FLORENCE, Italy and NEW YORK — November 24, 2025 — Leads & Copy — The Menarini Group and its subsidiary, Stemline Therapeutics, Inc., have announced the presentation of new data regarding ELZONRIS® (tagraxofusp-erzs) at the American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, December 6-9th.
The presentations will feature five abstracts, including two oral presentations. One oral session will highlight results from a triplet therapy combining tagraxofusp, azacitidine, and venetoclax, demonstrating efficacy and tolerability in individuals with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The therapy showed high response and bridge to transplant rates.
According to Elcin Barker Ergun, CEO of the Menarini Group, the data demonstrates the important role of tagraxofusp in both monotherapy and combination settings for treating BPDCN. It also shows potential to help patients with other aggressive hematologic malignancies.
Key presentations at the ASH Annual Meeting include:
Navarro Vicente I, et al.
Disease Presentation and Immunophenotype Characteristics in 257 Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm: a PETHEMA/PALG Study
Publication Number: 218
Session: 618. Acute Myeloid Leukemias: Biomarkers and Molecular Markers in Diagnosis and Prognosis: Redefining AML: Genetic, Phenotypic and Response-Based Insights
Oral Presentation
December 6, 2025
2:15 PM – 2:30 PM
OCCC – W414AB
Lane A, et al.
Tagraxofusp, azacitidine, and venetoclax (TAG-AZA-VEN) triplet therapy shows efficacy, tolerability, and transplant potential in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN): Results of a phase 2 trial
Publication Number: 653
Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Immunotherapy and chemotherapy combinations in AML
Oral Presentation
December 7, 2025
5:30 PM – 5:45 PM
OCCC – Chapin Theater (W320)
Stein A, et al.
Longer Survival with Tagraxofusp versus Venetoclax in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Results of A Real-World Analysis
Publication Number: 4612
Session: 908. Outcomes Research: Myeloid Malignancies: Poster II
Poster Presentation
December 7, 2025
6:00 PM – 8:00 PM
OCCC – West Halls B3-B4
Wang E, et al.
Favorable outcomes including post-transplant survival are seen independent of baseline skin burden in treatment-naïve patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) treated with tagraxofusp (TAG): Subgroup analysis of a pivotal trial
Publication Number: 5221
Session: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Poster III
Poster Presentation
December 8, 2025
6:00 PM – 8:00 PM
OCCC – West Halls B3-B4
Cho W, et al, Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123-Positive Relapsed or Refractory Acute Myeloid Leukemia. This will be an online-only publication.
ELZONRIS, approved by the FDA in December 2018 and by the European Commission in January 2021, is used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older.
BPDCN is a rare and aggressive hematologic malignancy affecting the skin, bone marrow, and blood. Approximately 85% to 90% of patients develop skin lesions. A key characteristic of BPDCN cancer cells is their high expression of a protein called CD123.
ELZONRIS® (tagraxofusp-erzs) carries a Boxed WARNING for Capillary Leak Syndrome (CLS). Patients should be monitored for signs and symptoms of CLS, including weight gain, edema, and hypotension. Other warnings include hypersensitivity reactions and hepatotoxicity. Common adverse reactions include capillary leak syndrome, nausea, fatigue, and fever.
To report suspected adverse reactions, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or the FDA at 1-800-FDA-1088.
Valeria Speroni Cardi, The Menarini Group, pressoffice@menarini.com
Cheya Pope, Stemline Therapeutics, Inc., media@menarinistemline.com
Source: The Menarini Group
