Clinical Data

https://vyxeos.eu/wp-content/uploads/2018/08/1_VYXEOS_GRAPH_16x9_OVERALL_SURVIVAL_180831.png

Overall Survival

https://vyxeos.eu/wp-content/uploads/2018/08/2_VYXEOS_GRAPH_16X9_RESPONSE_RATES_180828-3.png

Response Rates

https://vyxeos.eu/wp-content/uploads/2018/08/3_VXYEOS_GRAPH_16X9_TRANSPLANT_DATA_180828-1.png

Transplant Outcomes

*High-risk AML is defined as therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)

Vyxeos has demonstrated:

Significant improvement in overall survival1

  • Median of 9.6 months (Vyxeos) vs 6.0 months (7+3 chemotherapy) (P=0.005) (2-sided)
  • 31% reduction in risk of death for patients treated with Vyxeos vs 7+3 chemotherapy

Improved estimated 12 & 24 month overall survival1

  • 12 months OS: 41.5% (Vyxeos) vs 27.6% (7+3 chemotherapy)
  • 24 months OS: 31.1% (Vyxeos) vs 12.3% (7+3 chemotherapy)

Significantly higher complete response and overall remission rates1

  • Complete response rates were 37.3% (Vyxeos) vs 25.6% (7+3 chemotherapy) (P = 0.040)
  • Overall remission rates (CR + CRi) were 48% (Vyxeos) vs 33% (7+3 chemotherapy) (P = 0.016)

Reduced 30- and 60-day mortality1

  • 30-day mortality: 5.9% vs 10.6% and 60-day mortality: 13.7% vs 21.2%, respectively

More patients to transplant1

  • More patients treated with Vyxeos (34%) proceeded to transplant compared to 7+3 chemotherapy (25%)

Improved survival post-transplant1

  • Post-hoc analysis suggests that Vyxeos may improve patients’ transplant outcomes vs 7+3 chemotherapy

References

  1. Lancet JE et al. 2018. J Clin Oncol 2018. Published online ahead of print. doi: 10.1200/JCO.2017.77.6112
  2. VYXEOS Summary of product characteristics

 

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. In the United Kingdom, reporting forms and information can be found at https://yellowcard.mhra.gov.uk/. Adverse events should also be reported by email: AEreporting@jazzpharma.com or by fax to +44 (0) 1865 598765

 

EURW-INTVYX-0020a(1) | September 2019