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- Encouraging safety and preliminary efficacy analysis from the Phase 1b cohort of Elacestrant in combination with Capivasertib in the ELEVATE study to be presented.
- Efficacy data highlight the potential of Elacestrant plus Capivasertib to address key resistance mechanisms in ER+/HER2- mBC patients, including co-mutations inESR1 and PIK3CA.
- The company will also share updates on the Elacestrant clinical development program, underscoring its potential in combination therapy for mBC and as monotherapy in early-stage breast cancer.
For medical and pharmaceutical industry media only
Florence, Italy and New York, NYMay 31, 2026 /PRNewswire/ — Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and its wholly-owned subsidiary Stemline Therapeutics, Inc. (“Stemline”), dedicated to delivering breakthrough oncology treatments for cancer patients, will present safety and preliminary efficacy data from the Phase 1b/2 ELEVATE study of Elacestrant in combination with Capivasertib in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (mBC). Additionally, updates from several other ongoing trials will be presented, further highlighting the potential of Elacestrant as an endocrine therapy (ET) backbone across the breast cancer treatment continuum. These data will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
The ELEVATE study aims to evaluate the safety and efficacy of Elacestrant combination regimens to overcome different resistance mechanisms observed in ER+/HER2- mBC and improve patient outcomes, regardless of ESR1 mutation status. The study includes six treatment arms evaluating Elacestrant in combination with CDK4/6 inhibitors (Palbociclib, Abemaciclib, and Ribociclib) and PI3K/AKT/mTOR pathway inhibitors (Everolimus, Alpelisib, and Capivasertib).
In efficacy-evaluable patients at the RP2D, preliminary efficacy showed a disease control rate (DCR) of 88.9%, a 24-week clinical benefit rate (CBR24) of 66.7%, and an objective response rate (ORR) of 33.3%. All patients achieving ORR had co-mutations in ESR1 and PIK3CA. Median duration of response (mDOR) was not reached. Preliminary median progression-free survival (mPFS) in the overall RP2D population was 11.3 months, and 10.9 months in patients with ESR1 and PIK3CA co-mutations. Furthermore, these initial results indicate that the safety profile of the combination is consistent with the previously known safety profiles of each targeted therapy combined with standard endocrine therapy.
“Elacestrant in combination with Capivasertib is designed to address the unmet medical need in ER+/HER2- metastatic breast cancer patients with PI3K pathway alterations, particularly in the presence of ESR1 and PIK3CA co-mutations,” said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute. “These encouraging preliminary data suggest the potential for prolonged clinical benefit with a manageable safety profile, as this combination targets both ESR1 and PIK3CA mutations simultaneously, potentially avoiding the need for sequential therapy targeting each pathway individually.”
“We continue to be encouraged by the potential clinical benefit of Elacestrant in combination with a diverse range of agents in ER+/HER2- metastatic breast cancer, building on the data we saw at SABCS last year,” said Elcin Barker Ergun, CEO of the Menarini Group. “The breadth of our studies, including in early-stage breast cancer and multiple combinations in ER+/HER2- metastatic breast cancer, including with Capivasertib, reflects our commitment to bringing potentially transformative therapies to cancer patients.”
Additionally, other Elacestrant data will be presented at the ASCO meeting. Below is the full list of upcoming study presentations:
Presentation Title: “Elacestrant in combination with Capivasertib in patients with ER+/HER2- advanced breast cancer: An update from the Phase 1b/2 open-label, umbrella ELEVATE study”
Abstract Number: 1098
Presentation Date and Time: June 1, 2026; 1:30 PM – 4:30 PM (Central Time)
Location: Poster Board 212
Presenter: Wassim McHayleh
Presentation Title: “ADELA: A randomized, placebo-controlled, double-blind Phase 3 trial of Elacestrant plus Everolimus versus Elacestrant plus placebo in patients with ER+/HER2- advanced breast cancer with ESR1 mutations progressing on endocrine therapy + CDK4/6 inhibitors*#”
Abstract Number: TPS1154
Presentation Date and Time: June 1, 2026; 1:30 PM – 4:30 PM (Central Time)
Location: Poster Board 262b
Presenter: Antonio Llombart-Cussac
Presentation Title: “ELECTRA: An open-label, multicenter Phase 1b/2 study of Elacestrant plus Abemaciclib in patients with ER+/HER2- breast cancer and brain metastases”
Abstract Number: TPS1155
Presentation Date and Time: June 1, 2026; 1:30 PM – 4:30 PM (Central Time)
Location: Poster Board 263a
Presenter: Nuhad Ibrahim
Presentation Title: “CAPELA: A Phase II multicenter, open-label, randomized study of Capecitabine plus Elacestrant versus Capecitabine alone in advanced estrogen receptor (ER)-positive breast cancer (TBCRC 070)*”
Abstract Number: TPS1156
Presentation Date and Time: June 1, 2026; 1:30 PM – 4:30 PM (Central Time)
Location: Poster Board 263b
Presenter: Kristina Fanucci
Presentation Title: “ELEGANT: A global, multicenter, randomized, open-label Phase 3 study of Elacestrant versus standard endocrine therapy in women and men with high-risk, node-positive, estrogen receptor-positive (ER+), HER2-negative (HER2-) early-stage breast cancer”
Abstract Number: TPS1153
Presentation Date and Time: June 1, 2026; 1:30 PM – 4:30 PM (Central Time)
Location: Poster Board 262a
Presenter: Aditya Bardia
*Denotes investigator-initiated or collaborative studies
#The ADELA study is a pivotal study conducted in collaboration with MEDSIR
About the Elacestrant Clinical Development Program
Elacestrant is currently being studied in multiple company-sponsored clinical trials in metastatic breast cancer, both as a single agent and in combination with other therapies. ELEVATE (NCT05563220) is a Phase 1b/2 clinical trial evaluating the safety and efficacy of Elacestrant in combination with Alpelisib, Everolimus, Capivasertib, Palbociclib, Ribociclib, or Abemaciclib. ELECTRA (NCT05386108) is an open-label, multicenter Phase 1b/2 study evaluating Elacestrant in combination with Abemaciclib in patients with ER+, HER2- breast cancer. The Phase 2 portion evaluates this 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 have received one or two prior hormonal therapies and no prior CDK4/6 inhibitor in the metastatic setting. ADELA (NCT06382948) is a Phase 3 randomized, double-blind trial evaluating Elacestrant in combination with Everolimus in patients with ER+, HER2- mBC with ESR1-mutated tumors. ELEGANT (NCT06492616) is a Phase 3 trial evaluating Elacestrant versus standard endocrine therapy for the treatment of women and men with high-risk, node-positive, ER+, HER2- early-stage breast cancer. Elacestrant is also being evaluated in additional investigator-initiated studies and collaborative studies in metastatic breast cancer and early-stage disease.
For full prescribing information for Elacestrant, please visit https://www.ema.europa.eu/en/medicines/human/EPAR/orserdu#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 focuses on therapeutic areas with high unmet needs, including cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetes, inflammation, and analgesia. With 18 production sites and 9 R&D centers, Menarini products are available in 140 countries worldwide. For more 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 delivering breakthrough oncology treatments for patients. Stemline commercializes Elacestrant in the United States, Europe, and other global regions. This oral endocrine therapy is 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. Stemline also commercializes tagraxofusp-erzs in the United States, Europe, and other global regions. This is a novel targeted therapy directed at CD123 for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer. Additionally, Stemline commercializes selinexor in Europe, an XPO1 inhibitor for multiple myeloma. The company is also conducting multiple expansion studies for Elacestrant and tagraxofusp in breast cancer and hematologic cancer indications, respectively, and has a broad clinical development pipeline of other drug candidates at various stages of development for a range of solid tumors and hematologic cancers.
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[1] The safety and efficacy of the investigational combinations and unapproved indications discussed in this press release have not been established by the FDA, EMA, or any other regulatory authority. |