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      • This website is for UK Healthcare Professionals only

      This promotional website is for UK healthcare professionals involved in the care of patients with cancer. Adverse event reporting information can be found below.

      Venclyxto_UK_R_4C
      VENCLYXTO AML PRESCRIBING INFORMATION
      VENCLYXTO GB SUMMARY OF PRODUCT CHARACTERISTICS
      VENCLYXTO NI SUMMARY OF PRODUCT CHARACTERISTICS

      UK-VNCAML-240003  |  April 2024.

      Home

      Efficacy & Safety

      Dosing & TLS prophylaxis
      (tumour lysis syndrome)

      Drug-Drug Interactions

      Cytopenia Management

      FAQs

      References

      VENCLYXTO (venetoclax) is a BCL-2 inhibitor licensed for the treatment of AML across all mutational subtypes in adult patients with newly diagnosed AML who are ineligible for intensive chemotherapy.1

      Select from the options below to view the VIALE-A data:*

      *VIALE-A was a randomised (2:1), double-blind, placebo-controlled, Phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus AZA (n=286) vs AZA alone (n=145) in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The dual primary endpoints of median overall survival and composite complete remission rate (CR+CRi) were both met (P<0.001 for both).2

      At a median follow-up time of 43.2 months (range:<0.1-53.4), the median overall survival with VENCLYXTO plus AZA was 14.7 months vs 9.6 months for AZA alone (HR=0.58; 95% CI: 0.47-0.72; P<0.001).3

      Footnotes

      AEs=adverse events; AZA=azacitidine; BCL-2=B-cell lymphoma 2; CI=confidence interval; CR=complete remission; CRi=CR with incomplete blood count recovery; HR=hazard ratio. 

      VENCLYXTO (venetoclax) is a BCL-2 inhibitor licensed for the treatment of AML across all mutational subtypes in adult patients with newly diagnosed AML who are ineligible for intensive chemotherapy.1

      Select from the options below to view the VIALE-A data:*

      *VIALE-A was a randomised (2:1), double-blind, placebo-controlled, Phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus AZA (n=286) vs AZA alone (n=145) in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The dual primary endpoints of median overall survival and composite complete remission rate (CR+CRi) were both met (P<0.001 for both).2

      At a median follow-up time of 43.2 months (range:<0.1-53.4), the median overall survival with VENCLYXTO plus AZA was 14.7 months vs 9.6 months for AZA alone (HR=0.58; 95% CI: 0.47-0.72; P<0.001).3

      Footnotes

      AEs=adverse events; AZA=azacitidine; BCL-2=B-cell lymphoma 2; CI=confidence interval; CR=complete remission; CRi=CR with incomplete blood count recovery; HR=hazard ratio. 

      UK-VNCAML-240064  |  April 2024.

      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

      You are advised to read the Prescribing Information and Summary of Product Characteristics (GB SmPC; NI SmPC) to evaluate patient suitability for VENCLYXTO.

      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 GBPV@abbvie.com

      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 blasts with Auer rods; 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 CHEMOTHERAPY2,3

      VEN+AZA sustains OS benefit in AML patients ineligible for intensive chemotherapy with an additional 2 years of follow-up
      (HR=0.58; 95% CI: 0.47-0.72; P<0.001)3†

      Overall survival by patient subtype

      In the primary analysis, at a median follow-up time of 20.5 months (range <0.1-30.7), VEN+AZA extended median OS vs AZA alone (14.7 months vs 9.6 months, respectively [HR=0.66; 95% CI: 0.52-0.85]; P<0.001).2†

      Footnotes

      *HR reduction from 0.66 at the previous analysis. HR reduction was not statistically tested for significance.3

      †Hazard ratio estimate (VEN+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; OS=overall survival; 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)2

      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 blasts with Auer rods; absence of extramedullary disease.

      CRi=ANC ≤1,000/microlitre or platelets ≤100,000/microlitre1

      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 alone2

      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 blasts with Auer rods; 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 18.2 MONTHS WITH VENCLYXTO PLUS AZA PATIENTS vs 10.7 MONTHS WITH AZA ALONE AFTER 2 ADDITIONAL YEARS OF FOLLOW-UP3

      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 blasts with Auer rods; 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
      TLS Rates

      Please refer to the SmPC for full safety information

      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
      TLS Rates

      Please refer to the SmPC for full safety information

      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 ALONE2,3*

      EXTEND OVERALL SURVIVAL

      After 2 years of additional follow-up, 5.1-month increase in median overall survival vs AZA alone (14.7 months vs 9.6 months, respectively [HR=0.58; 95% CI: 0.47-0.72]; P<0.001)3

      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 vs AZA alone in patients with newly diagnosed AML who were ineligible for intensive chemotherapy(N=431). The dual primary endpoints of median overall survival and composite complete remission rate (CR+CRi) were both met (P<0.001 for both).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

      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 blasts with Auer rods; absence of extramedullary disease.

      CRi=ANC ≤1,000/microlitre or platelets ≤100,000/microlitre1

      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
      • Monitor blood chemistries for TLS at pre-dose, 6 to 8 hours after each new dose during titration and 24 hours after reaching final dose1

      Footnotes

      Please refer to the SmPC for full safety information

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

      What where the rates of discontinuation, dose interruption or reduction in VIALE-A?

      RATES OF TREATMENT DISCONTINUATION, DOSE INTERRUPTION OR DOSE REDUCTION DUE TO AEs WERE SIMILAR WITH VEN+AZA AT 20.5 MONTHS AND 43.2 MONTHS OF FOLLOW-UP2,3

      Footnotes

      *Delay between treatment cycles to allow for count recovery.2,3

      AEs=adverse events; AZA=azacitidine; VEN=VENCLYXTO.

      References

      1. VENCLYXTO Summary of Product Characteristics.
      2. DiNardo CD et al. N Engl J Med. 2020; 383(7): 617-29.
      3. Pratz KW et al. Oral Presentation 219. Presented at: 64th American Society of Hematology Annual Meeting; December 10-13, 2022; New Orleans, USA.

       

      VIALE-A: VENCLYXTO AND AZACITIDINE IN PREVIOUSLY UNTREATED AML

      Dr. Richard Dillon provides an overview of the VIALE-A trial of VENCLYXTO and azacitidine 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)

      Footnotes

      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, %0-15556
      2-34544
      AML type, %De novo7576
      Secondary2524
      Therapy related3626
      Post MDS/CMML6474
      Cytogenetic risk, %Intermediate6461
      Poor3639
      Molecular Marker by central lab, %IDH1/22522
      FLT31420
      TP532316
      NPM11720
      AML with myelodysplasia related changes (AML-MRC), % 3234
      Bone marrow blast count, %<30%†3028
      ≥30% to <50%2123
      ≥50%4949
      Transfusion dependent at baseline,*%RBC5052
      Platelet2422

      Footnotes

      *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 SUBTYPE AT 43.2 MONTHS OF FOLLOW-UP3

      The overall survival in the patient subtypes favoured VENCLYXTO plus AZA3*

      Adapted from Pratz et al.

      Footnotes

      *The hazard ratio between treatment arms were from unstratified Cox proportional hazards model; TP53 and NPM1 data are from the central lab using MyAML panel; IDH1/2 and FLT3 data are by CDX method. Data cut-off: 01 Dec 2021.3

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

      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 GBPV@abbvie.com

       

      This website is for UK Healthcare Professionals only

      UK-ABBV-230225. Date of preparation June 2023. This website has been developed and funded by AbbVie Ltd.

      © 2023 AbbVie Ltd. All rights reserved. Registered Number: 08004972 England.