INDIANAPOLIS, Nov. 1, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from the Phase 3 trial (EMBER-3) for imlunestrant, an oral selective estrogen receptor degrader (SERD), will be reported for the first time in a late-breaking oral presentation at the San Antonio Breast Cancer Symposium (SABCS) taking place December 10-13 in San Antonio, TX.

印第安纳波利斯，2024年11月1日/PRNewswire/--礼来公司（纽约证券交易所：LLY）今天宣布，口服选择性雌激素受体降解剂（SERD）imlunestrant的3期临床试验（EMBE-3）的数据将首次在12月10日至13日在德克萨斯州圣安东尼奥举行的圣安东尼奥乳腺癌研讨会（SABCS）上发表。

EMBER-3 is a study in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer. The trial is evaluating imlunestrant alone or in combination with Verzenio (abemaciclib; CDK4/6 inhibitor), in patients who were pretreated with endocrine therapy, with or without a CDK4/6 inhibitor..

EMBE-3是一项针对雌激素受体阳性（ER+），人表皮生长因子受体2阴性（HER2-）晚期乳腺癌的研究。该试验正在评估单独使用imlunestrant或与Verzenio（abemaciclib；CDK4/6抑制剂）联合使用，用于内分泌治疗预处理的患者，无论是否使用CDK4/6抑制剂。。

Lilly will also share results of a real-world analysis of risk of recurrence by nodal status and high-risk features in patients with hormone receptor positive (HR+), HER2- early breast cancer. Additional presentations from investigational mutant selective PI3Ka inhibitor assets include preclinical characterization data for LY4045004, which is expected to enter the clinic in the first half of 2025, and Phase 1a/b clinical data for a predecessor molecule, LOXO-783, which informed the development of LY4045004..

礼来公司还将分享激素受体阳性（HR+），HER2早期乳腺癌患者淋巴结状态和高危特征复发风险的现实分析结果。研究突变选择性PI3Ka抑制剂资产的其他介绍包括LY4045004的临床前表征数据，预计将于2025年上半年进入临床，以及前代分子LOXO-783的1a/b期临床数据，该数据为LY4045004的开发提供了信息。。

A full list of abstract titles and viewing details are listed below:

下面列出了摘要标题和查看详细信息的完整列表：

Imlunestrant (investigational oral SERD)Presentation Title: 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.Presentation Number: GS1-01Presentation Date & Time: Wednesday, Dec.11, 2024, 9:15-9:30 a.m.

Imlunestrant（研究性口服SERD）介绍标题：Imlunestrant，一种口服选择性雌激素受体降解剂（SERD），作为单一疗法并与Abemaciclib联合，用于ER+，HER2晚期乳腺癌（ABC）患者，用内分泌治疗（ET）预处理：3期EMBE-3试验的结果。演示编号：GS1-01演示日期和时间：2024年12月11日星期三上午9:15-9:30。

CSTLocation: Hall 1Presenter: Komal Jhaveri.

CST地点：1号大厅代表：科马尔·贾维里。

Presentation Title: Patient and health care provider perspectives on oral versus intramuscular endocrine therapy for locally advanced or metastatic breast cancerPresentation Number: P4-03-11Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CSTLocation: Halls 2-3Presenter: Rebecca Speck

演讲标题：患者和医疗保健提供者对局部晚期或转移性乳腺癌口服与肌肉内分泌治疗的观点演讲编号：P4-03-11演讲日期和时间：2024年12月12日星期四下午5:30-7点CST地点：2-3厅演讲人：Rebecca Speck

Presentation Title: Evaluation of pharmacokinetics and safety of imlunestrant in participants with hepatic impairmentPresentation Number: P4-10-07Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CSTLocation: Halls 2-3Presenter: Xuejing Aimee Wong

演讲标题：肝损伤参与者体内imlunestrant的药代动力学和安全性评估演讲编号：P4-10-07演讲日期和时间：2024年12月12日星期四下午5:30-7点CST地点：2-3厅演讲人：Xuejing Aimee Wong

Real World EvidencePresentation Title: Risk of Recurrence by Nodal Status and High-Risk Features in Patients with HR+, HER2-, Early Breast Cancer: An Analysis of Real-world DataPresentation Number: P1-11-02Presentation Date & Time: Wednesday, Dec.11, 2024, 12-2 p.m. CSTLocation: Halls 2-3Presenter: Sara Tolaney.

现实世界证据陈述标题：HR+，HER2-，早期乳腺癌患者淋巴结状态和高风险特征的复发风险：现实世界数据分析报告编号：P1-11-02报告日期和时间：2024年12月11日星期三下午12点至2点CST地点：2-3厅报告人：Sara Tolaney。

Verzenio® (abemaciclib)Presentation Title: Genomic profiling of ctDNA and association with efficacy in patients from the postMONARCH trial of abemaciclib + fulvestrant vs placebo + fulvestrant for HR+, HER2-, advanced breast cancer following progression on a prior CDK4/6i plus endocrine therapyPresentation Number: P1-01-26Presentation Date &Time: Wednesday, Dec.11, 2024, 12-2 p.m.

Verzenio®（abemaciclib）演讲标题：ctDNA的基因组分析以及abemaciclib+氟维司群与安慰剂+氟维司群治疗HR+，HER2-，晚期乳腺癌的绝经后试验患者的疗效相关性，之前的CDK4/6i加内分泌治疗进展编号：P1-01-26演讲日期和时间：2024年12月11日，星期三，下午12-2点。

CSTLocation: Halls 2-3Presenter: Seth Wander.

CST地点：2-3号大厅演示者：Seth Wander。

Presentation Title: Clinical Characteristics and Treatment Persistence in US Patients with HR+/HER2-, Node Positive Early Breast Cancer Treated with Abemaciclib: Real-World Study from First Year After ApprovalPresentation Number: P1-11-29Presentation Date & Time: Wednesday, Dec.11, 2024, 12-2 p.m. CSTLocation: Halls 2-3Presenter: Hatem Soliman.

报告标题：用Abemaciclib治疗的美国HR+/HER2-，淋巴结阳性早期乳腺癌患者的临床特征和治疗持续性：批准后第一年的现实世界研究报告编号：P1-11-29报告日期和时间：2024年12月11日星期三下午12-2点CST地点：2-3厅报告人：Hatem Soliman。

Presentation Title: Unveiling the Antitumor Mechanism of abemaciclib in Human Breast Cancer Through Circulating Tumor Chromatin AnalysisPresentation Number: P5-02-23Presentation Date & Time: Friday, Dec.13, 2024, 12-2 p.m. CSTLocation: Halls 2-3Presenter: Mamoru Takada

演讲题目：通过循环肿瘤染色质分析揭示abemaciclib在人乳腺癌中的抗肿瘤机制演讲编号：P5-02-23演讲日期和时间：2024年12月13日星期五下午12:00-2:00 CST地点：2-3厅演讲人：Mamoru Takada

PI3Ka Inhibitor (LOXO-783) Presentation Title: A first-in-human phase 1a/b trial of LOXO-783, a potent, highly mutant-selective, brain-penetrant, allosteric PI3Kα H1047R inhibitor advanced breast cancer and other solid tumors: Results from the PIKASSO-01 studyPresentation Number: PS7-03Presentation Date & Time: Wednesday, Dec.11, 2024, 7-8:30 a.m.

PI3Ka抑制剂（LOXO-783）介绍标题：LOXO-783（一种有效的，高度突变选择性的，脑渗透性的，变构的PI3KαH1047R抑制剂晚期乳腺癌和其他实体瘤）的首次人类1a/b期试验：PIKASSO-01研究结果介绍编号：PS7-03介绍日期和时间：2024年12月11日星期三上午7-8:30。

CSTLocation: TBDPresenter: Komal Jhaveri.

CST地点：待定代表：Komal Jhaveri。

Next-Gen PI3Ka Inhibitor (LY4045004) Presentation Title: Preclinical characterization of LY4045004, a next-generation, mutant-selective PI3Kα inhibitorPresentation Number: P4-12-24Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CST Location: Halls 2-3Presenter: Raymond Gilmour (Lilly)

下一代PI3Ka抑制剂（LY4045004）演示标题：LY4045004的临床前表征，下一代突变选择性PI3Kα抑制剂演示编号：P4-12-24演示日期和时间：2024年12月12日星期四下午5:30-7点CST地点：2-3厅演示者：雷蒙德·吉尔摩（礼来）

About Verzenio® (abemaciclib) Verzenio® (abemaciclib) is approved to treat people with certain HR+, HER2- breast cancers in the adjuvant and advanced or metastatic setting. Verzenio is the first CDK4/6 inhibitor approved to treat node-positive, high risk early breast cancer (EBC) patients. The National Comprehensive Cancer Network® (NCCN®) recommends consideration of two years of abemaciclib (Verzenio) added to endocrine therapy as a Category 1 treatment option in the adjuvant setting.1 NCCN® also includes Verzenio plus endocrine therapy as a preferred treatment option for metastatic breast cancer.1 .

关于Verzenio®（abemaciclib）Verzenio®（abemaciclib）被批准用于治疗某些HR+，HER2乳腺癌患者的辅助治疗和晚期或转移治疗。Verzenio是第一个被批准用于治疗淋巴结阳性，高危早期乳腺癌（EBC）患者的CDK4/6抑制剂。National Comprehensive Cancer Network®（NCCN®）建议考虑将两年的abemaciclib（Verzenio）作为辅助治疗中的1类治疗选择添加到内分泌治疗中。NCCN®还包括Verzenio加内分泌治疗作为转移性乳腺癌的首选治疗选择。

The collective results of Lilly's clinical development program continue to differentiate Verzenio as a CDK4/6 inhibitor. In high risk EBC, Verzenio has shown a persistent and deepening benefit beyond the two-year treatment period in the monarchE trial, an adjuvant study designed specifically to investigate a CDK4/6 inhibitor in a high-risk population.2 In metastatic breast cancer, Verzenio has demonstrated statistically significant OS in the Phase 3 MONARCH 2 study.3 Verzenio has shown a consistent and generally manageable safety profile across clinical trials..

礼来公司临床开发计划的集体结果继续将Verzenio区分为CDK4/6抑制剂。在高危EBC中，Verzenio在MONARCE试验（一项专门研究高危人群中CDK4/6抑制剂的辅助研究）中显示出持续且深入的益处。2在转移性乳腺癌中，Verzenio在3期MONARCH 2研究中显示出统计学上显着的OS。3 Verzenio在整个临床试验中显示出一致且通常可管理的安全性。。

Verzenio is an oral tablet taken twice daily and available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers, Verzenio was first approved in 2017 and is currently authorized for use in more than 90 counties around the world. For full details on indicated uses of Verzenio in HR+, HER2- breast cancer, please see full Prescribing Information, available at www.Verzenio.com..

Verzenio是一种口服片剂，每天服用两次，剂量分别为50 mg、100 mg、150 mg和200 mg。由礼来研究人员发现和开发的Verzenio于2017年首次获得批准，目前已授权在全球90多个国家使用。有关Verzenio在HR+，HER2-乳腺癌中指定用途的完整详细信息，请参阅www.Verzenio.com上提供的完整处方信息。。

INDICATIONS FOR VERZENIO®VERZENIO® is a kinase inhibitor indicated:

VERZENIO®的适应症VERZENIO®是一种激酶抑制剂：

in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.

联合内分泌治疗（他莫昔芬或芳香化酶抑制剂）辅助治疗激素受体（HR）阳性，人表皮生长因子受体2（HER2）阴性，淋巴结阳性，早期乳腺癌复发风险高的成年患者。

in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

与芳香化酶抑制剂联合作为初始内分泌治疗，用于治疗激素受体（HR）阳性，人表皮生长因子受体2（HER2）阴性的晚期或转移性乳腺癌成年患者。

in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

联合氟维司群治疗激素受体（HR）阳性，人表皮生长因子受体2（HER2）阴性的晚期或转移性乳腺癌患者，内分泌治疗后疾病进展。

as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

作为治疗HR阳性，HER2阴性晚期或转移性乳腺癌的成年患者的单一疗法，在内分泌治疗和转移性环境中先前的化疗后疾病进展。

IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, diarrhea occurred in 81 to 90% of patients who received Verzenio. Grade 3 diarrhea occurred in 8 to 20% of patients receiving Verzenio.

VERZENIO（abemaciclib）的重要安全信息VERZENIO治疗的患者发生与脱水和感染相关的严重腹泻。在3691名患者的四项临床试验中，接受Verzenio治疗的患者中有81%至90%发生腹泻。接受Verzenio治疗的患者中有8%至20%发生3级腹泻。

Most patients experienced diarrhea during the first month of Verzenio treatment. The median time to onset of diarrhea ranged from 6 to 8 days; and the median duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days, respectively. Across trials, 19 to 26% of patients with diarrhea required a Verzenio dose interruption and 13 to 23% required a dose reduction..

大多数患者在Verzenio治疗的第一个月内出现腹泻。腹泻发作的中位时间为6至8天；。在整个试验中，19%至26%的腹泻患者需要中断Verzenio剂量，13%至23%的患者需要减少剂量。。

Instruct patients to start antidiarrheal therapy, such as loperamide, at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose..

指示患者在第一次出现大便松弛的迹象时开始止泻治疗，如洛哌丁胺，增加口服液，并通知其医疗保健提供者进一步指导和适当的随访。对于3级或4级腹泻或需要住院治疗的腹泻，停用Verzenio直至毒性降至≤1级，然后以下一个较低剂量恢复Verzenio。。

Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio.

用Verzenio治疗的患者发生中性粒细胞减少症，包括发热性中性粒细胞减少症和致命性中性粒细胞减少性败血症。在3691名患者的四项临床试验中，接受Verzenio治疗的患者中有37%至46%发生中性粒细胞减少。在接受Verzenio治疗的患者中，有19%至32%的患者中性粒细胞计数下降≥3级（根据实验室检查结果）。

Across trials, the median time to first episode of Grade ≥3 neutropenia ranged from 29 to 33 days, and the median duration of Grade ≥3 neutropenia ranged from 11 to 16 days. Febrile neutropenia has been reported in <1% of patients exposed to Verzenio across trials. Two deaths due to neutropenic sepsis were observed in MONARCH 2.

在整个试验中，≥3级中性粒细胞减少症首次发作的中位时间为29至33天，≥3级中性粒细胞减少症的中位持续时间为11至16天。据报道，在整个试验中，接触Verzenio的患者中，发热性中性粒细胞减少症的发生率不到1%。在MONARCH 2中观察到两例中性粒细胞减少性败血症死亡。

Inform patients to promptly report any episodes of fever to their healthcare provider..

通知患者立即向其医疗保健提供者报告任何发烧事件。。

Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia..

在开始Verzenio治疗之前，每2周监测一次全血细胞计数，前2个月每2周监测一次，后2个月每月监测一次，并根据临床指示进行监测。对于出现3级或4级中性粒细胞减少症的患者，建议中断剂量，减少剂量或延迟开始治疗周期。。

Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. In Verzenio-treated patients in EBC (monarchE), 3% of patients experienced ILD or pneumonitis of any grade: 0.4% were Grade 3 or 4 and there was one fatality (0.1%).

用Verzenio和其他CDK4/6抑制剂治疗的患者可能会发生严重，危及生命或致命的间质性肺病（ILD）或肺炎。在EBC（Monarch）接受Verzenio治疗的患者中，3%的患者经历了任何级别的ILD或肺炎：0.4%为3级或4级，有1例死亡（0.1%）。

In Verzenio-treated patients in MBC (MONARCH 1, MONARCH 2, MONARCH 3), 3.3% of Verzenio-treated patients had ILD or pneumonitis of any grade: 0.6% had Grade 3 or 4, and 0.4% had fatal outcomes. Additional cases of ILD or pneumonitis have been observed in the postmarketing setting, with fatalities reported..

在接受Verzenio治疗的MBC患者（MONARCH 1，MONARCH 2，MONARCH 3）中，3.3%的接受Verzenio治疗的患者患有任何级别的ILD或肺炎：0.6%患有3级或4级，0.4%患有致命结局。在上市后的环境中还观察到了其他ILD或肺炎病例，并报告了死亡人数。。

Monitor patients for pulmonary symptoms indicative of ILD or pneumonitis. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded by means of appropriate investigations. Dose interruption or dose reduction is recommended in patients who develop persistent or recurrent Grade 2 ILD or pneumonitis.

监测患者是否有指示ILD或肺炎的肺部症状。放射学检查的症状可能包括缺氧，咳嗽，呼吸困难或间质浸润。应通过适当的调查排除此类症状的传染性，肿瘤性和其他原因。。

Permanently discontinue Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis..

所有3级或4级ILD或肺炎患者永久停用Verzenio。。

Grade ≥3 increases in alanine aminotransferase (ALT) (2 to 6%) and aspartate aminotransferase (AST) (2 to 3%) were reported in patients receiving Verzenio. Across three clinical trials in 3559 patients (monarchE, MONARCH 2, MONARCH 3), the median time to onset of Grade ≥3 ALT increases ranged from 57 to 87 days and the median time to resolution to Grade <3 was 13 to 14 days.

据报道，接受Verzenio治疗的患者丙氨酸氨基转移酶（ALT）（2%至6%）和天冬氨酸氨基转移酶（AST）（2%至3%）升高≥3级。在3559名患者（MONARCH，MONARCH 2，MONARCH 3）的三项临床试验中，≥3级ALT升高的中位发病时间为57至87天，达到3级的中位缓解时间为13至14天。

The median time to onset of Grade ≥3 AST increases ranged from 71 to 185 days and the median time to resolution to Grade <3 ranged from 11 to 15 days..

≥3级AST增加的中位发病时间为71至185天，而<3级的中位消退时间为11至15天。。

Monitor liver function tests (LFTs) prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or any Grade 3 or 4 hepatic transaminase elevation..

在开始Verzenio治疗之前，每2周监测一次肝功能检查（LFT），前2个月每2周监测一次，后2个月每月监测一次，并根据临床指示进行监测。对于发生持续性或复发性2级或任何3级或4级肝转氨酶升高的患者，建议中断剂量，减少剂量，停止剂量或延迟开始治疗周期。。

Venous thromboembolic events (VTE) were reported in 2 to 5% of patients across three clinical trials in 3559 patients treated with Verzenio (monarchE, MONARCH 2, MONARCH 3). VTE included deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis.

。VTE包括深静脉血栓形成，肺栓塞，盆腔静脉血栓形成，脑静脉窦血栓形成，锁骨下静脉和腋窝静脉血栓形成以及下腔静脉血栓形成。

In clinical trials, deaths due to VTE have been reported in patients treated with Verzenio..

在临床试验中，据报道，接受Verzenio治疗的患者因VTE死亡。。

Verzenio has not been studied in patients with early breast cancer who had a history of VTE. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate. Dose interruption is recommended for EBC patients with any grade VTE and for MBC patients with a Grade 3 or 4 VTE..

Verzenio尚未对有VTE病史的早期乳腺癌患者进行研究。监测患者静脉血栓形成和肺栓塞的体征和症状，并根据医学情况进行治疗。对于任何级别VTE的EBC患者和3级或4级VTE的MBC患者，建议中断剂量。。

Verzenio can cause fetal harm when administered to a pregnant woman, based on findings from animal studies and the mechanism of action. In animal reproduction studies, administration of abemaciclib to pregnant rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose.

根据动物研究和作用机制的发现，Verzenio给孕妇服用时会造成胎儿伤害。在动物繁殖研究中，在器官发生期间向怀孕大鼠施用abemaciclib会导致致畸性，并在母体暴露时降低胎儿体重，这与最大推荐人类剂量下基于曲线下面积（AUC）的人类临床暴露相似。

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Verzenio and for 3 weeks after the last dose. Based on findings in animals, Verzenio may impair fertility in males of reproductive potential. There are no data on the presence of Verzenio in human milk or its effects on the breastfed child or on milk production.

告知孕妇对胎儿的潜在风险。建议有生殖潜力的女性在用Verzenio治疗期间和最后一剂后3周内使用有效的避孕措施。。没有关于母乳中是否存在Verzenio的数据，也没有关于其对母乳喂养的孩子或牛奶生产的影响的数据。

Advise lactating women not to breastfeed during Verzenio treatment and for at least 3 weeks after the last dose because of the potential for serious adverse reactions in breastfed infants..

建议哺乳期妇女在Verzenio治疗期间以及最后一次给药后至少3周内不要母乳喂养，因为母乳喂养的婴儿可能会出现严重的不良反应。。

The most common adverse reactions (all grades, ≥10%) observed in monarchE for Verzenio plus tamoxifen or an aromatase inhibitor vs tamoxifen or an aromatase inhibitor, with a difference between arms of ≥2%, were diarrhea (84% vs 9%), infections (51% vs 39%), neutropenia (46% vs 6%), fatigue (41% vs 18%), leukopenia (38% vs 7%), nausea (30% vs 9%), anemia (24% vs 4%), headache (20% vs 15%), vomiting (18% vs 4.6%), stomatitis (14% vs 5%), lymphopenia (14% vs 3%), thrombocytopenia (13% vs 2%), decreased appetite (12% vs 2.4%), ALT increased (12% vs 6%), AST increased (12% vs 5%), dizziness (11% vs 7%), rash (11% vs 4.5%), and alopecia (11% vs 2.7 %)..

在Monarch中观察到的Verzenio加他莫昔芬或芳香化酶抑制剂与他莫昔芬或芳香化酶抑制剂最常见的不良反应（所有级别，≥10%），两组之间的差异≥2%，是腹泻（84%比9%），感染（51%比39%），中性粒细胞减少（46%比6%），疲劳（41%比18%），白细胞减少（38%比7%），恶心（30%比9%），贫血（24%比4%），头痛（20%比15%），呕吐（18%比4.6%），口腔炎（14%比5%），淋巴细胞减少（14%比3%），血小板减少（13%比2%），食欲下降（12%比2.4%），ALT升高（12%比6%），AST升高（12%比5%），头晕（11%比7%），皮疹（11%比4.5%）和脱发（11%比2.7%）。。

The most frequently reported ≥5% Grade 3 or 4 adverse reaction that occurred in the Verzenio arm vs the tamoxifen or an aromatase inhibitor arm of monarchE were neutropenia (19.6% vs 1%), leukopenia (11% vs <1%), diarrhea (8% vs 0.2%), and lymphopenia (5% vs <1%).

Verzenio组与他莫昔芬或Monarch芳香化酶抑制剂组相比，最常报告≥5%的3或4级不良反应为中性粒细胞减少症（19.6%比1%），白细胞减少症（11%比<1%），腹泻（8%比0.2%）和淋巴细胞减少症（5%比<1%）。

Lab abnormalities (all grades; Grade 3 or 4) for monarchE in ≥10% for Verzenio plus tamoxifen or an aromatase inhibitor with a difference between arms of ≥2% were increased serum creatinine (99% vs 91%; .5% vs <.1%), decreased white blood cells (89% vs 28%; 19.1% vs 1.1%), decreased neutrophil count (84% vs 23%; 18.7% vs 1.9%), anemia (68% vs 17%; 1% vs .1%), decreased lymphocyte count (59% vs 24%; 13.2 % vs 2.5%), decreased platelet count (37% vs 10%; .9% vs .2%), increased ALT (37% vs 24%; 2.6% vs 1.2%), increased AST (31% vs 18%; 1.6% vs .9%), and hypokalemia (11% vs 3.8%; 1.3% vs 0.2%)..

Verzenio加他莫昔芬或芳香化酶抑制剂组间差异≥2%的Monarch≥10%的实验室异常（所有等级；3级或4级）为血清肌酐升高（99%比91%；.5%比<.1%），白细胞减少（89%比28%；19.1%比1.1%），中性粒细胞计数减少（84%比23%；18.7%比1.9%），贫血（68%比17%；1%比1%），淋巴细胞计数减少（59%比24%；13.2%比2.5%），血小板计数减少（37%比10%；9%比2%），ALT升高（59%比24%；13.2%比2.5%）37%比24%；2.6%比1.2%），AST升高（31%比18%；1.6%比9%）和低钾血症（11%比3.8%；1.3%比0.2%）。。

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 3 for Verzenio plus anastrozole or letrozole vs anastrozole or letrozole, with a difference between arms of ≥2%, were diarrhea (81% vs 30%), fatigue (40% vs 32%), neutropenia (41% vs 2%), infections (39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3.1%), influenza-like illness (10% vs 8%), and thrombocytopenia (10% vs 2%)..

在MONARCH 3中观察到的Verzenio加阿那曲唑或来曲唑与阿那曲唑或来曲唑最常见的不良反应（所有级别，≥10%），两组之间的差异≥2%，是腹泻（81%比30%），疲劳（40%比32%），中性粒细胞减少（41%比2%），感染（39%比29%），恶心（39%比20%），腹痛（29%比12%），呕吐（28%比12%），贫血（28%比5%），脱发（27%比11%），食欲下降（24%比9%），白细胞减少（21%比2%），肌酐升高（19%比4%），便秘（16%比12）），ALT升高（16%比7%），AST升高（15%比7%），皮疹（14%比5%），瘙痒（13%比9%），咳嗽（13%比9%），呼吸困难（12%比6%），头晕（11%比9%），体重下降（10%比3.1%），流感样疾病（10%比8%）和血小板减少症（10%比2%）。。

The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 3 were neutropenia (22% vs 1%), diarrhea (9% vs 1.2%), leukopenia (7% vs <1%)), increased ALT (6% vs 2%), and anemia (6% vs 1%).

。

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 3 in ≥10% for Verzenio plus anastrozole or letrozole with a difference between arms of ≥2% were increased serum creatinine (98% vs 84%; 2.2% vs 0%), decreased white blood cells (82% vs 27%; 13% vs 0.6%), anemia (82% vs 28%; 1.6% vs 0%), decreased neutrophil count (80% vs 21%; 21.9% vs 2.6%), decreased lymphocyte count (53% vs 26%; 7.6% vs 1.9%), decreased platelet count (36% vs 12%; 1.9% vs 0.6%), increased ALT (48% vs 25%; 6.6% vs 1.9%), and increased AST (37% vs 23%; 3.8% vs 0.6%)..

Verzenio加阿那曲唑或来曲唑组≥10%的MONARCH 3实验室异常（所有等级；3级或4级），两组之间差异≥2%，血清肌酐升高（98%比84%；2.2%比0%），白细胞减少（82%比27%；13%比0.6%），贫血（82%比28%；1.6%比0%），中性粒细胞计数减少（80%比21%；21.9%比2.6%），淋巴细胞计数减少（53%比26%；7.6%比1.9%），血小板计数减少（36%比12%；1.9%比0.6%），ALT升高（48%）比25%；6.6%比1.9%）和AST增加（37%比23%；3.8%比0.6%）。。

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 2 for Verzenio plus fulvestrant vs fulvestrant, with a difference between arms of ≥2%, were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 2.7%), thrombocytopenia (16% vs 3%), alopecia (16% vs 1.8%), stomatitis (15% vs 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4.5%), pyrexia (11% vs 6%), and weight decreased (10% vs 2.2%)..

在MONARCH 2中观察到的Verzenio加氟维司群与氟维司群最常见的不良反应（所有级别，≥10%），两组之间的差异≥2%，是腹泻（86%比25%），中性粒细胞减少症（46%比4%），疲劳（46%比32%），恶心（45%比23%），感染（43%比25%），腹痛（35%比16%），贫血（29%比4%），白细胞减少症（28%比2%），食欲下降（27%比12%），呕吐（26%比10%），头痛（20%比15%），味觉障碍（18%比2.7%），血小板减少症（16%比3%），脱发（26%比10%）16%比1.8%），口腔炎（15%比10%），ALT升高（13%比5%），瘙痒（13%比6%），咳嗽（13%比11%），头晕（12%比6%），AST升高（12%比7%），外周水肿（12%比7%），肌酐升高（12%比1%），皮疹（11%比4.5%），发热（11%比6%），体重下降（10%比2.2%）。。

The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 2 were neutropenia (25% vs 1%), diarrhea (13% vs 0.4%), leukopenia (9% vs 0%), anemia (7% vs 1%), and infections (5.7% vs 3.5%).

Verzenio组与MONARCH 2的安慰剂组相比，最常报告≥5%的3或4级不良反应是中性粒细胞减少症（25%比1%），腹泻（13%比0.4%），白细胞减少症（9%比0%），贫血（7%比1%）和感染（5.7%比3.5%）。

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in ≥10% for Verzenio plus fulvestrant with a difference between arms of ≥2% were increased serum creatinine (98% vs 74%; 1.2% vs 0%), decreased white blood cells (90% vs 33%; 23.7% vs .9%), decreased neutrophil count (87% vs 30%; 32.5% vs 4.2%), anemia (84% vs 34%; 2.6% vs .5%), decreased lymphocyte count (63% vs 32%; 12.2% vs 1.8%), decreased platelet count (53% vs 15%; 2.1% vs 0%), increased ALT (41% vs 32%; 4.6% vs 1.4%), and increased AST (37% vs 25%; 3.9% vs 4.2%)..

Verzenio加氟维司群≥10%的MONARCH 2实验室异常（所有等级；3级或4级），两组之间差异≥2%，血清肌酐升高（98%比74%；1.2%比0%），白细胞减少（90%比33%；23.7%比9%），中性粒细胞计数减少（87%比30%；32.5%比4.2%），贫血（84%比34%；2.6%比5%），淋巴细胞计数减少（63%比32%；12.2%比1.8%），血小板计数减少（53%比15%；2.1%比0%），ALT升高（41%比32%；4.6%比1.4%），AST升高（37%比25%；3.9%比4.2%）。。

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough (19%), constipation (17%), leukopenia (17%), arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration (10%)..

在MONARCH 1与Verzenio患者中观察到的最常见的不良反应（所有级别，≥10%）是腹泻（90%），疲劳（65%），恶心（64%），食欲下降（45%），腹痛（39%），中性粒细胞减少症（37%），呕吐（35%），感染（31%），贫血（25%），血小板减少症（20%），头痛（20%），咳嗽（19%），便秘（17%），白细胞减少症（17%），关节痛（15%），口干（14%），体重下降（14%），口腔炎（14%），肌酐增加（13%），脱发（12%），味觉障碍（12%），发热（11%），头晕（11%）和脱水（10%）。。

The most frequently reported ≥5% Grade 3 or 4 adverse reactions from MONARCH 1 with Verzenio were diarrhea (20%), neutropenia (24%), fatigue (13%), and leukopenia (5%).

MONARCH 1与Verzenio最常报告≥5%的3或4级不良反应是腹泻（20%），中性粒细胞减少（24%），疲劳（13%）和白细胞减少（5%）。

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 with Verzenio were increased serum creatinine (99%; .8%), decreased white blood cells (91%; 28%), decreased neutrophil count (88%; 26.6%), anemia (69%; 0%), decreased lymphocyte count (42%; 13.8%), decreased platelet count (41%; 2.3%), increased ALT (31%; 3.1%), and increased AST (30%; 3.8%)..

患有Verzenio的MONARCH 1的实验室异常（所有等级；3级或4级）为血清肌酐升高（99%；0.8%），白细胞减少（91%；28%），中性粒细胞计数减少（88%；26.6%），贫血（69%；0%），淋巴细胞计数减少（42%；13.8%），血小板计数减少（41%；2.3%），ALT升高（31%；3.1%）和AST升高（30%；3.8%）。。

Strong and moderate CYP3A inhibitors increased the exposure of abemaciclib plus its active metabolites to a clinically meaningful extent and may lead to increased toxicity. Avoid concomitant use of ketoconazole. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold. In patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the Verzenio dose to 100 mg twice daily with concomitant use of strong CYP3A inhibitors other than ketoconazole.

强和中度CYP3A抑制剂将abemaciclib及其活性代谢物的暴露增加到临床上有意义的程度，并可能导致毒性增加。避免同时使用酮康唑。预计酮康唑可使abemaciclib的AUC增加16倍。对于推荐起始剂量为200 mg每日两次或150 mg每日两次的患者，将Verzenio剂量降至100 mg每日两次，同时使用除酮康唑以外的强CYP3A抑制剂。

In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the Verzenio dose to 50 mg twice daily with concomitant use of strong CYP3A inhibitors. If a patient taking Verzenio discontinues a strong CYP3A inhibitor, increase the Verzenio dose (after 3 to 5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor.

对于由于不良反应而每天两次剂量减少至100 mg的患者，进一步将Verzenio剂量减少至50 mg，每天两次，同时使用强CYP3A抑制剂。如果服用Verzenio的患者停止服用强效CYP3A抑制剂，则将Verzenio剂量（在抑制剂的3至5个半衰期后）增加至开始使用抑制剂之前的剂量。

With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements. Patients should avoid grapefruit products..

同时使用中度CYP3A抑制剂，监测不良反应，并考虑将Verzenio剂量减少50 mg。患者应避免使用葡萄柚制品。。

Avoid concomitant use of strong or moderate CYP3A inducers and consider alternative agents. Coadministration of strong or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity.

避免同时使用强或中度CYP3A诱导剂，并考虑替代药物。强效或中度CYP3A诱导剂的共同给药降低了abemaciclib及其活性代谢物的血浆浓度，并可能导致活性降低。

With severe hepatic impairment (Child-Pugh C), reduce the Verzenio dosing frequency to once daily. The pharmacokinetics of Verzenio in patients with severe renal impairment (CLcr <30 mL/min), end stage renal disease, or in patients on dialysis is unknown. No dosage adjustments are necessary in patients with mild or moderate hepatic (Child-Pugh A or B) and/or renal impairment (CLcr ≥30-89 mL/min)..

对于严重的肝功能损害（Child-Pugh C），将Verzenio给药频率降低至每天一次。Verzenio在严重肾功能不全（CLcr<30 mL/min），终末期肾病或透析患者中的药代动力学尚不清楚。轻度或中度肝脏（Child-Pugh A或B）和/或肾功能不全（CLcr≥30-89 mL/min）的患者无需调整剂量。。

Please see full Prescribing Information and Patient Information for Verzenio.

请参阅Verzenio的完整处方信息和患者信息。

AL HCP ISI 12OCT2021

2021年10月12日

About Imlunestrant  Imlunestrant is an oral selective estrogen receptor (ER) degrader, that delivers continuous ER inhibition, including in ESR1-mutant cancers.

关于Imlunestrant Imlunestrant是一种口服选择性雌激素受体（ER）降解剂，可提供持续的ER抑制作用，包括在ESR1突变型癌症中。

The estrogen receptor (ER) is the key therapeutic target for patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Novel degraders of ER may overcome endocrine therapy resistance while providing consistent oral pharmacology and convenience of administration.

雌激素受体（ER）是雌激素受体阳性（ER+），人表皮生长因子受体2阴性（HER2-）乳腺癌患者的关键治疗靶点。ER的新型降解剂可以克服内分泌治疗的耐药性，同时提供一致的口服药理学和给药的便利性。

Imlunestrant is currently being studied as a treatment for advanced breast cancer and as an adjuvant treatment in early breast cancer, including: NCT04975308, NCT05514054, NCT04188548, NCT05307705. .

目前正在研究Imlunestrant作为晚期乳腺癌的治疗方法和早期乳腺癌的辅助治疗方法，包括：NCT04975308，NCT05514054，NCT04188548，NCT05307705。

Verzenio® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Verzenio®是礼来公司、其子公司或附属公司拥有或许可的注册商标。

© Lilly USA, LLC 2024. ALL RIGHTS RESERVED.

。保留所有权利。

About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases.

关于LillyLilly是一家将科学转化为治疗的医药公司，旨在让世界各地的人们生活得更好。近150年来，我们一直在开创改变生活的发现，今天，我们的药物帮助了全球数以千万计的人。利用生物技术、化学和遗传医学的力量，我们的科学家正在迫切推进新发现，以解决世界上一些最重大的健康挑战：重新定义糖尿病护理；治疗肥胖并减少其最具破坏性的长期影响；推进与阿尔茨海默病的斗争；为一些最令人衰弱的免疫系统疾病提供解决方案；并将最难治疗的癌症转化为可控制的疾病。

With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn.P-LLY.

在迈向更健康世界的每一步中，我们都有一个动机：让数百万人的生活变得更好。这包括提供反映我们世界多样性的创新临床试验，并努力确保我们的药物可获得且负担得起。要了解更多信息，请访问Lilly.com和Lilly.com/news，或在Facebook、Instagram和LinkedIn上关注我们。P-LLY公司。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警示声明

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Verzenio® (abemaciclib), imlunestrant, LOXO-783 or LY4045004 as potential treatments for people with certain types of early breast cancer and reflects Lilly's current beliefs and expectations.

本新闻稿包含关于Verzenio®（abemaciclib）、imlunestrant、LOXO-783或LY4045004作为某些类型早期乳腺癌患者潜在治疗方法的前瞻性声明（该术语在1995年《私人证券诉讼改革法案》中有定义），并反映了礼来目前的信念和期望。

However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, or that Verzenio, imlunestrant, or LY4045004 will receive initial regulatory approvals or approvals for additional indications, as applicable, or that they will be commercially successful.

然而，与任何药品一样，药物研究，开发和商业化过程中存在重大风险和不确定性。除此之外，无法保证计划或正在进行的研究将按计划完成，未来的研究结果将与迄今为止的研究结果一致，或者Verzenio，Imlunestant或LY4045004将获得初始监管批准或其他适应症的批准（如适用），或者它们将取得商业成功。

For further discussion of risks and uncertainties relevant to Lilly's business that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release..

有关可能导致实际结果与礼来预期不同的礼来业务相关风险和不确定性的进一步讨论，请参阅礼来向美国证券交易委员会提交的表格10-K和表格10-Q。除法律要求外，礼来没有义务更新前瞻性声明以反映本发布日期后的事件。。

1 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed May 9, 2024. To view the most recent and complete version of the guidelines, go online to NCCN.org.

1经NCCN肿瘤临床实践指南（NCCN Guidelines®）乳腺癌V.2.2024许可引用。©National Comprehensive Cancer Network，Inc.2024年。保留所有权利。2024年5月9日访问。要查看指南的最新完整版本，请访问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..

NCCN对其内容、使用或应用不作任何形式的保证，也不以任何方式对其应用或使用承担任何责任。。

2 Johnston SRD, Toi M, O'Shaughnessy J, Rastogi P, et al. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomized, open-label, phase 3 trial. Lancet Oncol. 2023 Jan;24(1):77-90..

2 Johnston SRD，Toi M，O'Shaughnessy J，Rastogi P等。Abemaciclib加内分泌治疗激素受体阳性，HER2阴性，淋巴结阳性，高危早期乳腺癌（Monarch）：来自一项随机，开放标签，3期试验的预先计划的中期分析结果。柳叶刀Oncol。2023年1月；24（1）：77-90。。

3 Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2–negative breast cancer that progressed on endocrine therapy—MONARCH 2: a randomized clinical trial. JAMA Oncol. 2020;6(1):116-124. doi:10.1001/jamaoncol. 2019.4782..

3 Sledge GW Jr，Toi M，Neven P等。abemaciclib联合氟维司群对内分泌治疗MONARCH 2进展的激素受体阳性，ERBB2阴性乳腺癌总生存率的影响：一项随机临床试验。JAMA Oncol。2020年；6（1）：116-124。doi:10.1001/jamancol。2019.4782。。

Refer to:

Michelle Webb; michelle.webb@lilly.com; 463-206-4463 (Media)

米歇尔·韦伯；michelle.webb@lilly.com；463-206-4463（媒体）

Joe Fletcher; jfletcher@lilly.com; 317-296-2884 (Investors)

乔·弗莱彻；（笑声）jfletcher@lilly.com；317-296-2884（投资者）

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SOURCE Eli Lilly and Company

来源：礼来公司