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Jazz Pharmaceuticals to Highlight Growing Hematology Oncology Pipeline at ASH 2019 Annual Meeting

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DUBLIN, Nov. 7, 2019 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that 15 abstracts sponsored by Jazz Pharmaceuticals, including one oral presentation, one abstract from a collaboration trial with MD Anderson Cancer Center (MD Anderson) and two abstracts from investigator-sponsored trials, will be presented at the 61st American Society of Hematology (ASH) Annual Meeting in Orlando from December 7-10, 2019.

Jazz Pharmaceuticals Logo (PRNewsFoto/Jazz Pharmaceuticals plc) (PRNewsFoto/Jazz Pharmaceuticals plc)

"Jazz's ASH presence reflects our commitment to developing new medicines for patients who have limited or no treatment options," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "We are pleased with the progress we made over the last year to initiate new clinical trials and cooperative group studies, and further expanding our oncology pipeline."

Highlights at ASH will include:

  • An oral presentation comparing outcomes for Vyxeos® (daunorubicin and cytarabine), also known as CPX-351, versus 7+3 in the Study 301 subgroup of patients with pretreatment blood or bone marrow samples available evaluating secondary acute myeloid leukemia (AML) patient genetic characteristics and the association between gene mutations and outcomes
  • A poster presentation comparing outcomes for CPX-351 versus 7+3 in the Study 301 subgroup of patients who met the World Health Organization 2008 AML with myelodysplasia-related changes criteria and achieved a complete remission (CR) or CR with incomplete neutrophil or platelet recovery (CRi)
  • A poster presentation comparing outcomes for CPX-351 versus 7+3 in the Study 301 subgroup of patients with therapy-related AML who achieved a CR or CRi
  • A poster presentation from a collaboration study with MD Anderson evaluating CPX-351 in combination with gemtuzumab ozogamicin in relapsed refractory patients with AML and post-hypomethylating agent failure high-risk myelodysplastic syndrome
  • A poster presentation summarizing safety and outcome data from patients with severe veno-occlusive disease/sinusoidal obstruction syndrome after hematopoietic cell transplantation who were treated with defibrotide and assessing patterns of defibrotide utilization in the post-approval setting

A full list of Jazz-sponsored oral and poster presentations follows below:

Vyxeos (CPX-351) Presentations


Presentation Title

Author

Date / Time (ET) / Session / Location

Genetic Characteristics and Outcomes by Mutation Status in a Phase 3 Study of CPX-351 Versus 7+3 in Older Adults with Newly Diagnosed, High-Risk/Secondary Acute Myeloid Leukemia (AML) 

Lindsley et al.

Oral presentation:

Saturday, December 7

8:00 a.m., Room W304

 

613. Acute Myeloid Leukemia: Clinical Studies: Prognostic Factors and Treatment Outcomes

Efficacy and Safety of CPX-351 Versus 7+3 in a Phase 3 Exploratory Analysis in Patients with High-Risk/Secondary Acute Myeloid Leukemia (AML) with Prior Hypomethylating Agent Exposure Who Achieved Remission

Lin et al.

Saturday, December 7

5:30 p.m. – 7:30 p.m., Hall B

 

613. Acute Myeloid Leukemia: Clinical Studies: Poster I

A Descriptive Study on Healthcare Utilization and Costs in Secondary Acute Myeloid Leukemia (AML) Patients Treated with CPX-351 Versus Those Treated with 7+3

Price et al.

Saturday, December 7

5:30 p.m. – 7:30 p.m., Hall B

 

906. Outcomes Research—Malignant Conditions (Myeloid Disease): Poster I

Quantifying the Economic Burden of Myelodysplastic Syndromes Among Elderly US Patients

Shafrin et al.

Saturday, December 7

5:30 p.m. – 7:30 p.m., Hall B

 

903. Health Services Research—Malignant Conditions (Myeloid Disease): Poster I

Outcomes in Patients with Therapy-Related Acute Myeloid Leukemia (t-AML) Who Achieved Remission with CPX-351 Versus 7+3: Phase 3 Exploratory Analysis

Lancet et al.

Saturday, December 7

5:30 p.m. – 7:30 p.m., Hall B

 

613. Acute Myeloid Leukemia: Clinical Studies: Poster I

Outcomes in Patients with Acute Myeloid Leukemia with Myelodysplasia-Related Changes (AML-MRC) Who Achieved Remission with CPX-351 Versus 7+3: Phase 3 Exploratory Analysis

Ryan et al.

Monday, December 9

6:00 p.m. – 8:00 p.m., Hall B

 

613. Acute Myeloid Leukemia: Clinical Studies: Poster III

Phase 3 Exploratory Analysis of Outcomes in Patients with Acute Myeloid Leukemia with Myelodysplasia-Related Changes (AML-MRC) Who Received Consolidation with CPX-351 Versus Conventional Chemotherapy

Kolitz et al.

Monday, December 9

6:00 p.m. – 8:00 p.m., Hall B

 

613. Acute Myeloid Leukemia: Clinical Studies: Poster III

 

Defibrotide Presentations


Presentation Title

Author

Date / Time (ET) / Session / Location

A Multi-Center, Multinational, Prospective Observational Registry Study of Defibrotide in Patients Diagnosed with Severe Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS) after Hematopoietic Cell Transplantation (HCT)

Mohty et al.

Saturday, December 7

5:30 p.m. – 7:30 p.m., Hall B

 

721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Poster I

A Meta-Analysis Evaluating the Risk of Bleeding-Related Adverse Events with Defibrotide Treatment

Tappe et al.

Saturday, December 7

5:30 p.m. – 7:30 p.m., Hall B

 

723. Clinical Allogeneic and Autologous Transplantation: Late Complications and Approaches to Disease Recurrence: Poster I

Incidence and Cost of Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome with and without Multi-Organ Dysfunction: Analysis of the Premier Healthcare Database

Dvorak et al.

Monday, December 9

6:00 p.m. – 8:00 p.m., Hall B

 

901. Health Services Research—Non-Malignant Conditions: Poster III

 

JZP-458 Presentations


Presentation Title

Author

Date / Time (ET) / Session / Location

Open-label, Multicenter, Phase 2/3 Study of Recombinant Crisantaspase Produced in Pseudomonas fluorescens in Patients with Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) Following Hypersensitivity to Escherichia coli–derived Asparaginases

Maese et al.

Sunday, December 8

6:00 p.m. – 8:00 p.m., Hall B

 

612. Acute Lymphoblastic Leukemia: Clinical Studies: Poster II

A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Recombinant Crisantaspase Produced in Pseudomonas fluorescens (RC-P) in Healthy Adults

Hernandez-Illas et al.

Monday, December 9

6:00 p.m. – 8:00 p.m., Hall B

 

612. Acute Lymphoblastic Leukemia: Clinical Studies: Poster III

Additionally, data from the following investigator-sponsored and collaboration trials on Vyxeos and Defitelio, respectively, will be presented:

Presentation Title

Author

Date / Time (ET) / Session / Location

Liposomal Cytarabine and Daunorubicin (CPX-351) in Combination with Gemtuzumab Ozogamicin (GO) in Relapsed Refractory (R /R) Patients with Acute Myeloid Leukemia (AML) and Post-Hypomethylating Agent  (Post-HMA) Failure High-Risk Myelodysplastic Syndrome (HR-MDS) [MD Anderson collaboration trial]

Ramos Perez et al.

Sunday, December 8

6:00 p.m. – 8:00 p.m., Hall B

 

615. Acute Myeloid Leukemia: Commercially Available Therapy, excluding Transplantation: Poster II

CPX-351 As First Intensive Therapy for Elderly Patients with AML

Ritchie et al.

Monday, December 9

6:00 p.m. – 8:00 p.m., Hall B

 

613. Acute Myeloid Leukemia: Clinical Studies: Poster III

Defibrotide Inhibits Endothelial Cell Injury Induced by Plasmas of Patients with Thrombotic Microangiopathies

Elhadad et al.

Monday, December 9

6:00 p.m. – 8:00 p.m., Hall B

 

332. Anticoagulation and Antithrombotic Therapy: Poster III

About Vyxeos® (daunorubicin and cytarabine)
Vyxeos® (daunorubicin and cytarabine) is a liposomal formulation of a fixed combination of daunorubicin and cytarabine for intravenous infusion that represents the first, only and most proven chemotherapy treatment option specifically for two types of high-risk, secondary AML: newly diagnosed therapy-related acute myeloid leukemia (AML) and AML with myelodysplasia-related changes. Backed by a robust clinical development program including Phase 3 data, Vyxeos is currently approved in more than 30 countries including the U.S., and we continue to work with regulatory authorities worldwide to bring this innovative therapy to appropriate patients.

Important Safety Information for Vyxeos

Vyxeos has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute Vyxeos for other daunorubicin- and/or cytarabine- containing products.

Vyxeos should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine or any of its ingredients.

Vyxeos can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with Vyxeos. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.

Vyxeos can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:

  • shortness of breath or trouble breathing
  • swelling or fluid retention, especially in the feet, ankles or legs
  • unusual tiredness
  • Vyxeos may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:
  • trouble breathing
  • severe itching
  • skin rash or hives
  • swelling of the face, li
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