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.
VENCLYXTO regimens offer a chance for improved efficacy compared with HMAs or LDAC used alone in studied subgroups
- Overall survival: 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
- Remissions: More than double the remission rate vs AZA alone (66% CR+CRi vs 28%, respectively; P<0.001)1,2
- Transfusion independence: RBC and platelet transfusion independence achieved in ≥60% of patients1
VEN+LDAC in
VIALE-C†
- Overall survival: 3.1-month increase in median overall survival vs LDAC alone (7.2 months vs 4.1 months, respectively; HR=0.75 [95% CI: 0.52-1.07; P=0.114])1
- Remissions: Increased remission rates vs LDAC alone (48% CR+CRi vs 13%, respectively; P<0.001‡)1,3
- Transfusion independence: More than 40% of patients achieved independence from both RBC and platelet transfusions1
VEN+DEC in M14-358§
- Overall survival: median of 16.2 months (95% CI: 9.1–27.8; n=31)1
- Remission: CR+CRi rate of 74% (95% CI: 55-88)1
*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.
†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.
‡This P value is descriptive.
§M14-358 was a nonrandomized, phase 1/2 trial evaluating the safety and efficacy of VENCLYXTO + decitabine in patients with newly diagnosed AML who were ineligible for intensive chemotherapy.
HMA=hypomethylating agent; VEN+AZA=VENCLYXTO + azacitidine; VEN+LDAC=VENCLYXTO + low-dose cytarabine; VEN+DEC=VENCLYXTO + decitabine; CR=complete remission; CRi=complete remission with incomplete bone marrow recovery; RBC=red blood cell.
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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. 3. Wei AH, Montesinos P, Ivanov V, et al. Venetoclax plus LDAC for patients with untreated AML ineligible for intensive chemotherapy: phase 3 randomized placebo-controlled trial. Blood. 2020;135(24):2137-2145.