Note to Affiliates: VEN + LDAC is not approved in the EU. These are optional pages for affiliates with this combination in label. Localize use of the VENCLYXTO or VENCLEXTA brand names in accordance with your local label.
[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.
VIALE-C evaluated [VENCLYXTO] plus low-dose cytarabine (VEN+LDAC), an alternative to combination with hypomethylating agents (VEN+HMAs). The primary endpoint (statistically significant improvement in overall survival) was not met, therefore, secondary endpoints are descriptive only. VIALE-C was a randomised (2:1), double-blind, placebo-controlled, Phase 3 study that evaluated the efficacy and safety of VEN+LDAC in patients with newly diagnosed AML who were ineligible for intensive chemotherapy.1,2
SAFETY/TOLERABILITY FOR [VENCLYXTO] + LOW-DOSE CYTARABINE
DISCONTINUATION RATES WITH [VENCLYXTO] PLUS LDAC
DISCONTINUATIONS, DOSE INTERRUPTIONS, AND DOSE REDUCTIONS DUE TO AEs FOR VEN+LDAC VS LDAC ALONE, RESPECTIVELY1,2
| • | 25% of patients discontinued treatment vs 24% |
| • | 63% of patients experienced dose interruptions vs 53% |
| • | 9% of patients had dose reductions vs 6% |
| • | The most common AEs that led to dose reductions or interruptions were neutropaenia, thrombocytopaenia, pneumonia, febrile neutropaenia, and sepsis (excluding fungal) |
[VENCLYXTO] PLUS LDAC SAFETY AND TOLERABILITY PROFILE
Adverse events with [VENCLYXTO] plus LDAC were manageable and well-characterised1,2
MOST COMMON TREATMENT-EMERGENT AEs (≥20% IN EITHER TREATMENT ARM)
SERIOUS TREATMENT-EMERGENT AEs (ANY GRADE)
| • | Of the patients treated with [VENCLYXTO] plus LDAC, 8 (5.6%) experienced TLS, including those who died or experienced renal failure1,2 *Aligns with VENCLEXTA US Prescribing Information. |
[VENCLYXTO] + LDAC ADVERSE REACTIONS
ADVERSE REACTIONS (≥10%) IN PATIENTS WITH AML WHO RECEIVED VEN+LDAC IN VIALE-C STUDY1*
OTHER CLINICALLY IMPORTANT ADVERSE REACTIONS1
*Includes patients with a difference between arms of ≥5% for all grades or ≥2% for Grade 3 or 4 compared with placebo+LDAC.
†Includes other terms that can be found on [VENCLEXTO] US Prescribing Information.
AML=acute myeloid leukaemia; AE=adverse event; BCL-2=B-cell lymphoma 2; HMA=hypomethylating agent; LDAC=low-dose cytarabine; TLS=tumour lysis syndrome; VEN=VENCLYXTO.
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References: 1. VENCLEXTA Prescribing Information. North Chicago, IL: AbbVie Inc. 2. Wei AH, Montesinos P, Ivanov V, et al. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial. Blood. 2020;135(24):2137-2145. doi:10.1182/blood.2020004856
ALL-VNCAML-220066 October 2023
Note to Affiliates: VEN + LDAC is not approved in the EU. Use of the VENCLEXTA brand name in this piece necessitates use of the VENCLEXTA U.S. Prescribing Information (PI) in the references.