Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced today that nine abstracts, including two oral presentations, relating to the company’s hematology/oncology portfolio were accepted for the 60thAmerican Society of Hematology (ASH) Annual Meeting in San Diego from December 1-4.
‘We look forward to showcasing our commitment to the hematology/oncology community at ASH by advancing the science and addressing the clinical needs of patients with blood cancers and with complications of stem cell transplantation,’ said Allen Yang, M.D., Ph.D., head of clinical development and acting chief medical officer of Jazz Pharmaceuticals. ‘We’ve made great progress in the last year with the initiation of new clinical trials for Vyxeos and Defitelio, the marketing authorization of Vyxeos in the European Union, and a collaboration with MD Anderson Cancer Center to evaluate potential treatment options for hematologic malignancies.’
Jazz Pharmaceuticals data at the 2018 ASH Annual Meeting will highlight the following:Results from a post-hoc analysis from the pivotal Phase 3 randomized trial of Vyxeos®(daunorubicin and cytarabine) liposome for injection, also known as the molecule name CPX-351, in a subgroup of older patients with newly diagnosed high risk (secondary) AML with myelodysplasia-related changes (AML-MRC) that evaluated the efficacy of Vyxeos compared to conventional 7+3 chemotherapy on overall survival and remission rates as well as the safety profile in older adults with AML-MRC. Additionally, data will be presented from an exploratory analysis which evaluated the impact of hematopoietic cell transplantation (HCT) on survival in patients treated with Vyxeos compared to 7+3 in the Phase 3 trial.
Vyxeos abstracts include:
- Efficacy and Safety of CPX-351 versus 7+3 in a Subgroup of Older Patients with Newly Diagnosed Acute Myeloid Leukemia with Myelodysplasia-Related Changes (AML-MRC) Enrolled in a Phase 3 Study [Abstract #1425; Saturday, December 1, 6:15 PM – 8:15 PM PST]
- Population Pharmacokinetic (PK)/Pharmacodynamic (PD) Modeling of Myelosuppression in Patients with Hematologic Malignancies for CPX-351 and Standard-of-Care 7+3 Therapy [Abstract #4037; Monday, December 3, 6:00 PM – 8:00 PM PST]
- The Impact of Hematopoietic Cell Transplantation on Survival: An Exploratory Analysis of a Phase 3 Study of CPX-351 versus 7+3 in Older Patients with Newly Diagnosed, High-Risk/Secondary AML [Abstract #2706; Sunday, December 2, 6:00 PM – 8:00 PM PST]
- Final Safety and Efficacy Results from the CPX-351 Early Access Program (EAP) for Older Patients with High-Risk/Secondary Acute Myeloid Leukemia (sAML) [Abstract #1434; Saturday, December 1, 6:15 PM – 8:15 PM PST]
- Impact of Post-Hematopoietic Cell Transplant (HCT) Survival on Cost-effectiveness of CPX-351 versus 7+3 in the Treatment of Therapy-Related AML or AML-MRC in the United States (online only)
- A Phase I/Pilot Study of CPX-351 [Daunorubicin and Cytarabine Liposome for Injection (Vyxeos®)] for Children, Adolescents and Young Adults with Recurrent or Refractory Acute Leukemia [Abstract #336; Sunday, December 2, 10:45 AM PST(oral presentation)]
In addition, data from an expanded access program and post-hoc analyses of clinical trials for Defitelio® (defibrotide sodium) will be presented, including an oral presentation of a pooled analysis of survival based on timing of initiation in adults with Veno-Occlusive Disease/ Sinusoidal Obstruction Syndrome (VOC/SOS) following hematopoietic stem cell transplant (HSCT).
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