On June 13, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that ELZONRIS (tagraxofusp) is the subject of three clinical presentations at the Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) (Press release, Stemline Therapeutics, JUN 13, 2019, View Source [SID1234537065]). Data from the ongoing Phase 1/2 trials in chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), as well as the results from the pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN) will be delivered via poster presentation at the 24thCongress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Amsterdam, Netherlands.
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ELZONRIS (tagraxofusp) is FDA-approved for the treatment of patients, adults and pediatric 2 years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN), and is commercially available in the U.S.
Details on the presentations are listed below. Presentations will be available on the Stemline website (www.stemline.com) Scientific Presentations tab, after their delivery.
Results from Ongoing Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Relapsed/Refractory Chronic Myelomonocitic Leukemia (CMML)
• Abstract: PF672
• Presenter: Mrinal M. Patnaik, MBBS; Mayo Clinic
• Date: Friday, June 14
• Time: 5:30 – 7:00 PM CET
• Location: Poster Area
Results from Ongoing Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Intermediate, or High Risk, Relapsed/Refractory Myelofibrosis (MF)
• Abstract: PF668
• Presenter: Naveen Pemmaraju, MD; The University of Texas MD Anderson Cancer Center
• Date: Friday, June 14
• Time: 5:30 – 7:00 PM CET
• Location: Poster Area
Results of the Pivotal Phase 2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
• Abstract: PS1063
• Presenter: Naveen Pemmaraju, MD; The University of Texas MD Anderson Cancer Center
• Date: Saturday, June 15
• Time: 5:30 – 7:00 PM CET
• Location: Poster Area
Please visit the BPDCN disease awareness booth (#1351) during the 24thCongress of EHA (Free EHA Whitepaper).
About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).
About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.
About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.