FLORENCE, Italy and NEW YORK — November 24, 2025 — Leads & Copy — The Menarini Group and its subsidiary, Stemline Therapeutics, will present new data on ELZONRIS® (tagraxofusp-erzs) at the American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, December 6-9th.
The presentations include results from a triplet therapy combining tagraxofusp, azacitidine, and venetoclax, which demonstrated both efficacy and tolerability in individuals with blastic plasmacytoid dendritic cell neoplasm (BPDCN), as well as effectiveness as a monotherapy.
“At Menarini Stemline, our commitment to transforming the lives of people living with difficult-to-treat cancers is unwavering,” said Elcin Barker Ergun, CEO of the Menarini Group. She added that the data demonstrates tagraxofusp plays an important role in treating BPDCN and has potential to help patients living with other aggressive hematologic malignancies.
Key presentations at the ASH Annual Meeting 2025 include:
Oral Presentation – December 6, 2025, 2:15 PM – 2:30 PM, OCCC – W414AB:
Navarro Vicente I, et al., will present research on Disease Presentation and Immunophenotype Characteristics in 257 Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm: a PETHEMA/PALG Study (Publication Number: 218).
Oral Presentation – December 7, 2025, 5:30 PM – 5:45 PM, OCCC – Chapin Theater (W320):
Lane A, et al., will present results of a phase 2 trial on Tagraxofusp, azacitidine, and venetoclax (TAG-AZA-VEN) triplet therapy showing efficacy, tolerability, and transplant potential in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Publication Number: 653).
Poster Presentation – December 7, 2025, 6:00 PM – 8:00 PM, OCCC – West Halls B3-B4:
Stein A, et al., will present results of a real-world analysis on Longer Survival with Tagraxofusp versus Venetoclax in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (Publication Number: 4612).
Poster Presentation – December 8, 2025, 6:00 PM – 8:00 PM, OCCC – West Halls B3-B4:
Wang E, et al., will present a subgroup analysis of a pivotal trial on 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) (Publication Number: 5221).
An online-only publication from Cho W, et al, will cover Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123-Positive Relapsed or Refractory Acute Myeloid Leukemia.
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 highly aggressive, orphan hematologic malignancy affecting skin, bone marrow, and blood. Approximately 85% to 90% of patients develop skin lesions as a first sign of BPDCN. It affects all races and geographic locations, with a global prevalence of 0.4 – 0.5 per 100,000 people annually. BPDCN affects both men and women of all ages, with 75% of cases occurring in men, with a median age at onset of 60-70 years. 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. Hypersensitivity reactions and hepatotoxicity are also potential risks. Common adverse reactions include capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase.
The Menarini Group is focused on therapeutic areas with high unmet needs, including cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. Menarini’s products are available in 140 countries worldwide.
Stemline Therapeutics, Inc., a wholly-owned subsidiary of the Menarini Group, focuses on transformational oncology treatments. Stemline commercializes elacestrant for breast cancer and tagraxofusp-erzs for BPDCN in the U.S., Europe, and other global regions. Stemline also commercializes selinexor for multiple myeloma in Europe.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full prescribing information for ELZONRIS can be found at www.elzonris.com.
Contact Stemline Therapeutics, Inc. at 1-877-332-7961 for suspected adverse reactions.
Source: Menarini Group
