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EfficacyEfficacyEfficacyKey HighlightsSafetySafetySafetySelected Adverse EventsDosingDosingDosingAdditional Administration informationSupport & resourcesSupport & resourcesResource overviewPatient SupportGuidelinesELN 2022 GuidelinesKey topics in AML video seriesEfficacy and Safety videoPubExplainer videos

Patient Fitness in AML

The content of this website has been produced in line with the MYLOTARG® (gemtuzumab ozogamicin) Summary of Product Characteristics for Great Britain and is intended for Healthcare Professionals based in Great Britain. For  MYLOTARG® (gemtuzumab ozogamicin) and cytarabine Prescribing Information Click here. Adverse event reporting information can be found at the bottom of the page.

Efficacy

ALFA-0701 Study Schema1-2

The pivotal study for MYLOTARG is the randomised Phase III ALFA-0701 study. In this study, treatment-naive patients (n=280*,  ITT population), aged 50-70 years, with confirmed AML and normal cardiac function were randomised to receive either  MYLOTARG 3mg/m2 (maximum one 5mg vial) days 1, 4 and 7 plus DNR/AraC 3+7 (n=139*) OR DNR/AraC (SoC) 3+7 (n=138*).1-4

The primary endpoint was event free survival (EFS), defined as the time from randomisation to relapse, death from any cause or time to the date of assessment of response if CR or CRp had not been achieved.2

*A total of 277 patients received treatment (n = 139, DNR/AraC + MYLOTARG arm; n = 138 DNR/AraC arm). Full details regarding patient flow are reported in Lambert et al.3-4
†Eligible patients required a locally confirmed morphological diagnosis of AML and normal cardiac function, assessed by use of radionucleotide scintigraphy or echography. CD33+ leukaemic blast cells were not required for study entry.
‡Original study allowed consolidation for patients with a complete remission with incomplete platelet recovery (CRp) but dosing modifications preclude the use of MYLOTARG for consolidation in patients with a platelet count of < 100,000/mm3.
§Without MYLOTARG and in patients who did not achieve CR/CRp after Course 1.

Median EFS was significantly longer with MYLOTARG + standard chemotherapy vs standard chemotherapy alone3

EFS significantly improved with MYLOTARG in patients with intermediate and favourable cytogenetics vs standard chemotherapy6

A retrospective analysis of the 235 patients with non-CBF AML from the ALFA-0701 study assessed the efficacy of MYLOTARG plus SoC according to ELN 2017 risk classification.6-7 Results showed that the addition of MYLOTARG to SoC significantly prolonged EFS vs. SoC alone in patients who had favourable- and intermediate-risk cytogenetics, with no benefit shown in those with adverse cytogenetics.5 ​​​

ELN-Favourable 

HR: 0.54 [95% CI, 0.30=0.98]; p=0.04

Adapted from Fournier E, et al. Blood. 2020.6
*Primary endpoint: Investigator assessed event-free survival (EFS)
 

ELN-Intermediate 

HR: 0.57 [95% CI, 0.33-1.00]; p=0.05

Adapted from Fournier E, et al. Blood. 2020.6
*Primary endpoint: Investigator assessed event-free survival (EFS)
 

EFS in ELN-Adverse 

HR: 0.93 [95% CI, 0.61-1.453]; p=0.74

Adapted from Fournier E, et al. Blood. 2020.6
*Primary endpoint: Investigator assessed event-free survival (EFS)
 

For more information on Dosing and Administration, please access the Dosing page  Loading Please refer to the MYLOTARG Summary of Product Characteristics for full details Loading

Efficacy and safety of MYLOTARG video

Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA-0701 study.

Learn moreLoading

Treating Patients with de novo AML in the DGH Setting

Watch Dr. Sreetharan Munisamy discuss the current treatment landscape for de novo AML in Video 1 of the Key Topics in the Management of de novo AML video series. Click the link below to explore the rest of the on-demand series.

Learn moreLoading

AML, acute myeloid leukaemia; AraC, cytarabine; CBF, Core binding factor; CHEMO, chemotherapy; CI, confidence interval; CR, complete remission; CRp, complete remission with incomplete platelet recovery; DGH, District General Hospital; DNR, daunorubicin; EFS, event-free survival; ELN, European LeukemiaNet; HR, hazard rarios; ITT, intention-to-treat; mo, months; MYLO, MYLOTARG; SoC, standard chemotherapy
 

References

MYLOTARG Summary of Product Characteristics for Great Britain click here. MYLOTARG Summary of Product Characteristics for Northern Ireland click here.Castaigne S, et al. Lancet 2012;379:1508-1516Lambert J, et al. Haematologica 2019;104:113–119Lambert J, et al. Haematologica 2019;104:113–119. Supplementary analysis.Pfizer Ltd. Data on File. CSR. 2018Fournier E et al. Blood 2020;135(8):542-546Dohner H et al. Blood 2017;129(4):424-447
PP-MYL-GBR-0680. April 2023

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Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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