Clinical Data

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Overall Survival

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Response Rates

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Transplant Outcomes

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Induction and Consolidation

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Patients Achieving CR or CRi

*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 survival1

  • Median of 9.6 months (Vyxeos Liposomal) vs 6.0 months (conventional chemotherapy*) (P=0.003) (1-sided)1
  • 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 month overall survival1

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

Significantly higher complete response and overall remission rates1

  • CR rates were 37.3% (Vyxeos Liposomal) vs 25.6% (conventional chemotherapy*) (P=0.040)1
  • Overall remission rates (CR + CRi) were 47.7% (Vyxeos Liposomal) vs 33.3% (conventional chemotherapy*) (P=0.016)1
  • Post-hoc analysis suggests that, in patients with a CR or CRi, overall survival was greater for those receiving Vyxeos Liposomal vs conventional chemotherapy*3,4

Reduced 30- and 60-day mortality1

  • 30-day mortality: 5.9% vs 10.6% (P=0.149)
  • 60-day mortality: 13.7% vs 21.2% (P=0.097)

More patients to transplant1

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

Improved survival post-transplant1

  • Post-hoc analysis suggests that Vyxeos Liposomal may improve patients’ transplant outcomes vs conventional chemotherapy*

References

  1. Lancet JE et al. J Clin Oncol 2018; 36(26): 2684-2692
  2. Kolitz JE et al. AML-275. Poster presented at the 6th Annual Meeting of the Society of Hematologic Oncology, Houston, USA. September 2018
  3. Faderl S et al. Ann Hematol 2019; 98(1): 39-40
  4. Faderl S et al. Presented at the International Symposium on Acute Leukemias (ISAL) XVII, February 2019, Munich, Germany
  5. Vyxeos Liposomal – Summary of Product Characteristics, October 2019
  6. Jazz Pharmaceuticals. Data on File (1)

 

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-1900008 | January 2020