Jazz Pharmaceuticals to Present New Data at the Annual ASH Meeting
"The data presentations at ASH reflect our efforts in advancing our diversified pipeline of programs in hematology and oncology, including rare blood disorders such as acute lymphoblastic leukemia (ALL) and AML, and in complications of hematopoietic stem-cell transplantation (HSCT) such as hepatic VOD," said
The following oral and poster presentations focusing on Defitelio® (defibrotide sodium) injection, Erwinaze® (asparaginase Erwinia chrysanthemi) and CPX-351(cytarabine and daunorubicin liposome injection) will be presented at ASH.
Defitelio Related Oral and Poster Presentations
Presentation Title |
Author |
Presentation Number / Date / Time / Location |
Timing of Initiation of Defibrotide Post-Diagnosis of Hepatic Veno-Occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome (SOS) Post-Hematopoietic Stem Cell Transplantation (HSCT): Exploratory Age-Group Analysis From an Expanded Access Study
|
Grupp S, et al. |
Oral Presentation 66: - December 3; 8:45 AM (PT); Manchester Grand Hyatt San Diego, Grand Hall B - Session 721: Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Post-Transplant Complications |
Impact on Outcomes of Baseline Bilirubin in Patients with Hepatic VOD/SOS Receiving Defibrotide Treatment: A Post-Hoc Analysis
|
Richardson P, et al. |
Poster Presentation 2213: - December 3; 5:30-7:30 PM (PT); San Diego Convention Center, Hall GH - Session 721: Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Poster I |
Treatment of Hepatic VOD/SOS Post-HSCT in Patients With Acute Leukemias: A Subgroup Analysis From the Defibrotide Expanded-Access Program |
Richardson P, et al. |
Poster Presentation 3412: - December 4; 6:00-8:00 PM (PT); San Diego Convention Center, Hall GH - Session 721: Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Poster II |
VOD Related Abstract
Abstract Title |
Author |
Details |
Stratification of Allogeneic HSCT Patients by Risk of Developing VOD: A Model for Assigning a Risk Score
|
Strouse C, et al. |
Oral Presentation 983: - December 5; 3:45 PM (PT); Manchester Grand Hyatt San Diego, Grand Hall B Session 721: Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Post-Transplant Complications II |
Diagnosis of VOD/SOS With or Without Multi-Organ Dysfunction (MOD) After HSCT: Analysis of a Multicenter Chart Review |
Doede T, et al. |
Online Only Publication; Abstract 5756 |
Erwinaze Related Oral and Poster Presentations
Presentation Title |
Author |
Presentation Date / Time / Location |
Population Pharmacokinetic Modeling of Intravenous Asparaginase Erwinia Chrysanthemi: Impact of Varied Infusion Rates on Exposure
|
Zomorodi K, et al. |
Poster Presentation 1631: - December 3; 5:30-7:30 PM (PT), San Diego Convention Center, Hall GH - 614: Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Poster I |
CPX-351 Related Oral and Poster Presentations
Presentation Title |
Author |
Presentation Date / Time / Location |
Analysis of Efficacy by Age for Patients Aged 60–75 With Untreated Secondary Acute Myeloid Leukemia (AML) Treated With CPX-351 Liposome Injection Versus Conventional Cytarabine and Daunorubicin in a Phase III Trial |
Medeiros B, et al. |
Oral Presentation 902: - December 5; 3:00 PM (PT); Marriot Marquis San Diego Marina, San Diego Ballroom AB - Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Clinical Trials of Novel Drugs and Combinations in AML |
Survival Following Allogeneic Hematopoietic Cell Transplantation in Older High-Risk Acute Myeloid Leukemia Patients Initially Treated With CPX-351 Liposome Injection Versus Standard Cytarabine and Daunorubicin: Subgroup Analysis of a Large Phase III Trial |
Lancet J, et al. |
Oral Presentation 906: - December 5; 4:00 PM (PT); Marriot Marquis San Diego Marina, San Diego Ballroom AB - Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Clinical Trials of Novel Drugs and Combinations in AML |
Enhanced Cytarabine and Daunorubicin Population Pharmacokinetics When Administered as CPX-351: A Novel Liposomal Formulation Not Requiring Dose Reduction for Mild Renal or Hepatic Dysfunction
|
Nikanjam M, et al. |
Poster Presentation 3955: - December 5; 6:00 – 8:00 PM (PT); San Diego Convention Center, Hall GH - Session 604: Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster III |
AML Related Poster
Presentation Title |
Author |
Presentation Number / Date / Time / Location |
Burden of Acute Myeloid Leukemia (AML) Among Older Newly-Diagnosed Patients |
Sacks N, et al. |
Poster Presentation 4780: - December 5; 6:00 – 8:00 PM (PT); San Diego Convention Center, Hall GH - Session 904: Outcomes Research—Malignant Conditions: Poster III |
Additionally, one
Presentation Title |
Author |
Presentation Number / Date / Time / Location |
CPX-351 for the Treatment of High-Risk Patients (pts) With Acute Myeloid Leukemia (AML) |
Assi, R, et al.
|
Poster Presentation 4047: - December 5; 6:00 – 8:00 PM (PT); San Diego Convention Center, Hall GH - Session 616: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III |
Full details of the ASH 2016 annual meeting can be found here (http://www.hematology.org/Annual-Meeting/) and abstracts can be found here (https://ash.confex.com/ash/2016/webprogram/start.html).
About Defitelio1
In the U.S., Defitelio® (defibrotide sodium) injection 80mg/mL received
Defitelio is contraindicated in patients currently taking anticoagulants or fibrinolytics and in patients who are allergic to Defitelio or any of its ingredients. Defitelio may increase the risk of bleeding and should be withheld or stopped if significant bleeding occurs. Patients should be monitored for allergic reactions, especially if there is a history of previous exposure to Defitelio. The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds.
Please see full Prescribing Information for Defitelio. (https://defitelio.com/DefitelioPI.pdf)
In
About VOD
HSCT is an aggressive, potentially curative procedure to treat patients with malignant and non-cancerous hematologic disorders such as leukemia, lymphoma and aplastic anemia, and congenital immunodeficiency and autoimmune disorders.2 VOD is a rare complication of HSCT, which occurs in approximately 9-14% of HSCT patients.3,4 Hepatic VOD, also known as SOS, is an early and life-threatening complication affecting the sinusoidal endothelial cells of the liver, which can typically occur within the first 21 days following HSCT.4,5 Hepatic VOD progresses to multi-organ dysfunction in approximately 30-50% of cases.5 VOD with multi-organ dysfunction (MOD) is associated with an overall mortality (death) rate of 84%.3 MOD is characterized by the presence of renal or pulmonary dysfunction.6,7 VOD is often characterized by sudden weight gain, hepatomegaly (abnormally enlarged liver), and elevated bilirubin.6,7
About Erwinaze
Erwinaze® (asparaginase Erwinia chrysanthemi) is currently approved in the U.S. for administration via intramuscular injection or via intravenous infusion in conjunction with chemotherapy. It is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.8 Erwinaze is derived from the bacterium Erwinia chrysanthemi and is therefore immunologically distinct from E. coli-derived asparaginase and suitable for patients with hypersensitivity to E. coli-derived treatments9. Outside of the U.S., Erwinaze is sold under the name Erwinase®. Please consult local labeling for product information specific to your country.
Erwinaze is contraindicated in patients who have had serious allergic reactions to Erwinaze, or had serious swelling of the pancreas, serious blood clots, or serious bleeding with past L-asparaginase treatment. Erwinaze should be discontinued if any of the following occur: serious allergic reactions, including a feeling of tightness in the throat, unusual swelling/redness in the throat and/or tongue, or trouble bleeding; or severe inflammation of the pancreas. Glucose intolerance has been reported, which in some cases may be irreversible. If blood clots of bleeding occur, discontinue Erwinaze until symptoms resolve. The most common side effects of Erwinaze are allergic reactions, too much sugar in the blood, fever, swelling of the pancreas, local reactions (swelling, rash, etc. where the needle entered the skin), vomiting, nausea, blood clots, liver problems, stomach pain/discomfort, and diarrhea. Please see full Prescribing Information for Erwinaze. (https://www.jazzpharma.com/wp-content/uploads/2016/01/erwinaze-en-PI.pdf)
About Vyxeos (CPX-351)
CPX-351 (cytarabine and daunorubicin liposome injection) is an investigational product being evaluated for the treatment of AML and is a combination of cytarabine and daunorubicin encapsulated within a nano-scale liposome at a 5:1 molar ratio. The proposed trade name, Vyxeos™, is conditionally approved by the
About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a rapidly progressing and life-threatening blood cancer that rises in frequency with age.16
The median age at diagnosis is 67 and with rising age there is progressive worsening of prognosis.10,12 Advancing age is associated with increasing risk of specific chromosomal/mutational changes and risk of pre-malignant marrow disorders which give rise to more aggressive and less responsive forms of AML.13,14 As patients age there is also reduced tolerance for intensive chemotherapy.15 As a consequence, advances in supportive care, intensive chemotherapy, and bone marrow transplantation have primarily benefitted younger patients with approximately one third of patients 18-60 years of age achieving cure.13,15 Older patients have not achieved higher rates of cure or improved upon a 5-year survival rate of 10-20% in spite of 40 years of research.15,16
About
References:
1 Defitelio (defibrotide sodium) [package insert].
2 Ikehara S. New strategies for BMT and organ transplantation. Int J Hematol. 2002;76(Suppl 1):161-4.
3 Coppell JA, Richardson PG, Soiffer R, et al. Hepatic veno-occlusive disease following stem cell transplantation: incidence, clinical course, and outcome. Biol Blood Marrow Transplant. 2010;16(2):157-168.
4Tsirigotis PD, Resnick IB, Avni B, et al. Incidence and risk factors for moderate-to-severe veno-occlusive disease of the liver after allogeneic stem cell transplantation using a reduced intensity conditioning regimen. Bone Marrow Transplant. 2014;49(11):1389-1392.
5 Carreras E, Díaz-Beyá M, Rosiñol L, et al. The incidence of veno-occlusive disease following allogeneic hematopoietic stem cell transplantation has diminished and the outcome improved over the last decade. Biol Blood MarrowTransplant. 2011;17(11):1713-1720.
6 Carreras E. How I manage sinusoidal obstruction syndrome after haematopoietic cell transplantation. Brit J Haematol. 2015 Feb.; 168 (4); 481-91.
7 Mohty M, Malard F, Abecassis M, et al. Sinusoidal obstruction syndrome/veno‐occlusive disease: current situation and perspectives—a position statement from the
8 Erwinaze® (asparaginase Erwinia chrysanthemi) [prescribing information].
9 Pieters R, Hunger SP, Boos J, et al. L-asparaginase treatment in acute lymphoblastic leukemia: a focus on Erwinia asparaginase. Cancer. 2011 Jan 15; 117(2): 238–249.
10
11
12 Baer M, George S, Sanford B, et al. Escalation of daunorubicin and addition of etoposide in the ADE regimen in acute myeloid leukemia patients aged 60 years and older: Cancer and Leukemia Group B Study 9720. Leukemia. 2011;25(5):10.1038/
13 Ferrara F, Schiffer CA. Acute myeloid leukaemia in adults. Lancet. 2013
14 Dohner H, Estey EH, Amadori S, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010 Jan 21;115(3):453-474.
15 Stone RM, O'Donnell MR, Sekeres MA. Acute myeloid leukemia. Hematology Am Soc Hematol Educ Program. 2004:98-117.
16 Kadia TM, Ravandi F, Cortes J, Kantarjian H. New drugs in acute myeloid leukemia. Ann Oncol. 2016 May;27(5):770-778.
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