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.
FOR NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML)
WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY1
VENCLYXTO IS THE FIRST APPROVED BCL-2
INHIBITOR FOR THE TREATMENT OF AML1
FOR NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY1
VENCLYXTO IS THE FIRST APPROVED BCL-2 INHIBITOR FOR THE TREATMENT OF AML1
FOR NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY1
VENCLYXTO IS THE FIRST APPROVED BCL-2 INHIBITOR FOR THE TREATMENT OF AML1
Study M14-358 was a nonrandomised Phase 1/2 clinical trial of VENCLYXTO in combination with azacitidine (n=84) or decitabine (DEC) (n=31) in newly diagnosed patients with AML who were ineligible for intensive chemotherapy. VENCLYXTO + DEC demonstrated a 74% remission rate (CR+CRi) (95% CI: 55-88).1
VENCLYXTO + DECITABINE
M14-358: A PHASE 1/2 TRIAL EVALUATING VENCLYXTO PLUS DEC IN FIRST-LINE TREATMENT1
A nonrandomised study in patients with newly diagnosed AML who were ineligible for intensive chemotherapy1
| • | Patients received VENCLYXTO via a daily titration to a final daily dose of 400 mg. DEC 20 mg/m2 was administered intravenously on Days 1-5 of each 28-day cycle, beginning on Cycle 1 Day 1 |
| • | The median age of patients treated with VENCLYXTO plus DEC was 72 years (range: 65-86 years), 87% were white, 48% were male, and 87% had an ECOG status of 0 or 1 |
| • | The median duration of follow-up was 40.4 months (range: 0.7–42.7 months) |
AML=acute myeloid leukaemia; BCL-2=B-cell lymphoma 2; CR=complete remission; CRi=complete remission with incomplete haematological recovery; CI=confidence interval; DEC=decitabine; ECOG=Eastern Cooperative Oncology Group; VEN=VENCLYXTO.
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Reference: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. December 2022.
ALL-VNCAML-220066 October 2023