PHASE 3: STUDY DESIGN

A PHASE 3, RANDOMIZED, MULTICENTRE, OPEN-LABEL STUDY EVALUATED THE EFFICACY AND SAFETY OF VYXEOS IN ADULTS WITH NEWLY DIAGNOSED HIGH-RISK sAML^1,2*

Study design of the phase 3 study — Adapted from the VYXEOS Product Monograph.

Study design of the phase 3 study mobile — Adapted from the VYXEOS Product Monograph.

PATIENT CHARACTERISTICS WERE SIMILAR ACROSS THE TREATMENT ARMS^1,3

Adapted from the VYXEOS Product Monograph and Lancet JE, et al (2018).

Adapted from the VYXEOS Product Monograph and Lancet JE, et al (2018).

CMMoL AML: Chronic myelomonocytic leukemia AML

ECOG: Eastern Cooperative Oncology Group

HMA: Hypomethylating agents

MDS: Myelodysplastic syndromes

PS: Performance status

*sAML defined as AML occurring after therapy and/or an antecedent myeloid disease e.g. MDS or MPN, excluding chronic myeloid leukemia, regardless of prior cytotoxic therapy for these disorders. This includes the subtypes, t-AML, AML-MRC and CMMoL AML.^2,4

†Stratified by age and AML subtype.

‡Conventional chemotherapy includes the 7+3/5+2 regimen for induction and consolidation, using cytarabine and daunorubicin.³

§As determined by the NCCN criteria.

References: 1. Current VYXEOS^® Product Monograph, Jazz Pharmaceuticals Canada, Inc. 2. Granfeldt Østgård LS, Medeiros BC, Sengeløv H, et al. Epidemiology and clinical significance of secondary and therapy-related acute myeloid leukemia: A national population-based cohort study. J Clin Oncol 2015;33:3641–9. 3. Lancet JE, Uy GL, Cortes JE, et al. CPX-351 (cytarabine and daunorubicin) liposome for injection versus conventional cytarabine plus daunorubicin in older patients with newly diagnosed secondary acute myeloid leukemia. J Clin Oncol 2018;36:2684–2692. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Acute Myeloid Leukemia V.2.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed January 2021. To view the most recent and complete version of the guideline, go online to NCCN.org.

PHASE 3: STUDY DESIGN

A PHASE 3, RANDOMIZED, MULTICENTRE, OPEN-LABEL STUDY EVALUATED THE EFFICACY AND SAFETY OF VYXEOS IN ADULTS WITH NEWLY DIAGNOSED HIGH-RISK sAML1,2*

PATIENT CHARACTERISTICS WERE SIMILAR ACROSS THE TREATMENT ARMS1,3

A PHASE 3, RANDOMIZED, MULTICENTRE, OPEN-LABEL STUDY EVALUATED THE EFFICACY AND SAFETY OF VYXEOS IN ADULTS WITH NEWLY DIAGNOSED HIGH-RISK sAML^1,2*

PATIENT CHARACTERISTICS WERE SIMILAR ACROSS THE TREATMENT ARMS^1,3