New and updated data from an ongoing Phase 2 trial of zanidatamab, an investigational dual HER2-targeted bispecific antibody, in combination with chemotherapy for first-line treatment of HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA)

正在进行的扎尼达单抗（一种研究性双重HER2靶向双特异性抗体）2期临床试验的新数据和最新数据，结合化疗一线治疗HER2阳性转移性胃食管腺癌（mGEA）

DUBLIN, Sept. 9, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company, along with its partners, will present five abstracts at the European Society for Medical Oncology (ESMO) Congress 2024 from September 13-17, 2024, in Barcelona, Spain. Presentations include data from trials of zanidatamab and Zepzelca® (lurbinectedin)..

都柏林，2024年9月9日/PRNewswire/--Jazz Pharmaceuticals plc（纳斯达克：Jazz）今天宣布，该公司及其合作伙伴将于2024年9月13日至17日在西班牙巴塞罗那举行的2024年欧洲肿瘤内科学会（ESMO）大会上发表五篇摘要。演示包括来自扎尼达单抗和Zepzelca®（lurbinectedin）试验的数据。。

New and updated data with longer follow-up, including overall survival findings, will be presented from an ongoing Phase 2 trial of zanidatamab, an investigational dual HER2-targeted bispecific antibody, in combination with chemotherapy for the first-line treatment of HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA).

新的和更新的数据以及更长的随访时间，包括总体生存结果，将从正在进行的扎尼达单抗（一种研究性双重HER2靶向双特异性抗体）的2期临床试验中提供，并与化疗联合用于HER2阳性转移性胃食管腺癌（mGEA）的一线治疗。

Additional data from a Phase 2 study evaluating zanidatamab in combination with chemotherapy and bevacizumab as first-line treatment in HER2-positive metastatic colorectal cancer demonstrating encouraging antitumor activity will be presented as a mini-oral presentation at the congress..

来自第二阶段研究的其他数据评估了扎尼达单抗联合化疗和贝伐单抗作为HER2阳性转移性结直肠癌的一线治疗，显示出令人鼓舞的抗肿瘤活性，将在大会上作为小型口服介绍。。

'We look forward to presenting new and more mature data from our oncology solid tumor clinical development program at this year's ESMO congress, in particular for zanidatamab in HER2-positive metastatic gastroesophageal adenocarcinoma,' said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals.

。

'We look forward to continuing to advance our clinical development program for zanidatamab in GEA, including the Phase 3 clinical trial expected to read out in the second quarter of 2025 that could support global regulatory submissions.'.

“我们期待着继续推进GEA中扎尼达单抗的临床开发计划，包括预计将于2025年第二季度公布的3期临床试验，该试验可能支持全球监管提交。”。

Data on Zepzelca will also be presented at the congress, including findings from a Phase 2 trial evaluating the safety and efficacy of lurbinectedin and irinotecan in relapsed small cell lung cancer (SCLC) patients, including those with CTFI (Chemotherapy-Free Interval) 30-90 days, who typically have a poor prognosis.

Zepzelca的数据也将在大会上介绍，包括评估lurbinectedin和伊立替康在复发性小细胞肺癌（SCLC）患者中的安全性和有效性的2期试验结果，包括CTFI（无化疗间隔）30-90天的患者，他们通常预后不良。

These findings support the rationale for this combination in the ongoing LAGOON confirmatory trial..

这些发现支持了正在进行的泻湖验证性试验中这种组合的基本原理。。

The full ESMO abstracts for posters are available at:https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal_2/presentation

海报的完整ESMO摘要可在以下网址获得：https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal_2/presentation

The full ESMO abstracts for presentations are available at: ESMO Congress 2024 - Conference Calendar - ESMO Congress 2024 (ctimeetingtech.com)

完整的ESMO演讲摘要可在以下网站获得：2024年ESMO大会-会议日历-2024年ESMO大会（ctimeetingtech.com）

The full list of Jazz or partner-supported presentations at the 2024 ESMO Congress includes:

2024年ESMO大会上Jazz或合作伙伴支持的演讲的完整列表包括：

Zanidatamab Presentations

Zanidatamab介绍

Topic

主题

Author

作者

Presentation Details

演示文稿详细信息

Zanidatamab + Chemotherapy for First-Line (1L) Treatment of HER2+Advanced or Metastatic Gastro-oesophageal Adenocarcinoma(mGEA): New and Updated Data Froma Phase 2 Trial

扎尼达单抗+化疗一线（1L）治疗HER2+晚期或转移性胃食管腺癌（mGEA）：来自2期试验的新数据和更新数据

Elena Elimova,et al.

Elena Elimova等人。

Type: Poster

类型：海报

Date: Monday, September 16

日期：9月16日星期一

Presentation Number: 1432P

演示编号：1432P

Zanidatamab (Zani) + Chemotherapy(CT) in First-Line (1L) HumanEpidermal Growth Factor Receptor 2-Positive (HER2+) Advanced/MetastaticColorectal Cancer (mCRC)

Zanidatamab（Zani）+化疗（CT）治疗一线（1L）人类表皮生长因子受体2阳性（HER2+）晚期/转移性结直肠癌（mCRC）

Sun Young Rha,et al.

Sun Young Rha等人。

Type: Mini Oral session

类型：小型口头会议

Date: Saturday, September 14,2:50-2:55 p.m. CEST

日期：9月14日星期六下午2:50-2:55

Presentation Number: #516MO

演示文稿编号：#516MO

HERIZON-BTC-02: A Phase 3 Study ofZanidatamab With Standard-of-Care(SOC) Therapy vs SOC Alone ForFirst-Line (1L) Treatment of HumanEpidermal Growth Factor Receptor 2(HER2)-Positive Advanced/MetastaticBiliary Tract Cancer (BTC)

HERIZON-BTC-02:zanidatamab与标准治疗（SOC）治疗与单独SOC治疗人类表皮生长因子受体2（HER2）阳性晚期/转移性胆道癌（BTC）一线（1L）治疗的3期研究

TescaMacarulla, et al.

TescaMacarulla等人。

Type: Poster

类型：海报

Date: Monday, September 16

日期：9月16日星期一

Presentation Number: 62TiP

演示编号：62TiP

Zepzelca Presentations

Topic

主题

Author

作者

Presentation Details

演示文稿详细信息

Phase 2 data of lurbinectedin andirinotecan in relapsed SCLC: efficacyand safety results in patients withCTFI>30 days [PharmaMar]

lurbinectedin andirinotecan治疗复发性小细胞肺癌的2期数据：CTFI>30天患者的疗效和安全性结果[PharmaMar]

JonZugazagoitia, etal.

JonZugasagoitis等。

Type: Poster

类型：海报

Date: Saturday, September 14

日期：9月14日星期六

Presentation Number: 1790P

演示文稿编号：1790P

LINNOVATE: A phase 1/2 study ofsafety/efficacy of lurbinectedincombined with ipilimumab andnivolumab for advanced soft tissuesarcoma [IST]

Erlinda Gordonet al.

Erlinda Gordonet Al。

Type: Poster

类型：海报

Date: Saturday, September 14

日期：9月14日星期六

Presentation Number: 1739P

演示编号：1739P

About Zanidatamab Zanidatamab is an investigational dual HER2-targeted bispecific antibody that simultaneously binds to two distinct sites on HER2, known as biparatopic binding. This unique design and enhanced binding results in multiple mechanisms of action, including HER2 and HER3 signal inhibition, removal of HER2 protein from the cell surface and enhanced immune effector functions, such as complement-dependent cytotoxicity (CDC), which leads to encouraging antitumor activity. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2.

关于Zanidatamab Zanidatamab是一种研究性双重HER2靶向双特异性抗体，可同时结合HER2上的两个不同位点，称为双特异性结合。这种独特的设计和增强的结合导致多种作用机制，包括HER2和HER3信号抑制，从细胞表面去除HER2蛋白和增强的免疫效应功能，例如补体依赖性细胞毒性（CDC），这导致鼓励抗肿瘤活性。Zanidatamab正在多项临床试验中开发，作为表达HER2的实体瘤患者的靶向治疗选择。

Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule..

。。

The U.S. Food and Drug Administration (FDA) has granted priority review for the Biologics License Application (BLA) for zanidatamab for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC) with a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2024.

美国食品和药物管理局（FDA）已批准优先审查扎尼达单抗的生物制剂许可证申请（BLA），用于治疗先前治疗的，不可切除的，局部晚期或转移性HER2阳性胆道癌（BTC），处方药使用费法案（PDUFA）的目标行动日期为2024年11月29日。

The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA).

FDA批准了先前治疗过HER2基因扩增BTC患者的扎尼达单抗开发突破性治疗方案，以及扎尼达单抗的两种快速治疗方案：一种作为难治性BTC的单一药物，另一种与1L胃食管腺癌（GEA）的标准治疗化疗联合使用。

Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China..

此外，zanidatamab已获得FDA关于治疗BTC和GEA的孤儿药指定，以及欧洲药品管理局关于治疗BTC和胃癌的孤儿药指定。扎尼达单抗还被中国药物评估中心（CDE）授予突破性治疗称号。。

About Zepzelca® (lurbinectedin)Zepzelca is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.1.

关于Zepzelca®（lurbinectedin），Zepzelca是一种烷基化药物，可结合DNA中的鸟嘌呤残基。这引发了一系列事件，这些事件可能会影响DNA结合蛋白的活性，包括转录因子和DNA修复途径，从而导致细胞周期的破坏和最终的细胞死亡。

The FDA approved Zepzelca under accelerated approval in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. The approval is based on overall response rate (ORR) and duration of response demonstrated in an open-label, monotherapy clinical study.

FDA于2020年6月加速批准Zepzelca用于治疗铂类化疗期间或之后疾病进展的成年转移性小细胞肺癌患者。该批准基于开放标签的单一疗法临床研究中显示的总体缓解率（ORR）和缓解持续时间。

In December 2021, Jazz and PharmaMar announced the initiation of LAGOON, a confirmatory Phase 3 clinical trial of Zepzelca for the treatment of patients with relapsed small cell lung cancer. If positive, LAGOON could confirm the benefit of Zepzelca in the treatment of small cell lung cancer (SCLC) when patients progress following 1L treatment with a platinum-based regimen and support full approval in the U.S..

2021年12月，Jazz和PharmaMar宣布启动LAGOON，这是Zepzelca治疗复发性小细胞肺癌患者的一项确认性3期临床试验。如果呈阳性，LAGOON可以证实Zepzelca在治疗小细胞肺癌（SCLC）方面的益处，当患者在使用铂类方案进行1L治疗后取得进展，并支持美国的全面批准。。

Zepzelca is a prescription medicine used to treat adults with SCLC that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. Zepzelca is approved based on response rate and how long the response lasted.

Zepzelca是一种处方药，用于治疗已扩散到身体其他部位（转移性）且接受含铂化疗治疗的成人小细胞肺癌，该药无效或不再有效。Zepzelca是根据回复率和回复持续时间批准的。

Additional studies will further evaluate the benefit of Zepzelca for this use..

其他研究将进一步评估Zepzelca在这方面的益处。。

Important Safety Information for ZEPZELCA

ZEPZELCA的重要安全信息

Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you:

在收到ZEPZELCA之前，请告知您的医疗保健提供者您的所有医疗状况，包括您是否：

have liver or kidney problems.

有肝脏或肾脏问题。

are pregnant or plan to become pregnant. ZEPZELCA can harm your unborn baby.

怀孕或计划怀孕。ZEPZELCA会伤害未出生的婴儿。

Females who are able to become pregnant:

能够怀孕的女性：

Your healthcare provider should do a pregnancy test before you start treatment with ZEPZELCA.

您的医疗保健提供者应该在您开始使用ZEPZELCA治疗之前进行妊娠测试。

You should use effective birth control (contraception) during treatment with and for 6 months after your last dose of ZEPZELCA.

在最后一剂ZEPZELCA治疗期间和治疗6个月后，您应该使用有效的节育（避孕）。

Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZEPZELCA.

如果您在服用ZEPZELCA期间怀孕或认为自己怀孕了，请立即告诉您的医疗保健提供者。

Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after their last dose of ZEPZELCA.

有能够怀孕的女性伴侣的男性应在最后一剂ZEPZELCA治疗期间和治疗后4个月内使用有效的节育措施。

are breastfeeding or plan to breastfeed. It is not known if ZEPZELCA passes into your breastmilk. Do not breastfeed during treatment with ZEPZELCA and for 2 weeks after your last dose of ZEPZELCA. Talk to your healthcare provider about the best way to feed your baby during treatment with ZEPZELCA.

正在母乳喂养或计划母乳喂养。不知道ZEPZELCA是否会进入你的母乳。在服用ZEPZELCA期间以及服用最后一剂ZEPZELCA后的2周内，不要母乳喂养。与您的医疗保健提供者讨论在ZEPZELCA治疗期间喂养宝宝的最佳方式。

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works.

告诉你的医疗保健提供者你服用的所有药物，包括处方药和非处方药、维生素和草药补充剂。某些其他药物可能会影响ZEPZELCA的工作方式。

What should I avoid while using ZEPZELCA? Avoid eating or drinking grapefruit, Seville oranges, or products that contain grapefruit juice and Seville oranges during treatment with ZEPZELCA. ZEPZELCA can cause serious side effects, including:

使用ZEPZELCA时应该避免什么？在用ZEPZELCA治疗期间，避免食用或饮用葡萄柚、塞维利亚橙子或含有葡萄柚汁和塞维利亚橙子的产品。ZEPZELCA会引起严重的副作用，包括：

Low blood cell counts. Low blood counts including low neutrophil counts (neutropenia) and low platelet counts (thrombocytopenia) are common with ZEPZELCA, and can also be severe. Some people with low white blood cell counts may get fever, or an infection throughout the body (sepsis), that can cause death.

血细胞计数低。ZEPZELCA常见低血细胞计数，包括低中性粒细胞计数（中性粒细胞减少症）和低血小板计数（血小板减少症），也可能很严重。一些白细胞计数低的人可能会发烧，或全身感染（败血症），可能导致死亡。

Your healthcare provider should do blood tests before you receive each treatment with ZEPZELCA to check your blood cell counts. .

您的医疗保健提供者应该在您接受ZEPZELCA治疗之前进行血液检查，以检查您的血细胞计数。。

Tell your healthcare provider right away if you develop:

如果您发现以下情况，请立即告知您的医疗保健提供者：

fever or any other signs of infection

发烧或任何其他感染迹象

unusual bruising or bleeding

异常瘀伤或出血

tiredness

疲倦

pale colored skin

浅色皮肤

Liver problems. Increased liver function tests are common with ZEPZELCA and can also be severe. Your healthcare provider should do blood tests to check your liver function before you start and during treatment with ZEPZELCA.

肝脏问题。‡ZEPZELCA的肝功能检查增加很常见，也可能很严重。您的医疗保健提供者应该在您开始使用ZEPZELCA之前和使用ZEPZELCA治疗期间进行血液检查以检查您的肝功能。

Tell your healthcare provider right away if you develop symptoms of liver problems including:

如果您出现肝病症状，请立即告知您的医疗保健提供者，包括：

loss of appetite

食欲不振

nausea or vomiting

恶心或呕吐

pain on the right side of your stomach area (abdomen)

腹部右侧疼痛

Leakage of ZEPZELCA out of your vein during the infusion. If ZEPZELCA leaks into the tissues around your infusion site, it can cause damage and death of tissue cells around the infusion site. You may need to have surgery to remove any dead tissue. Tell your healthcare provider right away if you see any ZEPZELCA leaking out of your vein or around the catheter during your infusion, or if you notice any redness, swelling, itching or discomfort at the infusion site at any time..

输注过程中ZEPZELCA从静脉渗漏。‡如果ZEPZELCA渗入输注部位周围的组织，可能会导致输注部位周围组织细胞的损伤和死亡。您可能需要进行手术以去除任何死亡组织。如果您在输液过程中发现ZEPZELCA从静脉或导管周围泄漏，或者您在任何时候都注意到输液部位有任何发红、肿胀、瘙痒或不适，请立即告诉您的医疗保健提供者。。

Severe muscle problems (rhabdomyolysis). Tell your healthcare provider if you have severe muscle pain or weakness.

严重的肌肉问题（横纹肌溶解）。‡如果你有严重的肌肉疼痛或无力，请告诉你的医疗保健提供者。

Your healthcare provider may temporarily stop treatment, lower your dose, or permanently stop ZEPZELCA if you develop serious side effects during treatment with ZEPZELCA.

如果您在使用ZEPZELCA治疗期间出现严重副作用，您的医疗保健提供者可能会暂时停止治疗，降低剂量或永久停止ZEPZELCA。

The most common side effects of ZEPZELCA include:

ZEPZELCA最常见的副作用包括：

tiredness

疲倦

low white and red blood cell counts

白细胞和红细胞计数低

increased kidney function blood test (creatinine)

肾功能增强血液检查（肌酐）

increased liver function blood tests

肝功能血液检查增加

increased blood sugar (glucose)

血糖（葡萄糖）升高

nausea

恶心

decreased appetite

食欲下降

muscle and joint (musculoskeletal) pain

肌肉和关节（肌肉骨骼）疼痛

low level of albumin in the blood

血液中白蛋白水平低

constipation

trouble breathing

呼吸困难

low levels of sodium and magnesium in the blood

血液中钠和镁含量低

vomiting

呕吐

cough

咳嗽

diarrhea

腹泻

These are not all of the possible side effects of ZEPZELCA.

这些并不是ZEPZELCA所有可能的副作用。

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.

打电话给你的医生，询问有关副作用的医疗建议。鼓励您向FDA报告处方药的负面副作用。访问‡www.fda.gov/medwatch‡或致电‡1-800-fda-1088。您也可以通过‡1-800-520-5568向Jazz Pharmaceuticals报告副作用。

Please see full Prescribing Information including Patient Information, and discuss with your doctor.

请参阅完整的‡处方信息‡包括‡患者信息，并与您的医生讨论。

ZEPZELCA is a trademark of Pharma Mar, S.A. used by Jazz Pharmaceuticals under license.

ZEPZELCA是 Pharma Mar，S.a. 的商标，由 Jazz Pharmaceuticals 许可使用。

About Jazz PharmaceuticalsJazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases—often with limited or no therapeutic options.

关于Jazz PharmaceuticalsJazz Pharmaceuticals plc（纳斯达克：Jazz）是一家全球生物制药公司，其宗旨是创新，改变患者及其家人的生活。我们致力于为患有严重疾病的人开发改变生命的药物，这些患者通常只有有限的或没有治疗选择。

We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.

我们有多种上市药物，包括治疗睡眠障碍和癫痫的领先疗法，以及不断增长的癌症治疗组合。我们以患者为中心，以科学为驱动的方法，在我们强大的肿瘤学和神经科学创新疗法管道中推动了开创性的研究和开发进展。

Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information..

Jazz总部位于爱尔兰都柏林，在多个国家拥有研发实验室、制造设施和员工，致力于为全球患者提供服务。有关更多信息，请访问www.jazzpharmaticals.com。。

Contacts:

联系人：

Jazz Media Contact:Kristin BhavnaniHead of Global Corporate CommunicationsJazz Pharmaceuticals plcCorporateAffairsMediaInfo@jazzpharma.comIreland +353 1 637 2141U.S. +1 215 867 4948

Jazz媒体联系人：Kristin Bhavnani Jazz Pharmaceuticals全球企业传播负责人plcCorporateAffairsMediaInfo@jazzpharma.comIreland+353 1 637 2141U。S、 +1 215 867 4948

Jazz Investor Contact:Andrea N. Flynn, Ph.D.Vice President, Head, Investor RelationsJazz Pharmaceuticals plcinvestorinfo@jazzpharma.comIreland +353 1 634 3211U.S. +1 650 496 2717

Jazz投资者联系人：Andrea N.Flynn博士，副总裁，投资者关系主管Azz Pharmaceuticalsplcinvestorinfo@jazzpharma.comIreland+353 1 634 3211单位。S、 +16504962717

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SOURCE Jazz Pharmaceuticals plc

来源：Jazz Pharmaceuticals plc