On June 3, 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) Phase 2 clinical data in chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF) data are being presented today at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, being held from May 31-June 4, 2019, at McCormick Place in Chicago, Illinois (Press release, Stemline Therapeutics, JUN 3, 2019, View Source [SID1234536814]).

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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 as follows:

Results from Ongoing Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML)

Abstract: 7059
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenter: Mrinal M. Patnaik, MBBS; Mayo Clinic
Date: Monday, June 3
Time: 8:00 to 11:00 AM CT
Results from Ongoing Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Intermediate or High Risk Relapsed/Refractory Myelofibrosis (MF)

Abstract: 7058
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenter: Naveen Pemmaraju, MD; The University of Texas MD Anderson Cancer Center
Date: Monday, June 3
Time: 8:00 to 11:00 AM CT
Please visit our Stemline corporate booth (#19156) during the 2019 ASCO (Free ASCO Whitepaper) annual meeting.

Stemline Provides Further Details on Next Steps for the ELZONRIS CMML Program
Given the encouraging clinical data generated from the ELZONRIS Phase 2 trial in patients with CMML, combined with feedback and guidance from the Food and Drug Administration (FDA), Stemline intends to open a Stage 3 cohort of the currently enrolling 0314 trial to serve as the pivotal program for ELZONRIS in patients with CMML. The planned primary endpoint is overall response rate (ORR); in addition, if certain other endpoints, including spleen size, are shown to have clinical benefit in the initial, Stage 3a, portion of the new cohort, then these endpoints could contribute to the primary evidence of efficacy in the final, Stage 3b, portion of the pivotal program. CD123 levels will also be evaluated in Stage 3a for potential enrichment in 3b.

Stage 3 will enroll patients with previously-treated CMML, and will be a single-arm, non-randomized trial designed to support potential registration. The protocol is currently being designed, and we expect to provide further details, including sample size, during 3Q19, with an expectation of opening the new cohort to enrollment later this year.

Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented "With ELZONRIS now FDA-approved and commercially available for patients with BPDCN, our focus is on both ensuring patient access to ELZONRIS in the commercial setting as well as broadening the potential for ELZONRIS in additional indications. With this in mind, we are very excited to advance another ELZONRIS clinical program toward a potential second approval, this time in CMML, an aggressive and underserved malignancy."

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.