, et al. Azacitidine and venetoclax in previously untreated acute myeloid leukemia. N Engl J Med. 2020;387(7):617-629.