Phase III NAPOLI 3 trial is the largest and has the longest follow-up for an interventional study in metastatic pancreatic adenocarcinoma

第三期NAPOLI 3试验是最大型的，并且在转移性胰腺癌的介入性研究中拥有最长的随访时间。

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Post-hoc analysis of NAPOLI 3 study determined characteristics associated with long-term survival, with median overall survival of 19.5 months amongst long-term survivors receiving Onivyde

NAPOLI 3研究的事后分析确定了与长期生存相关的特征，接受Onivyde治疗的长期生存者的中位总生存期为19.5个月。

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plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) regimen as a first-line therapy

奥沙利铂、氟尿嘧啶和亚叶酸（NALIRIFOX）方案作为一线治疗

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Dose reductions and/or treatment delays for the management of adverse events enabled patients to stay on treatment longer and achieve high cumulative doses of liposomal irinotecan and oxaliplatin

通过减少剂量和/或延迟治疗来管理不良事件，使患者能够延长治疗时间，并获得高累积剂量的脂质体伊立替康和奥沙利铂。

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PARIS, France, 31 May 2025

法国巴黎，2025年5月31日

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Late-breaking (LBA4175) post-hoc analysis data from the Phase III NAPOLI 3 study were presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. These results found a median overall survival (mOS) of 19.5 months among long-term survivors (n=15) with metastatic pancreatic adenocarcinoma (mPDAC) treated with the Onivyde.

2025年美国临床肿瘤学会（ASCO）年会上，今天公布了来自III期NAPOLI 3研究的最新（LBA4175）事后分析数据。这些结果显示，在接受Onivyde治疗的转移性胰腺腺癌（mPDAC）长期生存者（n=15）中，中位总生存期（mOS）为19.5个月。

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(irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) regimen as a first-line treatment (n=120), with younger age at diagnosis, and certain tumor and metastasis locations associated with long-term survivorship.

（伊立替康脂质体注射液）联合奥沙利铂、氟尿嘧啶和亚叶酸（NALIRIFOX）方案作为一线治疗（n=120），诊断时年龄较轻，以及某些肿瘤和转移部位与长期生存率相关。

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Pancreatic adenocarcinoma (PDAC) is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed annually in the U.S. and nearly 500,000 people globally.

胰腺腺癌 (PDAC) 是胰腺中最常见的癌症类型，美国每年有超过 60,000 人被诊断出患有该病，全球范围内则接近 500,000 人。

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It is often detected after the disease has spread to other parts of the body (metastatic or stage IV)

它通常在疾病扩散到身体其他部位（转移性或第四期）后才被检测到。

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and fewer than 20% of people diagnosed with metastatic pancreatic adenocarcinoma (mPDAC) survive longer than one year.

诊断为转移性胰腺癌（mPDAC）的患者中，存活时间超过一年的人数不到20%。

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Overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.

总体而言，胰腺癌在全球和美国的所有癌症类型中，五年生存率最低。

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“When people are diagnosed with metastatic pancreatic adenocarcinoma, the most important question remains: how long will they have with their loved ones,” said Dr. Vincent Chung, Medical Oncologist, City of Hope. “Findings from the NAPOLI 3 post-hoc analysis provide important context on long-term overall survival with the Onivyde (NALIRIFOX) treatment regimen.” .

“当人们被诊断出患有转移性胰腺癌时，最重要的问题仍然是：他们与亲人还能共度多久，”希望之城的医学肿瘤学家文森特·钟博士说道。“NAPOLI 3事后分析的结果为使用Onivyde（NALIRIFOX）治疗方案的长期整体生存提供了重要的背景信息。”

The analysis included patients who survived for 18 months or longer (N=15), with findings showing long-term survivors living with mPDAC had a mOS of 19.5 months (interquartile range [IQR]: 18.8–22.6).

分析包括生存18个月或更长时间的患者（N=15），结果显示，长期存活的转移性胰腺导管腺癌（mPDAC）患者的中位总生存期（mOS）为19.5个月（四分位距 [IQR]：18.8–22.6）。

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Clinical and pathological factors of long-term survivors included younger than average age at time of diagnosis (median age 61.0 (IQR: 49.0–70.5) as well as tumor location.

长期幸存者的临床和病理因素包括诊断时的年龄小于平均年龄（中位年龄61.0岁，四分位距：49.0-70.5）以及肿瘤位置。

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Fewer patients had tumors in the head or tail of the pancreas (53.3% had the main pancreatic tumor located in the body of the pancreas), a substantial proportion had liver metastasis (66.7%) and ≥3 metastatic sites (53.3%).

较少患者的肿瘤位于胰腺头部或尾部（53.3%的患者主要胰腺肿瘤位于胰腺体部），相当大比例的患者存在肝转移（66.7%）和≥3个转移部位（53.3%）。

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Additionally, findings indicate dose reduction and treatment delays resulted in prolonged exposure and higher cumulative doses of the Onivyde (NALIRIFOX) regimen.

此外，研究结果表明，剂量减少和治疗延迟导致了Onivyde（NALIRIFOX）方案的长期暴露和更高的累积剂量。

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Liver metastasis and ≥3 metastatic sites, dose modifications and an otherwise good clinical profile enabled people to achieve a long mOS.

肝转移和≥3个转移部位、剂量调整以及良好的临床特征使患者获得了较长的mOS。

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Consideration should be taken when interpreting these results as a post-hoc analysis with a small sample size.

在解释这些结果时应谨慎，因为这是对小样本量的后验分析。

“Data from the Phase III NAPOLI 3 trial were the first positive data of its kind in a decade and continue to reinforce the potential for long-term outcomes with the Onviyde (NALIRIFOX) regimen,” said Sandra Silvestri, MD, PhD, Executive Vice President, Chief Medical Officer, Ipsen. “With people on average living just 4-6 months following diagnosis with pancreatic adenocarcinoma, these data help us to understand the characteristics associated with long-term survival seen in the NAPOLI trial, an important advancement for this difficult-to-treat cancer where data of this kind are scarce.”.

“三期NAPOLI 3试验的数据是十年来首次出现的积极数据，进一步证实了Onivyde（NALIRIFOX）方案在长期疗效方面的潜力，”益普生执行副总裁、首席医学官Sandra Silvestri博士表示。“胰腺腺癌患者在确诊后平均仅能存活4到6个月，这些数据帮助我们理解与NAPOLI试验中观察到的长期生存相关的特征，这是针对这种难以治疗的癌症的重要进展，因为这类数据非常稀缺。”

ENDS

结束

About Onivyde (irinotecan liposome injection)

关于Onivyde（伊立替康脂质体注射液）

Onivyde is a long-circulating liposomal topoisomerase inhibitor. In Onivyde, irinotecan is enclosed in tiny fat particles called liposomes which accumulate in the tumor and release slowly over time.

Onivyde 是一种长循环脂质体拓扑异构酶抑制剂。在 Onivyde 中，伊立替康被包裹在称为脂质体的微小脂肪颗粒中，这些颗粒会在肿瘤中积聚并随着时间缓慢释放。

Onivyde is administered via intravenous infusion over 90 minutes every two weeks with recommendations on dosing modifications. Onivyde, as part of the NALIRIFOX regimen (combined with oxaliplatin, fluorouracil (FU) and leucovorin (LV)), is for people living with mPDAC who are treatment naïve or used in combination with FU and LV following gemcitabine-based therapy.

Onivyde每两周通过90分钟的静脉输注给药，并提供了剂量调整建议。Onivyde作为NALIRIFOX方案（与奥沙利铂、氟尿嘧啶（FU）和亚叶酸（LV）联合使用）的一部分，适用于未经治疗的转移性胰腺导管腺癌（mPDAC）患者，或在基于吉西他滨的治疗后与FU和LV联合使用。

Onivyde is not indicated as a single agent for the treatment of adult patients with metastatic pancreatic adenocarcinoma..

Onivyde 不被指示作为治疗成人转移性胰腺腺癌的单一药物。

Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent international pharmaceutical company governed by a foundation and with an international presence in 140 countries, is responsible for the commercialization of Onivyde outside of the U.S., Taiwan and Canada.

PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan..

PharmaEngine是一家总部位于台北的商业阶段肿瘤学公司，负责在台湾地区推广Onivyde。

About NAPOLI 3 Study

关于那不勒斯3研究

NAPOLI 3 is a randomized, open-label Phase III trial of an Onivyde treatment regimen (NALIRIFOX) in treatment-naïve mPDAC. NAPOLI 3 enrolled 770 patients across 187 trial site locations in 18 countries across Europe, North America, South America, Asia, and Australia. Patients were randomized to receive Onivyde plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX regimen; n=383) twice in a month (days 1 and 15 of 28-day cycle) compared to an injection of nab-paclitaxel and gemcitabine (n=387) administered three times a month (days 1, 8, 15 of a 28-day cycle).

NAPOLI 3 是一项随机、开放标签的 III 期试验，评估 Onivyde 治疗方案（NALIRIFOX）在未接受过治疗的转移性胰腺导管腺癌（mPDAC）中的效果。NAPOLI 3 在欧洲、北美、南美、亚洲和澳大利亚的 18 个国家的 187 个试验地点招募了 770 名患者。患者被随机分配接受 Onivyde 加奥沙利铂、氟尿嘧啶和亚叶酸（NALIRIFOX 方案；n=383），每月两次（28 天周期的第 1 天和第 15 天），或每月三次注射白蛋白结合型紫杉醇和吉西他滨（n=387）（28 天周期的第 1 天、第 8 天和第 15 天）。

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About Ipsen

关于益普生

We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.

我们是一家全球生物制药公司，专注于在肿瘤学、罕见病和神经科学三个治疗领域为患者带来变革性药物。

Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries.

我们的产品线得益于外部创新，并得到近百年开发经验以及美国、法国和英国的全球中心的支持。我们在 40 多个国家/地区的团队以及世界各地的合作伙伴关系使我们能够将药物带给 100 多个国家/地区的患者。

Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.

益普生在巴黎（泛欧证券交易所：IPN）和美国通过一级赞助美国存托凭证计划（ADR：IPSEY）上市。欲了解更多信息，请访问ipsen.com。

Ipsen Media contacts

益普生媒体联系人

Investors

投资者

Khalid Deojee | +33 666019526 | khalid.deojee@ipsen.com

哈立德·德奥杰 | +33 666019526 | khalid.deojee@ipsen.com

Media

媒体

Sally Bain |

萨莉·贝恩 |

+1 8573200517

+1 8573200517

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sally.bain@ipsen.com

sally.bain@ipsen.com

Anne Liontas | +33 0767347296

安妮·里昂塔斯 | +33 0767347296

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anne.liontas.ext@ipsen.com

anne.liontas.ext@ipsen.com

Disclaimers and/or Forward-Looking Statements

免责声明和/或前瞻性声明

The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein.

本文件中包含的前瞻性声明、目标和指标均基于益普生的管理战略、当前观点和假设。这些声明涉及已知和未知的风险与不确定性，可能导致实际结果、业绩或事件与本文预期的情况有重大差异。

All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations.

上述所有风险均可能影响益普生未来实现其财务目标的能力，这些目标是在假设宏观经济状况合理的情况下，根据当前可获得的信息设定的。使用“相信”、“预期”和“预计”等词语及其类似表述旨在识别前瞻性陈述，包括益普生对未来事件的预期，包括监管文件提交和决定。

Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data.

此外，本文件中描述的目标是在未考虑外部增长假设和潜在未来收购的情况下制定的，这些假设和收购可能会改变这些参数。这些目标基于Ipsen认为合理的数据和假设。这些目标取决于未来可能发生的条件或事实，而不仅仅依赖于历史数据。

Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons.

鉴于某些风险和不确定性的发生，特别是处于早期开发阶段或临床试验中的有前景的药物可能最终无法上市或达到其商业目标，实际结果可能与这些目标存在显著差异，尤其是出于监管或竞争原因。

Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards t.

益普生可能面临或可能会面临来自仿制药的竞争，这可能会导致市场份额的损失。此外，研发过程涉及多个阶段，每个阶段都存在益普生可能无法实现其目标并被迫放弃相关努力的重大风险。

References

参考文献

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Wainberg

瓦因贝格

et al.

等。

NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-1281.

NALIRIFOX对比白蛋白结合型紫杉醇和吉西他滨在未经治疗的转移性胰腺导管腺癌患者中的疗效（NAPOLI 3）：一项随机、开放标签、III期试验。《柳叶刀》。2023年10月7日；402(10409):1272-1281。

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Chung

钟

et

和

al. NAPOLI 3 phase 3 study of NALIRIFOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): final overall survival (OS) analysis and characteristics of the long-term survivors. As presented at ASCO Congress 2025 Chicago, USA

那不勒斯3期研究：NALIRIFOX用于转移性胰腺导管腺癌（mPDAC）患者的第三阶段研究：最终总生存期（OS）分析及长期生存者特征。于2025年美国芝加哥ASCO大会上发表。

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American Cancer Society – Cancer Facts and Figures 2024. Available : https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf

美国癌症协会——2024年癌症事实与数据。可用链接：https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf

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https://www.cancer.net/cancer-types/pancreatic-cancer/statistics

https://www.cancer.net/cancer-types/pancreatic-cancer/statistics

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Orth, M., Metzger, P., Gerum, S.

奥尔特，M.，梅茨格，P.，格鲁姆，S.

et al.

等。

Pancreatic ductal adenocarcinoma: biological hallmarks, current status, and future perspectives of combined modality treatment approaches. Radiat Oncol 14, 141 (2019). https://doi.org/10.1186/s13014-019-1345-6

胰腺导管腺癌：生物学特征、现状及未来联合治疗模式的展望。《放射肿瘤学》2019年，第14卷，第141页。https://doi.org/10.1186/s13014-019-1345-6

Attachment

附件

Ipsen PR_ASCO NAPOLI_31052025

益普生公关_ASCO那不勒斯_2025年5月31日