The presentations include an oral session highlighting results from a triplet therapy combining tagraxofusp, azacitidine, and venetoclax, which demonstrated both efficacy (high response and bridge to transplant rates) and tolerability in individuals with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
"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. "These data demonstrate that tagraxofusp plays an important role in both monotherapy and combination settings for the treatment of BPDCN, and that it also has potential to help patients living with other aggressive hematologic malignancies, where more effective treatment options are desperately needed."
ELZONRIS was approved by the FDA in December 2018 for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-naïve and previously-treated populations. In January 2021, ELZONRIS was approved by the European Commission.
About BPDCN
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), is a highly aggressive, orphan hematologic malignancy that primarily affects skin, bone marrow and blood. It can also affect other parts of the body, such as the lymph nodes, spleen, liver and central nervous system. Approximately 85% to 90% of patients develop skin lesions as a first sign of BPDCN. BPDCN affects all people of all races and geographic locations, with the global prevalence likely in the range of 0.4 – 0.5 per 100,000 people annually. While BPDCN affects both men and women of all ages, 75% of cases occur 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, which can be observed on the surface of the cells. This makes CD123 a crucial diagnostic marker as well as a prime target for precision therapies to strike the cancer directly.
About ELZONRIS® (tagraxofusp-erzs)
U.S. Indication: ELZONRIS (tagraxofusp-erzs) is a prescription medicine used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients 2 years and older.
Full prescribing information for the U.S. can be found at www.elzonris.com.
About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit www.menarini.com.
About Stemline Therapeutics Inc.
Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers.
