Clinical Data

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Study Design

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Patient and Disease Characteristics

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AML Subtypes

Study overview
The Phase 3 study was a randomised, open-label, active-controlled study of Vyxeos® Liposomal vs cytarabine and daunorubicin (conventional chemotherapy*) in patients aged 60-75 years with newly-diagnosed t-AML or AML-MRC1,2
Patients were diagnosed with t-AML, de novo AML with MDS karyotype, and AML with a history of MDS and chronic myelomonocytic leukaemia (CMML) with a performance score between 0 and 21,2
*comparator arm conventional chemotherapy is 7+3 in induction, 5+2 in second induction and consolidation where given
309 patients took part in the study: 153 were randomised to Vyxeos Liposomal and 156 patients were randomised to the conventional chemotherapy* arm1,2
There were similar patient characteristics across both treatment arms1,2
The primary endpoint of the study was overall survival. Efficacy was established on the basis of overall survival from the date of randomisation until death due to any cause1,2

References

  1. Vyxeos Liposomal – Summary of Product Characteristics, October 2019
  2. Lancet JE et alJ Clin Oncol 2018; 36(26): 2684-2692

 

ADVERSE EVENTS REPORTING

 

Reporting of side effects: Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via their national reporting system. Adverse events should also be reported to Jazz Pharmaceuticals by email: AEreporting@jazzpharma.com or by fax to +44 (0) 1865 598765

 

INT-VYX-2000063 | June 2020