A Short-term Preoperative, Window-of-opportunity Study, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer

A prospective randomized trial designed to evaluate the mean decrease in Ki67 after 4 weeks of elacestrant monotherapy and in combination with leuprorelin in patients with early-stage HR+ BC. This preoperative study will enroll consecutive patients with early stage HR+ BC who are not candidates for neoadjuvant chemotherapy but are eligible for short-term preoperative treatment with elacestrant, with or without leuprorelin, followed by breast surgery. A total of three dedicated Formalin-fixed paraffin embedded (FFPE) samples (mandatory for all patients), along with two frozen biopsy (only for participants at Gustave Roussy), are planned to be collected at the time of inclusion from the biopsy sample and from the surgical specimen. Blood samples will also be collected throughout the study.

开始日期2025-09-23

申办/合作机构

Gustave Roussy, Cancer Campus, Grand Paris

[+1]

NCT07005882

/ Not yet recruiting临床2期IIT

Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Adaptive Radiotherapy: a Phase II Study (HELP Trial)

This is a proof-of-concept phase II trial to assess the safety (as primary endpoint) and clinical efficacy of neoadjuvant therapy with Elacestrant and PULSAR.
The study will enroll 21 postmenopausal patients with early HR+ HER2- node positive BC, clinically staged II-III. Patients will receive Elacestrant 345 mg orally once daily for 24 weeks and PULSAR on the MRI-based breast gross tumor volume (GTVt), consisting of 10 Gy "pulse" every 4 weeks for a maximum of 5 or less in case of radiologic complete response.
Surgery will be planned 24 weeks after Elacestrant initiation and at least 2 weeks from the last pulse and will be performed as per recommended clinical practice. Patients will then receive adjuvant systemic therapy as per standard of care and postoperative RT to the locoregional lymph nodes in case of nodal residual disease, if indicated.

开始日期2025-09-01

申办/合作机构

Azienda Ospedaliero-Universitaria Careggi

NCT06923527

/ Recruiting临床2期IIT

A Single Arm Phase II Trial of Circulating Tumor DNA-guided Adjuvant Therapy With Elacestrant in Hormone Receptor Positive HER2 Negative Breast Cancers at Risk for Late Recurrence (CATE)

This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial.

开始日期2025-09-01

申办/合作机构

Yale University

[+2]

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2025-05-01·Molecular Diagnosis & Therapy

Clinical Actionability of Molecular Targets in Multi-Ethnic Breast Cancer Patients: A Retrospective Single-Institutional Study

Article

作者: Naghi, Leah ; Mortimer, Joanne ; Yost, Susan E ; Kang, Irene

BACKGROUND:

Precision oncology is making remarkable advancements in optimizing patient care by personalizing treatments. To date, the US Food and Drug Administration (FDA) has approved poly(ADP-ribose) polymerase inhibitors (PARPi) olaparib (Lynparza, AstraZeneca and Merck) and talazoparib (Talzenna, Pfizer Oncology Together™) for germline or somatic BRCA1/2-mutated metastatic breast cancer (BC) patients, and PI3K inhibitor alpelisib (Piqray, Novartis) plus fulvestrant for patients with hormone receptor-positive human epidermal growth factor receptor 2-negative (HR+HER2-) PIK3CA-mutated advanced BC. In addition, the FDA approved capivasertib (Trucap, AstraZeneca) for HR+HER2- locally advanced or metastatic BC patients with one or more AKT1, PIK3CA, or PTEN alterations. Finally, the FDA recently approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for postmenopausal patients with ER+ HER2- ESR1-mutated advanced or metastatic BC with disease progression following at least one line of endocrine therapy.

METHODS:

This study presents a single institutional retrospective review of genomic reports of patients with BC. Analysis of genomic reports of 1361 BC sequencing reports was performed for 1010 patients with BC from 2013 to 2023 (23% of patients had multiple reports). Eligible patients had at least one primary or metastatic tumor. Multiple sequencing platforms were used for FFPE specimens including Tempus xT targeted next-generation sequencing (NGS), Foundation One Medicine, HopeSeq, Ashion Analytics GEM ExTra, and Exact Sciences Oncomap. Liquid biopsies were performed by Guardant, Tempus, and Foundation One Medicine. Chart reviews were performed to collect patient characteristics. BRCA1/2-mutated, metastatic BC patients who initiated treatment with olaparib or talazoparib, and PIK3CA-mutated, HR+ metastatic BC patients who initiated treatment with alpelisib were reported. In addition, patients with ESR1 or AKT1/PIK3CA/PTEN mutations were identified. Clinical outcomes, including progression-free survival (PFS) and overall survival (OS) were analyzed for BRCA1/2 and PIK3CA-mutated patients who received PARPi or alpelisib. Survival curves were generated using the Kaplan Meier method.

RESULTS:

A cohort of 1010 BC patients with 1361 genomic reports was identified. A total of 935/1361 (69%) specimens were formalin-fixed paraffin-embedded (FFPE) tumor biopsies and 426/1361 (31%) were liquid biopsies. Receptor status included 65% HR+HER2-, 8% HR+HER2+, 4% HR-HER2+, and 23% TNBC. Racial and ethnic distribution of these patients included 50% non-Hispanic White, 26% Hispanic, 17% Asian, 6% African American, 1% other (Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native, or unknown). Sequencing platforms included 30% Tempus xT, 31% Foundation One, 10% HopeSeq, 20% GEM ExTra, and 9% Exact Sciences. Liquid biopsies included 79% Guardant, 20% Tempus, and 1% Foundation One. Of 1010 patients, the most common mutations were TP53 (44%), PIK3CA (38%), ESR1 (14%), PTEN (12%), CCND1 (11%), FGFR1 (10%), CDH1 (10%), ERBB2 (9%), MYC (9%), FGF3 (8%), GATA3 (8%), FGF19 (8%), FGF4 (7%), ARID1A (6%), RB1 (5%), BRCA2 (5%), MAP3K1 (4%), AKT1 (4%), NF1 (4%), MLL3 (4%), ZNF703 (4%), CDKN2A (4%), BRCA1 (4%), MCL1 (3%), ATM (3%), PALB2 (1%), and CHEK2 (1%). The majority of reports with tumor mutation burden (TMB) results (97%) had low or intermediate TMB. A total of 784 actionable mutations in 1010 patients were reported, including 381/1010 (38%) PIK3CA; 144/1010 (14%) ESR1; 122/1010 (12%) PTEN; 48/1010 (5%) BRCA2; 36/1010 (4%) BRCA1; 41/1010 (4%) AKT1; and 12/1010 (1%) PALB2. Of the 96/1010 (10%) patients with BRCA1, BRCA2, or PALB2 mutations not including variants of uncertain significance (VUS), 33/96 (34.4%) received olaparib and 3/96 (3%) received talazoparib in the metastatic setting, and 28 were eligible for response (one had toxicity, two were lost to follow-up, and two went to hospice). Median PFS was 9.0 months and median OS was 21.8 months for patients receiving PARPi. Of the 381/1010 (38%) patients with PIK3CA mutations, 84/381 (22%) received alpelisib and 41 were eligible for response (22 had toxicity, 13 were discontinued, six were lost to follow-up, and two went to hospice). Median PFS was 7.9 months and median OS was 31.2 months for patients receiving alpelisib. A total of 544/1010 (54%) patients had AKT1, PIK3CA, or PTEN mutations which are now FDA approved for capivasertib in HR+HER2- metastatic BC patients. In addition, 144/1010 (14%) patients had ESR1 mutations which are FDA approved for elacestrant in HR+HER2- metastatic BC patients.

CONCLUSIONS:

In this study, a total of 784 clinically actionable mutations were reported for 1010 patients with genomic sequencing. Of these, 96/1010 (10%) patients had at least one actionable mutation in homologous recombination repair genes (BRCA1, BRCA2, PALB2) and 36/96 (37.5%) patients received PARP inhibitors (33 olaparib and three talazoparib). In addition, 381/1010 (38%) patients had at least one clinically actionable PIK3CA mutation, and 84/381 (22%) received alpelisib. Additionally, 544/1010 (54%) of patients had either AKT1 (41/1010), PIK3CA (381/1010), or PTEN (122/1010) alterations that were FDA approved in November 2023 for capivasertib in the treatment of HR+HER2- metastatic BC (MBC) patients. Furthermore, 144/1010 (14%) patients in this study had at least one ESR1 mutation, a clinically actionable mutation that was FDA approved in January 2023 for elacestrant in the treatment of ER+HER2- MBC patients (44% detected by liquid biopsy). Future studies are needed to determine the efficacy of elacestrant and capivasertib for patients with these mutations, and to tailor strategies for optimal patient quality of life and cancer outcome.

2025-04-01·CANCER TREATMENT REVIEWS

Post-progression treatment options after CDK4/6 inhibitors in hormone receptor-positive, HER2-negative metastatic breast cancer

Review

作者: Sahin, Taha Koray ; Aksoy, Sercan ; Guven, Deniz Can ; Rizzo, Alessandro

The combination of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) and endocrine therapy (ET) is the standard first-line treatment for hormone receptor-positive (HR + ) and HER2-negative metastatic breast cancer (mBC). Despite their efficacy, resistance inevitably develops, necessitating alternative therapeutic strategies post-progression. This review explores current and emerging treatment options following progression on CDK4/6i, focusing on endocrine therapies, targeted therapies, combination approaches, and the continued use of CDK4/6i. Endocrine therapies, including fulvestrant and novel oral selective estrogen receptor degraders (SERDs) like elacestrant, show promise, especially in patients with ESR1 mutations. Targeted therapies such as PI3K/AKT/mTOR inhibitors, exemplified by alpelisib and capivasertib, offer potential by addressing downstream signaling pathways involved in resistance. Additionally, FGFR inhibitors like erdafitinib are under investigation for their role in overcoming specific resistance mechanisms. Combination strategies involving CDK4/6 inhibitors with immune checkpoint inhibitors or other targeted agents are also being explored, with early trials suggesting possible synergistic effects, although further validation is required. Continuation of CDK4/6 inhibitors beyond progression has shown potential benefits in selected patients, but the data are heterogeneous, and further studies are needed to clarify their role. While chemotherapy remains a standard option for patients who progress on these treatments, the goal is to delay its use through the effective utilization of endocrine and targeted therapies. Understanding resistance mechanisms and tailoring treatment to individual patient profiles is crucial for optimizing outcomes. Ongoing clinical trials are expected to provide deeper insights, guiding the development of more effective post-progression therapeutic strategies. This evolving landscape highlights the need for continuous research and individualized patient care to improve survival and quality of life in HR + mBC patients.

2025-04-01·CLINICAL CANCER RESEARCH

Elacestrant in Women with Estrogen Receptor–Positive and HER2-Negative Early Breast Cancer: Results from the Preoperative Window-of-Opportunity ELIPSE Trial

Article

作者: Bellet, Meritxell ; Cortadellas, Tomás ; Gonzalez-Farré, Xavier ; Muñoz-Mateu, Montserrat ; Falato, Claudette ; Siso, Christian ; Pascual, Tomás ; Amillano, Kepa ; Bergamino, Milana A. ; Espinosa Guerrero, Alejandra ; Luna, Miguel A. ; Salvador, Fernando ; Cebrecos, Isaac ; Galván, Patricia ; Ferrero-Cafiero, Juan M. ; Sanfeliu, Esther ; Prat, Aleix ; Margelí Vila, Mireia ; Vidal, Maria ; Sanchez-Bayona, Rodrigo ; Pare, Laia

Abstract:

Purpose::

Elacestrant has shown significantly prolonged progression-free survival compared with standard-of-care endocrine therapy in estrogen receptor–positive (ER-positive), HER2-negative metastatic breast cancer, whereas potential benefit in early-stage disease requires further exploration. The SOLTI-ELIPSE window-of-opportunity trial investigated the biological changes induced by a short course of preoperative elacestrant in postmenopausal women with early breast cancer.

Patients and Methods::

Eligible patients with untreated T1c (≥1.5 cm)-T3, N0, ER-positive/HER2-negative breast cancer with locally assessed Ki67 ≥10% received elacestrant at a daily dose of 345 mg for 4 weeks. The primary efficacy endpoint was complete cell cycle arrest, defined as Ki67 ≤2.7%, on day 28.

Results::

Overall, 22 patients were evaluable for the primary endpoint. Elacestrant was associated with a complete cell cycle arrest rate of 27.3% and a statistically significant Ki67 geometric mean change of −52.9% (P = 0.007; 95% confidence interval, −67.4 to −32.1). Notably, the treatment with elacestrant led to a shift toward a more endocrine-sensitive and less proliferative tumor phenotype based on PAM50-based gene signatures. Elacestrant increased the expression of immune-response genes (GZMB, CD4, and CD8A) and suppressed proliferation and estrogen-signaling genes (MKI67, ESR1, and AR). These biological changes were independent of the levels of Ki67 suppression on day 28. The most common adverse events were grade 1 anemia (21.7%), hot flushes (8.7%), constipation (8.7%), and abdominal pain (8.7%). One patient experienced a grade 3 cutaneous rash, leading to treatment discontinuation. No other serious adverse events were reported.

Conclusions::

Preoperative treatment with elacestrant in early breast cancer demonstrated relevant biological and molecular responses and exhibited a manageable safety profile. These findings support further investigation of elacestrant in the early setting.

235

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·BiG生物创新社

礼来的时代已然开启

作者｜momo 专利悬崖、政策摇摆、竞争白热化……医药圈的“水逆期”好像看不到头。但就在这一片混沌中，一条最强主线已杀出重围，到2030年，礼来将强势碾压所有对手，登顶全球药企营收榜！凭什么？就凭它用GLP-1撕开市场，用口服SERD巩固战线，再用神经科学布局未来。EvaluatePharma在《World Preview 2025》报告中预测，礼来营收将达到昔日巨头辉瑞、诺华的两倍之多，增速更是一骑绝尘，让对手望尘莫及。 01 瞄准10亿美元大药 9月25日，礼来宣布其口服雌激素受体拮抗剂Inluriyo（imlunestrant）获FDA批准，用于治疗ER阳性、HER2阴性、携带ESR1突变的晚期或转移性乳腺癌成人患者。这是全球第二款获批的口服选择性雌激素受体降解剂（SERD）药物，对标SERD领域的王牌药物年销售额超过10亿美元的氟维司群。作为第一代SERD药物，氟维司群由阿斯利康开发，于2002年获批上市。其通过阻断雌激素受体信号传导同时诱导受体降解发挥作用，能够从根本上切断乳腺癌细胞的生长信号。然而，氟维司群存在生物利用度低、患者依从性差、联合用药便利性不足等显著缺陷，为口服SERD药物的发展创造了机会。研究发现，大约30%-40%的晚期乳腺癌患者存在ESR1突变，在接受过CDK4/6抑制剂治疗的患者中，这一比例高达40%。这种突变会导致雌激素受体过度活跃，驱动癌症生长，并常常引起对传统内分泌治疗的耐药。礼来Inluriyo聚焦于ESR1突变亚群，采用每日一次的口服给药方式，极大地提高了用药的便利性。在III期EMBER-3试验中，与标准内分泌治疗相比，Inluriyo将疾病进展或死亡风险降低了38%。在携带ESR1突变的患者中，与氟维司群或依西美坦相比，Inluriyo相较于氟维司群或依西美坦显著改善了无进展生存期 (PFS)，中位PFS为5.5个月 vs 3.8个月。图1.Inluriyo III期EMBER-3试验临床数据值得注意的是，礼来意图将Inluriyo的治疗应用从晚期向前线设置扩展。目前，Inluriyo正在进行的III期EMBER-4试验计划在全球招募约8000名患者，评估Inluriyo用于ER阳性、HER2阴性早期乳腺癌辅助治疗的效果,潜在市场空间巨大。图2.全球III期及上市SERD结构随着礼来Inluriyo的加入，口服SERD赛道的竞争格局日益清晰。目前，全球已有四款口服SERD药物顺利完成III期研究，除了已上市的艾拉司群，Inluriyo还面临着来自罗氏的Giredestrant和来自阿斯利康的Camizestrant等在研口服SERD候选药物的潜在竞争。未来，礼来还需要交出足够亮眼的成绩来证明Inluriyo的差异化优势。 02 GLP-1最大赢家 2025年全球医药市场最具看点的竞争莫过于GLP-1类药物领域的“药王”之争。2025年上半年，诺和诺德的司美格鲁肽以166.32亿美元销售额暂时领跑，但礼来的替尔泊肽以121.3%的惊人增速紧追不舍，斩获147.34亿美元销售额。更具里程碑意义的是，在第二季度，替尔泊肽单季销售额（85.80亿美元）已成功反超司美格鲁肽（80.34亿美元）。2025年全球“药王”宝座极有可能易主。替尔泊肽的崛起速度令人惊叹，作为GLP-1/GIP双受体激动剂，替尔泊肽在降糖和减重方面展现出优于单靶点药物的疗效。礼来通过精准的市场策略，将替尔泊肽以降糖版Mounjaro和减重版Zepbound两个品牌推向市场。2025年H1，Mounjaro同比增长85%至90.41亿美元，Zepbound更是大卖56.93亿美元，增速高达223%。礼来在市场份额上也已取得领先，2025年Q1，礼来GLP-1产品在美国市场的处方量占比达到53.3%，超过诺和诺德的46.1%。到上半年结束时，这一差距进一步扩大至57.0%对42.5%，显示出强劲的市场渗透力。礼来还积极拓展适应症范围，Zepbound可能在2025年底解锁射血分数保留型心力衰竭（HFpEF）第三项适应症，这将为其业绩增长提供新的增量。据EvaluatePharma预测，到2030年替尔泊肽的全球销售额将达到617亿美元，这一数字将是现任“药王”帕博利珠单抗2024年销售额（295亿美元）的两倍多（图3）。图3.替尔泊肽2030预测全球销售额另外，在替尔泊肽之后，礼来正在打造新的增长引擎，口服GLP-1药物Orforglipron。与需要注射的替尔泊肽不同，Orforglipron是一种每日一次的口服小分子GLP-1受体激动剂，ACHIEVE-3 III期临床研究结果显示，Orforglipron在降糖和减重方面均表现出色。第52周时，接受12 mg、36 mg Orforglipron治疗患者的A1C水平分别平均降低1.9 %与2.2 %；而接受7 mg与14 mg活性对照药物患者的A1C则分别降低1.1%与1.4%（图4）。图4.ACHIEVE-3 III期临床研究结果在体重管理方面，接受12 mg、36 mg Orforglipron治疗患者的平均体重下降分别为14.6磅（6.7%）与19.7磅（9.2%）；而接受7 mg与14 mg活性对照药物患者的体重则分别下降7.9磅（3.7%）与11.0磅（5.3%）（图4）。在最高剂量组比较中，Orforglipron组患者的体重下降幅度相对高出73.6%。此外，Orforglipron还在非高密度脂蛋白胆固醇、收缩压与甘油三酯等关键心血管危险因素上带来具有临床意义的改善。礼来已于2025年8月公布了orforglipron的关键性III期临床（ATTAIN-1）数据，每日口服一次36毫克该药物可以让体重减轻12.4%。其计划在2025年底前向美国、英国、欧盟和日本等国递交Orforglipron的上市申请。 EvaluatePharma预测，orforglipron 2030年销售额预计将达到127亿美元。随着2025年下半年替尔泊肽增势延续，它极有可能从司美格鲁肽手中接过“药王”权杖。而Orforglipron作为便利性更强的口服制剂，将成为礼来巩固市场领导地位的关键棋子，礼来在这场竞赛中的霸主地位已经很明显了。 03 加码布局CNS赛道血脑屏障（BBB）曾是将绝大多数中枢神经系统药物拒之门外的天堑，如今正成为MNC攻坚的下一个前沿。 BBB是CNS疾病药物研发面临的主要生理障碍，它由脑毛细血管壁与神经胶质细胞构成，仅允许特定类型分子通过，阻止绝大多数小分子和大分子药物进入大脑（图5）。图5.大多数药物无法渗透血脑屏障 2025年4月，礼来与Sangamo Therapeutics达成14亿美元合作，获得的STAC-BBB技术是一种高效穿透血脑屏障的腺相关病毒（AAV）衣壳，该衣壳在非人灵长类动物模型中表现出强力穿越血脑屏障能力和神经元转导效果。根据Sangamo数据，与传统AAV9衣壳相比，STAC-BBB驱动转基因在CNS神经元中表达的能力提高了700倍。这意味着，研究人员可以开发静脉注射的基因组药物，治疗以往难以触及的CNS系统疾病。此外，礼来获得的许可是全球独家的，涵盖一个初始疾病靶点，并有权增加最多四个神经系统疾病靶点。这种灵活性使礼来能够针对多种CNS疾病开发基因疗法。然而，这只是礼来在神经科学领域布局的冰山一角。 2024年，礼来心血管代谢板块贡献了295.21亿美元收入，占总营收的66%，而神经科学板块仅占3%，业绩主要依赖偏头痛药物Galcanezumab。然而，面对激烈的市场竞争，Galcanezumab增长乏力，神经科学板块亟需新产品接棒。因此，礼来正在积极构建新的增长曲线，一方面依托内部研发，已获批的Donanemab及在研药物Remternetug有望接棒增长；另一方面，礼来也积极通过收购与合作，持续拓展其在神经科学领域的产品管线。 2020年12月，礼来以10.4亿美元收购Prevail，获得其针对帕金森病和戈谢病的GBA1基因疗法PR001； 2022年10月，以约6.1亿美元收购Akouos，加码用于额颞叶痴呆症的听力基因疗法AK-OTOF； 2024年3月，参与蛋白降解公司TRIMTECH Therapeutics的种子轮融资，该公司专注于靶向致病蛋白聚集，开发神经退行性疾病及炎症性疾病疗法； 2024年6月，礼来以超过6亿美元引进QurAlis公司的渐冻症反义寡核苷酸药物QRL-204； 2024年9月，礼来中国宣布成立独立的神经科学事业部，进一步彰显公司对该领域的重视； 2025年1月，与Alchemab合作，利用其抗体平台开发多达五种治疗肌萎缩侧索硬化症的抗体； 2025年5月，与韩国Rznomics达成13亿美元合作，共同开发用于感音神经性听力损失的RNA编辑疗法。结语在GLP-1赛道，礼来凭借替尔泊肽的惊人增速与市场渗透力，正试图从诺和诺德手中夺过“药王”权杖；在肿瘤领域，口服SERD药物Inluriyo的成功获批，进一步凸显了其在乳腺癌领域的差异化实力；而在被视为“未来战场”的神经科学领域，礼来通过收购、合作与自主研发，为中长期增长开辟新的可能性。 2025，礼来的时代依然开启。参考资料 [1]https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-adults-er-her2-esr1 [2]https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-superior-oral-semaglutide-head [3]https://www.chemicalbook.com/ProductIndex.aspx [4]https://app.evaluate.com/ux/WebReport/Welcome2.aspx [5]https://www.fusfoundation.org/the-technology/mechanisms-of-action/blood-brain-barrier-opening/ 共建Biomedical创新生态圈！如何加入BiG会员？

临床3期

2025-09-29

·Firstwordpharma

FDA OKs Guardant Health companion diagnostic for Lilly's breast cancer drug

Guardant Health announced Monday that the FDA has cleared its Guardant360 companion diagnostic (CDx) to identify patients with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer who may benefit from Eli Lilly's Inluriyo (imlunestrant), an oral selective oestrogen receptor degrader (SERD) approved last week.The clearance "provides another treatment for breast cancer patients with ESR1 mutations for their specific type of cancer along with expanded access to comprehensive genomic profiling with a simple blood draw," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. The blood-based test detects key ESR1 mutations —including E380, V422del, S463, L469, L536, Y537 and D538 — which are associated with resistance to endocrine therapy. In the Phase III EMBER-3 trial, patients selected by Guardant360 CDx and treated with Inluriyo showed a 38% reduction in disease progression or death versus standard endocrine therapy. When combined with Lilly's Verzenio (abemaciclib), the benefit increased to 43%.The clearance is Guardant360 CDx's second for breast cancer; it was previously cleared to identify patients with advanced or metastatic breast cancer with ESR1 mutations who might benefit from treatment with Menarini's Orserdu (elacestrant). It has also been authorised by the FDA to identify patients with lung cancer eligible for treatment with AstraZeneca's Tagrisso (osimertinib), Johnson & Johnson's Rybrevant (amivantamab-vmjw), Daiichi Sankyo and AstraZeneca's Enhertu (fam-trastuzumab deruxtecan-nxki) and Amgen's Lumakras (sotorasib).

临床结果临床3期上市批准

2025-09-27

·医药地理

礼来口服SERD新药Inluriyo获批上市

9月25日，礼来宣布其口服雌激素受体拮抗剂Inluriyo（imlunestrant，200mg片剂）已获得FDA批准，用于治疗雌激素受体阳性（ER+）、HER2阴性（HER2-）且携带ESR1突变的晚期或转移性乳腺癌成人患者，这些患者在接受至少一线内分泌治疗后出现疾病进展。Inluriyo是全球第二款获批上市的口服SERD药物，此前仅有艾拉司群（Menarini）获批。此外，阿斯利康的camizestrant已申报上市，罗氏的giredestrant近期也宣布III期研究成功。此次批准主要基于III期EMBER-3临床试验的结果。研究显示，与标准内分泌治疗相比，Inluriyo将疾病进展或死亡风险降低了38%。在携带ESR1突变的患者中，Inluriyo组的中位无进展生存期（PFS）为5.5个月，显著优于对照组的3.8个月（HR=0.62，95% CI: 0.46-0.82；p=0.0008）。安全性方面，大多数不良事件为1-2级，常见不良反应包括血红蛋白降低、肌肉骨骼疼痛、血钙降低等。仅有4.6%的患者因不良事件永久停药，剂量减少和中断的比例分别为2.4%和10%。 Inluriyo通过结合并降解雌激素受体发挥作用，尤其适用于ESR1突变导致的受体过度活化患者。其每日一次的口服给药方式为患者提供了更便捷的治疗选择。礼来肿瘤事业部执行总裁Jacob Van Naarden表示，该批准体现了公司在推进全口服治疗方案方面的重要进展，有望使乳腺癌治疗更易管理。目前，Inluriyo还在进行EMBER-4 III期试验，旨在评估其作为辅助治疗用于高风险早期乳腺癌患者的效果，计划全球入组约8000人。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

临床3期上市批准

100 项与艾拉司群相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11671	艾拉司群	-	DB06374

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期乳腺癌	英国	Stemline Therapeutics, Inc.	2024-01-05
转移性乳腺癌	英国	Stemline Therapeutics, Inc.	2024-01-05
ER阳性/HER2阴性/ESR1突变乳腺癌	美国	Stemline Therapeutics, Inc.	2023-01-27

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	申请上市	美国	Radius Pharmaceuticals, Inc.	2022-06-22
淋巴结阳性乳腺癌	临床3期	美国	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	阿根廷	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	澳大利亚	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	奥地利	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	比利时	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	巴西	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	加拿大	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	捷克	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	丹麦	Stemline Therapeutics, Inc.	2024-09-27

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06382948 (ADELA, ASCO2025)	临床3期	ER阳性/HER2阴性/ESR1突变乳腺癌 \| HER2 阴性乳腺癌 \| ER阳性乳腺癌 ... ESR1-mutated tumors 更多	240	Elacestrant 345 mg + Everolimus 7.5 mg	憲獵蓋鏇夢積築衊製蓋(鬱鑰鹽鬱範糧願願糧觸) = 簾構膚衊鏇簾願積網簾廠遞餘簾築餘遞鑰選餘 (鏇構鏇獵壓淵製蓋淵獵 ) 更多	积极	2025-05-30
NCT06492616 (ELEGANT, ASCO2025)	临床3期	淋巴结阳性乳腺癌 \| ER阳性乳腺癌辅助 Ki67	-	Elacestrant	願廠選衊膚積鑰餘衊遞(顧醖廠構構艱築醖鹹淵) = 觸鹽壓簾襯膚蓋鏇顧膚網簾觸構壓膚築觸襯簾 (鏇顧簾遞積襯齋獵糧餘 )	积极	2025-05-30
				Standard Endocrine Therapy (AI or tamoxifen)	願廠選衊膚積鑰餘衊遞(顧醖廠構構艱築醖鹹淵) = 製顧鬱製襯觸齋鹽製製網簾觸構壓膚築觸襯簾 (鏇顧簾遞積襯齋獵糧餘 )
NCT05563220 (ELEVATE, ASCO2025)	临床1/2期	ER阳性/HER2阴性乳腺癌	-	Elacestrant + Ribociclib	齋簾膚齋顧願鏇鏇鏇構(鏇鹹鹽選繭簾鹽蓋淵艱) = 43% (7% ≥Gr3) with Ela + Eve 網鏇製鏇鹽觸製鏇艱網 (顧蓋築壓艱鑰夢壓鏇糧 ) 更多	-	2025-05-30
				Elacestrant + Everolimus
NCT03778931 (EMERALD, ESMO_BC2025)	临床3期	转移性乳腺癌 ESR1	966	elacestrant (ESR1 mutation testing by liquid biopsy using ddPCR)	襯繭餘積醖鹽鹹獵餘鑰(襯製繭醖襯鹹選製淵願) = 選鑰憲觸築鏇夢窪築簾製壓淵構憲鬱艱構艱願 (鑰鹽餘窪壓鹹願壓製醖, 33.2% ~ 39.4) 更多	积极	2025-05-14
SABCS2024 人工标引	N/A	ER阳性/HER2阴性乳腺癌 HER2 Negative	212	Elacestrant	簾齋鹽憲構簾遞鹽簾衊(鬱鹽觸窪齋積構築觸醖) = 願顧範艱願襯襯鹽繭淵製窪膚膚觸鹹糧鹽簾鑰 (蓋積獵鑰選廠遞壓範顧, 5.4 ~ NR)	积极	2024-12-10
				Elacestrant (1-2 lines of prior ET)	簾齋鹽憲構簾遞鹽簾衊(鬱鹽觸窪齋積構築觸醖) = 範鏇鹹蓋鑰鹹鏇築糧遞製窪膚膚觸鹹糧鹽簾鑰 (蓋積獵鑰選廠遞壓範顧, 4.9 ~ NR)
NCT05563220 \| NCT05386108 (ELEVATE, SABCS2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 HER2 Negative	55	Elacestrant + Abemaciclib (all efficacy-evaluable)	蓋窪淵鹽壓艱網壓窪夢(膚構築衊壓艱鑰憲醖蓋) = 鏇選憲選製鹽製網鹹鑰構糧糧蓋鹹餘顧窪鏇淵 (願遞鹽鑰網繭簾餘築夢 )	积极	2024-12-10
				Elacestrant + Abemaciclib (ESR1-mut population)	蓋窪淵鹽壓艱網壓窪夢(膚構築衊壓艱鑰憲醖蓋) = 淵衊艱積積糧繭積鏇糧構糧糧蓋鹹餘顧窪鏇淵 (願遞鹽鑰網繭簾餘築夢 )
NCT05563220 (ELEVATE, ESMO2024)	临床1/2期	ER阳性/HER2阴性乳腺癌 ER+ \| HER2-negative \| ESR1-mut	-	Elacestrant + Everolimus	膚壓製衊網顧繭膚鬱鬱(壓鏇廠網遞鹽鹽壓範醖) = 10 (43) 2 (9) 壓餘願鑰築願窪襯簾鹹 (蓋積範選窪餘製夢築範 ) 更多	积极	2024-09-16
				Elacestrant + Palbociclib
NCT05386108 (ELECTRA, ASCO2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌二线 ER Positive \| HER2 Negative \| ESR1 Mutation	26	Elacestrant + Abemaciclib	鑰窪襯夢糧鬱鏇製網蓋(窪齋鹹鑰鑰壓夢願鏇繭) = 鬱構製選窪構襯鏇顧憲憲製繭淵膚餘醖壓壓鹹 (衊製積遞鏇襯餘餘鹽衊 ) 更多	积极	2024-05-24
NCT05563220 (ELEVATE, ASCO2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 HER2 Positive	20	Elacestrant + Ribociclibribociclib	夢範糧襯鑰觸窪範壓網(壓糧廠廠簾鹽鑰鏇憲獵) = Most common (≥30%) all-grade (Gr) AEs were decreased neutrophils/neutropenia (n=6, 50%; Gr3+ n=4, 33%) in the elacestrant (86-172 mg) + ribociclib (400 mg) cohorts 鬱蓋鏇壓夢觸鏇獵膚築 (遞鏇壓鹽壓範餘遞窪廠 ) 更多	积极	2024-05-24
				elacestrantelacestrant (258-345 mg) + palbociclib (100 mg) cohorts
EMERALD study (ASCO2024)	N/A	HR阳性/HER2阴性乳腺癌 ESR1-mutant	418	Elacestrant	簾鬱夢窪鬱築構築糧鏇(壓鬱鏇構醖窪遞構獵願) = 鬱鏇遞選繭願壓糧遞夢鏇獵膚網遞遞淵觸淵遞 (艱顧衊廠膚繭鬱餘憲膚, 4.2 ~ not reached [NR]) 更多	积极	2024-05-24