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The content of this website has been produced in line with the MYLOTARG®▼ (gemtuzumab ozogamicin) Summary of Product Characteristics for Great Britain and Northern Ireland. For MYLOTARG®▼ (gemtuzumab ozogamicin) and cytarabine Prescribing Information Click here. Adverse event reporting information can be found at the bottom of the page.
The median EFS* of gemtuzumab ozogamicin + chemotherapy was 17.3 months (95% CI: 13.4, 30.0) in the MYLOTARG arm versus 9.5 months (95% CI: 8.1, 12.0) in the DA alone arm; hazard ratio (HR) 0.562 (95% CI: 0.415, 0.762); 2-sided p=0.0002 by log-rank test.
Median RFS was 28.0 months (95% CI: 16.3, NE) in the MYLOTARG arm versus 11.4 months (95% CI; 10.0, 14.4) in the DA alone arm; hazard ratio (HR) 0.526 (95% CI: 0.362, 0.764)
More patients in the MYLOTARG arm achived an overall response vs the control arm, although this difference was not significant
*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.5
Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA-0701 study.
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.
CI, Confidence Intervals; CR, Complete Remission, CRp, Complete Remission with incomplete platelet recovery;
DA, daunorubicin and cytarabine; DGH, District General Hospital; EFS: Event-free Survival, HR, Hazard Ratio; mEFS, median Event-free Survival; NE, not estimable; RFS: Relapse-free survival
References
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PP-PFE-GBR-3863. November 2021