・Data spans seven presentations across both solid tumors and hematologic malignancies, providing updates on the potential benefit these therapies may bring to patients. 

・Data from the elacestrant plus capivasertib regimen of the ELEVATE study will be presented underscoring its potential in combination settings in mBC, along with updates from the elacestrant clinical development program, including its potential role as a monotherapy option in adjuvant breast cancer.

・Stemline's partner, Karyopharm Therapeutics, will present a late-breaking oral presentation from the phase 3 SENTRY trial of selinexor in myelofibrosis

"FOR MEDICAL AND PHARMACEUTICAL TRADE MEDIA ONLY"

FLORENCE, Italy and NEW YORK, May 25, 2026 /PRNewswire/ -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, announced that new data related to elacestrant and tagraxofusp will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

New data exploring the safety and preliminary efficacy of elacestrant in combination with capivasertib in patients with ER+/HER2- PI3K/AKT/PTEN- pathway altered metastatic breast cancer (mBC) from the phase 1/2 ELEVATE study will be presented. Additional details on ongoing studies of elacestrant in combination, in the advanced setting, will be shared: ADELA (pivotal phase 3 combination with everolimus); ELECTRA (phase 1b/2 combination with abemaciclib in patients with brain metastases); and CAPELA (phase 2 combination with capecitabine). Lastly, an update from the ELEGANT study, exploring elacestrant as adjuvant treatment in node-positive early breast cancer with high risk of recurrence, will be presented at the congress.

Also accepted for presentation is new phase 2 tagraxofusp combination data in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), which will be presented by Naveen Pemmaraju, MD, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. Additionally, Stemline's partner, Karyopharm Therapeutics, will present a late-breaking oral presentation from the phase 3 SENTRY trial of selinexor in JAKi naïve patients with myelofibrosis (MF). Selinexor is marketed in the U.S. by Karyopharm Therapeutics, and in the EU by Stemline.

"The extensive oncology data that will be presented, encompassing both solid tumors and hematologic malignancies, highlights our dedication to tackling the most difficult-to-treat cancers with high unmet needs," said Elcin Barker Ergun, CEO of the Menarini Group. "Our focus remains on accelerating innovation to provide transformational, targeted therapies that offer meaningful advances to patients and the healthcare communities dedicated to their care."

See below for full details of upcoming presentations:

About The Elacestrant Clinical Development Program
Elacestrant is also being investigated in several company-sponsored clinical trials in breast cancer disease, alone or in combination with other therapies. ELEGANT (NCT06492616) is a phase 3 trial evaluating the effectiveness of elacestrant versus standard endocrine therapy in women and men with node-positive, ER+, HER2- early breast cancer with high risk of recurrence. ADELA (NCT06382948) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. ELEVATE (NCT05563220) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA (NCT05386108) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease.    

To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. 
at adverseevents@menarinistemline.com.  All of the relevant information can be found at https://stemline.com/contact/

Full prescribing information for elacestrant can be found at https://www.ema.europa.eu/en/medicines/human/EPAR/orserdu#product-info

Full prescribing information for selinexor can be found at https://www.ema.europa.eu/en/medicines/human/EPAR/nexpovio#product-info

Full prescribing information for tagraxofusp can be found at https://www.ema.europa.eu/en/medicines/human/EPAR/elzonris#product-info 

About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $5.5 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.

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