Menarini Group to Present Comprehensive Oncology Data at ASCO 2026, Featuring Elacestrant Combination Studies
核心洞察
Menarini Group (搜索) will present seven oncology presentations at ASCO 2026, spanning both solid tumors and hematologic malignancies with focus on difficult-to-treat cancers.
New data from the ELEVATE study will showcase elacestrant plus capivasertib combination therapy in ER+/HER2 (搜索)- metastatic breast cancer (搜索) patients with PI3K/AKT/PTEN (搜索) pathway alterations.
Updates from multiple elacestrant clinical trials will be shared, including the phase 3 ELEGANT study evaluating adjuvant treatment in high-risk early breast cancer (搜索).
The Menarini Group (搜索) and its subsidiary Stemline Therapeutics (搜索) announced they will present new data across seven presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting advances in both solid tumor and hematologic malignancy treatments.
Elacestrant Combination Data Takes Center Stage
The presentations will feature new safety and preliminary efficacy data from the phase 1/2 ELEVATE study, specifically examining elacestrant in combination with capivasertib in patients with ER+/HER2 (搜索)- metastatic breast cancer (搜索) (mBC) who have PI3K/AKT/PTEN (搜索) pathway alterations. This combination approach represents a targeted strategy for addressing specific molecular drivers in breast cancer (搜索).
Additional elacestrant combination studies will provide updates on ongoing research in the advanced setting. The ADELA trial, a pivotal phase 3 randomized, double-blinded study, is evaluating elacestrant combined with everolimus in patients with ER+, HER2 (搜索)- mBC harboring ESR1-mutated tumors. The ELECTRA study, a phase 1b/2 multicenter trial, is investigating elacestrant plus abemaciclib specifically in patients with brain metastases. The CAPELA phase 2 study is examining the combination of elacestrant with capecitabine.
Expanding Into Early Breast Cancer Treatment
An important development in the elacestrant clinical program is the ELEGANT study update, which explores the drug's potential as adjuvant treatment. This phase 3 trial is evaluating elacestrant versus standard endocrine therapy in women and men with node-positive, ER+, HER2 (搜索)- early breast cancer (搜索) with high risk of recurrence, representing a significant expansion beyond the metastatic setting.
Hematologic Malignancy Advances
The ASCO presentations will also include new phase 2 combination data for tagraxofusp in patients with blastic plasmacytoid dendritic cell neoplasm (搜索) (BPDCN), to be presented by Naveen Pemmaraju, MD, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center.
Additionally, Stemline's partner Karyopharm Therapeutics will deliver a late-breaking oral presentation featuring phase 3 SENTRY trial results for selinexor in JAK inhibitor-naïve patients with myelofibrosis (搜索). Selinexor is marketed by Karyopharm in the United States and by Stemline in the European Union.
Comprehensive Clinical Development Portfolio
The elacestrant clinical development program encompasses multiple ongoing trials beyond those being presented at ASCO. The ELCIN phase 2 trial is evaluating efficacy in patients with ER+, HER2 (搜索)- advanced/metastatic breast cancer (搜索) who received one or two prior hormonal therapies but no prior CDK4/6 inhibitors in the metastatic setting. The broader ELEVATE study is a phase 1b/2 trial assessing elacestrant's safety and efficacy when combined with various agents including alpelisib, everolimus, capivasertib, palbociclib, ribociclib, or abemaciclib.
Strategic Focus on Unmet Medical Needs
"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 (搜索). "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."
Stemline Therapeutics (搜索) currently commercializes elacestrant as an oral endocrine therapy indicated for postmenopausal women or adult men with estrogen receptor (搜索)-positive, HER2 (搜索)-negative, ESR1-mutated advanced or metastatic breast cancer (搜索) with disease progression following at least one line of endocrine therapy. The drug is available in the United States, Europe, and other global regions.
The company also markets tagraxofusp-erzs, a novel CD123 (搜索)-directed targeted therapy for patients with BPDCN, and selinexor, an XPO1 (搜索) inhibitor for multiple myeloma (搜索) in Europe. The Menarini Group (搜索), with a turnover of $5.5 billion and over 17,000 employees, operates 18 production sites and 9 Research and Development centers, making its products available in 140 countries worldwide.