Oncology:
Our other therapy areas

    • {%itemName%}
        {%brandMenuItems%}
    • {%itemName%} {%arrowSpan%}
        {%subBrandMenuItems%}
    • {%itemName%} {%arrowSpan%}
        {%productMenuItems%}
    • {%itemKeyName%} {%itemBadges%} {%arrowSpan%}
      {%selfProduct%}
    • {%itemName%}
      • {%countries%}
    • {%allMenuItem%}
      • {%languages%}

      • This website is for UK Healthcare Professionals only

      Prescribing information can be accessed by the Prescribing Information button on the left

      UK-VNCAML-220168  |  November 2022. 

      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.1

      Adverse events should be reported.
      Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. 
      Adverse events should also be reported to AbbVie on [email protected]

      How was the VIALE-A study designed?

      VIALE-A: A PHASE 3 TRIAL COMPARING VENCLYXTO PLUS AZA vs AZA ALONE IN FIRST-LINE PATIENTS INELIGIBLE FOR INTENSIVE CHEMOTHERAPY2*

      A randomised, double-blind, placebo-controlled study in newly diagnosed AML patients2

      Study enrolled a range of patients including those with adverse cytogenetic risk2

      Treatment was continued for as long as patients showed a clinical benefit or until disease progression2

      STUDY ENDPOINTS1,2  

      Primary efficacy endpoints

      Overall survival
      CR+CRi rate

      Key secondary efficacy endpoints

      Overall survival by mutational subgroup
      CR rate
      CR+CRi MRD response rate
      CR+CRi rate by mutational subgroup
      Transfusion independence rate, red blood cells
      Transfusion independence rate, platelets
      Viale-A video
      Inclusion / Exclusion criteria
      Baseline characteristics

      Footnotes

      *Patients were considered ineligible for intensive chemotherapy if they were 75 years of age or older or had comorbidities that precluded the use of intensive induction chemotherapy.2

      †Treatment with VENCLYXTO was initiated at 100 mg on day 1, 200 mg on day 2, and the target dose of 400 mg was reached on day 3.2

      CR = absolute neutrophil count (ANC ) ≥1 ,000 /microlitre, platelets ≥100 ,000 /microlitre, RBC transfusion independence, and bone marrow with <5 % blasts; absence of circulating blasts and blast with Auer rods, and absence of extramedullary disease.

      CRi=ANC <1 ,000 /microlitre or platelets <100 ,000 /microlitre.1

      AZA=azacitidine; CR=complete remission; CRi=CR with incomplete blood count recovery; MRD=minimal residual disease;
      PO=by mouth; SC/IV=subcutaneous/intravenous; VEN=VENCLYXTO

      What was the median overall survival?

      VENCLYXTO PLUS AZA SIGNIFICANTLY EXTENDED MEDIAN OVERALL SURVIVAL vs AZA ALONE IN FIRST-LINE PATIENTS INELIGIBLE FOR INTENSIVE CHEMOTHERAPY2

      VENCLYXTO plus AZA demonstrated a 5.1 month increase in median overall survival vs AZA alone (14.7 months vs 9.6 months, respectively [HR=0.66; 95% CI: 0.52-0.85]; P<0.001)2*

      Overall survival by patient subtype

      Footnotes

      *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 randomisation; P-value based on log-rank test stratified by the same factors.2

      AZA=azacitidine; CI=confidence interval; HR=hazard ratio; VEN=VENCLYXTO. 

      What about composite complete remission rate (CR+CRi)?

      A STATISTICALLY SIGNIFICANT INCREASE IN CR+CRi WAS ACHIEVED WITH VENCLYXTO PLUS AZA vs AZA ALONE (66% vs 28%, P<0.001)1

      VENCLYXTO plus AZA more than DOUBLED the CR+CRi rate vs AZA alone2

      Clinical remission by patient subtype

      Footnotes

      *CR=absolute neutrophil count (ANC) ≥1,000/microlitre, platelets ≥100,000/microlitre, RBC transfusion independence, and bone marrow with <5% blasts; absence of circulating blasts and blast with Auer rods, and absence of extramedullary disease.

      CRi=ANC <1,000/microlitre or platelets <100,000/microlitre.2

      AZA=azacitidine; CI=confidence interval; CR=complete remission; CRi=CR with incomplete blood count recovery; RBC=red blood cell; VEN=VENCLYXTO.

      How many patients had minimal residual disease
      (CR+CRi MRD)?

      VENCLYXTO PLUS AZA MORE THAN TRIPLED THE CR+CRi MRD RESPONSE RATE*
      VS AZA ALONE      1,2

      Footnotes

      CR+CRi MRD response rate was defined as the % of patients who achieved a CR or CRi and demonstrated an MRD response of <10-3 blasts in bone marrow.1

      AZA=azacitidine; CI=confidence interval; CR=complete remission; CRi=CR with incomplete blood count recovery;
      MRD=minimal residual disease; VEN=VENCLYXTO.

      How quickly did patients achieve remission?

      43.4% OF PATIENTS  ON VENCLYXTO PLUS AZA ACHIEVED CR/CRi BEFORE THE INITIATION OF CYCLE 2 vs 7.6% FOR AZA ALONE (P<0.001)2*

      23.0% of patients receiving VEN+AZA achieved CR/CRi after cycle 2 vs 20.7% for AZA alone1

      Footnotes

      *Cycle is 28 days.2

      CR = absolute neutrophil count (ANC ) ≥1 ,000 /microlitre, platelets ≥100 ,000 /microlitre, RBC transfusion independence, and bone marrow with <5 % blasts; absence of circulating blasts and blast with Auer rods, and absence of extramedullary disease.

      CRi=ANC <1 ,000 /microlitre or platelets <100 ,000 /microlitre.1

      AZA=azacitidine; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete blood count recovery; VEN=VENCLYXTO.

      How durable was a patient’s remission?

      MEDIAN DURATION OF CR+CRi WAS 17.5 MONTHS WITH VENCLYXTO PLUS AZA PATIENTS vs 13.4 MONTHS WITH AZA ALONE2

      Footnotes

      *Median duration of response is from Kaplan-Meier estimate and was defined as time from first response of CR/CRi to the first date of confirmed morphologic relapse, confirmed progressive disease, or death due to disease progression, whichever occurred earlier.1

      CR = absolute neutrophil count (ANC ) ≥1 ,000 /microlitre, platelets ≥100 ,000 /microlitre, RBC transfusion independence, and bone marrow with <5 % blasts; absence of circulating blasts and blast with Auer rods, and absence of extramedullary disease.

      CRi=ANC <1 ,000 /microlitre or platelets <100 ,000 /microlitre.1

      AZA=azacitidine; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete blood count recovery; NR=not reached; VEN=VENCLYXTO.

      How durable was a patient’s remission?

      MEDIAN DURATION OF CR+CRi WAS 17.5 MONTHS WITH VENCLYXTO PLUS AZA PATIENTS vs 13.4 MONTHS WITH AZA ALONE2

      Footnotes

      *Median duration of response is from Kaplan-Meier estimate and was defined as time from first response of CR/CRi to the first date of confirmed morphologic relapse, confirmed progressive disease, or death due to disease progression, whichever occurred earlier.1

      CR = absolute neutrophil count (ANC ) ≥1 ,000 /microlitre, platelets ≥100 ,000 /microlitre, RBC transfusion independence, and bone marrow with <5 % blasts; absence of circulating blasts and blast with Auer rods, and absence of extramedullary disease.

      CRi=ANC <1 ,000 /microlitre or platelets <100 ,000 /microlitre.1

      AZA=azacitidine; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete blood count recovery; NR=not reached; VEN=VENCLYXTO.

      What affect does VENCLYXTO have on their need for blood transfusions?

      VENCLYXTO PLUS AZA OFFERED GREATER TRANSFUSION INDEPENDENCE vs AZA ALONE2

      Significantly more patients who received VENCLYXTO plus AZA achieved transfusion independence vs AZA alone2

      Footnotes

      *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 post-treatment therapy, whichever is earlier.1,2

      AZA=azacitidine; CI=confidence interval; RBC=red blood cell; VEN=VENCLYXTO.

      What were the most common adverse events (AEs)?

      VENCLYXTO PLUS AZA DEMONSTRATED A GENERALLY MANAGEABLE ADVERSE EVENT PROFILE2

      Most commonly reported AEs2

      Please refer to the SmPC for full safety information

      TLS Rates

      Footnotes

      *Adverse events of Grade 3 or higher that were reported in at least 10% of patients in either treatment group are listed.1

      †Adverse events reported in at least 20% of patients in either treatment group are listed.1

      AE=adverse event; AZA=azacitidine; TLS=tumour lysis syndrome; VEN=VENCLYXTO; WBC=white blood cell count.

      What were the most serious adverse events (AEs)?

      VENCLYXTO PLUS AZA DEMONSTRATED A GENERALLY MANAGEABLE ADVERSE EVENT PROFILE2

      MOST SERIOUS AEs2

      Please refer to the SmPC for full safety information

      TLS Rates

      Footnotes

      *Serious adverse events that were reported in at least 5% of patients in either treatment group are listed.2

      AE=adverse event; AZA=azacitidine; VEN=VENCLYXTO.

      Summary

      SIGNIFICANTLY EXTEND OVERALL SURVIVAL IN FIRST-LINE TREATMENT
      WITH VENCLYXTO PLUS AZA vs AZA ALONE2*

      EXTEND OVERALL SURVIVAL

      5.1-month increase in median overall survival vs AZA alone (14.7 months vs 9.6 months, respectively [HR=0.66; 95% CI: 0.52-0.85]; P<0.001)2

      DOUBLE REMISSION RATES

      More than DOUBLE the CR+CRi vs AZA alone (66.4% CR+CRi vs 28.3%, respectively; P<0.001)2

      MINIMISE TRANSFUSION DEPENDENCE

      RBC transfusion independence achieved in 60% vs 35% in AZA alone (P<0.001)2

      Platelet transfusion independence achieved in 69% vs 50% in AZA alone (P<0.001)2

      GENERALLY MANAGEABLE ADVERSE EVENT PROFILE

      Please refer to the SmPC for full safety information.

      VENCLYXTO is a BCL-2 inhibitor licensed for the treatment of AML across all mutational subtypes2

      Footnotes

      *VIALE-A was a randomised (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 (N=431).2

      AZA=azacitidine; BCL-2=b-cell lymphoma 2; CI=confidence interval; CR=complete remission; CRi=CR with incomplete blood count recovery;
      HR=hazard ratio; RBC=red blood cell.

      GREATER CR+CRi IMPROVEMENT WAS SEEN ACROSS GENOMIC RISK AND MUTATION SUBGROUPS IN PATIENTS INELIGIBLE FOR INTENSIVE CHEMOTHERAPY WITH VENCLYXTO PLUS AZA vs AZA ALONE2

      More than half of patients achieved CR+CRi in the VENCLYXTO plus AZA group across mutation subgroups2

      CR = absolute neutrophil count (ANC ) ≥1 ,000 /microlitre, platelets ≥100 ,000 /microlitre, RBC transfusion independence, and bone marrow with <5 % blasts; absence of circulating blasts and blast with Auer rods, and absence of extramedullary disease.

      CRi=ANC <1 ,000 /microlitre or platelets <100 ,000 /microlitre.1

      AZA=azacitidine; CR=complete remission; CRi=CR with incomplete blood count recovery; VEN=VENCLYXTO. 

      RATES OF TLS WITH VENCLYXTO PLUS AZA WERE LOW (1%, N=3) AND THE RISK CAN BE MANAGED BY FOLLOWING RECOMMENDED PROPHYLAXIS MEASURES1,2

      3 patients (1%) experienced TLS
      (1 case of clinical TLS; all in the VENCLYXTO plus AZA arm)2

      • All cases occurred in the dose ramp-up period and were resolved with uricosuric agents and calcium supplements without treatment interruption1
      • All patients should have a WBC count <25 x 109/L prior to initiation of VENCLYXTO1
      • Cytoreduction prior to treatment may be required1
      • Patients should be adequately hydrated and receive anti-hyperuricaemic agents prior to initiation of first dose of VENCLYXTO and throughout the dose-titration period1
      • Assess blood chemistries and correct abnormalities prior to the initiation of VENCLYXTO1

      Please refer to the SmPC for full safety information

      AZA=azacitidine; TLS=tumour lysis syndrome; VEN=VENCLYXTO; WBC=white blood count.

      References

      1. VENCLYXTO Summary of Product Characteristics.
      2. DiNardo CD et al. N Engl J Med. 2020; 383(7): 617-29.

      VIALE-A: VENCLYXTO AND AZACITIDINE IN PREVIOUSLY UNTREATED AML

      Dr. Richard Dillon provides an overview of the VIALE-A trial of VENCLYXTO and azacytidine in previously untreated acute myeloid leukaemia patients who were ineligible for intensive chemotherapy

      INCLUSION/EXCLUSION CRITERIA2

      SELECT INCLUSION CRITERIA2
      KEY ELIGIBILITY:
      AML previously untreated
      ≥75 years of age or ≥18 to 74 years of age with comorbidities that make them ineligible for standard induction regimens

      -A history of CHF for which treatment was warranted
      -Chronic stable angina
      -EF of ≤50%
      -DLCO of ≤65%
      -FEV1 of ≤65%
      -ECOG of 2-3
      ECOG of 0 to 2 for patients ≥75 years of age or 0 to 3 for patients ≥18 to 74 years of age
      SELECT EXCLUSION CRITERIA2
      KEY INELIGIBILITY:
      Patients who have previously received any HMA, VENCLYXTO, or chemotherapy for myelodysplastic syndrome

      Patients with core-binding factor for AML
      Patients who had favourable risk cytogenetics such as t(8, 21), inv(16), t(16; 16), or t(15;17)

      Full eligibility criteria are listed in DiNardo CD et al N Engl J Med. 2020; 383(7): 617-29 (supplementary appendix). 

      CHF=congestive heart failure; DLCO=diffusing capacity of the lungs for carbon monoxide; ECOG=Eastern Cooperative Oncology Group; EF=ejection fraction; FEV1=forced expiratory volume in one second; HMA=hypomethylating agent. 

      BASELINE DEMOGRAPHIC AND DISEASE CHARACTERISTICS WERE SIMILAR BETWEEN THE TREATMENT ARMS2

      SELECT INCLUSION CRITERIA2   VEN+AZA (n=286) AZA ALONE (n=145)
      Age, median (range), years   76 (49-91) 76 (60-90)
      ECOG performance status, % 0-1 55 56
      2-3 45 44
      AML type, % De novo 75 76
      Secondary 25 24
      Therapy related 36 26
      Post MDS/CMML 64 74
      Cytogenetic risk, % Intermediate 64 61
      Poor 36 39
      Molecular Marker by central lab, % IDH1/2 25 22
      FLT3 14 20
      TP53 23 16
      NPM1 17 20
      AML with myelodysplasia related changes (AML-MRC), %   32 34
      Bone marrow blast count, % <30%† 30 28
      ≥30%to <50% 21 23
      ≥50% 49 49
      Transfusion dependent at baseline,*% RBC 50 52
      Platelet 24 22
      SELECT INCLUSION CRITERIA2   VEN+
      AZA       (n=286)      		 AZA ALONE (n=145)
      Age, median (range), years   76 (49-91) 76 (60-90)
      ECOG performance status, % 0-1 55 56
      2-3 45 44
      AML type, % De novo 75 76
      Secondary 25 24
      Therapy related 36 26
      Post MDS/CMML 64 74
      Cytogenetic risk, % Intermediate 64 61
      Poor 36 39
      Molecular Marker by central lab, % IDH1/2 25 22
      FLT3 14 20
      TP53 23 16
      NPM1 17 20
      AML with myelodysplasia related changes (AML-MRC), %   32 34
      Bone marrow blast count, % <30%† 30 28
      ≥30%to <50% 21 23
      ≥50% 49 49
      Transfusion dependent at baseline,*% RBC 50 52
      Platelet 24 22

      *Transfusion dependence was defined as transfusion within 8 weeks before the first dose of VEN+AZA or AZA alone or randomisation.1

      †These bone marrow blast counts were between 20% and 29%.2

      AZA=azacitidine; CMML=chronic myelomonocytic leukaemia; ECOG=Eastern Cooperative Oncology Group; MDS=myelodysplastic syndrome;
      RBC=red blood cell; VEN=VENCLYXTO.

      OVERALL SURVIVAL BY PATIENT SUBTYPE1,2

      The overall survival in the patient subtypes favoured VENCLYXTO plus AZA1,2*

      *The hazard ratio for death was estimated with the unstratified Cox proportional-hazards model.2

      AZA=azacitidine; CI=confidence interval; ECOG=Eastern Cooperative Oncology Group; VEN=VENCLYXTO