INDIANAPOLIS

印第安纳波利斯

,

，

June 2, 2025

2025年6月2日

/PRNewswire/ --

/PRNewswire/ --

Eli Lilly and Company

礼来公司

(NYSE: LLY) today announced new Phase 1 data showing that its folate receptor alpha (FRα) antibody-drug conjugate (ADC) (LY4170156) demonstrated an encouraging safety profile and anti-tumor activity across dose and FRα expression levels in women with heavily pre-treated platinum-resistant ovarian cancer, including patients previously treated with mirvetuximab soravtansine.

(NYSE: LLY) 今天宣布了新的第一阶段数据，显示其叶酸受体α（FRα）抗体药物偶联物（ADC）（LY4170156）在经过多线治疗的铂耐药卵巢癌女性患者中，表现出令人鼓舞的安全性及抗肿瘤活性，涵盖不同剂量和FRα表达水平，包括之前接受过mirvetuximab soravtansine治疗的患者。

A preliminary overall objective response rate (ORR) of 55% was observed at the potential recommended Phase 2 dose of 4 mg/kg. Lilly's FRα targeting ADC is composed of an Fc-silent, FRα specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker.

在潜在推荐的二期剂量4 mg/kg下，观察到初步的总体客观缓解率（ORR）为55%。礼来公司的FRα靶向ADC由一个Fc静默、FRα特异性的人源化单克隆抗体通过专有的可裂解聚肌氨酸连接子与拓扑异构酶I抑制剂艾沙替康链接而成。

These data will be presented today in a poster presentation at the .

这些数据将会在今天的海报展示中呈现。

American Society of Clinical Oncology

美国临床肿瘤学会

(ASCO) Annual Meeting.

(ASCO)年会。

'ADCs have begun to change the treatment paradigm for some women with ovarian cancer, but a large proportion of patients still have a significant need for new therapies that improve outcomes regardless of FRα expression level,' said

“ADC已经开始改变部分卵巢癌女性的治疗模式，但很大一部分患者仍然需要新的疗法来改善预后，无论FRα表达水平如何，”

Isabelle Ray-Coquard

伊莎贝尔·雷科夸尔

, M.D., Ph.D., president of the ENGOT (European Network of Gynecological Oncology Trial) group, medical oncologist at the Centre Léon Bérard Lyon France and principal investigator for the trial. 'These initial data show activity across all doses and levels of FRα expression, including in patients previously treated with a FRα targeting treatment.

医学博士、博士、欧洲妇科肿瘤试验网络（ENGOT）组主席、法国里昂Centre Léon Bérard医疗肿瘤学家以及该试验的首席研究员表示：“这些初步数据显示，在所有剂量和FRα表达水平中均具有活性，包括之前接受过FRα靶向治疗的患者。”

Taken together with the emerging safety and tolerability profile, these data demonstrate early potential to meaningfully improve outcomes for women living with advanced ovarian cancer.'  .

综合考虑其新兴的安全性和耐受性特征，这些数据展示了早期潜力，可为晚期卵巢癌女性患者带来有意义的疗效改善。

As of the

截至

March 9, 2025

2025年3月9日

data cutoff, the study enrolled 95 participants with high-grade serous ovarian cancer across four dose levels (2 - 6 mg/kg). Patients received a median of five prior systemic regimens (range 1-10), and 15% were previously treated with mirvetuximab soravtansine. Among the 95 patients, 51% had tumors with FRα expression less than 75%, 34% had FRα expression of 75% or higher, and 16% had expression results pending.

数据截止时，研究共招募了95名高级别浆液性卵巢癌患者，涵盖四个剂量水平（2-6 mg/kg）。患者接受的既往系统治疗方案中位数为五种（范围1-10），其中15%曾接受过mirvetuximab soravtansine治疗。在95名患者中，51%的肿瘤FRα表达低于75%，34%的肿瘤FRα表达为75%或更高，16%的表达结果尚待确定。

Key endpoints were safety, pharmacokinetics, and anti-tumor activity per RECIST v1.1..

主要终点是安全性、药代动力学和根据RECIST v1.1的抗肿瘤活性。

Efficacy results demonstrate responses at all dose levels, across all FRα expression levels, including in patients who progressed on prior mirvetuximab soravtansine. In the 58 efficacy-evaluable patients (37 patients remain ongoing prior to first response assessment and were therefore not yet efficacy-evaluable at the time of the data cutoff), the ORR was 45% (26/58 patients), and the disease control rate was 74% (43/58).

疗效结果显示，在所有剂量水平和所有FRα表达水平的患者中均有反应，包括那些之前接受过mirvetuximab soravtansine治疗后进展的患者。在58名可评估疗效的患者中（37名患者在首次反应评估前仍在进行中，因此在数据截止时还未达到疗效评估标准），客观缓解率（ORR）为45%（26/58名患者），疾病控制率为74%（43/58）。

At the potential recommended Phase 2 dose of 4 mg/kg, the ORR was 55% (11/20 patients). The most common treatment-emergent adverse events across all dose levels included nausea (64%), anemia (40%), fatigue (32%), vomiting (32%), diarrhea (28%), and neutropenia (27%). Treatment-emergent neuropathy and ocular toxicity has not been observed to date.

在推荐的二期试验剂量4 mg/kg下，客观缓解率（ORR）为55%（20名患者中有11人）。在所有剂量水平中，最常见的治疗相关不良事件包括恶心（64%）、贫血（40%）、疲劳（32%）、呕吐（32%）、腹泻（28%）和中性粒细胞减少（27%）。迄今为止，尚未观察到治疗相关的神经病变和眼部毒性。

No maximum tolerated dose has been established..

尚未确定最大耐受剂量。

'We are excited to share these first clinical data for our FRα targeting ADC, demonstrating a promising tolerability and efficacy profile across all FRα expression levels,' said

“我们很高兴分享针对FRα的ADC的首批临床数据，这些数据显示在所有FRα表达水平上都具有良好的耐受性和有效性。”

David Hyman

大卫·海曼

, M.D., Chief Medical Officer, Lilly. 'Based on these results, we believe there is the potential to significantly expand the number of ovarian cancer patients who could benefit from a FRα ADC. We are now focused on rapidly advancing this potential new medicine into registrational Phase 3 clinical trials.' .

，医学博士，礼来公司首席医疗官。“基于这些结果，我们相信有可能大幅扩大可能受益于FRα ADC的卵巢癌患者数量。我们现在正专注于快速将这种潜在的新药推进到注册性的第三阶段临床试验。”

For more information on Lilly's oncology pipeline click

有关礼来肿瘤学管线的更多信息，请点击

here

这里

.

。

About LY4170156

关于LY4170156

LY4170156 is an investigational, next-generation antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα). FRα is a cell-surface

LY4170156 是一种研究中的下一代抗体药物偶联物 (ADC)，靶向叶酸受体α (FRα)。FRα是一种细胞表面

glycoprotein

糖蛋白

encoded by the gene

由基因编码

FOLR1

叶酸受体1

that binds to the essential nutrients folic acid and reduced

结合必需营养素叶酸和还原型的

folates

叶酸

, bringing them into cells to facilitate cell division and growth.

，将它们带入细胞以促进细胞分裂和生长。

1,2

1,2

FRα is

FRα 是

overexpressed

过表达

in many solid tumors such as ovarian, non-small cell lung, and colorectal cancers.

在许多实体瘤中，如卵巢癌、非小细胞肺癌和结直肠癌。

1,3,4

1,3,4

LY4170156 was designed to target FRα across expression levels with an improved therapeutic index. LY4170156 is composed of an Fc-silent, FRα specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker (PSARlink™). PSARlink's unique structure 'masks' the cytotoxic molecules enabling them to stay in the body longer, providing the potential to broaden the therapeutic index of ADCs.

LY4170156旨在针对不同表达水平的FRα，具有更高的治疗指数。LY4170156由一个无Fc效应、特异性针对FRα的人源化单克隆抗体组成，该抗体通过一种专有的可裂解多聚肌氨酸链接子（PSARlink™）与拓扑异构酶I抑制剂艾沙替康相连。PSARlink的独特结构能够“掩蔽”细胞毒性分子，使它们在体内停留时间更长，从而有望拓宽ADC的治疗指数。

LY4170156 is currently being studied in patients with ovarian cancer as well as other FRα-expressing solid tumors, .

LY4170156目前正在卵巢癌以及其他表达FRα的实体瘤患者中进行研究。

NCT06400472

NCT06400472

.

。

About Lilly

关于Lilly

Lilly 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.

礼来是一家医药公司，将科学转化为治愈力量，改善世界各地人们的生活。近150年来，我们一直在开创改变生命的发现，如今我们的药物帮助了全球数千万人。通过利用生物技术、化学和基因医学的力量，我们的科学家正在加速推进新的发现，以解决一些全球最重要的健康挑战：重新定义糖尿病护理；治疗肥胖症并遏制其最具破坏性的长期影响；推动对抗阿尔茨海默病的斗争；为一些最严重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管理的疾病。

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 .

每迈向更健康的世界一步，我们都受到一个目标的激励：让数百万人的生活变得更好。这包括开展反映世界多样性的创新临床试验，并努力确保我们的药物可及且负担得起。欲了解更多信息，请访问。

Lilly.com

莉莉网

and

和

Lilly.com/news

Lilly.com/新闻

, or follow us on

，或者在以下平台关注我们

Facebook

Facebook

,

，

Instagram

图享

, and

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领英

. P-LLY

. P-LLY

Trademarks and

商标和

Trade Names

商标名称

All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto.

本新闻稿中提到的所有商标或商号均为公司财产，或者，若涉及属于其他公司的商标或商号，则为其各自所有者的财产。为方便起见，本新闻稿中的商标和商号未标注®和™符号，但此类引用不应被解释为表明公司或在适用的情况下其各自所有者不会根据适用法律最大程度地主张公司或其对该等权利的所有权。

We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies..

我们无意使用或展示其他公司的商标和商号，以暗示我们与任何其他公司存在关系，或得到其认可或赞助。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警示性声明

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about preclinical data for an antibody-drug conjugate targeting folate receptor alpha and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization.

本新闻稿包含关于靶向叶酸受体α的抗体药物偶联物的临床前数据的前瞻性声明（该术语定义见1995年《私人证券诉讼改革法案》），并反映了礼来公司当前的信念和期望。然而，与任何医药产品一样，在药物研究、开发和商业化的进程中存在重大风险和不确定性。

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, that any of these therapies will prove to be a safe and effective treatment or receive regulatory approval, or that Lilly will execute its strategy as expected.

其中，不能保证计划中的或正在进行的研究会按计划完成，未来的研究结果将与迄今为止的研究结果一致，这些疗法中的任何一种将被证明是一种安全有效的治疗方法或获得监管机构的批准，或者礼来公司将如期执行其战略。

For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the .

有关这些风险和其他可能导致实际结果与礼来公司预期不同的不确定性的进一步讨论，请参阅礼来公司向美国证券交易委员会提交的Form 10-K和Form 10-Q报告。

United States Securities and Exchange Commission

美国证券交易委员会

. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

除非法律要求，礼来公司没有义务更新前瞻性声明以反映本发布日期之后的事件。

Bax, Heather J et al. 'Folate receptor alpha in ovarian cancer tissue and patient serum is associated with disease burden and treatment outcomes.'

巴克斯，希瑟 J 等。‘卵巢癌组织和患者血清中的叶酸受体α与疾病负担和治疗结果相关。’

British journal of cancer

英国癌症杂志

vol. 128,2 (2023): 342-353. doi:10.1038/s41416-022-02031-x Bax HJ, et al.

第128卷，第2期（2023年）：342-353页。doi:10.1038/s41416-022-02031-x Bax HJ等。

Br

溴

J Cancer

癌症期刊

. 2023;128(2):342-353.

. 2023;128(2):342-353.

Scaranti, Mariana et al. 'Exploiting the folate receptor α in oncology.'

斯卡拉蒂，马里亚娜等。《在肿瘤学中利用叶酸受体α》

Nature reviews. Clinical oncology

自然综述：临床肿瘤学

vol. 17,6 (2020): 349-359. doi:10.1038/s41571-020-0339-5.

第17卷，第6期（2020年）：349-359页。doi:10.1038/s41571-020-0339-5。

Kalli, Kimberly R et al. 'Folate receptor alpha as a tumor target in epithelial ovarian cancer.'

Kalli，Kimberly R 等人。《叶酸受体α作为上皮性卵巢癌的肿瘤靶点》

Gynecologic oncology

妇科肿瘤学

vol. 108,3 (2008): 619-26. doi:10.1016/j.ygyno.2007.11.020.

第108卷，第3期（2008年）：619-26页。doi:10.1016/j.ygyno.2007.11.020。

Viricel W, et al.

维里塞尔 W，等。

Cancer Res

癌症研究

. 2023;83(suppl 7):1544.

. 2023;83(增刊7):1544.

Refer to:

参考：

Megan Talon;

梅根·塔隆；

megan.talon@lilly.com

梅根·塔隆@礼来公司.com

; 463-209-1470 (Media)

；463-209-1470（媒体）

Michael Czapar

迈克尔·查帕尔

;

；

czapar_michael_c@lilly.com

czapar_michael_c@lilly.com

; 317-617-0983 (Investors)

；317-617-0983（投资者）

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Eli Lilly and Company

礼来公司