Clinical Data

INCLUDING NEW 5-YEAR FOLLOW-UP DATA
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Overall Survival

https://vyxeos.eu/wp-content/uploads/2020/06/01_VYXEOS_GRAPH_RESPONSE_RATES-1.jpg

Response Rates

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Transplant Outcomes

*comparator arm conventional chemotherapy is 7+3 in induction, 5+2 in second induction and consolidation where given

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

Vyxeos Liposomal has demonstrated:

Significant improvement in overall survival

  • Primary endpoint: Median of 9.6 months (Vyxeos Liposomal) vs 6.0 months (conventional chemotherapy*) (P=0.003) (1-sided)1
  • Median follow-up of 20.7 months: 31% reduction in relative risk of death for patients treated with Vyxeos Liposomal vs conventional chemotherapy*1
  • Median of over 2 years overall survival when Vyxeos Liposomal is used for induction and consolidation2

Improved estimated 12-, 24- and 60-month overall survival

  • 12 months OS: 41.5% (Vyxeos Liposomal) vs 27.6% (conventional chemotherapy*)1
  • 24 months OS: 31.1% (Vyxeos Liposomal) vs 12.3% (conventional chemotherapy*)1
  • 60 months OS: 18% (Vyxeos Liposomal) vs 8% (conventional chemotherapy*)3
    Adapted from Kaplan-Meier-estimated OS curve

Significantly higher complete response and overall remission rates

  • CR rates were 37.3% (Vyxeos Liposomal) vs 25.6% (conventional chemotherapy*) (P=0.040) (Median follow-up of 20.7 months)1
  • Overall remission rates (CR + CRi) were 47.7% (Vyxeos Liposomal) vs 33.3% (conventional chemotherapy*) (P=0.016)1

Reduced 30- and 60-day mortality1

  • 30-day mortality: 5.9% (Vyxeos Liposomal) vs 10.6% (conventional chemotherapy*) (P=0.149)
  • 60-day mortality: 13.7% (Vyxeos Liposomal) vs 21.2% (conventional chemotherapy*) (P=0.097)

More patients to transplant1

  • More patients treated with Vyxeos Liposomal (34%) proceeded to transplant compared with conventional chemotherapy* (25%) (P=0.098)

Improved survival post transplant3

  • Overall survival maintained above 50% at 5 years in a post-hoc analysis3

References

  1. Lancet JE et al. J Clin Oncol 2018; 36(26): 2684-2692
  2. Kolitz JE et al. Leuk Lymphoma 2020;61(3):631-640
  3. Lancet JE et al. Poster presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. Virtual Format. May 29-31, 2020
  4. Vyxeos Liposomal – Summary of Product Characteristics, October 2019
  5. Faderl S et al. Ann Hematol 2019; 98(1): 39-40
  6. Faderl S et al. Poster presented at the International Symposium on Acute Leukemias (ISAL) XVII, Munich, Germany. February 2019
  7. Lin TL et al. Poster presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. Virtual Format. May 29-31, 2020

 

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