{"id":39498,"date":"2025-11-24T22:34:00","date_gmt":"2025-11-24T15:34:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=39498"},"modified":"2025-11-24T22:34:00","modified_gmt":"2025-11-24T15:34:00","slug":"menarini-group-announces-new-data-on-elzonris-tagraxofusp-erzs-to-be-presented-at-the-67th-american-society-of-hematology-annual-meeting-and-exposition","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=39498","title":{"rendered":"Menarini Group Announces New Data on ELZONRIS\u00ae (tagraxofusp-erzs) to be Presented at the 67th American Society of Hematology Annual Meeting and Exposition"},"content":{"rendered":"<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2296569\/Menarini_Industrie_Farmaceutiche_Riunite_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul type=\"disc\">\n<li><i>Data spans five abstracts including two oral presentations with important findings for patients living with\u00a0blastic plasmacytoid dendritic cell neoplasm (BPDCN)\n<p><\/p><\/i><\/li>\n<li><i>BPDCN is a highly aggressive, orphan hematologic malignancy that primarily affects skin, bone marrow, and blood<\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">FLORENCE<\/span>, Italy\u00a0and\u00a0NEW YORK<\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Nov. 24, 2025<\/span><\/span> \/PRNewswire\/ &#8212;\u00a0The Menarini Group (&#8220;Menarini&#8221;), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (&#8220;Stemline&#8221;), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, today announced that the company will present new data related to ELZONRIS\u00ae (tagraxofusp-erzs) at the American Society of Hematology (ASH) Annual Meeting and Exposition in <span class=\"xn-location\">Orlando<\/span>, <span class=\"xn-chron\">December 6-9<\/span><sup>th<\/sup>.<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>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).<\/p>\n<p>&#8220;At Menarini Stemline, our commitment to transforming the lives of people living with difficult-to-treat cancers is unwavering,&#8221; said\u00a0Elcin Barker Ergun, CEO of the Menarini Group. &#8220;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.&#8221;<\/p>\n<p>See below for full details of the\u00a0Menarini Group\/Stemline Therapeutics&#8217; upcoming presentations and publication:<\/p>\n<p><b>American Society of Hematology (ASH) Annual Meeting 2025<\/b><\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prnpr2 prnpl2 prnvab prntal prncbts prnbrbrs prnbbbs prnbsbls\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Lead Author<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Title and Publication Number<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Session Name<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Presentation Details<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">Navarro Vicente I, et al.<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Disease Presentation and Immunophenotype Characteristics in 257 Patients with <br \/>Blastic Plasmacytoid Dendritic Cell Neoplasm: a PETHEMA\/PALG Study*<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">Publication Number: 218<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">618. Acute Myeloid Leukemias: <br \/>Biomarkers and Molecular Markers <br \/>in Diagnosis and Prognosis: <br \/>Redefining AML: Genetic, Phenotypic <br \/>and Response-Based Insights<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Oral Presentation<\/b><\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">\u00a0<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">December 6, 2025<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">2:15 PM &#8211; 2:30 PM <\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">OCCC &#8211; W414AB<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">\u00a0<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Lane A, et al.<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Tagraxofusp, azacitidine, and venetoclax (TAG-AZA-VEN) triplet therapy shows <br \/>efficacy, tolerability, and transplant potential in patients with blastic plasmacytoid <br \/>dendritic cell neoplasm (BPDCN): Results of a phase 2 trial*<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">Publication Number: 653<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">\u00a0616. Acute Myeloid Leukemias: <br \/>Investigational Drug and Cellular <br \/>Therapies: Immunotherapy and <br \/>chemotherapy combinations in AML<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Oral <\/b><b>Presentation<\/b><\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">December 7, 2025<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">5:30 PM &#8211; 5:45 PM<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">OCCC &#8211; Chapin Theater (W320)<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Stein A, et al.<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Longer Survival with Tagraxofusp versus Venetoclax in Patients with Blastic <br \/>Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Results of A Real-World Analysis<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">Publication Number: 4612<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">908. Outcomes Research: <br \/>Myeloid Malignancies: Poster II<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Poster Presentation<\/b><\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">\u00a0<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">December 7, 2025<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">6:00 PM &#8211; 8:00 PM<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">OCCC &#8211; West Halls B3-B4<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Wang E, et al.<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Favorable outcomes including post-transplant survival are seen independent <br \/>of baseline skin burden in treatment-na\u00efve patients (pts) with blastic <br \/>plasmacytoid dendritic cell neoplasm (BPDCN) treated with tagraxofusp (TAG): Subgroup analysis of a pivotal trial<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">Publication Number: 5221<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">617. Acute Myeloid Leukemias: <br \/>Commercially Available <br \/>Therapies: Poster III<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Poster presentation<\/b><\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">December 8, 2025<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">6:00 PM &#8211; 8:00 PM<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">OCCC &#8211; West Halls B3-B4<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Cho W, et al,<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123-Positive <br \/>Relapsed or Refractory Acute Myeloid Leukemia*<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\"><\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Online-only publication<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p><i>*<\/i><i>Denotes investigator sponsored research or collaborative research.<\/i><\/p>\n<p>\u00a0<\/p>\n<p>ELZONRIS was approved by the FDA\u00a0in <u><a href=\"http:\/\/www.elzonris.com\/\" target=\"_blank\" rel=\"nofollow\"><span class=\"xn-chron\">December 2018<\/span><\/a><\/u>\u00a0for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-na\u00efve and previously-treated populations. In <a href=\"https:\/\/www.menarini.com\/en-us\/news\/news-archive\/article-details\/menarini-receives-european-commission-approval-of-elzonris-tagraxofusp-for-the-treatment-of-blastic-plasmacytoid-dendritic-cell-neoplasm-bpdcn\" target=\"_blank\" rel=\"nofollow\"><span class=\"xn-chron\">January 2021<\/span><\/a>, ELZONRIS was approved by the European Commission.\u00a0<\/p>\n<p><b>About BPDCN<\/b><\/p>\n<p>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 \u2013 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.<\/p>\n<p><b>About ELZONRIS<sup>\u00ae<\/sup>\u00a0(tagraxofusp-erzs)<\/b><\/p>\n<p><b>U.S. Indication: <\/b>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.<\/p>\n<p>Full prescribing information for the U.S. can be found at <u><a href=\"http:\/\/www.elzonris.com\/\" target=\"_blank\" rel=\"nofollow\">www.elzonris.com<\/a><\/u>.<\/p>\n<p><b>IMPORTANT SAFETY INFORMATION, ELZONRIS\u00ae<\/b><\/p>\n<p><b>Boxed WARNING: CAPILLARY LEAK SYNDROME<\/b><\/p>\n<ul type=\"disc\">\n<li><b>Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended.<\/b><\/li>\n<\/ul>\n<p><b><i>Warnings and Precautions<\/i><\/b><\/p>\n<p><b><i>Capillary Leak Syndrome<\/i><\/b><\/p>\n<p>Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with ELZONRIS. In patients receiving ELZONRIS in clinical trials, the overall incidence of CLS was 53% (65\/122), including Grade 1 or 2 in 43% (52\/122) of patients, Grade 3 in 7% (8\/122) of patients, Grade 4 in 1% (1\/122) of patients, and four fatalities (3%). The median time to onset was 4 days (range &#8211; 1 to 46 days), and all but 5 patients experienced an event in Cycle 1.<\/p>\n<p>Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g\/dL. During treatment with ELZONRIS, monitor serum albumin levels prior to the initiation of each dose of ELZONRIS and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonary edema, hypotension or hemodynamic instability.<\/p>\n<p><b><i>Hypersensitivity Reactions<\/i><\/b><\/p>\n<p>ELZONRIS can cause severe hypersensitivity reactions. In patients receiving ELZONRIS in clinical trials, hypersensitivity reactions were reported in 43% (53\/122) of patients treated with ELZONRIS and were Grade \u2265 3 in 7% (9\/122). Manifestations of hypersensitivity reported in\u00a0\u2265 5%\u00a0of patients include rash, pruritus, and stomatitis. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur.<\/p>\n<p><b><i>Hepatotoxicity<\/i><\/b><\/p>\n<p>Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients receiving ELZONRIS in clinical trials, elevations in ALT occurred in 79% (96\/122) and elevations in AST occurred in 76% (93\/122). Grade 3 ALT elevations were reported in 26% (32\/122) of patients. Grade 3 AST elevations were reported in 30% (36\/122) and Grade 4 AST elevations were reported in 3% (4\/122) of patients. Elevated liver enzymes occurred in the majority of patients in Cycle 1 and were reversible following dose interruption.<\/p>\n<p>Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Withhold ELZONRIS temporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved.<\/p>\n<p><b><i>Adverse Reactions<\/i><\/b><\/p>\n<p>Most common adverse reactions (incidence \u2265 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence \u2265 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST.<\/p>\n<p>\u00a0<b>Please see full\u00a0<\/b><b><a href=\"http:\/\/pi.elzonris.com\/\" target=\"_blank\" rel=\"nofollow\">Prescribing Information<\/a><\/b><b>, including Boxed WARNING.<\/b><\/p>\n<p>To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or\u00a0<a href=\"https:\/\/www.fda.gov\/medwatch\" target=\"_blank\" rel=\"nofollow\">www.fda.gov\/medwatch<\/a>.<\/p>\n<p><b>About The Menarini Group<\/b><\/p>\n<p>The\u00a0Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of <span class=\"xn-money\">$4.7 billion<\/span> 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&#8217;s products are available in 140 countries worldwide. For further information, please visit <a href=\"https:\/\/www.menarini.com\/\" target=\"_blank\" rel=\"nofollow\">www.menarini.com<\/a>.\u00a0<\/p>\n<p><b>About Stemline Therapeutics Inc.<\/b><\/p>\n<p>Stemline Therapeutics, Inc. (&#8220;Stemline&#8221;), 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, <i>ESR1<\/i>-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., <span class=\"xn-location\">Europe<\/span>, 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 <span class=\"xn-location\">the United States<\/span>, <span class=\"xn-location\">Europe<\/span>, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in <span class=\"xn-location\">Europe<\/span>. 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.<\/p>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2296569\/Menarini_Industrie_Farmaceutiche_Riunite_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul type=\"disc\">\n<li><i>Data spans five abstracts including two oral presentations with important findings for patients living with\u00a0blastic plasmacytoid dendritic cell neoplasm (BPDCN)\n<\/p>\n<p><\/i><\/li>\n<li><i>BPDCN is a highly aggressive, orphan hematologic malignancy that primarily affects skin, bone marrow, and blood<\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">FLORENCE<\/span>, Italy\u00a0and\u00a0NEW YORK<\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Nov. 24, 2025<\/span><\/span> \/PRNewswire\/ &#8212;\u00a0The Menarini Group (&#8220;Menarini&#8221;), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (&#8220;Stemline&#8221;), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, today announced that the company will present new data related to ELZONRIS\u00ae (tagraxofusp-erzs) at the American Society of Hematology (ASH) Annual Meeting and Exposition in <span class=\"xn-location\">Orlando<\/span>, <span class=\"xn-chron\">December 6-9<\/span><sup>th<\/sup>.<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>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).<\/p>\n<p>&#8220;At Menarini Stemline, our commitment to transforming the lives of people living with difficult-to-treat cancers is unwavering,&#8221; said\u00a0Elcin Barker Ergun, CEO of the Menarini Group. &#8220;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.&#8221;<\/p>\n<p>See below for full details of the\u00a0Menarini Group\/Stemline Therapeutics&#8217; upcoming presentations and publication:<\/p>\n<p><b>American Society of Hematology (ASH) Annual Meeting 2025<\/b><\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prnpr2 prnpl2 prnvab prntal prncbts prnbrbrs prnbbbs prnbsbls\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Lead Author<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Title and Publication Number<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Session Name<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Presentation Details<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\">Navarro Vicente I, et al.<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Disease Presentation and Immunophenotype Characteristics in 257 Patients with <br \/>Blastic Plasmacytoid Dendritic Cell Neoplasm: a PETHEMA\/PALG Study*<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">Publication Number: 218<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">618. Acute Myeloid Leukemias: <br \/>Biomarkers and Molecular Markers <br \/>in Diagnosis and Prognosis: <br \/>Redefining AML: Genetic, Phenotypic <br \/>and Response-Based Insights<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Oral Presentation<\/b><\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">\u00a0<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">December 6, 2025<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">2:15 PM &#8211; 2:30 PM <\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">OCCC &#8211; W414AB<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">\u00a0<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Lane A, et al.<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Tagraxofusp, azacitidine, and venetoclax (TAG-AZA-VEN) triplet therapy shows <br \/>efficacy, tolerability, and transplant potential in patients with blastic plasmacytoid <br \/>dendritic cell neoplasm (BPDCN): Results of a phase 2 trial*<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">Publication Number: 653<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">\u00a0616. Acute Myeloid Leukemias: <br \/>Investigational Drug and Cellular <br \/>Therapies: Immunotherapy and <br \/>chemotherapy combinations in AML<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap>\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Oral <\/b><b>Presentation<\/b><\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">December 7, 2025<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">5:30 PM &#8211; 5:45 PM<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">OCCC &#8211; Chapin Theater (W320)<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Stein A, et al.<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Longer Survival with Tagraxofusp versus Venetoclax in Patients with Blastic <br \/>Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Results of A Real-World Analysis<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">Publication Number: 4612<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">908. Outcomes Research: <br \/>Myeloid Malignancies: Poster II<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Poster Presentation<\/b><\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">\u00a0<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">December 7, 2025<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">6:00 PM &#8211; 8:00 PM<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">OCCC &#8211; West Halls B3-B4<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Wang E, et al.<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Favorable outcomes including post-transplant survival are seen independent <br \/>of baseline skin burden in treatment-na\u00efve patients (pts) with blastic <br \/>plasmacytoid dendritic cell neoplasm (BPDCN) treated with tagraxofusp (TAG): Subgroup analysis of a pivotal trial<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">Publication Number: 5221<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">617. Acute Myeloid Leukemias: <br \/>Commercially Available <br \/>Therapies: Poster III<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Poster presentation<\/b><\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">December 8, 2025<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">6:00 PM &#8211; 8:00 PM<\/span><\/p>\n<p class=\"prnml4\"><span class=\"prnews_span\">OCCC &#8211; West Halls B3-B4<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Cho W, et al,<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123-Positive <br \/>Relapsed or Refractory Acute Myeloid Leukemia*<\/span><\/p>\n<p class=\"prnml4\">\u00a0<\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\"><\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><b>Online-only publication<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p><i>*<\/i><i>Denotes investigator sponsored research or collaborative research.<\/i><\/p>\n<p>\u00a0<\/p>\n<p>ELZONRIS was approved by the FDA\u00a0in <u><a href=\"http:\/\/www.elzonris.com\/\" target=\"_blank\" rel=\"nofollow\"><span class=\"xn-chron\">December 2018<\/span><\/a><\/u>\u00a0for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-na\u00efve and previously-treated populations. In <a href=\"https:\/\/www.menarini.com\/en-us\/news\/news-archive\/article-details\/menarini-receives-european-commission-approval-of-elzonris-tagraxofusp-for-the-treatment-of-blastic-plasmacytoid-dendritic-cell-neoplasm-bpdcn\" target=\"_blank\" rel=\"nofollow\"><span class=\"xn-chron\">January 2021<\/span><\/a>, ELZONRIS was approved by the European Commission.\u00a0<\/p>\n<p><b>About BPDCN<\/b><\/p>\n<p>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 \u2013 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.<\/p>\n<p><b>About ELZONRIS<sup>\u00ae<\/sup>\u00a0(tagraxofusp-erzs)<\/b><\/p>\n<p><b>U.S. Indication: <\/b>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.<\/p>\n<p>Full prescribing information for the U.S. can be found at <u><a href=\"http:\/\/www.elzonris.com\/\" target=\"_blank\" rel=\"nofollow\">www.elzonris.com<\/a><\/u>.<\/p>\n<p><b>IMPORTANT SAFETY INFORMATION, ELZONRIS\u00ae<\/b><\/p>\n<p><b>Boxed WARNING: CAPILLARY LEAK SYNDROME<\/b><\/p>\n<ul type=\"disc\">\n<li><b>Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended.<\/b><\/li>\n<\/ul>\n<p><b><i>Warnings and Precautions<\/i><\/b><\/p>\n<p><b><i>Capillary Leak Syndrome<\/i><\/b><\/p>\n<p>Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with ELZONRIS. In patients receiving ELZONRIS in clinical trials, the overall incidence of CLS was 53% (65\/122), including Grade 1 or 2 in 43% (52\/122) of patients, Grade 3 in 7% (8\/122) of patients, Grade 4 in 1% (1\/122) of patients, and four fatalities (3%). The median time to onset was 4 days (range &#8211; 1 to 46 days), and all but 5 patients experienced an event in Cycle 1.<\/p>\n<p>Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g\/dL. During treatment with ELZONRIS, monitor serum albumin levels prior to the initiation of each dose of ELZONRIS and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonary edema, hypotension or hemodynamic instability.<\/p>\n<p><b><i>Hypersensitivity Reactions<\/i><\/b><\/p>\n<p>ELZONRIS can cause severe hypersensitivity reactions. In patients receiving ELZONRIS in clinical trials, hypersensitivity reactions were reported in 43% (53\/122) of patients treated with ELZONRIS and were Grade \u2265 3 in 7% (9\/122). Manifestations of hypersensitivity reported in\u00a0\u2265 5%\u00a0of patients include rash, pruritus, and stomatitis. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur.<\/p>\n<p><b><i>Hepatotoxicity<\/i><\/b><\/p>\n<p>Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients receiving ELZONRIS in clinical trials, elevations in ALT occurred in 79% (96\/122) and elevations in AST occurred in 76% (93\/122). Grade 3 ALT elevations were reported in 26% (32\/122) of patients. Grade 3 AST elevations were reported in 30% (36\/122) and Grade 4 AST elevations were reported in 3% (4\/122) of patients. Elevated liver enzymes occurred in the majority of patients in Cycle 1 and were reversible following dose interruption.<\/p>\n<p>Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Withhold ELZONRIS temporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved.<\/p>\n<p><b><i>Adverse Reactions<\/i><\/b><\/p>\n<p>Most common adverse reactions (incidence \u2265 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence \u2265 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST.<\/p>\n<p>\u00a0<b>Please see full\u00a0<\/b><b><a href=\"http:\/\/pi.elzonris.com\/\" target=\"_blank\" rel=\"nofollow\">Prescribing Information<\/a><\/b><b>, including Boxed WARNING.<\/b><\/p>\n<p>To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or\u00a0<a href=\"https:\/\/www.fda.gov\/medwatch\" target=\"_blank\" rel=\"nofollow\">www.fda.gov\/medwatch<\/a>.<\/p>\n<p><b>About The Menarini Group<\/b><\/p>\n<p>The\u00a0Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of <span class=\"xn-money\">$4.7 billion<\/span> 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&#8217;s products are available in 140 countries worldwide. For further information, please visit <a href=\"https:\/\/www.menarini.com\/\" target=\"_blank\" rel=\"nofollow\">www.menarini.com<\/a>.\u00a0<\/p>\n<p><b>About Stemline Therapeutics Inc.<\/b><\/p>\n<p>Stemline Therapeutics, Inc. (&#8220;Stemline&#8221;), 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, <i>ESR1<\/i>-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., <span class=\"xn-location\">Europe<\/span>, 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 <span class=\"xn-location\">the United States<\/span>, <span class=\"xn-location\">Europe<\/span>, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in <span class=\"xn-location\">Europe<\/span>. 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.<\/p>\n<p><!-- \/wp:html --><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-39498","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/39498","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=39498"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/39498\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=39498"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=39498"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=39498"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}