A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

The purpose of the study is to assess the efficacy and safety of the addition of LY4064809 to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.

Start Date27 Oct 2025

Sponsor / Collaborator

Eli Lilly & Co.

[+1]

ISRCTN99425493

/ RecruitingPhase 2IIT

Randomised Phase II open-label window of opportunity trial AKTivate - Identifying target engagement and biomarkers of response, including an imaging biomarker, in participants receiving Capivasertib plus Exemestane and Capivasertib alone in post-menopausal participants with oestrogen receptor positive (ER+) early-stage breast cancer

Start Date01 Oct 2025

Sponsor / Collaborator

Cambridge University Hospitals NHS Foundation Trust

100 Clinical Results associated with Exemestane

100 Translational Medicine associated with Exemestane

100 Patents (Medical) associated with Exemestane

2,246

Literatures (Medical) associated with Exemestane

01 Feb 2026·Biomaterials advances

Exploring the efficacy and mechanisms of exemestane-loaded nanoparticles in targeted breast cancer therapy

Review

Author: Wahab, Shadma ; Goh, Khang Wen ; Kesharwani, Prashant ; Sahebkar, Amirhossein ; Chauhan, Meghna ; Gupta, Garima ; Almoyad, Mohammad Ali Abdullah

Exemestane (EXE), an irreversible aromatase inhibitor, is a well-established therapeutic agent for the management of estrogen receptor-positive (ER⁺) breast cancer. Despite its proven clinical benefits, its broader therapeutic potential is limited by factors such as poor bioavailability, short plasma half-life, and undesirable off-target effects. Recent advances in nanotechnology have introduced promising strategies to address these limitations. Encapsulating EXE within nanoparticles (NPs) offers a novel platform to improve drug delivery, enhance tumor targeting, and optimize therapeutic efficacy. Various NP systems including lipid-based, polymeric, and inorganic carriers have been investigated for EXE encapsulation and delivery. These nanoformulations confer multiple advantages, such as improved solubility, sustained and controlled release, and selective delivery to malignant cells. The presented review examines the in vitro and in vivo evidence supporting the superior anticancer performance of EXE-loaded NPs, alongside their potential to overcome key challenges in breast cancer therapy. In addition, safety profiles, translational potential, and future perspectives for integrating EXE NPs into precision medicine approaches are discussed, offering insights into their application in combination with conventional treatment regimens for improved breast cancer management.

01 Dec 2025·FISH PHYSIOLOGY AND BIOCHEMISTRY

Exemestane induces liver toxicity in zebrafish larvae by upregulating the p53 signaling pathway

Article

Author: Cao, Zigang ; Chen, Wanqing ; Xiao, Juhua ; Wang, Ziang ; Yuan, Wenbin ; Zhang, Shouhua ; Zhou, Xiying ; Li, Weirong ; Xiao, Zhonghao ; Hu, Weitao ; Lian, Jianping ; Wang, Bin

Exemestane is an aromatase inhibitor that is used for the treatment of breast cancer. The aim of this study was to evaluate the effects of exemestane on liver development of zebrafish embryos. In this study, zebrafish embryos at 72 h post-fertilization (hpf) were exposed to varying concentrations (1, 2, and 3 mg/L) of exemestane for 72 h (until 144 hpf). The results demonstrated that exemestane exposure significantly reduced liver area and expanded the yolk sac in a dose-dependent manner, accompanied by progressive lipid accumulation. At the highest concentration (3 mg/L), exemestane markedly downregulated the expression of key liver development markers, including fatty acid-binding protein (fabp10a) and ceruloplasmin (cp). The study further revealed that exemestane exposure at 2 mg/L and 3 mg/L significantly increased reactive oxygen species (ROS) levels while decreasing the activities of antioxidant enzymes, specifically catalase (CAT) and superoxide dismutase (SOD). Interestingly, higher concentrations of exemestane resulted in reduced levels of the lipid peroxidation product malondialdehyde (MDA) and decreased mitochondrial numbers. Additionally, exemestane treatment altered the expression of genes related to sugar and lipid metabolism and upregulated pro-apoptotic genes, including bax, p53, and caspase 3, in zebrafish embryos. A crucial finding was that p53 knockdown in zebrafish embryos effectively mitigated the hepatotoxic effects induced by exemestane. These collective results indicate that exemestane induces hepatotoxicity in zebrafish primarily through activation of the p53 signaling pathway. This study provides valuable insights into the potential hepatotoxic effects of exemestane, offering important references for its clinical safety evaluation.

01 Dec 2025·Oral Surgery Oral Medicine Oral Pathology Oral Radiology

Medication-related osteonecrosis of the jaw induced by a CDK 4/6 inhibitor (Palbociclib) in a patient who was naïve to antiresorptive bone therapy: a case report

Article

Author: Pallois, Elodie ; Devoize, Laurent ; Chenu, Eva ; Pham Dang, Nathalie

Medication-related osteonecrosis of the jaw (MRONJ) is a well-documented adverse effect initially linked to antiresorptive agents such as bisphosphonates. Over time, other drug classes have been associated with MRONJ: monoclonal antibodies targeting RANK ligand, monoclonal antibodies targeting VEGF, tyrosine kinase inhibitors, and mammalian target of rapamycin (mTOR) inhibitors. This article presents the case of an 83-year-old female patient referred to the maxillofacial surgery department due to a submental cutaneous fistula with purulent discharge and localized pain. Her notable medical history includes treatment with palbociclib and exemestane for breast cancer. Palbociclib (cyclin-dependent kinase [CDK] 4/6 inhibitors) are commonly used in combination with hormone therapy for the treatment of HR+/HER2- metastatic breast cancer. Whereas its efficacy in prolonging progression-free survival is well established, its potential impact on bone remodeling and the risk of MRONJ remain under investigation. This case highlights a potential new etiology of MRONJ associated with palbociclib. As CDK 4/6 inhibitors gain widespread use in oncology, clinicians should be aware of this possible complication and closely monitor patients for signs of jaw osteonecrosis.

News (Medical) associated with Exemestane

02 Dec 2025

·www.businesswire.com

New Data to be Presented at the 2025 SABCS Demonstrates Potential Expanded Utility of the Breast Cancer Index Test, the Leading Biomarker in Personalizing Endocrine Therapy Duration

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., today announced that 11 studies featuring the Breast Cancer Index® (BCI™) Test will be presented at the 2025 San Antonio Breast Cancer Symposium® (SABCS). Findings from these studies support the company’s ongoing commitment to help inform personalized treatment recommendations for patients with early-stage, hormone receptor-positive (HR+) breast cancer. Building on the test’s established position as the only guideline-recognized and most extensively validated test to predict which patients are likely to benefit from extended endocrine therapy,1-7 these new insights explore potential expanded utility in premenopausal women and comparison to the 21-gene assay for extended endocrine therapy treatment decisions. New Data to be Presented at the 2025 SABCS Demonstrates Potential Expanded Utility of the Breast Cancer Index Test, the Leading Biomarker in Personalizing Endocrine Therapy Duration “These data reinforce Hologic’s continued commitment to oncology innovation and advancing precision diagnostics in breast cancer care,” said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. “This impressive volume of evidence provides deeper insight into premenopausal patient populations, supports more nuanced endocrine therapy decision-making and highlights the consistency of the BCI Test’s performance across diverse patient subgroups and sample types.” Among the new findings to be presented, one study, “Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27],” explores the BCI Test’s potential ability to identify a group of premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. Results from this translational analysis of the two largest landmark ovarian function suppression (OFS) trials, Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT), support the potential utility of BCI Testing in identifying premenopausal women who may forgo the addition of OFS therapy to primary adjuvant endocrine therapy.8^* “As we observe an increasing number of women being diagnosed with breast cancer at a younger age, it is imperative to balance the need for effective recurrence prevention with the preservation of patient quality of life,” said primary study author Dr. Ruth O’Regan, MD. “The ability to accurately identify premenopausal women who can safely avoid more aggressive treatment regimens would represent a significant advancement in the field of personalized medicine, allowing us to tailor therapies to individual patient needs while minimizing unnecessary side effects.” A full list of studies to be presented at the 2025 SABCS conference includes: Poster Session 2: December 10, 2025, 5:00pm – 6:30pm CST Endocrine Sensitivity and Predicted Benefit of Extended Endocrine Therapy Based on Breast Cancer Index (BCI) in BRCA1, BRCA2 and CHEK2 Pathogenic Variant Carriers with ER+/HER2– Breast Cancer [#PS2-08-25]: Examines how BCI Testing may help identify differences in hormone-therapy benefit among women with inherited BRCA1, BRCA2 or CHEK2 gene variants. 9 * Endocrine Sensitivity and Predicted Benefit of Extended Endocrine Therapy Based on Breast Cancer Index (BCI) in BRCA1, BRCA2 and CHEK2 Pathogenic Variant Carriers with ER+/HER2– Breast Cancer [#PS2-08-25]: Examines how BCI Testing may help identify differences in hormone-therapy benefit among women with inherited BRCA1, BRCA2 or CHEK2 gene variants. 9 * Poster Session 3: December 11, 2025, 12:30pm – 2pm CST Breast Cancer Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy Benefit: Final Analysis of the BCI Registry Study [#PS3-07-24]: Demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning and emphasizes the need to use the right test for each clinical decision. 10 * Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]: Highlights the BCI Test’s ability to identify premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. 8 ^* Prognostic Performance of Breast Cancer Index in Patients with Early-Stage HR+ HER2+ Breast Cancer Treated with Adjuvant Trastuzumab: NCCTG N9831 (Alliance) [#PS3-07-28]: Supports the BCI Test’s ability to assess recurrence risk in patients with HER2+ disease. 11 * Comparative Analysis of Breast Cancer Index Testing in Hispanic and Non-Hispanic Populations [#PS3-08-07]: Evaluates ethnicity-based differences in BCI Results and treatment patterns. 12 * Comparison of Breast Cancer Index Scores from Core-Needle Biopsies Versus Surgical Excisions in Early-Stage Breast Cancer [#PS3-08-26]: Demonstrates that BCI Testing delivers consistent results from both biopsies and surgical tissue samples. 13 * Breast Cancer Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy Benefit: Final Analysis of the BCI Registry Study [#PS3-07-24]: Demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning and emphasizes the need to use the right test for each clinical decision. 10 * Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]: Highlights the BCI Test’s ability to identify premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. 8 ^* Prognostic Performance of Breast Cancer Index in Patients with Early-Stage HR+ HER2+ Breast Cancer Treated with Adjuvant Trastuzumab: NCCTG N9831 (Alliance) [#PS3-07-28]: Supports the BCI Test’s ability to assess recurrence risk in patients with HER2+ disease. 11 * Comparative Analysis of Breast Cancer Index Testing in Hispanic and Non-Hispanic Populations [#PS3-08-07]: Evaluates ethnicity-based differences in BCI Results and treatment patterns. 12 * Comparison of Breast Cancer Index Scores from Core-Needle Biopsies Versus Surgical Excisions in Early-Stage Breast Cancer [#PS3-08-26]: Demonstrates that BCI Testing delivers consistent results from both biopsies and surgical tissue samples. 13 * Five additional studies featuring data on the clinical utility of the BCI Test will be presented by external investigators at 2025 SABCS, including: Poster Session 3: December 11, 2025, 12:30pm – 2pm CST Guidelines for Breast Cancer Index Test before and after Epic software enhancement [#PS3-03-18] 14 Higher Breast Tumor Grades Could More Likely Benefit from Extended Adjuvant Endocrine Therapy [#PS3-09-10] 15 Correlation Between Breast Cancer Index (BCI) and RSClin Late in Assessing 5-10 Year Recurrence Risk in Early-Stage Hormone Receptor-Positive Breast Cancer [#PS3-09-19] 16 Retrospective study on breast cancer index testing in a community hospital and analyzing its impact on physician-decision making for extended endocrine therapy in early breast cancer [#PS3-10-23] 17 Guidelines for Breast Cancer Index Test before and after Epic software enhancement [#PS3-03-18] 14 Higher Breast Tumor Grades Could More Likely Benefit from Extended Adjuvant Endocrine Therapy [#PS3-09-10] 15 Correlation Between Breast Cancer Index (BCI) and RSClin Late in Assessing 5-10 Year Recurrence Risk in Early-Stage Hormone Receptor-Positive Breast Cancer [#PS3-09-19] 16 Retrospective study on breast cancer index testing in a community hospital and analyzing its impact on physician-decision making for extended endocrine therapy in early breast cancer [#PS3-10-23] 17 Poster Session 4: December 11, 2025, 5:00pm – 6:30pm CST Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood [#PS4-07-08] 18 Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood [#PS4-07-08] 18 “The research to be presented at 2025 SABCS continues to offer insight into expanded clinical applications of the BCI Test,” said Schneiders. “With more than a decade of clinical use by over 9,000 providers, and its proven ability to influence extended endocrine therapy decisions, it’s encouraging to see additional real-world and independent data reinforcing the BCI Test’s impact. These findings underscore our ongoing commitment to help clinicians deliver more personalized, confident care for patients.” About the Breast Cancer Index Test The Breast Cancer Index Test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. The Breast Cancer Index Test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO® Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) acknowledge the Breast Cancer Index Test as a biomarker to help inform extended endocrine treatment decisions.6,7 It is the only test recognized by guidelines to predict which early-stage, HR+ breast cancer patients are likely to benefit from extended endocrine therapy.6,7 The Breast Cancer Index Test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a sole-source laboratory-developed test (LDT) performed by Biotheranostics, Inc., a CLIA-certified and CAP-accredited diagnostic laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information, visit www.breastcancerindex.com. About Hologic, Inc. Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube. Forward-Looking Statements This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s and its subsidiaries’ products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based. ^Note: Incorporation of refined risk estimates in the results reported by the Breast Cancer Index test are pending appropriate regulatory approvals. For the Breast Cancer Index Intended Uses and Limitations, please visit breastcancerindex.com. *Biotheranostics, Inc. researchers are named authors in this study. Hologic, Breast Cancer Index, BCI and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks are the property of their respective owners. References Zhang Y, et al. Breast Cancer Index identifies early-stage estrogen receptor–positive breast cancer patients at risk for early- and late-distant recurrence. Clin Cancer Res. 2013;19(15):4196-4205. doi:10.1158/1078-0432.CCR-13-0804. Sgroi DC, et al. Prediction of late disease recurrence and extended adjuvant letrozole benefit by the HOXB13/IL17BR biomarker. JNCI J Natl Cancer Inst . 2013;105(14):1036-1042. doi:10.1093/jnci/djt146. Bartlett JMS, et al. Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the Adjuvant Tamoxifen–To Offer More? (aTTom) trial. Ann Oncol. 2019;30(11):1776-1783. doi:10.1093/annonc/mdz289. Noordhoek I, et al. Breast Cancer Index predicts extended endocrine benefit to individualize selection of patients with HR‐positive early-stage breast cancer for 10 years of endocrine therapy. Clin Cancer Res. 2021;27(1):311-319. doi:10.1158/1078-0432.CCR-20-2737. Mamounas EP, et al. Breast Cancer Index (BCI) and prediction of benefit from extended aromatase inhibitor therapy in HR+ breast cancer: NRG Oncology/NSABP B-42. J Clin Oncol . 2021;39(15_suppl):501. doi:10.1200/JCO.2021.39.15_suppl.501 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for Breast Cancer V.5.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed November 6, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Andre F, et al. J Clin Oncol. 2022;40(16):1816-1837. Referenced with permission from the American Society of Clinical Oncology (ASCO): Clinical Practice Guideline Endorsements for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer. © American Society of Clinical Oncology, 2025. All rights reserved. To view the most recent and complete version of the guideline, go online to https://ascopubs.org/guidelines [ascopubs.org]. ASCO Clinical Practice Guideline makes no warranties of any kind whatsoever regarding their content, use of application and disclaims any responsibility for their application or use in any way. O’Regan R, et al. Identifying premenopausal patients with early-stage hormone receptor–positive node-negative breast cancer at minimal risk of distant recurrence by Breast Cancer Index. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Yadav S, et al. Endocrine sensitivity and predicted benefit of extended endocrine therapy based on Breast Cancer Index (BCI) in BRCA1, BRCA2, and CHEK2 pathogenic variant carriers with ER+/HER2– breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 10, 2025; San Antonio, TX. Chuy V, et al. Breast Cancer Index re-stratifies 21-gene assay risk groups for risk of recurrence and extended endocrine therapy benefit: Final analysis of the BCI Registry Study. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Chumsri S, et al. Prognostic performance of Breast Cancer Index in patients with early-stage HR+ HER2+ breast cancer treated with adjuvant trastuzumab: NCCTG N9831 (Alliance). Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Sandoval-Leon AC, et al. Comparative analysis of Breast Cancer Index testing in Hispanic and non-Hispanic populations. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Kapoor NS, et al. Comparison of Breast Cancer Index scores from core-needle biopsies versus surgical excisions in early-stage breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Tran CC, et al. Guidelines for Breast Cancer Index test before and after Epic software enhancement. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Ogunsesan Y, et al. Higher breast tumor grades could more likely benefit from extended adjuvant endocrine therapy . Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Rupani KV, et al. Correlation between Breast Cancer Index (BCI) and RSClin late in assessing 5–10-year recurrence risk in early-stage hormone receptor–positive breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Essarani M, et al. Retrospective study on Breast Cancer Index testing in a community hospital and analysis of its impact on physician decision-making for extended endocrine therapy in early breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Flood B, et al. Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood . Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. SOURCE: Hologic, Inc.

ASCO

06 Oct 2025

·www.globenewswire.com

Onco360® Has Been Selected as a Specialty Pharmacy Partner for INLURIYO™ (imlunestrant)

LOUISVILLE, Ky., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by Eli Lilly for Inluriyo™ (imlunestrant), indicated for the treatment of adults with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.1 This indication was approved based on the phase III, EMBER-3 study.2 “For patients living with advanced or metastatic breast cancer, new treatment options like Inluriyo can mean renewed strength along their journey,” said Benito Fernandez, Chief Commercial Officer. “We are honored to partner with Eli Lilly to distribute this important therapy, and to further our mission of improving the lives of patients battling breast cancer." Inluriyo is an estrogen receptor (ER) antagonist that binds to ERα. In vitro, Inluriyo induced degradation of ERα, leading to inhibition of ER-dependent gene transcription and cellular proliferation in ER+ breast cancer cells. Inluriyo demonstrated in vitro and in vivo anti-tumor activity in ER+ breast cancer xenograft models, including models with ESR1 mutations.1 Some breast cancers develop ESR1 mutations that can cause estrogen receptors to become overactive and drive cancer growth. Inluriyo binds, blocks, and facilitates the degradation of these receptors, helping to slow disease progression. EMBER-3 is a Phase 3, randomized, open-label study evaluating Inluriyo, as an investigator's choice of endocrine therapy, or Inluriyo in combination with abemaciclib in patients with ER+, HER2– locally advanced or metastatic breast cancer whose disease has recurred or progressed during or following an aromatase inhibitor (AI) therapy with or without a CDK 4/6 inhibitor.2 The trial showed that it reduced the risk of progression or death by 38% versus endocrine therapy. Among patients with ESR1-mutated MBC, Inluriyo significantly improved progression-free survival (PFS) versus fulvestrant or exemestane, with a median progression free survival (PFS) of 5.5 months versus 3.8 months (HR=0.62 [95% CI: 0.46-0.82]).2 Inluriyo demonstrated manageable safety and tolerability to adverse events, with most being low grade (grade 1-2). The most common adverse reactions (incidence ≥ 10%) including laboratory abnormalities, were decreased hemoglobin, musculoskeletal pain, decreased calcium, decreased neutrophils, increased AST, fatigue, diarrhea, increased ALT, increased triglycerides, nausea, decreased platelets, constipation, increased cholesterol, and abdominal pain.1 Please read the full prescribing information for Inluriyo™. About Onco360 Oncology PharmacyOnco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com. Media Contact: Benito Fernandez, Chief Commercial OfficerBenito.fernandez@onco360.com516-640-1332 References: 1Inluriyo™ (imlunestrant) [Package Insert]. Indianapolis, IN. Eli Lilly and Company. 2025. 2Jhaveri KL, Neven P, Casalnuovo ML, et al. Imlunestrant, an oral selective estrogen receptor degrader (SERD), as monotherapy and combined with abemaciclib, for patients with ER+, HER2- advanced breast cancer (ABC), pretreated with endocrine therapy (ET): results of the phase 3 EMBER-3 trial. N Engl J Med. 2025;392(12):1189 202. doi:10.1056/NEJMoa2410858.

Clinical ResultPhase 3Drug Approval

03 Oct 2025

·pmlive.com

Eli Lilly’s Inluriyo approved by FDA for breast cancer

The US Food and Drug Administration (FDA) has approved Eli Lilly’s Inluriyo (imlunestrant) to treat advanced or metastatic breast cancer, following positive phase 3 trial data. Certain breast cancers develop ESR1 mutations, which cause oestrogen receptors to become overactive and drive tumour growth. Inluriyo is a once-daily oral oestrogen receptor antagonist that binds to, blocks and degrades these overactive receptors. “This therapy represents an important step toward advancing innovative, all-oral treatment approaches,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology. In the phase 3 EMBER-3 trial, Inluriyo reduced the risk of progression or death by 38% versus ET. Among patients with ESR1-mutated MBC, Inluriyo significantly improved progression-free survival (PFS) versus fulvestrant or exemestane, with a median PFS of 5.5 months vs 3.8 months. Inluriyo is expected to be available in the US shortly. It is indicated for adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET). “This represents an important advancement for patients with ESR1-mutated MBC, a mutation found in nearly half of patients who have taken hormone therapies, often contributing to treatment resistance,” said Komal Jhaveri, section head of Endocrine Therapy Research and clinical director of Early Drug Development at Memorial Sloan Kettering Cancer Center, and a principal investigator of EMBER-3. “With its demonstrated efficacy, tolerability profile and oral administration, this therapy provides a meaningful alternative treatment option for this patient population.”

Clinical ResultPhase 3Drug Approval

100 Deals associated with Exemestane

External Link

KEGG	Wiki	ATC	Drug Bank
D00963	Exemestane	L02BG06	DB00990

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Estrogen receptor positive breast cancer	United States	Pfizer Inc.	21 Oct 1999
Breast Cancer	Switzerland	Pfizer Inc.	14 Oct 1999

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	NDA/BLA	China	Benova(Tianjin)Innovation Pharmaceutical Research Co., Ltd.	13 May 2022
Neoplasms	NDA/BLA	China	Cipla Ltd.	13 May 2022
Premenopausal breast cancer	Phase 3	China	Pfizer Inc.	09 Aug 2018
Hormone receptor positive HER2 negative breast cancer	Phase 3	Austria	AstraZeneca PLC	13 Mar 2014
Hormone receptor positive HER2 negative breast cancer	Phase 3	Austria	Pfizer Inc.	13 Mar 2014
Hormone receptor positive HER2 negative breast cancer	Phase 3	Hungary	Pfizer Inc.	13 Mar 2014
Hormone receptor positive HER2 negative breast cancer	Phase 3	Hungary	AstraZeneca PLC	13 Mar 2014
Hormone receptor positive HER2 negative breast cancer	Phase 3	Israel	Pfizer Inc.	13 Mar 2014
Hormone receptor positive HER2 negative breast cancer	Phase 3	Israel	AstraZeneca PLC	13 Mar 2014
Hormone receptor positive HER2 negative breast cancer	Phase 3	Spain	Pfizer Inc.	13 Mar 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04272801 (POWER, CTgov)	Phase 2	Early Stage Breast Carcinoma	84	Patient reported outcomes+letrozole+tamoxifen+exemestane+anastrozole	jcjpbldmse = kvlpdhyvam efmekcugbb (ocaxqmvcdw, uodrfurwht - kgxxhwcfrv) View more	-	22 Oct 2025
NCT00253422 (SoFEA, CTgov)	Phase 3	Breast Cancer	698	fulvestrant+anastrozole (Faslodex + Placebo)	flibqqraoe(jhwgdimbpk) = cdjqyamegz brhcxqtglv (vawgewqduo, idiccslxsv - jcssjwzewt) View more	-	04 Jun 2025
				fulvestrant+anastrozole (Faslodex + Arimidex)	flibqqraoe(jhwgdimbpk) = nxkkhxqsjn brhcxqtglv (vawgewqduo, bfrjxmvqpt - mpmemoeudk) View more
NCT03300557 (CTgov)	Phase 2	Endometrioid intraepithelial neoplasia \| Endometrial Endometrioid Adenocarcinoma \| Endometrial Hyperplasia ... View more	40	Pharmacokinetic Study+Exemestane	tzvvymufue(wpkmlaxnyf) = aboeffzuge nnkfzhuveo (iyompakhwf, 0.22) View more	-	03 Jun 2025
SOFT and TEXT (ASCO2025)	Not Applicable	Hormone receptor positive breast cancer Adjuvant hormone receptor-positive	-	Exemestane + Ovarian Function Suppression	rpsngnpnmj(cpbdhksfta) = weytxnszhu ojzgmbvxfb (qazirpxsfk ) View more	Positive	30 May 2025
				Tamoxifen + Ovarian Function Suppression	rpsngnpnmj(cpbdhksfta) = ljaelucoqq ojzgmbvxfb (qazirpxsfk ) View more
NCT02990845 (Pubmed) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer ER Positive \| HER2 Negative	15	Pembrolizumab + exemestane + leuprolide	yisfxdliod(evgnevsgdr) = gtvzhplmpk tmmdvnwinj (muwekkvrwu ) View more	Positive	18 Dec 2024
NCT02028507 (PEARL \| GEICAM/2013-02 PEARL \| PEARL study, CTgov)	Phase 3	Metastatic breast cancer \| Hormone receptor positive HER2 negative breast cancer	693	palbociclib+Exemestane (Cohort 1: Palbociclib Plus Exemestane)	sokqojnksw(vpeazzihhu) = vormzofvjv hrblizacke (ylfbyzacdr, lkjbpgpgxm - iqfnhduien) View more	-	25 Sep 2024
				fulvestrant+palbociclib (Cohort 2: Palbociclib Plus Fulvestrant)	sokqojnksw(vpeazzihhu) = etgvatjhlw hrblizacke (ylfbyzacdr, kluzoedrwu - tvzpucnixc) View more
NCT06009627 (ESMO2024) Manual	Phase 2	Premenopausal breast cancer Neoadjuvant HER2 Negative \| HR Positive	32	Dalpiciclib, Exemestane, and Goserelin	myvdfcvffm(szafgzuubl) = rvuzmgzmhd fwcijwefdg (khrhldbdxy )	Positive	16 Sep 2024
				TAC (docetaxel, doxorubicin, and cyclophosphamide)	myvdfcvffm(szafgzuubl) = jvuhxvppiy fwcijwefdg (khrhldbdxy )
NCT03312738 (BOLERO-5, Pubmed) Manual	Phase 2	ER-positive/HER2-negative Breast Cancer HER2 Negative \| ER Positive	159	Everolimus (EVE) + Exemestane (EXE)	qjlnzjpplb(upkechllvd) = rpoigktjqk ndeleiybqa (mdmxlqzlqa, 5.5 - 9.0)	Positive	21 Jun 2024
				Placebo (PBO) + Exemestane (EXE)	qjlnzjpplb(upkechllvd) = odgeddjxqb ndeleiybqa (mdmxlqzlqa, 1.9 - 3.6)
NCT01594216 (CTgov)	Phase 2	Estrogen receptor positive breast cancer	25	Ruxolitinib+Exemestane (First Stage)	pqrvwxkixs = honwtjnuus dhezcnxshe (bmavgugtyu, hurrfmbdth - jnfirlsgln) View more	-	12 Jun 2024
				Ruxolitinib+Exemestane (Second Stage)	pqrvwxkixs = oevrnpfbeh dhezcnxshe (bmavgugtyu, rwoekqofmn - emxmoyhscy) View more
ASCO2024	Not Applicable	Menopausal symptoms	128	Anastrozole/Letrozole	qoffdwjtxe(vrbltnowrs) = yhsimbueug unfiydufpg (kkprmmhyey ) View more	Positive	24 May 2024
				Exemestane	qoffdwjtxe(vrbltnowrs) = uesjgopiux unfiydufpg (kkprmmhyey )

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