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The comparison in the EMBER-3 trial shows a hazard ratio of 0.62, but the absolute progression-free survival gain is modest at 1.7 months, raising questions about clinical relevance. The letter highlights grade ≥3 adverse events, equity concerns around ESR1 testing access in low- and middle-income settings, and proposes clearer outcomes, toxicity reporting, testing availability initiatives, and long-term safety registries.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/inluriyo-imlunestrant-for-esr1-mutant-breast-cancer-modest-gains-unmet-concerns-letter-to-the-editor/435709/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/inluriyo-imlunestrant-for-esr1-mutant-breast-cancer-modest-gains-unmet-concerns-letter-to-the-editor/435709.png","ImageObject",300,407,{"name":92,"@type":93},"dawugda","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-04","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":24},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What efficacy result does the letter highlight from the EMBER-3 trial?","Question",{"text":112,"@type":113},"The EMBER-3 comparison reports a hazard ratio of 0.62 (95% CI: 0.46–0.82; P=0.0008). The mean progression-free survival gain is 1.7 months (5.5 vs 3.8 months).","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Which safety issues are raised regarding imlunestrant?",{"text":117,"@type":113},"Grade ≥3 treatment-related adverse events mentioned include cytopenias, elevations of hepatic enzymes, anemia, musculoskeletal pain, and gastrointestinal toxicity. The letter calls for open reporting of grade ≥3 toxicities and discontinuation rates and for long-term monitoring in real-world settings.",{"name":119,"@type":110,"acceptedAnswer":120},"How does the letter address equity concerns about ESR1 mutation testing?",{"text":121,"@type":113},"It argues that while ESR1 testing is scientifically justified, many low- and middle-income countries lack the testing infrastructure, face high costs, or experience delays. Without parallel investment in diagnostics, the therapy could widen disparities in access to precision oncology.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},435709,1790977396,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":24,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":14,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":24,"preview_page_count":4},3985747870947,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","Letter to the Editor  \nInluriyo (imlunestrant) for ESR1-mutant breastcancer: modest gains, unmet concerns  \nZehra Sadia, MBBSa , Zarmeen Azhar, MBBSa , Joshua Ekouo, MDb ,*  \nDear Editor,  \nThe most recent US Food and Drug Administration approvalof Inluriyo (imlunestrant) for ESR1-mutated, ER-positive,HER2-negative advanced breast cancer has been referred to asa milestone of biomarker-guided endocrine therapy. Scrutiny ofthe development reveals promise but also caution.  \nForthe comparison of imlunestrant with fulvestrant/exemestanein the EMBER-3 trial, there was a hazard ratio of 0.62 (95% CI:0.46–0.82; P = 0.0008) that translated to a mean gain in progres -sion-free survival of only 1.7 months (5.5 vs 3.8 months)[1] . Whilststatistically significant, the relatively narrow magnitude of theabsolute benefit indeed calls into question the clinical relevance ofthe benefit observed. The overall survival data are immature, whilstconditional survival data were not a focus of the regulatory file[1] .This study follows the TITAN 2025 guidelines to ensure 14 trans -parent and reproducible methods[2] .  \nThese safety signals also require vigilance. Grade ≥3 treatment -related adverse events mentioned in the prescribing informationinclude cytopenias, elevations of hepatic enzymes, anemia, mus -culoskeletal pain, and gastrointestinal toxicity[1] . Grade ≥3 toxi -cities and discontinuation rates need open reporting. Monitoringover the long term in the real world is also imperative.  \nFurthermore, the requirement for testing for ESR1 mutationsbefore treatment, although scientifically justified, raises issues ofequity. In the majority of low- and middle-income countries,such testing does not exist, is costly, or delayed[3,4] . Withoutparallel investment in diagnostic infrastructure, this therapyrisks deepening disparities in access to precision oncology.  \nWe propose: (1) confirmatory trials with overall survival andvalidated patient-reported outcomes as primary endpoints; (2)transparent reporting of grade ≥3 toxicities and discontinuations;  \naDepartment of Internal Medecine, Karachi Medical and Dental College, Karachi,Pakistan and bDepartment of Research, Medical Research Circle (MedReC), Goma,DR Congo  \nSponsorships or competing interests that maybe relevant to content are disclosedatthe end of this article.  \n*Corresponding author. Address: Department of Research, Medical Research Circle(MedReC), Kyeshero Lusaka rue 218, Goma, DR 73, Congo. Tel.: +243 995442369.E-mail: ekouojoshua@gmail.com (J. Ekouo).  \nCopyright © 2025 The Author(s). Published by Wolters Kluwer Health, Inc. This isanopen access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where itis permissibleto download and share the work provided itis properly cited. The work cannot bechanged in any way or used commercially without permission from the journal.  \nAnnals of Medicine & Surgery (2026) 88:1015–1016Received 4 November 2025; Accepted 5 November 2025Published online 24 November 2025http://dx.doi.org/10.1097/MS9.0000000000004357  \n(3) global initiatives to ensure ESR1 testing availability; and (4)registries to monitor long-term safety and effectiveness.  \nImlunestrantis incremental progress, but its deployment hasto be guided by rigor, transparency, and fairness not enthusiasmalone.  \nEthical approval  \nNot applicable.  \n# Sources of funding\n\nThe authors did not receive any financial support for this work.No funding has been received forthe conduct of this study.  \n# Author contributions\n\nZ.S.: conceptualization, methodology, project administration,supervision, writing – original draft, review & editing; Z.A.:writing – original draft, review & editing; J.E.: methodology,project administration, supervision, writing – review & editing.  \n# Conflicts of interest disclosure\n\nAll authors declare that they have no known competing financialinterests or personal relationships that could have appeared ","cbCaicJC9VcWMwul","https://ap.wps.com/l/cbCaicJC9VcWMwul","pdf",167159,"English","# Sources of funding\n# Author contributions\n# Conflicts of interest disclosure\n# Provenance and peer review\n# Data availability statement\n# Use of artificial intelligence tools\n# Acknowledgements\n# References","[{\"question\":\"What efficacy result does the letter highlight from the EMBER-3 trial?\",\"answer\":\"The EMBER-3 comparison reports a hazard ratio of 0.62 (95% CI: 0.46–0.82; P=0.0008). The mean progression-free survival gain is 1.7 months (5.5 vs 3.8 months).\"},{\"question\":\"Which safety issues are raised regarding imlunestrant?\",\"answer\":\"Grade ≥3 treatment-related adverse events mentioned include cytopenias, elevations of hepatic enzymes, anemia, musculoskeletal pain, and gastrointestinal toxicity. The letter calls for open reporting of grade ≥3 toxicities and discontinuation rates and for long-term monitoring in real-world settings.\"},{\"question\":\"How does the letter address equity concerns about ESR1 mutation testing?\",\"answer\":\"It argues that while ESR1 testing is scientifically justified, many low- and middle-income countries lack the testing infrastructure, face high costs, or experience delays. Without parallel investment in diagnostics, the therapy could widen disparities in access to precision oncology.\"}]","Inluriyo (imlunestrant) for ESR1-mutant breast cancer: modest gains, unmet concerns - Letter to the Editor | PDF",1790674868]