A Phase II Study of Elacestrant, an Oral Selective Estrogen Receptor Degrader (SERD) Combined With Everolimus in Patients With Recurrent or Metastatic ER-Positive (ER+) Endometrial Cancer (ELAVERA)

This phase II trial tests how well elacestrant with everolimus works for the treatment of estrogen receptor (ER) positive endometrial cancer that has come back after a period of improvement (recurrent), that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Estrogen can cause the growth of cancer cells. Elacestrant lowers the amount of estrogen made by the body. This may help stop the growth of cancer cells that need estrogen to grow. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping cancer cells from reproducing and by decreasing blood supply to the cancer cells. Giving elacestrant with everolimus may be effective for treating patients with recurrent, advanced or metastatic ER positive endometrial cancer.

Start Date18 Dec 2026

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

[+1]

NCT07753954

/ Not yet recruitingPhase 2IIT

Imaging to Re-evaluate Elacestrant Clinical Application

The goal of this clinical trial is to evaluate whether elacestrant, an oral selective oestrogen receptor degrader, can improve outcomes in patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer without detectable ESR1 mutation after progression on endocrine therapy plus a CDK4/6 inhibitor.
The study aims to answer two key questions:
* Does [18F]-fluor-oestradiol positron emission tomography/computed tomography (18F-FES-PET/CT) result (homogeneous vs. heterogeneous) determine the efficacy of elacestrant in participants with advanced/metastatic ER-positive breast cancer and ESR1-mut-nd?
* Does 18F-FES-PET/CT imaging predict patient outcomes, including progression-free survival, overall survival, or tumor response?
There is no comparison group in this study. All participants receive elacestrant. Researchers will compare outcomes in people who have different levels of estrogen-receptor heterogeneity on FES-PET/CT imaging.
Participants in the study will:
* Take elacestrant 345 mg orally once a day, in 28-day treatment cycles (the dose may be lowered to 258 mg if needed due to side effects).
* Undergo 18F-FES-PET/CT and 18F-FDG-PET/CT imaging both at the beginning of the study and as part of routine clinical evaluation every 8 weeks
* Undergo blood sample collection every 8 weeks
* If selected for a sub-study, undergo an additional FES-PET/CT scan 4 weeks after starting treatment

Start Date13 Sep 2026

Sponsor / Collaborator

Jules Bordet Institute

[+2]

NCT07766018

/ RecruitingPhase 2

A Phase 2 Open-Label, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Elacestrant Monotherapy for the Treatment of Japanese Participants With ER+/HER2- Advanced or Metastatic Breast Cancer With ESR1-mutation Following CDK4/6 Inhibitor Therapy

This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 gene mutation (ESR1-mut) whose disease has relapsed or progressed on at least 1 and no more than 2 prior lines of endocrine therapy for metastatic breast cancer, which must have included cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy in combination with fulvestrant or an aromatase inhibitor.

Start Date18 Aug 2026

Sponsor / Collaborator

Stemline Therapeutics, Inc.

100 Clinical Results associated with Elacestrant hydrochloride

100 Translational Medicine associated with Elacestrant hydrochloride

100 Patents (Medical) associated with Elacestrant hydrochloride

132

Literatures (Medical) associated with Elacestrant hydrochloride

23 Oct 2026·ORGANIC LETTERS

Manganese-Catalyzed Asymmetric Hydrogenation of α-Substituted Tetralones via Dynamic Kinetic Resolution

Article

Author: Hu, Xiang-Ping ; Wan, Yin-Bo ; Abbas, Nasir

Abstract:

Developing earth-abundant metal catalysts as alternatives to precious metals is highly appealing for asymmetric hydrogenation. However, low enantioselectivity and activity remain critical challenges. Herein, we disclose an efficient manganese-catalyzed asymmetric hydrogenation of α-substituted tetralones via dynamic kinetic resolution. A wide range of chiral tetrahydronaphthols containing two contiguous stereogenic centers were obtained in high yields and stereoselectivities (up to 99% yield, 99% ee, and >20:1 dr). The practicality of this protocol was demonstrated by a gram-scale synthesis of the key intermediate of (+)-elacestrant, a therapeutic agent for metastatic breast cancer, at a catalyst loading of 0.0038 mol %, with a TON (26 000) that was significantly higher than that achieved with the precious-metal catalysts for this hydrogenation.

15 Oct 2026·JOURNAL OF CLINICAL INVESTIGATION

Selective estrogen receptor degraders and their effect on the breast cancer immune microenvironment

Review

Author: Young, Kristen S. ; Fanning, Sean W.

One in eight women will be diagnosed with breast cancer in their lifetime. Most breast cancers express estrogen receptor α (ERα) and depend on its signaling, which promotes tumor growth, survival, and metastatic spread through hormone-dependent transcriptional reprogramming. Selective estrogen receptor degraders/downregulators (SERDs), such as fulvestrant (faslodex), which was FDA approved in 2002, are second-line endocrine therapies for the treatment of advanced metastatic disease. Tumors containing activating hotspot mutations in ESR1 (the gene encoding ERα) retain some sensitivity to fulvestrant but require higher doses to achieve inhibition of the mutant receptor. Substantial efforts to develop next-generation SERDs with improved pharmacology over fulvestrant have led to the FDA approval of the first-in-class orally available SERD elacestrant (Orserdu), followed by imlunestrant (Inluriyo), and the anticipated approval of several more therapies. Excitingly, recent studies show that in addition to their previously described antitumoral mechanisms, SERDs also act by increasing antitumor immunity. In this Review, we detail the current SERD clinical landscape and our emerging understanding of the interplay among SERDs, breast cancer cells, and the tumor immune microenvironment.

01 Oct 2026·ESMO Open

Outcomes of elacestrant in patients with ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer who received prior endocrine therapy and cyclin-dependent kinase inhibitor in a real-world setting

Article

Author: Sears, E ; Maitland, J ; García-Sáenz, J Á ; Bayona, R Sanchez ; Harbeck, N ; Kuemmel, S ; Pistilli, B ; Wasserman, T ; Okines, A ; Rea, D ; Kloss, S ; Curigliano, G ; Ignatiadis, M ; De Laurentiis, M

BACKGROUND:

Real-world data analyses show durable benefits with elacestrant, with or without prior treatment with cyclin-dependent kinase 4/6 inhibitor (CDK4/6i). This cohort focused on patients with ER-positive/HER2-negative estrogen receptor 1 (ESR1)-mutated metastatic breast cancer (mBC) treated with elacestrant after at least one line of endocrine therapy (ET) combined with CDK4/6i (N = 281).

PATIENTS AND METHODS:

Claims data from the Komodo Research Dataset linked with Foundation Medicine clinical-genomics data were used. Primary outcome was median time-to-next-treatment (mTTNT).

RESULTS:

In patients with ER-positive/HER2-negative ESR1-mutated mBC who received one to two prior lines of ET + CDK4/6i (n = 108), mTTNT with elacestrant was 8.2 months [95% confidence interval (CI) 6.0-12.2]. In patients who received one to two prior lines of ET + CDK4/6i for ≥12 months (n = 85), mTTNT was 9.0 months (95% CI 7.7-13.7), including an mTTNT of 12.2 months (95% CI 9.0-not reached) in those who received one prior line of ET (n = 31). In patients with liver and/or lung metastasis (n = 169), mTTNT was 6.9 months (95% CI 5.8-8.3), whereas it was 7.4 months (95% CI 5.6-12.9) in patients with brain metastasis (n = 68). In patients with coexisting ESR1- and phosphoinositide 3-kinase-pathway-mutated tumors (n = 115), mTTNT was 6.1 months (95% CI 5.0-8.1).

CONCLUSIONS:

Elacestrant showed durable benefits in patients with ER-positive/HER2-negative ESR1-mutated mBC previously exposed to at least one line of ET + CDK4/6i, reinforcing the role of elacestrant as a potential first-choice option for patients with endocrine-sensitive tumors.

159

News (Medical) associated with Elacestrant hydrochloride

09 Nov 2026

·www.biospace.com

Caris Life Sciences Publishes Study Highlighting the Value of Comprehensive Molecular Profiling in Characterizing ESR1-Mutated Metastatic Breast Cancer

Findings suggest ESR1 variant type, number of mutations and estrogen receptor (ER) pathway activity may provide information beyond ESR1 mutation status alone IRVING, Texas , Nov. 9, 2026 /PRNewswire/ -- Caris Life Sciences ® (Caris), a leading TechBio company, today announced the publication of a study in Clinical Cancer Research that used comprehensive molecular profiling to identify important biological differences among ESR1 -mutated breast tumors and examine their association with time on treatment among patients receiving elacestrant. The study, "Differential impact of tumor-derived ESR1 mutations on elacestrant benefit in metastatic breast cancer," analyzed molecular profiling data from 38,865 breast tumors, including 3,344 harboring pathogenic or likely pathogenic ESR1 mutations. For patients treated with elacestrant, researchers linked comprehensive molecular profiling results with real-world insurance claims data to assess time on treatment. Elacestrant is an oral selective estrogen receptor degrader approved for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer whose disease has progressed following endocrine therapy. The study identified molecular features associated with shorter time on elacestrant. ESR1 mutations are a well-recognized mechanism of acquired resistance to endocrine therapy and have become an important biomarker for treatment selection in metastatic breast cancer. However, ESR1 mutation status is commonly treated as a binary biomarker despite laboratory evidence suggesting individual ESR1 variants may differ in their biology and therapeutic sensitivity. "This study highlights the complexity that exists within biomarkers that are often considered binary," said Caris Chief Medical Officer George W. Sledge, Jr., MD , lead author of the study. "Our findings suggest that not all ESR1 mutations behave the same way. By combining comprehensive molecular profiling with real-world clinical outcomes, we can begin to identify biologically meaningful differences that may contribute to a more refined understanding of treatment benefit in metastatic breast cancer. Importantly, these findings require prospective validation and are not yet ready to guide clinical decision-making." Among patients treated with elacestrant, tumors harboring ESR1 L536 mutations were associated with shorter median time on treatment compared with tumors carrying other common ESR1 variants, including E380Q/K, Y537 and D538G. Patients with L536-mutant tumors remained on therapy for a median of 1.38 months versus 2.99 months for patients with other common ESR1 variants. This association remained significant after adjustment for prior therapy and specimen site. The study also found that patients whose tumors contained two ESR1 mutations had a median time on elacestrant of 2.04 months compared with 3.16 months among patients with a single ESR1 mutation, further supporting the finding that comprehensive molecular profiling may provide additional information beyond a binary ESR1 mutation result. In the subset of tumors with RNA sequencing data, L536-mutant tumors had lower expression of GREB1 , a downstream marker of ER signaling, as well as reduced enrichment of estrogen-response pathways. Patients with lower GREB1 expression also experienced shorter time on elacestrant treatment than those with higher expression. Together, the findings suggest that variant-level ESR1 characterization and RNA-based measures of ER pathway activity may provide biological context beyond a simple positive-or-negative ESR1 result. The study further highlights the value of linking comprehensive molecular profiling with large-scale real-world outcomes data to uncover additional insights within established biomarkers. By integrating molecular profiling with longitudinal outcomes information, researchers can better characterize tumor biology and identify opportunities for future biomarker development. The publication is available through the Caris website . About Caris Life Sciences Caris Life Sciences® (Caris) is a leading TechBio company actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling (Whole Genome, Whole Exome and Whole Transcriptome Sequencing), advanced AI and machine learning, Caris has created the large-scale, multimodal clinico-genomic database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of next-generation sequencing, AI and machine learning technologies and high-performance computing provides a differentiated platform for developing the latest generation of advanced precision medicine diagnostic solutions for early detection, diagnosis, monitoring, therapy selection and drug development. Caris was founded with a vision to realize the potential of precision medicine to improve the human condition. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets. Forward-Looking Statements This press release contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding our business, solutions, plans, objectives, goals, industry trends, financial outlook and guidance. In some cases forward-looking statements can be identified by words such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "potential," "contemplate," "believe," "estimate," "predict," or "continue" or similar expressions. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in these forward-looking statements are reasonable based on information currently available to us, we cannot guarantee that the future results, discoveries, levels of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. Forward-looking statements involve known and unknown risks and uncertainties, some of which are beyond our control. Risks and uncertainties that could cause our actual results to differ materially from those indicated or implied by the forward-looking statements in this press release include, among other things: continued development, performance and commercialization of Caris Detect and Caris Confirm; developments in the precision medicine industry; our future financial performance, results of operations or other operational results or metrics; development, analytical and clinical validation, timing and performance of future solutions by us and our competitors; commercial market acceptance for our solutions, including acceptance of preventive as well as diagnostic testing paradigms, and our ability to meet resulting demand; the rapidly evolving competitive environment in which we operate; third-party payer reimbursement and coverage decisions related to our solutions, including the effect of legislative, regulatory, or administrative actions on reimbursement; the impact on our future volumes of the continued execution of our strategy to re-align and expand our sales organization; risks related to data management, storage, and processing capabilities and our ability to integrate and deploy artificial intelligence and advanced data analytics technologies; our ability to protect and enhance our intellectual property; regulatory requirements, decisions or approvals (including the timing and conditions thereof) related to our solutions; reliance on third-party suppliers; risks related to data security, patient privacy, and compliance with healthcare data protection regulations as well as potential cybersecurity threats to our data platforms; our compliance with laws and regulations; the outcome of government investigations and litigation; risks related to our indebtedness; and our ability to hire and retain key personnel as well as risks, uncertainties, and other factors described in the section titled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed on March 3, 2026, and in our other filings we make with the SEC from time to time. We undertake no obligation to update any forward-looking statements to reflect changes in events, circumstances or our beliefs after the date of this press release, except as required by law. Caris Life Sciences Media: Corporate Communications CorpComm@CarisLS.com 214.294.5606 View original content to download multimedia: SOURCE Caris Life Sciences

Clinical ResultClinical Study

04 Nov 2026

·www.globenewswire.com

Menarini Group and Ryvu Therapeutics Announce First Clinical Data from the Phase II JASPIS-01 Study of dapolsertib (MEN1703, SEL24) in Heavily Pretreated Relapsed/Refractory Aggressive B-cell non-Hodgkin Lymphoma at the 2026 ASH Annual Meeting

First clinical data for dapolsertib monotherapy: initial results from the Phase II JASPIS-01 study of dapolsertib (MEN1703), a first-in-class oral dual PIM/FLT3 kinase inhibitor, in patients with relapsed/refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (B-NHL) who have exhausted available standard treatment options.Clinical activity observed in a heavily pretreated population: clinical activity was observed in a population with a median of four prior lines of therapy; 53% of patients had previously received CAR-T cell therapy and 60% CD3×CD20 bispecific antibodies.New treatment options needed: patients whose disease progresses after CAR-T cell therapy and/or CD3×CD20 bispecific antibodies have limited therapeutic options and poor outcomes.Poster presentation at ASH 2026: the data will be presented on December 13, 2026, at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, U.S. FLORENCE, Italy and KRAKOW, Poland, Nov. 04, 2026 (GLOBE NEWSWIRE) -- 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, along with Ryvu Therapeutics (WSE: RVU), today announced that the first clinical data from the ongoing Phase II JASPIS-01 study (NCT06534437) of dapolsertib (MEN1703, SEL24) in patients with r/r aggressive B-NHL will be presented in a poster session at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 12-15, 2026, in New Orleans, Louisiana, and virtually. Dapolsertib is a first-in-class oral dual PIM/FLT3 kinase inhibitor that has demonstrated preclinical antitumor activity and synergy with anti-CD20-directed therapies. The abstract reports the first clinical results from Group 2 of the JASPIS-01 study, which evaluates dapolsertib monotherapy (125 mg orally once daily on days 1-14 of 21-day cycles) in adults with r/r aggressive B-NHL who have exhausted available standard treatment options following at least two prior systemic therapies. Clinical activity was observed in heavily pretreated patients. The safety profile was manageable and allowed dosing of dapolsertib at the intended dose level. “Patients with aggressive B-cell lymphoma whose disease progresses after CAR-T cell therapy and bispecific antibodies have limited treatment options and face very poor outcomes,” said Elcin Barker Ergun, CEO of the Menarini Group. “The encouraging initial findings in heavily pretreated patients support the continued clinical development of dapolsertib, a first-in-class oral dual PIM/FLT3 inhibitor, as a potential option for this grim disease, and we look forward to further results from the ongoing study.” “We are very pleased that the first clinical data from JASPIS-01 will be presented at ASH, a leading hematology meeting. The activity seen in the JASPIS-01 study are particularly encouraging, given the highly aggressive biology of the disease in this population,” said Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics. “As dapolsertib inventors and Menarini’s operational partner for the study, we remain committed to advancing dapolsertib for patients with aggressive B-cell lymphoma, who urgently need new treatment options.” Details on the poster presentation are as follows: Poster Title: Preliminary clinical activity and safety of dapolsertib (MEN1703), a first-in-class dual PIM/FLT3 inhibitor, in heavily pretreated relapsed/refractory aggressive B-cell non-Hodgkin lymphoma: Initial results from the Phase II JASPIS-01 trialPublication Number: 3662Session: 627. Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster IISession date and time: Sunday, December 13, 2026, 6:00-8:00 PM CST (1:00-3:00 AM CET on December 14)Location: Ernest N. Morial Convention Center, Hall F, New Orleans, Louisiana The abstract is available on the ASH website: https://www.hematology.org/meetings/annual-meeting About JASPIS-01JASPIS-01 (NCT06534437) is an ongoing multicenter, open-label Phase II study evaluating dapolsertib as monotherapy and in combination with glofitamab in adults with r/r aggressive B-NHL, including diffuse large B-cell lymphoma (DLBCL), after at least two prior systemic therapies. Group 1 evaluates dapolsertib in combination with glofitamab in patients naïve to CD3×CD20 bispecific antibodies. Group 2 evaluates dapolsertib as monotherapy in patients who have exhausted available standard treatment options. The primary endpoint is overall response rate (ORR) per the Lugano Classification; secondary endpoints include duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety. About dapolsertibDapolsertib (MEN1703, SEL24) is a first-in-class, oral, selective small-molecule dual inhibitor of PIM and FLT3 kinases, discovered by Ryvu. Global development and commercial rights to dapolsertib are licensed to the Menarini Group. Since September 2023, Ryvu has been Menarini’s operational partner for Phase II study execution, with Menarini funding all research and development costs. Dapolsertib is an investigational agent and has not been approved by any regulatory authority. About The Menarini GroupThe 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. About Ryvu TherapeuticsRyvu Therapeutics is a clinical-stage drug discovery and development company focused on novel therapies that address emerging targets in oncology. Internally discovered pipeline candidates at Ryvu use diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules and antibody-drug conjugates directed at kinases, synthetic lethality, and immune-oncology targets. Ryvu’s most advanced program is romaciclib (RVU120, SEL120), a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies and solid tumors. Romaciclib is currently in Phase II development in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study – and is also being evaluated in an investigator-initiated Phase I study in pediatric medulloblastoma – the MEDWAY study. Dapolsertib (MEN1703, SEL24) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently being investigated in a Phase II study in diffuse large B-cell lymphoma (DLBCL) – the JASPIS-01 study – with a further Phase II study in myelofibrosis (SPHENE-01) planned to start in Q1 2027. RVU305, a potentially best-in-class, brain-permeable PRMT5 inhibitor aiming to treat multiple solid tumors, has completed IND/CTA-enabling studies. Ryvu Therapeutics is also engaged in oncology collaborations with BioNTech and Exelixis, and offers dedicated early clinical development services to biotech and pharma partners through its Keelira business. Ryvu was founded in 2007 and is headquartered in Kraków, Poland. It is listed on the Warsaw Stock Exchange and is a component of the sWIG80 index. For more information, please visit www.ryvu.com Contacts The Menarini GroupValeria Speroni CardiEmail: pressoffice@menarini.com Stemline Therapeutics, Inc.Cheya PopeEmail: media@menarinistemline.comRyvu TherapeuticsAnna Wilk+48 532 698 425anna.wilk@ryvu.com

Phase 2Clinical ResultPhase 1ASH

27 Oct 2026

·firstwordpharma.com

Menarini bets $1.1B on Georgiamune's preclinical oral immunotherapy

Italy's Menarini has struck a global licensing deal with US biotech Georgiamune centred on GIM-621, a preclinical-stage small molecule designed to harness the immune system against several types of solid tumours.Georgiamune will receive $45 million in upfront and near-term payments, with the deal's total value reaching $1.1 billion if the potential first-in-class drug clears a series of milestones. The biotech is also eligible for royalties on future sales."This programme is a strong complement to our solid tumour portfolio, and our established oncology development and commercial capabilities position us well to accelerate its progress," stated Elcin Barker Ergun, chief executive at Menarini, in a release Thursday.The Italian pharma's oncology portfolio includes the oral selective oestrogen receptor degrader (SERD) Orserdu (elacestrant) for breast cancer, and Elzonris (tagraxofusp), a CD123-directed cytotoxin and fusion protein for blastic plasmacytoid dendritic cell neoplasm.Stemline Therapeutics, Menarini's wholly owned oncology subsidiary, will gain exclusive worldwide rights to develop, manufacture and commercialise GIM-621. The companies haven't revealed its molecular target or specific indications, nor did they give a timeline as to when the programme would move into clinical testing.Georgiamune, whose work focuses on mechanisms governing immune activation, suppression and homeostasis, is advancing three clinical-stage programmes of its own. These include GIM-407, an oral regulatory T-cell (Treg) activator for autoimmune diseases; GIM-531, an oral Treg inhibitor in oncology; and GIM-122, a dual-functioning antibody being developed for oncology as well.The Maryland-based biotech completed a $75-million series A round in 2023.

License out/inImmunotherapy

100 Deals associated with Elacestrant hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D11672	Elacestrant hydrochloride	L02BA04	DB06374

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Locally advanced breast cancer	Australia	A. Menarini Australia Pty Ltd.	01 Apr 2026
Metastatic breast cancer	Australia	A. Menarini Australia Pty Ltd.	01 Apr 2026
Advanced breast cancer	United Kingdom	Stemline Therapeutics, Inc.	05 Jan 2024
ER-positive/HER2-negative/ ESR1-mutated breast cancer	United States	Stemline Therapeutics, Inc.	27 Jan 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	NDA/BLA	United States	Radius Pharmaceuticals, Inc.	22 Jun 2022
Hormone receptor positive HER2 negative breast cancer	Phase 3	Germany	Berlin-Chemie/Menarini Pharma GmbH	29 Apr 2026
Estrogen receptor positive breast cancer	Phase 3	United States	Stemline Therapeutics, Inc.	27 Sep 2024
Estrogen receptor positive breast cancer	Phase 3	Argentina	Stemline Therapeutics, Inc.	27 Sep 2024
Estrogen receptor positive breast cancer	Phase 3	Australia	Stemline Therapeutics, Inc.	27 Sep 2024
Estrogen receptor positive breast cancer	Phase 3	Austria	Stemline Therapeutics, Inc.	27 Sep 2024
Estrogen receptor positive breast cancer	Phase 3	Belgium	Stemline Therapeutics, Inc.	27 Sep 2024
Estrogen receptor positive breast cancer	Phase 3	Brazil	Stemline Therapeutics, Inc.	27 Sep 2024
Estrogen receptor positive breast cancer	Phase 3	Canada	Stemline Therapeutics, Inc.	27 Sep 2024
Estrogen receptor positive breast cancer	Phase 3	Czechia	Stemline Therapeutics, Inc.	27 Sep 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2026	Not Applicable	ER-positive/HER2-negative/ ESR1-mutated breast cancer ESR1 mutations \| PIK3CA mutations	64	Elacestrant	mljqvkvmti(rxvfblmnus) = dagfrotuvp ddxeoaqjja (lbpqsuuckk, 3.24 - 6.75) View more	Positive	23 Oct 2026
				Elacestrant (PIK3CA co-mutation)	mljqvkvmti(rxvfblmnus) = lgwnagzvmq ddxeoaqjja (lbpqsuuckk )
NCT05563220 (ELEVATE, ASCO2026)	Phase 1/2	ER-positive/HER2-negative Breast Cancer Second line \| First line ER+/HER2−	31	CapivasertibElacestrant + CapivasertibElacestrantb	nviglueaot(lauysxxdvo) = hzvephhkjg tekfamllnz (mkijzrfiib ) View more	Positive	29 May 2026
NCT07159451 (ESMO_BC2026)	Phase 2	Hormone receptor positive HER2 negative breast cancer HR+ \| HER2-	140	Elacestrant 345 mg	emwrosiort(tvrgxtddmg) = kkiplwpnum xpozsurxrk (aowmgtwhxc ) View more	Positive	07 May 2026
				Leuprorelin 3.75 mgElacestrant 345 mg daily + Leuprorelin 3.75 mgElacestrant 345 mg daily (GnRH agonist therapy)	poenlpmaff(wqzjxkmslt) = pdqudnsxpk igechvczaf (csepbkjovg ) View more
NCT05982093 (SOLTI-2104 PremiÈRe Part B, ESMO_BC2026)	Phase 2	Hormone receptor positive HER2 negative breast cancer HR positive \| HER2 negative	48	Elacestrant 345 mg	ogrclmnabj(znaaqfqyiu) = alrkowxuth utbevltcjx (poxtuedrrd )	Positive	07 May 2026
				Tamoxifen 20 mg	ijpogpfogq(gmdmbmtbmf) = cxekxmxbpu eplmnpxish (ptfuvgspzw ) View more
AACR2026	Phase 2/3	Hormone receptor positive HER2 negative breast cancer HR Positive \| HER2 Negative	16	Imlunestrant alone	gtjpgrzcwl(oweubvicpn) = lawudeiplo yoeatrollt (rbvrexwnzg ) View more	Positive	21 Apr 2026
				Camizestrant 75mg	gtjpgrzcwl(zknkueovbr) = hcfjamlfrf xryoaiyekw (deokstosiw ) View more
NCT06492616 (ELEGANT, SABCS2025)	Phase 3	ER-positive/HER2-negative Breast Cancer ESR1-mut \| ER+ \| HER2-	4,220	Elacestrant	kvorfrbnmn(phifiwkoli) = wznqdlnybd pcyiscvbhv (otozzxueza )	Positive	11 Dec 2025
NCT06382948 (ADELA, SABCS2025)	Phase 3	ESR1-mutated \| ER+/HER2-	240	Elacestrant + Everolimus	wbnhzgdxgy(nlofscpwdw) = nmgsrptetc yoaapotirj (fddqosoncy )	Positive	10 Dec 2025
				Elacestrant + Placebo	eqwdahogoi(foekmhefps) = ldnryulkyf lkuemujkbp (crkgldqpoq )
SABCS2025	Not Applicable	Hormone receptor positive breast cancer PIK3CA \| ESR1	107	alpelisib+fulvestrant	aqowuvlvbh(pfzcrmzlsy) = One patient with alpelisib experienced treatment interruption and dose reduction due to skin toxicity, while Elacestrant was well-tolerated without major adverse effects. mnyvphnmki (ominjoixay )	Positive	10 Dec 2025
				capivasertib+fulvestrant
ESMO2025	Not Applicable	Advanced breast cancer HR+ \| HER2-	16	Camizestrant	-	Positive	17 Oct 2025
				Ribociclib plus ET
NCT05563220 (ELEVATE, ASCO2025)	Phase 1/2	ER-positive/HER2-negative Breast Cancer	-	Elacestrant + Ribociclib	ewtiucsayp(flougaqpbq) = 43% (7% ≥Gr3) with Ela + Eve owpfsibqrq (jgmjxqkqew ) View more	-	30 May 2025
				Elacestrant + Everolimus

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis