Orserdu (elacestrant) / Radius, Menarini, DRI Healthcare, SciClone - LARVOL DELTA

A Rare Presentation of Esophageal Metastasis From Breast Carcinoma in a Patient Presenting With Bilateral Pulmonary Emboli Complicated by Intraventricular Hemorrhage (ACG 2026) - "Case Description/ A 65 year old female with a history of bilateral lower extremity deep vein thromboses, prior pulmonary embolism, and metastatic ER+ / HER2- breast cancer on Abemaciclib and Elacestrant presented with 1.5 weeks of shortness of breath, cough, and progressive dysphagia to solids and liquids, along with a 16-pound unintentional weight loss over 2 months. Figure: Sagittal view of the CTA chest showing a mid-esophageal mass with proximal esophageal dilatation. Figure: Upper EGD demonstrating a mid-esophageal stricture prior to dilation."

Clinical • Breast Cancer • Cardiovascular • Cough • Esophageal Cancer • Estrogen Receptor Positive Breast Cancer • Gastrointestinal Disorder • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pulmonary Embolism • Respiratory Diseases • Solid Tumor • Triple Negative Breast Cancer • GATA3 • HER-2

A Bleeding Ulcer That Wasn't: Gastric Metastasis From Invasive Ductal Breast Carcinoma (ACG 2026) - "Her oncologic course was marked by axillary nodal recurrence in 2017, followed by progressive metastatic disease involving lung, bone, liver, and brain, treated with anastrozole, letrozole, fulvestrant/everolimus, alpelisib, trastuzumab deruxtecan, and elacestrant. Gastroenterologists evaluating GI bleeding in patients with breast cancer history should pursue targeted biopsy with breast-directed immunohistochemistry, as accurate classification carries direct therapeutic implications. Figure: Endoscopic findings showing a 2.5 cm ulcer on the greater curvature of the proximal body and multiple additional ulcers up to 1.5 cm along the antrum, distal body, and proximal body of the stomach."

Breast Cancer • Gastric Cancer • Gastrointestinal Disorder • HER2 Positive Breast Cancer • Oncology • Peptic Ulcer • Solid Tumor • CDH1 • GATA3 • PGR

Oral selective estrogen receptor degraders in ER+/HER2- breast cancer: a systematic review with pooled analysis of metastatic randomized trials and narrative synthesis of adjuvant evidence. (PubMed, Front Oncol) - "We searched PubMed, Cochrane CENTRAL, and conference abstract archives (SABCS, ESMO, ASCO; 2020-2026) for Phase II/III randomized controlled trials comparing oral SERDs (giredestrant, imlunestrant, elacestrant, camizestrant, vepdegestrant, amcenestrant) with standard endocrine therapy in ER-positive, HER2-negative breast cancer. This evidence synthesis across the full breast cancer continuum offers a framework for clinical decision-making as oral SERDs expand from advanced to early-stage disease. https://www.crd.york.ac.uk/prospero/display_record.php, identifier CRD420261358420."

Journal • Retrospective data • Review • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Targeted Protein Degradation • ER • HER-2

Elacestrant in combination with everolimus or abemaciclib in patients with ER+/HER2- locally advanced or metastatic breast cancer (mBC): phase 2 results from ELEVATE, an open-label, umbrella study (SABCS 2025) - " ELEVATE is evaluating elacestrant combined with everolimus, alpelisib, capivasertib, abemaciclib, ribociclib,or palbociclib to address different resistance mechanisms...PFS benefit was consistent across subgroups, including those with visceral metastases, prior fulvestrant or primary ET resistance... Elacestrant in combination shows a consistent PFS benefit irrespective of ESR1m status in pts with ER+/HER2-mBC after progressive disease on ET ± prior CDK4/6i. Elacestrant has the potential to become an ET backbone for combination strategies with targeted agents, supporting an all-oral approach that may delay the need for chemo or ADC-based regimens in this patient population. Table 1:Phase 2 mPFS, mo[95% CI] in all patients and subgroupsNR, not reached"

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2 • PIK3CA

Global phase III studies evaluating vepdegestrant in estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer: VERITAC-2 and VERITAC-3 (ESMO Asia 2023) - P1, P1/2, P3 | "VERITAC-3 will compare vepdegestrant + palbociclib vs letrozole + palbociclib as 1st-line treatment in pts with ER+/HER2- locoregional recurrent/metastatic breast cancer; no prior treatment in the advanced setting; and no prior treatment in any setting with CDK4/6 inhibitors, vepdegestrant, fulvestrant, elacestrant, or other investigational agents. In the phase 3 portion, pts (N≈1130) will be randomized to vepdegestrant + palbociclib or letrozole + palbociclib. The primary endpoint is PFS by BICR."

Clinical • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Elacestrant (Ela) in combination with everolimus (Eve) or abemaciclib (Abema) in patients with ER+/HER2- locally advanced or metastatic breast cancer mBC: phase 2 results from ELEVATE, an open-label, umbrella study (AACR 2026) - "ELEVATE is evaluating Ela combined with Eve, alpelisib, capivasertib, Abema, ribociclib, or palbociclib to address resistance mechanisms. Ela combinations show a consistent clinically meaningful PFS irrespective of ESR1m status in pts with ER+/HER2- mBC after progressive disease on ET ± prior CDK4/6i, and could become an ET backbone for combination strategies, supporting an all-oral approach.NR, not reached *Maturity not reached for PFS (95% CI) for genomic subgroups (ESR1 / PIK3CA) or by prior CDK4/6i exposure."

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2 • PIK3CA

Elacestrant in combination with abemaciclib in patients (pts) with brain metastasis (mets) from estrogen receptor-positive (ER+), HER2-negative (HER2-) breast cancer: Preliminary data from ELECTRA, an open-label, multicenter, phase Ib/II study (ESMO 2024) - P1/2 | "The elacestrant + abemaciclib combination shows a manageable/predictable safety profile and favorable efficacy. Elacestrant has the potential to become the ET backbone for combination regimens. The Phase 2 portion of the study is currently enrolling."

Clinical • Combination therapy • P1/2 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Elacestrant in combination with abemaciclib in patients (pts) with brain metastasis from estrogen receptor-positive (ER+), HER2-negative (HER2-) breast cancer: Preliminary data from ELECTRA, an open-label, multicenter, phase 1b/2 study. (ASCO 2024) - P1/2 | "The RP2D for elacestrant + abemaciclib will be reported; the combinationdemonstrated a manageable and predictable safety profile. Preliminary efficacy data showed encouraging antitumor activity. Elacestrant has the potential to become the ET backbone for combination regimens."

Clinical • Combination therapy • P1/2 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • ER • HER-2

Elacestrant alone or in combination with triptorelin in premenopausal women with ER+/HER2- early breast cancer: primary analysis from the phase 2 SOLTI-2104- PremiÈRe trial (SABCS 2025) - P2 | "Ovarian function suppression (OFS) in combination with tamoxifen or aromatase inhibitors improves disease-free survival but has limitations such as toxicity, suboptimal estrogen suppression, and poor adherence. This study provides the first evidence that ELA ± OFS elicits antiproliferative and molecular responses in premenopausal women with ER+/HER2- EBC. Both regimens had comparable and significant reductions in Ki67, CCCA, ROR-P scores, and proliferation gene expression. PremiÈRe trial support the potential role of ELA as a novel ET in this population, potentially sparing the need for OFS."

Clinical • Combination therapy • P2 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Elacestrant in ESR1-mutant mBC: Establishing the Standard of Care (ESMO 2026) - "Sponsored by Menarini Stemline"

Breast Cancer • Oncology • Solid Tumor • ER

Adjuvant dynamic marker-adjusted personalized therapy with elacestrant vs standard endocrine therapy (ET) in biological high-risk, clinical low-to-intermediate-risk estrogen receptor-positive (ER+)/HER2- early breast cancer (eBC): ADAPTela (ESMO 2026) - No abstract available

Clinical • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Real-world elacestrant outcomes in ESR1-mutant HR+/HER2− metastatic breast cancer: a Two-centre NHS audit (ESMO 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

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. (PubMed, ESMO Open) - "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."

Journal • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

elacestrant (Korserdu) is accepted for restricted use within NHSScotland (Scottish Medicines Consortium) - "Indication under review: as monotherapy for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor. SMC restriction: patients who have disease progression after receiving ≥12 months prior treatment with endocrine therapy plus a cyclin-dependent kinase (CDK) 4/6 inhibitor. In an open-label phase III study, elacestrant significantly improved progression-free survival (PFS) compared with investigator’s choice of endocrine monotherapy, which may be relevant in a small proportion of patients in Scotland."

Reimbursement • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer

Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. (PubMed, J Clin Oncol) - "Elacestrant is the first oral selective ER degrader demonstrating a significant PFS improvement versus SOC both in the overall population and in patients with ESR1 mutations with manageable safety in a phase III trial for patients with ER-positive/HER2-negative advanced breast cancer."

Journal • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: Updated results by duration of prior CDK4/6i in metastatic setting (SABCS 2022) - P3 | " EMERALD (NCT03778931) is a randomized, open-label, phase 3 trial that enrolled pts with ER+/HER2- MBC who previously had 1-2 lines of endocrine therapy, mandatory CDK4/6i, and ≤1 chemotherapy; prior treatment with fulvestrant was allowed. EMERALD is the first phase 3 trial to demonstrate a significant PFS improvement versus SoC in all pts and in the subgroup with ESR1 mutations in pts with ER-positive/HER2-negative MBC with 1-2 prior lines of endocrine treatment ± one line of chemotherapy. Elacestrant demonstrated longer PFS versus SOC that was positively associated with the duration of prior treatment with CDK4/6i, which was more pronounced in pts with ESR1-mut MBC. In this 2nd and 3rd line setting, elacestrant was well tolerated with significantly longer PFS versus SoC, highlighting its potential role as a therapeutic option for pts with ER+/HER2- MBC."

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2

Elacestrant in postmenopausal women with estrogen receptor positive and HER2-negative early breast cancer: primary efficacy and safety analysis of the preoperative, window of opportunity SOLTI-1905-ELIPSE trial (SABCS 2022) - P1 | "Conclusions In untreated ER+/HER2-negative early BC a short-course preoperative treatment with elacestrant was associated with relevant biological and molecular response and with manageable safety profile. Globally, these findings support further exploration of this highly potent, novel oral SERD in early BC."

Clinical • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • BIRC5 • BRCA2 • CCND1 • CD4 • CD8 • ER • GZMB • HER-2 • MYBL2 • UBE2T

EMERALD trial analysis of patient-reported outcomes (PROs) in patients with ER+/HER2_ advanced or metastatic breast cancer (mBC) comparing oral elacestrant vs standard of care (SoC) endocrine therapy (ESMO-BC 2023) - P3 | "Conclusions This analysis confirmed that QoL was maintained between treatment groups in the EMERALD trial. Together with the previously described statistically significant prolonged PFS and manageable safety profile, these PRO results provide additional evidence that oral elacestrant is clinically meaningful in this patient population with limited therapeutic options."

Clinical • Metastases • Patient reported outcomes • Breast Cancer • Fatigue • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Oncology • Pain • Solid Tumor • CDK4 • ER • HER-2

Elacestrant vs standard-of-care in ER+/HER2- advanced or metastatic breast cancer (mBC) with ESR1 mutation: key biomarkers and clinical subgroup analyses from the phase 3 EMERALD trial (SABCS 2023) - P3 | " Patients with ER+/HER2- advanced or mBC who previously had 1-2 lines of endocrine therapy, and prior CDK4/6i, were randomized 1:1 to receive elacestrant or SOC (aromatase inhibitor or fulvestrant). Elacestrant showed significantly greater PFS when prior treatment duration with CDK4/6i was at least 12 months, suggesting prior exposure to CDK4/6i is a surrogate marker for endocrine sensitivity. In this population, elacestrant demonstrated superior efficacy, compared to SOC, even in patients with concomitant PIK3CA or TP53 mutations, expression of HER2 low, or presence of liver and/or lung metastases. These results suggest an active ER-driven pathway for this group despite the presence of other resistance mechanisms, where single-agent oral elacestrant could be an attractive option compared to combination therapies or intravenous HER2 low-targeted ADCs."

Biomarker • Clinical • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2 • PIK3CA • TP53

Elacestrant in ER+, HER2- MBC with ESR1-mutated tumors: Subgroup Analyses from the Phase III EMERALD Trial by Prior Duration of Endocrine Therapy Plus CDK4/6 Inhibitor and in Clinical Subgroups. (PubMed, Clin Cancer Res) - "Duration of prior ET+CDK4/6i ≥12 months in mBC was associated with a clinically meaningful improvement in PFS for elacestrant compared to SOC and was consistent across all subgroups evaluated in patients with ER+, HER2-, ESR1-mutated tumors."

Journal • P3 data • Oncology • Solid Tumor • ER • HER-2 • PIK3CA • TP53

EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA). (ASCO 2025) - P3 | "Study conducted under the Breast International Group (BIG) umbrella. Collaborative groups: GIM, CTI, SUCCESS, SOLTI, HeCOG, HORG, BOOG, SweBCG and ETOP-IBCSG."

Circulating tumor DNA • Clinical • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

ABC-RWS-01 interim analysis of elacestrant in Chinese ESR1-mutated ER+/HER2- advanced breast cancer (ESMO 2026) - No abstract available

Metastases • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

BGB-43395-101: BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=433 | Recruiting | Sponsor: BeOne Medicines | Trial completion date: Nov 2028 ➔ Dec 2029 | Trial primary completion date: Nov 2028 ➔ Dec 2029

Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Oral selective estrogen receptor degraders and biomarker-driven therapy in ER-positive breast cancer: mechanisms, clinical evidence, and future directions. (PubMed, Front Oncol) - "This review comprehensively examines the mechanisms of SERD action, their role in overcoming resistance to conventional endocrine therapy, and clinical applications of approved agents including fulvestrant, elacestrant, imlunestrant, and vepdegestrant, the first FDA-approved PROTAC estrogen receptor degrader. We discuss emerging oral SERDs such as giredestrant and camizestrant, novel PROTAC-based approaches, and combination strategies with CDK4/6 inhibitors, PI3K inhibitors, and other targeted agents. Special attention is given to ESR1 mutations as biomarkers for patient selection and therapy optimization. The review highlights key clinical trials including EMERALD, EMBER-3, SERENA-6, and lidERA that have shaped current treatment guidelines and points toward future directions in SERD development."

Biomarker • Journal • Review • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Gynecology • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Targeted Protein Degradation • ER

Elacestrant in Combination with Everolimus for Estrogen Receptor-Positive, HER2-Negative Previously Treated Advanced Breast Cancer: Results from ELEVATE. (PubMed, Clin Cancer Res) - "Elacestrant plus everolimus showed a clinically meaningful PFS benefit across clinical/genomic subgroups, irrespective of ESR1 or PIK3CA-mutation status. Elacestrant has the potential to become an ET backbone for combinations to inhibit the PI3K/AKT/mTOR-pathway with everolimus as a promising all-oral treatment."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2 • PIK3CA