Jazz制药公司将在2026年ASCO会议上展示Ziihera®（扎尼达单抗-hrii）在胃食管腺癌和Zepzelca®（卢比奈丁）方面的进展数据-动脉网

Jazz Pharmaceuticals to Present Data at ASCO 2026 Highlighting Advancements for Ziihera® (zanidatamab-hrii) in Gastroesophageal Adenocarcinoma and Zepzelca® (lurbinectedin)

CISION 等信源发布 2026-04-22 04:05

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可切换为仅中文

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Rapid oral presentation of PD-L1 subgroup data from HERIZON-GEA-01 evaluating zanidatamab combinations, and additional analyses of tolerability, biomarker response and real-world treatment patterns in HER2+ GEA

快速口头报告来自HERIZON-GEA-01的PD-L1亚组数据，评估zanidatamab联合疗法，以及对HER2+ GEA中耐受性、生物标志物反应和真实世界治疗模式的更多分析。

For U.S. media and investors only

仅限美国媒体和投资者

DUBLIN

都柏林

，

April 21, 2026

2026年4月21日

/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq:

/PRNewswire/ -- Jazz Pharmaceuticals plc（纳斯达克：

JAZZ

爵士乐

) today announced that the Company and its partners will present three rapid oral and seven poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 29-June 2, 2026, in Chicago. The data reflect Jazz's continued momentum in oncology and the Company's focus on advancing treatment approaches in difficult-to-treat cancers through late-stage clinical research, real-world evidence and ongoing pipeline innovation..

）今天宣布，该公司及其合作伙伴将在美国临床肿瘤学会（ASCO）年会上进行三次快速口头报告和七次海报展示，会议将于2026年5月29日至6月2日在芝加哥举行。这些数据反映了Jazz在肿瘤学领域的持续进展，以及公司通过晚期临床研究、真实世界证据和持续的管线创新，专注于推进难治性癌症的治疗方法。

Key ASCO 2026 presentations include:

ASCO 2026 的重点报告包括：

Data from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera

评估Ziihera的3期HERIZON-GEA-01试验数据

(zanidatamab-hrii) in combination with chemotherapy with or without the PD-1 inhibitor Tevimbra

(zanidatamab-hrii) 联合化疗，伴或不伴 PD-1 抑制剂 Tevimbra

(tislelizumab) in previously untreated HER2-positive (HER2+) gastroesophageal adenocarcinoma (GEA), including a rapid oral presentation of analyses of progression-free survival (PFS) and overall survival (OS) across PD-L1 subgroups, as well as analyses of the characterization and management of gastrointestinal adverse events..

（替雷利珠单抗）用于既往未经治疗的HER2阳性（HER2+）胃食管腺癌（GEA），包括快速口头报告PD-L1亚组中无进展生存期（PFS）和总生存期（OS）的分析，以及胃肠道不良事件的特征和管理分析。

Analyses from the Phase 3 IMforte trial evaluating Zepzelca

评估Zepzelca的3期IMforte试验分析

(lurbinectedin) plus atezolizumab (Tecentriq

(lurbinectedin)联合阿特珠单抗(Tecentriq)

) as first-line maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC), including quality-adjusted time without symptoms or toxicity, as well as a rapid oral presentation on outcomes across SCLC molecular subtypes.

）作为广泛期小细胞肺癌（ES-SCLC）的一线维持治疗，包括无症状或毒性调整后的质量时间，以及关于SCLC分子亚型结果的快速口头报告。

'Building on the strength of the HERIZON-GEA-01 trial results, additional analyses being presented at ASCO will provide further details on the impact of zanidatamab in HER2+ GEA, including across PD-L1 subgroups. These data will continue to inform treatment decision-making and enable the successful treatment integration of zanidatamab in clinical practice,' 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.

“基于HERIZON-GEA-01试验结果的优势，将在ASCO上展示的更多分析将进一步提供zanidatamab在HER2+ GEA中的影响细节，包括在PD-L1亚组中的表现。这些数据将继续为治疗决策提供信息，并促进zanidatamab在临床实践中的成功整合。” Jazz Pharmaceuticals执行副总裁、全球研发主管及首席医学官Rob Iannone博士表示。

'Together with additional analyses of .

“结合对...的进一步分析。

Zepzelca

泽普泽卡

from the Phase 3 IMforte study in first-line maintenance extensive-stage small cell lung cancer and progress in our pipeline, these data reflect our growing and increasingly differentiated oncology portfolio, as well as our commitment to advancing innovative approaches for patients facing some of the most difficult-to-treat cancers.'.

来自III期IMforte研究，该研究针对一线维持治疗广泛期小细胞肺癌，以及我们管线的进展，这些数据反映了我们不断增长且日益差异化的肿瘤学产品组合，以及我们致力于为那些面临最难治疗癌症的患者推进创新方法的承诺。

The ASCO abstracts are available at:

ASCO摘要可在此处获取：

https://meetings.asco.org/meetings/2026-asco-annual-meeting/335/program-guide/scheduled-sessions

The full list of Jazz- and partner-supported presentations at the 2026 ASCO Annual Meeting are:

2026年ASCO年会上由Jazz及合作伙伴支持的演示完整列表如下：

Zanidatamab Presentations:

Zanidatamab 演示文稿：

Presentation Title

演示标题

Authors

作者

Presentation Details

演示详情

Molecular circulating

分子循环

tumor DNA (ctDNA)

肿瘤DNA (ctDNA)

profiling from patients

患者画像

(pts) treated with

（分）处理方式为

zanidatamab +

扎尼达单抗 +

chemotherapy (CT) in

化疗 (CT) 在

first-line (1L) HER2-

首行 (1L) HER2-

positive (HER2+)

阳性（HER2+）

advanced or

高级或者

metastatic

转移性的

gastroesophageal

胃食管的

adenocarcinoma (mGEA)

腺癌 (mGEA)

Elimova E, Ku GY, Lee KW, Rha SY,

埃利莫娃 E，顾 GY，李 KW，拉 SY，

Wienke S, Yalamanchili G, Garfin PM,

温克·S，亚拉曼奇利·G，加芬·PM，

Loro E, Shpektor D, Ajani JA

洛罗·E，什佩克托尔·D，阿贾尼·JA

你

pe:

Poster

海报

Session:

会话：

Poster Session –

海报会议 -

Gastrointestinal Cancer-

胃肠道癌症-

Gastroesophageal, Pancreatic,

胃肠、胰腺、

and Hepatobiliary

肝胆

Date/Time:

日期/时间：

May 30, 2026,

2026年5月30日，

9 a.m.-Noon CDT

上午9点至中午（中部夏令时间）

Abstract number:

抽象编号：

4050

Real-world treatment

现实世界的治疗

patterns and overall

模式和总体

survival (OS) in

生存期（OS）在

patients (pts) with

患者（pts）伴有

HER2-positive

HER2阳性

(HER2+) advanced or

(HER2+)晚期或

metastatic

转移性

gastroesophageal

胃食管的

adenocarcinomas

腺癌

(mGEA) in the US

美国的（mGEA）

Dayyani F, Fan X, Zape J, Murphy R,

达亚尼 F，范 X，扎佩 J，墨菲 R，

Betts KA, Wang Y, Wang S, Chao A, Su

贝茨 KA，王 Y，王 S，晁 A，苏

W, Fuller DS, Sabater J, Gibson MK,

W，富勒 DS，萨巴特 J，吉布森 MK，

Enzinger PC

恩齐格PC

你

pe:

Poster

海报

Session:

会话：

Poster Session –

海报会议 -

Gastrointestinal Cancer-

胃肠道癌症-

Gastroesophageal, Pancreatic,

胃肠、胰腺、

and Hepatobiliary

肝胆

Date/Time:

日期/时间：

May 30, 2026, 9

2026年5月30日，9

a.m.-Noon CDT

上午-中午中部夏令时间

Abstract number:

抽象编号：

4053

Characterization and

表征与

management of

管理

gastrointestinal (GI)

胃肠道 (GI)

adverse events (AEs)

不良事件 (AEs)

with zanidatamab +

与zanidatamab +

chemotherapy (CT) ±

化疗 (CT) ±

tislelizumab in first-line

一线治疗中的替雷利珠单抗

(1L) HER2-positive

(1L) HER2阳性

(HER2+) locally

（HER2+）局部

advanced or

高级或

metastatic

转移性

gastroesophageal

胃食管的

adenocarcinoma

腺癌

(mGEA): Analysis

(mGEA): 分析

from HERIZON-GEA-

来自赫里zon-GEA-

Elimova E, Rha SY, Shitara K, Liu T,

埃利莫娃 E，罗莎 SY，下寺 K，刘 T，

Tabernero J, Lee KW, Schenker M,

塔贝内罗 J，李 KW，申克 M，

Tebbutt NC, Ajani JA, Salimin N, Ku GY,

特布特 NC，阿贾尼 JA，萨利明 N，库 GY，

Kim JG, Diaz IA, Zhang J, Pietrantonio F,

金JG，迪亚兹IA，张J，皮特兰通尼奥F，

Bai LY, Le Sourd SL, Chen Y, Grim JE,

白丽云，勒索尔德，陈宇，格里姆·杰克逊，

Shen L

沈 L

你

pe:

Poster

海报

Session:

会话：

Poster Session –

海报会议 -

Gastrointestinal Cancer-

胃肠道癌症-

Gastroesophageal, Pancreatic,

胃食管、胰腺、

and Hepatobiliary

肝胆

Date/Time:

日期/时间：

May 30, 2026, 9

2026年5月30日，9

a.m.-Noon CDT

上午-中午中部夏令时间

Abstract number:

抽象编号：

4042

Combining

结合

zanidatamab,

扎尼达单抗，

FOLFOX, and

FOLFOX，以及

pembrolizumab as

pembrolizumab作为

first-line therapy for

一线治疗

HER2/PD-L1-positive

HER2/PD-L1阳性

gastroesophageal

胃食管的

adenocarcinoma –

腺癌 –

The phase ll IKF-

第二阶段 IKF-

090/AIO ZANGEA trial

090/AIO ZANGEA 试验

with translational

带有平移的

analysis

分析

Tintelnot J, Goekkurt E, Al-Batran SE,

Tintelnot J，Goekkurt E，Al-Batran SE，

Arnold D, Dechow TN, Ettrich TJ, Goetze

阿诺德·D、德肖·T·N、埃特里希·T·J、戈策

TO, Heinrich K, Kurreck A, Lorenzen S,

致，海因里希·K，库雷克·A，洛伦岑·S，

Moehler MH, Rempel V, Schlenska-Lange

莫勒 MH，伦佩尔 V，施伦斯卡-朗格

A, Stein A

A，斯坦A

你

pe:

Poster

海报

Session:

会话：

Poster Session –

海报会议 -

Gastrointestinal Cancer-

胃肠道癌症-

Gastroesophageal, Pancreatic,

胃食管、胰腺、

and Hepatobiliary

肝胆

Date/Time:

日期/时间：

May 30, 2026, 9

2026年5月30日，9

a.m.-Noon CDT

上午-中午中部夏令时间

Abstract number:

抽象编号：

TPS4244

Zanidatamab +

扎尼达单抗 +

chemotherapy (CT) ±

化疗 (CT) ±

tislelizumab for first-

替雷利珠单抗用于一线治疗

line (1L) HER2-

行（1L）HER2-

positive (HER2+)

阳性（HER2+）

locally advanced or

局部晚期或

metastatic

转移性

gastroesophageal

胃食管的

adenocarcinoma

腺癌

(mGEA): PD-L1

subgroup analysis

亚组分析

from HERIZON-GEA

来自赫里zon-GEA

-01

Rha SY, Shitara K, Shen L, Tabernero J,

Rha SY，Shitara K，Shen L，Tabernero J，

Liu T, Lee KW, Schenker M, Tebbutt NC,

刘 T，李 KW，申克 M，特伯特 NC，

Ajani JA, Salimin N, Ku GY, Kim JG, Diaz

阿贾尼 JA，萨利明 N，顾 GY，金 JG，迪亚兹

IA, Zhang J, Pietrantonio F, Bai LY, Sourd

IA，张J，皮特兰通尼奥F，白LY，索德

SL, Chen Y, Grim JE, Elimova E

SL，陈 Y，格里姆 JE，埃利莫娃 E

你

pe:

Rapid Oral

快速口腔

Session:

会话：

Rapid Oral Abstract

快速口头摘要

Session – Gastrointestinal

会议 – 胃肠

Cancer-Gastroesophageal,

癌症-胃食管，

Pancreatic, and Hepatobiliary

胰腺、肝胆

Date/Time:

日期/时间：

June 1, 2026, 1:15-2:45 p.m. CDT

2026年6月1日，下午1:15-2:45（中部夏令时间）

Abstract number:

抽象编号：

4010

Lurbinectedin Presentations:

卢比内克丁展示：

Presentation Title

演示标题

Authors

作者

Presentation Details

演示详情

Real-world (RW)

现实世界 (RW)

effectiveness and

有效性和

safety of lurbinectedin

lurbinectedin的安全性

(lurbi) for previously

（lurbi）用于之前

treated extensive-

处理广泛-

stage small cell lung

分期小细胞肺癌

cancer (ES-SCLC):

癌症（ES-SCLC）：

Final primary and

最终的初步和

subgroup analysis

亚组分析

results of Jazz

爵士乐的结果

EMERGE 402

显现 402

Badin FB, Lammers PE, Liu G,

Badin FB，Lammers PE，Liu G，

Shunyakov L, Kassam SN, Patel MP, Ji Y,

顺亚科夫 L，卡萨姆 SN，帕特尔 MP，纪 Y，

Labbé C, Rabara V, Hashmi MH, Dakhil

拉贝 C，拉巴拉 V，哈希米 MH，达赫勒

SR, Weiss M, Gowan AC, Bouchard N,

SR，Weiss M，Gowan AC，Bouchard N，

Rengarajan B, Fuller DS, Naveh N,

雷恩加拉扬 B，富勒 DS，纳维 N，

Halmos B

哈尔莫斯 B

你

pe:

Poster

海报

Session:

会话：

Poster Session –

海报会议 -

Lung Cancer-Non-Small Cell

肺癌-非小细胞型

Local-Regional/Small Cell/Other

本地区域/小型蜂窝/其他

Thoracic Cancers

胸腔癌症

Date/Time:

日期/时间：

May 31, 2026, 9

2026年5月31日，9

a.m.-Noon CDT

上午-中午中部夏令时

Abstract number:

抽象编号：

8079

Comparison of real-

对比真实

world overall survival

世界总体生存率

between

之间

atezolizumab- and

阿特珠单抗和

durvalumab-containing

含德瓦鲁单抗的

first-line induction and

一线诱导和

maintenance regimens

维护方案

in extensive stage

广泛期

small cell lung cancer

小细胞肺癌

Ganti AK, Snider J, Yan J, Rinaldi C,

更换AK，斯奈德J，严J，里纳尔迪C，

Nguyen A, Rengarajan B, Profant DA,

阮A，兰加拉扬B，普罗方特DA，

Fuller DS, Hu E, Le TK, Naveh N, Fan X

富勒 DS，胡 E，乐 TK，纳维 N，范 X

你

pe:

Poster

海报

Session:

会话：

Poster Session –

海报会议 -

Lung Cancer-Non-Small Cell

肺癌-非小细胞型

Local-Regional/Small Cell/Other

本地-区域/小蜂窝/其他

Thoracic Cancers

胸腔癌症

Date/Time:

日期/时间：

May 31, 2026, 9

2026年5月31日，9

a.m.-Noon CDT

上午-中午中部夏令时间

Abstract number:

抽象编号：

8093

IMforte: Quality

IMforte：质量

-adjusted time without

-调整后的时间，没有

symptoms or toxicity

症状或毒性

(Q-TWiST) analysis of

(Q-TWiST) 分析

first-line maintenance

一线维护

(1Lm) treatment (Tx)

(1Lm) 治疗 (Tx)

with lurbinectedin

使用 lurbinectedin

(lurbi) + atezolizumab

(lurbi) + 阿特珠单抗

(atezo) vs atezo in

(atezo) 与 atezo 在

extensive-stage small

广泛期小细胞肺癌

cell lung cancer (ES-

细胞肺癌 (ES-

SCLC)

小细胞肺癌）

Borghaei H, Paz-Ares LG, Reck M, Herbst

博尔加埃 H，帕兹-阿雷斯 LG，雷克 M，赫尔斯特

RS, Peters S, Bhatt K, Wang X, Gable J,

RS、Peters S、Bhatt K、Wang X、Gable J，

Connor-Ahmad S, Mamolo C, Lin YC, Liu

康纳-艾哈迈德 S，马莫洛 C，林 YC，刘

瑞典语

你

pe:

Poster

海报

Session:

会话：

Poster Session –

海报会议 -

Lung Cancer-Non-Small Cell

肺癌-非小细胞型

Local-Regional/Small Cell/Other

本地-区域/小细胞/其他

Thoracic Cancers

胸腔癌症

Date/Time:

日期/时间：

May 31, 2026, 9

2026年5月31日，9

a.m.-Noon CDT

上午-中午中部夏令时

Abstract number:

抽象编号：

8086

Transcriptomic

转录组的

analyses of molecular

分子分析

subsets and

子集和

correlations with

与...的相关性

clinical outcomes from

临床结果来自

the Phase 3 IMforte

第三阶段 IMforte

study of lurbinectedin

鲁比奈汀的研究

(lurbi) + atezolizumab

(lurbi) + 阿特珠单抗

(atezo) maintenance

(atezo) 维护

treatment (Tx) in

治疗（Tx）在

extensive-stage small-

广泛期小细胞-

cell lung cancer (ES-

细胞肺癌（ES-

SCLC)

小细胞肺癌）

Paz-Ares L, Borghaei H, Reck M, Peters

帕兹-阿雷斯 L，博尔盖 H，雷克 M，彼得斯

S, Herbst RS, Kazarnowicz A, Szczesna

S，赫布斯特RS，卡扎诺维茨A，什切斯纳

A, Cubukcu E, Kilickap S, Ahn JS,

A，Cubukcu E，Kilickap S，Ahn JS，

Califano R, Wei YF, Srivastava MK, Nabet

卡利法诺·R，魏·YF，斯里瓦斯塔瓦·MK，纳贝特

BY, Graupner V, Lin YC, Cai G, Brock G,

由Graupner V、Lin YC、Cai G、Brock G提供支持，

Bhatt K, Liu SV

巴特 K，刘 SV

你

pe:

Rapid Oral

快速口腔

Session:

会话：

Rapid Oral Abstract

快速口头摘要

Session – Lung Cancer-Non-

会议 – 肺癌-非

Small Cell Local-Regional/Small

小型细胞局部-区域/小型

Cell/Other Thoracic Cancers

细胞/其他胸部癌症

Date/Time:

日期/时间：

May 31, 2026, 4:30-

2026年5月31日，4:30-

6 p.m. CDT

下午6点（中部夏令时）

Abstract number:

抽象编号：

8014

Safety and

安全和

pharmacokinetics (PK)

药代动力学 (PK)

of lurbinectedin (lurbi)

鲁比奈克丁（lurbi）

in pediatric patients

在儿科患者中

(pts) with

（分）与

relapsed/refractory

复发/难治性

(R/R) solid tumors and

复发/难治性实体瘤和

preliminary antitumor

初步的抗肿瘤

activity in pediatric and

儿科领域的活动和

young adult pts with

年轻成年患者

R/R Ewing sarcoma

复发/难治性尤文肉瘤

(EwS): Results from a

(EwS): 结果来自一个

phase 1 study

第一阶段研究

Glade Bender JL, Pressey JG, Wagner

格莱德·本德JL，普雷斯科特JG，瓦格纳

LM, Kim AR, Shah AT, Federico SM,

LM，Kim AR，Shah AT，Federico SM，

Morgenstern DA, Hoogstra DJ, Crane J,

Morgenstern DA、Hoogstra DJ、Crane J，

Bhatt K, Prakash R, Faderl S, Parikh P,

巴特 K，普拉卡什 R，法德尔 S，帕里克 P，

Daniels M, Shi S, Wang X, Cai G, Miao X,

丹尼尔斯 M，史 S，王 X，蔡 G，苗 X，

Ma J, Laetsch TW

马杰，拉埃奇 TW

你

pe:

Rapid Oral

快速口服

Session:

会话：

Rapid Oral Abstract

快速口头摘要

Session – Sarcoma

会议 – 肉瘤

Date/Time:

日期/时间：

May 31, 2026, 4:30-

2026年5月31日，4:30-

6 p.m. CDT

下午6点（中部夏令时）

Abstract number:

抽象编号：

11518

About Ziihera

关于Ziihera

(zanidatamab-hrii)

（扎尼达单抗-hrii）

Ziihera

梓赫拉

(zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP).

(zanidatamab-hrii) 是一种双特异性 HER2 导向抗体，能够结合 HER2 的两个胞外位点。Zanidatamab-hrii 与 HER2 的结合会导致内化，从而减少肿瘤细胞表面受体的 HER2 表达。Zanidatamab-hrii 能够诱导补体依赖性细胞毒性 (CDC)、抗体依赖性细胞毒性 (ADCC) 和抗体依赖性细胞吞噬作用 (ADCP)。

These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.[1] In the United States, .

这些机制在体外和体内都会导致肿瘤生长抑制和细胞死亡。[1] 在美国，。

Ziihera

齐赫拉

is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.

适用于治疗经FDA批准的检测方法确认的先前接受过治疗、无法切除或转移性的HER2阳性（IHC 3+）胆道癌（BTC）成人患者。

The FDA granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

基于总体响应率和响应持续时间，FDA加速批准了该适应症。此适应症的持续批准可能取决于在确证性试验中对临床益处的验证和描述。

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule.

Zanidatamab正在多个临床试验中开发，作为针对表达HER2的实体瘤患者的靶向治疗选择。Zanidatamab由Jazz和BeOne根据与最初开发该分子的Zymeworks的许可协议进行开发。

A supplemental biologics license application for zanidatamab was submitted to the FDA under Real-Time Oncology Review in first-line HER2+ locally advanced or metastatic GEA. The FDA granted two Breakthrough Therapy designations for zanidatamab's development: one as a single agent for previously treated HER2 gene-amplified BTC, and one in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab for first-line HER2+ unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma.

针对zanidatamab的补充生物制品许可申请已根据实时肿瘤审评（Real-Time Oncology Review）提交给FDA，用于一线治疗HER2阳性局部晚期或转移性GEA。FDA授予了zanidatamab两项突破性疗法认定：一项是作为单药治疗既往接受过治疗的HER2基因扩增型BTC，另一项是与含氟嘧啶和铂类化疗联合使用、无论是否联合tislelizumab，用于一线治疗HER2阳性不可切除的局部晚期或转移性胃癌、胃食管结合部（GEJ）或食管腺癌。

The FDA also granted two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for first-line GEA. Additionally, zanidatamab has received Orphan Drug designations from the FDA for the treatment of BTC, gastric (including GEJ) cancer, and esophageal cancer, as well as Orphan Drug designations from the European Medicines Agency for the treatment of BTC, gastric/gastroesophageal junction cancer and oesophageal cancer. .

FDA还授予zanidatamab两个快速通道资格：一个作为单一药物用于难治性BTC，另一个与标准化疗联合用于一线GEA。此外，zanidatamab已获得FDA授予的治疗BTC、胃癌（包括胃食管交界处癌）和食管癌的孤儿药资格，同时也获得了欧洲药品管理局（EMA）授予的治疗BTC、胃/胃食管交界处癌和食管癌的孤儿药资格。

Important Safety Information for ZIIHERA

ZIIHERA重要安全信息

WARNING: EMBRYO-FETAL TOXICITY

警告：胚胎-胎儿毒性

Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients

怀孕期间接触ZIIHERA可能会对胚胎或胎儿造成伤害。请告知患者。

of the risk and need for effective contraception.

关于风险和对有效避孕的需求。

WARNINGS AND PRECAUTIONS

警告和注意事项

Embryo-Fetal Toxicity

胚胎-胎儿毒性

ZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

ZIIHERA 会给孕妇腹中的胎儿造成伤害。文献报道显示，妊娠期间使用 HER2 导向抗体可导致羊水过少以及表现为肺发育不全、骨骼异常和新生儿死亡的羊水过少序列征。

Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA. .

在开始使用ZIIHERA之前，验证具有生殖潜力的女性的怀孕状态。告知孕妇和具有生殖潜力的女性，在怀孕期间或受孕前4个月内接触ZIIHERA可能会对胎儿造成伤害。建议具有生殖潜力的女性在使用ZIIHERA治疗期间以及在最后一次使用ZIIHERA后的4个月内使用有效的避孕措施。

Left Ventricular Dysfunction

左心室功能障碍

ZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). LVEF declined by >10% and decreased to <50% in 4.3% of 233 patients. Left ventricular dysfunction (LVD) leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7).

ZIIHERA 可能导致左心室射血分数 (LVEF) 下降。在 233 名患者中，有 4.3% 的患者 LVEF 下降超过 10%，并降至低于 50%。有 0.9% 的患者因左心室功能障碍 (LVD) 而永久停用 ZIIHERA。LVD 首次出现的中位时间为 5.6 个月（范围：1.6 至 18.7）。

LVD resolved in 70% of patients. .

LVD在70%的患者中得到解决。

Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions.

在开始使用ZIIHERA之前和治疗期间定期评估LVEF。根据不良反应的严重程度，暂停剂量或永久停用ZIIHERA。

The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50%.

ZIIHERA 在基线射血分数低于 50% 的患者中的安全性尚未确定。

Infusion-Related Reactions

输液相关反应

ZIIHERA can cause infusion-related reactions (IRRs). An IRR was reported in 31% of 233 patients treated with ZIIHERA as a single agent in clinical studies, including Grade 3 (0.4%), and Grade 2 (25%). IRRs leading to permanent discontinuation of ZIIHERA were reported in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients; 97% of IRRs resolved within one day. .

ZIIHERA可能引起输液相关反应（IRRs）。在临床研究中，233名接受ZIIHERA单药治疗的患者中，有31%报告了IRRs，其中包括3级（0.4%）和2级（25%）。导致永久停用ZIIHERA的IRRs在0.4%的患者中被报告。28%的患者在首次给药当天发生了IRRs；97%的IRRs在一天内得到解决。

Prior to each dose of ZIIHERA, administer premedications to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use. .

在每次使用ZIIHERA之前，应给予预防性药物以防止潜在的输注相关反应（IRRs）。在ZIIHERA给药期间以及输注完成后根据临床需要监测患者是否出现IRRs的体征和症状。准备好治疗IRRs的药物和急救设备以供立即使用。

If an IRR occurs, slow, or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs.

如果发生IRR，减慢或停止输注，并进行适当的医疗管理。在症状和体征完全消除前持续监测患者，然后方可恢复用药。对于出现复发性严重或危及生命的IRR的患者，永久停用ZIIHERA。

Diarrhea

腹泻

ZIIHERA can cause severe diarrhea.

ZIIHERA可能引起严重腹泻。

Diarrhea was reported in 48% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Withhold or permanently discontinue ZIIHERA based on severity. .

在临床研究中，接受治疗的233名患者中有48%报告出现腹泻，其中包括3级（6%）和2级（17%）。如果发生腹泻，根据临床需要给予止泻治疗。根据临床需要进行诊断测试，以排除其他引起腹泻的原因。根据严重程度暂停或永久停止使用ZIIHERA。

ADVERSE REACTIONS

不良反应

Serious adverse reactions occurred in 53% of 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA. Serious adverse reactions in >2% of patients included biliary obstruction (15%), biliary tract infection (8%), sepsis (8%), pneumonia (5%), diarrhea (3.8%), gastric obstruction (3.8%), and fatigue (2.5%).

在80名接受ZIIHERA治疗的不可切除或转移性HER2阳性胆道癌患者中，53%的患者发生了严重不良反应。超过2%的患者出现的严重不良反应包括胆道梗阻（15%）、胆道感染（8%）、败血症（8%）、肺炎（5%）、腹泻（3.8%）、胃梗阻（3.8%）和疲劳（2.5%）。

A fatal adverse reaction of hepatic failure occurred in one patient who received ZIIHERA. .

一名接受ZIIHERA治疗的患者发生了致命的肝衰竭不良反应。

The most common adverse reactions in 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA (≥20%) were diarrhea (50%), infusion-related reaction (35%), abdominal pain (29%), and fatigue (24%).

在80名接受ZIIHERA治疗的不可切除或转移性HER2阳性BTC患者中，最常见的不良反应（≥20%）是腹泻（50%）、输液相关反应（35%）、腹痛（29%）和疲劳（24%）。

USE IN SPECIFIC POPULATIONS

特定人群中的使用

Pediatric Use

儿科使用

Safety and efficacy of ZIIHERA have not been established in pediatric patients.

ZIIHERA 在儿科患者中的安全性和有效性尚未确定。

Geriatric Use

老年使用

Of the 80 patients who received ZIIHERA for unresectable or metastatic HER2-positive BTC, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were aged 65-74 years old and 2 (3%) were aged 75 years or older.

在80名接受ZIIHERA治疗的不可切除或转移性HER2阳性胆管癌患者中，有39名（49%）患者年龄在65岁及以上。其中，37名（46%）患者的年龄在65至74岁之间，2名（3%）患者的年龄在75岁及以上。

No overall differences in safety or efficacy were observed between these patients and younger adult patients.

这些患者与较年轻的成年患者在安全性和有效性方面未观察到总体差异。

The full U.S. Prescribing Information for ZIIHERA, including BOXED Warning, is available at:

ZIIHERA 的完整美国处方信息，包括加框警告，可在此处获取：

https://pp.jazzpharma.com/pi/ziihera.en.USPI.pdf

About Zepzelca

关于Zepzelca

(lurbinectedin)

(卢比奈克丁)

Zepzelca

泽普泽卡

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 some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and potentially cell death.

是一种烷基化药物，可与DNA内的鸟嘌呤残基结合。这会触发一系列事件，影响DNA结合蛋白的活性，包括一些转录因子和DNA修复途径，导致细胞周期中断并可能引起细胞死亡。

In October 2025, the FDA approved

2025年10月，FDA批准了

Zepzelca

泽普泽卡

in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, as maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide..

与阿特珠单抗或阿特珠单抗和透明质酸酶-tqjs联合使用，作为维持治疗，用于广泛期小细胞肺癌（ES-SCLC）成人患者，这些患者在使用阿特珠单抗或阿特珠单抗和透明质酸酶-tqjs、卡铂和依托泊苷的一线诱导治疗后疾病未进展。

In June 2020, the FDA approved

2020年6月，FDA批准了

Zepzelca

泽普泽卡

under accelerated approval for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on ORR and DOR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)..

获得加速批准，用于治疗接受铂类化疗期间或之后疾病进展的成人转移性小细胞肺癌（SCLC）患者。该适应症是基于ORR和DOR获得加速批准的。此适应症的持续批准可能取决于在确证性试验中对临床获益的验证和描述。

Important Safety Information for ZEPZELCA

ZEPZELCA的重要安全信息

Myelosuppression

骨髓抑制

ZEPZELCA can cause severe and fatal myelosuppression including febrile neutropenia and sepsis, thrombocytopenia and anemia.

ZEPZELCA可能引起严重和致命的骨髓抑制，包括发热性中性粒细胞减少症和败血症、血小板减少症以及贫血。

Administer ZEPZELCA only to patients with baseline neutrophil count of at least 1,500 cells/mm

仅对基线中性粒细胞计数至少为1,500个细胞/mm的患者给予ZEPZELCA。

and platelet count of at least 100,000/mm

血小板计数至少为100,000/mm

. To reduce the risk of febrile neutropenia during treatment with ZEPZELCA in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, administer granulocyte colony-stimulating factor (G-CSF). Monitor blood counts including neutrophils, red blood cells and platelets prior to each ZEPZELCA administration.

为了降低在使用ZEPZELCA联合阿特珠单抗或阿特珠单抗和透明质酸酶-tqjs治疗期间发热性中性粒细胞减少的风险，给予粒细胞集落刺激因子（G-CSF）。在每次使用ZEPZELCA前，监测包括中性粒细胞、红细胞和血小板在内的血细胞计数。

For neutrophil count less than 500 cells/mm.

中性粒细胞计数小于500个细胞/立方毫米。

or any value less than lower limit of normal, the use of G-CSF is recommended. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity.

或任何低于正常下限的值，建议使用G-CSF。根据严重程度，暂停、减少剂量或永久停用ZEPZELCA。

ZEPZELCA with Intravenous Atezolizumab

ZEPZELCA 联合静脉注射阿特珠单抗

In the IMforte study, primary prophylaxis of G-CSF was administered to 84% of patients. Based on laboratory values, decreased neutrophils occurred in 36%, including 18% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. The median time to onset of Grade 3 and 4 decreased neutrophil cells was 31 days and a median duration of 10 days.

在 IMforte 研究中，84% 的患者接受了 G-CSF 的初级预防。根据实验室数据，36% 的患者出现中性粒细胞减少，其中 18% 为 3 级或 4 级，这些患者接受了 ZEPZELCA 联合 atezolizumab 治疗。3 级和 4 级中性粒细胞减少的中位发病时间为 31 天，中位持续时间为 10 天。

Febrile neutropenia occurred in 1.7%. Sepsis occurred in 1%. There were 7 fatal infections: pneumonia (n=3), sepsis (n=3), and febrile neutropenia (n=1)..

发热性中性粒细胞减少症发生在1.7%。脓毒症发生在1%。有7例致命感染：肺炎（n=3），脓毒症（n=3），发热性中性粒细胞减少症（n=1）。

Based on laboratory values, decreased platelets occurred in 54%, including 15% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. The median time to onset of Grade 3 and 4 decreased platelet cells was 31 days and a median duration of 12 days.

基于实验室值，54%的患者出现血小板减少，其中15%为3级或4级，这些患者接受了ZEPZELCA与atezolizumab的联合治疗。3级和4级血小板减少的中位发病时间为31天，中位持续时间为12天。

Based on laboratory values, decreased hemoglobin occurred in 51%, including 13% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. The median time to onset of Grade 3 and 4 decreased hemoglobin was 64 days and a median duration of 8 days.

基于实验室数值，接受ZEPZELCA联合阿特珠单抗治疗的患者中有51%出现血红蛋白减少，其中13%为3级或4级。3级和4级血红蛋白减少的中位发病时间为64天，中位持续时间为8天。

ZEPZELCA as a Single Agent

ZEPZELCA作为单一药物

In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA as a single agent

在554名接受ZEPZELCA单药治疗的晚期实体瘤患者的临床研究中

，

Grade 3 or 4 neutropenia occurred in 41% of patients, with a median time to onset of 15 days and a median duration of 7 days. Febrile neutropenia occurred in 7% of patients. Sepsis occurred in 2% of patients and was fatal in 1% (all cases occurred in patients with solid tumors other than SCLC). Grade 3 or 4 thrombocytopenia occurred in 10%, with a median time to onset of 10 days and a median duration of 7 days.

3级或4级中性粒细胞减少症发生在41%的患者中，中位发病时间为15天，中位持续时间为7天。发热性中性粒细胞减少症发生在7%的患者中。2%的患者发生脓毒症，其中1%致命（所有病例均发生在非小细胞肺癌的实体瘤患者中）。3级或4级血小板减少症发生在10%的患者中，中位发病时间为10天，中位持续时间为7天。

Grade 3 or 4 anemia occurred in 17% of patients..

3级或4级贫血发生在17%的患者中。

Hepatotoxicity

肝毒性

ZEPZELCA can cause hepatotoxicity which may be severe.

ZEPZELCA 可能导致严重肝毒性。

Monitor liver function tests prior to initiating ZEPZELCA and periodically during treatment as clinically indicated. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity.

在开始使用ZEPZELCA之前和治疗期间，根据临床需要定期监测肝功能测试。根据严重程度，暂停、减少剂量或永久停用ZEPZELCA。

ZEPZELCA with Intravenous Atezolizumab

ZEPZELCA联合静脉注射阿特珠单抗

In the IMforte study, based on laboratory values, increased alanine aminotransferase (ALT) occurred in 25%, including 3% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. Increased aspartate aminotransferase (AST) occurred in 24% including 3% Grade 3 or Grade 4. The median time to onset of Grade ≥3 elevation in transaminases was 52 days (range: 6 to 337)..

在 IMforte 研究中，基于实验室数值，25% 接受 ZEPZELCA 联合阿特珠单抗治疗的患者出现丙氨酸氨基转移酶 (ALT) 升高，其中 3% 为 3 级或 4 级。24% 的患者出现天门冬氨酸氨基转移酶 (AST) 升高，其中 3% 为 3 级或 4 级。转氨酶升高至 3 级或以上的中位发病时间为 52 天（范围：6 至 337）。

ZEPZELCA as a Single Agent

ZEPZELCA作为单一药剂

In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA as a single agent

在554名接受ZEPZELCA单药治疗的晚期实体瘤患者的临床研究中

，

Grade 3 elevations of ALT and AST were observed in 6% and 3% of patients, respectively, and Grade 4 elevations of ALT and AST were observed in 0.4% and 0.5% of patients, respectively. The median time to onset of Grade ≥3 elevation in transaminases was 8 days (range: 3 to 49), with a median duration of 7 days..

分别有6%和3%的患者观察到ALT和AST的3级升高，而分别有0.4%和0.5%的患者观察到ALT和AST的4级升高。转氨酶≥3级升高的中位发生时间为8天（范围：3至49天），中位持续时间为7天。

Extravasation Resulting in Tissue Necrosis

渗漏导致组织坏死

Extravasation of ZEPZELCA can cause skin and soft tissue injury, including necrosis requiring debridement. Consider use of a central venous catheter to reduce the risk of extravasation, particularly in patients with limited venous access. Monitor patients for signs and symptoms of extravasation during the ZEPZELCA infusion.

ZEPZELCA外渗可导致皮肤和软组织损伤，包括需要清创的坏死。考虑使用中心静脉导管以降低外渗风险，特别是对于静脉通路有限的患者。在ZEPZELCA输注期间，监测患者外渗的体征和症状。

If extravasation occurs, immediately discontinue the infusion, remove the infusion catheter, and monitor for signs and symptoms of tissue necrosis. The time to onset of necrosis after extravasation may vary..

如果发生外渗，立即停止输液，移除输液导管，并监测组织坏死的迹象和症状。外渗后坏死的发作时间可能有所不同。

ZEPZELCA with Intravenous Atezolizumab

ZEPZELCA联合静脉注射阿特珠单抗

In the IMforte study, extravasation resulting in skin necrosis occurred in one patient who received ZEPZELCA in combination with atezolizumab.

在 IMforte 研究中，一名接受 ZEPZELCA 联合 atezolizumab 治疗的患者发生了导致皮肤坏死的外渗。

Administer supportive care and consult with an appropriate medical specialist as needed for signs and symptoms of extravasation. Administer subsequent infusions at a site that was not affected by extravasation.

对于渗漏的迹象和症状，提供支持性护理，并在需要时咨询合适的医学专家。在未受渗漏影响的部位进行后续输液。

Rhabdomyolysis

横纹肌溶解症

Rhabdomyolysis has been reported in patients treated with ZEPZELCA.

据报道，使用ZEPZELCA治疗的患者出现了横纹肌溶解症。

Monitor creatine phosphokinase (CPK) prior to initiating ZEPZELCA and periodically during treatment as clinically indicated. Withhold or reduce the dose based on severity

在开始使用ZEPZELCA之前和治疗期间，根据临床需要定期监测肌酸磷酸激酶（CPK）。根据严重程度，暂停或减少剂量。

。

ZEPZELCA with Intravenous Atezolizumab

ZEPZELCA 联合静脉注射阿特珠单抗

In the IMforte study, among 235 patients who had a creatine phosphokinase laboratory evaluation, increased creatine phosphokinase occurred in 9% who received ZEPZELCA in combination with atezolizumab.

在 IMforte 研究中，在 235 名进行了肌酸磷酸激酶实验室评估的患者中，9% 接受 ZEPZELCA 联合阿特珠单抗治疗的患者出现肌酸磷酸激酶升高。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

ZEPZELCA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 7 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 4 months after the last dose..

ZEPZELCA 在给予孕妇时可能会对胎儿造成伤害。请告知孕妇对胎儿的潜在风险。建议有生殖潜力的女性患者在使用 ZEPZELCA 治疗期间以及最后一剂后的 7 个月内使用有效的避孕措施。建议有具生殖潜力女性伴侣的男性患者在使用 ZEPZELCA 治疗期间以及最后一剂后的 4 个月内使用有效避孕措施。

Lactation

泌乳

There are no data on the presence of ZEPZELCA in human milk, however, because of the potential for serious adverse reactions from ZEPZELCA in breastfed children, advise women not to breastfeed during treatment with ZEPZELCA and for 2 weeks after the last dose.

目前尚无关于ZEPZELCA是否存在于人乳中的数据，但由于ZEPZELCA可能对哺乳婴儿造成严重不良反应，建议女性在使用ZEPZELCA治疗期间及最后一剂后的2周内不要进行母乳喂养。

ADVERSE REACTIONS

不良反应

ZEPZELCA with Intravenous Atezolizumab

ZEPZELCA联合静脉注射Atezolizumab

Serious adverse reactions occurred in 31% of patients receiving ZEPZELCA in combination with atezolizumab. Serious adverse reactions occurring in >2% were pneumonia (2.5%), respiratory tract infections (2.1%), dyspnea (2.1%), and decreased platelet count (2.1%). Fatal adverse reactions occurred in 5% of patients receiving ZEPZELCA with atezolizumab including pneumonia (3 patients), sepsis (3 patients), cardio-respiratory arrest (2 patients), myocardial infarction (2 patients), and febrile neutropenia (1 patient)..

在接受ZEPZELCA联合阿特珠单抗治疗的患者中，31%发生了严重不良反应。发生率超过2%的严重不良反应包括肺炎（2.5%）、呼吸道感染（2.1%）、呼吸困难（2.1%）和血小板计数减少（2.1%）。在接受ZEPZELCA联合阿特珠单抗治疗的患者中，5%发生了致死性不良反应，其中包括肺炎（3例患者）、败血症（3例患者）、心肺骤停（2例患者）、心肌梗死（2例患者）和发热性中性粒细胞减少（1例患者）。

The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received ZEPZELCA with atezolizumab were decreased lymphocytes (55%), decreased platelets (54%), decreased hemoglobin (51%), decreased neutrophils (36%), nausea (36%), and fatigue/asthenia (32%).

接受ZEPZELCA与atezolizumab治疗的患者中，最常见的不良反应（≥30%），包括实验室异常，为淋巴细胞减少（55%）、血小板减少（54%）、血红蛋白减少（51%）、中性粒细胞减少（36%）、恶心（36%）以及疲劳/乏力（32%）。

ZEPZELCA as a Single Agent

ZEPZELCA作为单一药物

Serious adverse reactions occurred in 34% of patients who received ZEPZELCA. Serious adverse reactions in ≥3% of patients included pneumonia, febrile neutropenia, neutropenia, respiratory tract infection, anemia, dyspnea, and thrombocytopenia.

接受ZEPZELCA治疗的患者中有34%发生了严重不良反应。≥3%的患者中出现的严重不良反应包括肺炎、发热性中性粒细胞减少、中性粒细胞减少、呼吸道感染、贫血、呼吸困难和血小板减少。

The most common adverse reactions, including laboratory abnormalities, (≥20%) are leukopenia (79%), lymphopenia (79%), fatigue (77%), anemia (74%), neutropenia (71%), increased creatinine (69%), increased alanine aminotransferase (66%), increased glucose (52%), thrombocytopenia (37%), nausea (37%), decreased appetite (33%), musculoskeletal pain (33%), decreased albumin (32%), constipation (31%), dyspnea (31%), decreased sodium (31%), increased aspartate aminotransferase (26%), vomiting (22%), decreased magnesium (22%), cough (20%), and diarrhea (20%)..

最常见的不良反应，包括实验室指标异常，（≥20%）为白细胞减少（79%）、淋巴细胞减少（79%）、疲劳（77%）、贫血（74%）、中性粒细胞减少（71%）、肌酐升高（69%）、丙氨酸氨基转移酶升高（66%）、血糖升高（52%）、血小板减少（37%）、恶心（37%）、食欲下降（33%）、肌肉骨骼疼痛（33%）、白蛋白降低（32%）、便秘（31%）、呼吸困难（31%）、钠降低（31%）、天冬氨酸氨基转移酶升高（26%）、呕吐（22%）、镁降低（22%）、咳嗽（20%）和腹泻（20%）。

DRUG INTERACTIONS

药物相互作用

Effect of CYP3A Inhibitors and Inducers

CYP3A抑制剂和诱导剂的影响

Avoid coadministration with a strong or a moderate CYP3A inhibitor (including grapefruit and Seville oranges) as this increases lurbinectedin systemic exposure which may increase the incidence and severity of adverse reactions to ZEPZELCA. If coadministration cannot be avoided, reduce the ZEPZELCA dose as appropriate..

避免与强效或中效CYP3A抑制剂（包括葡萄柚和塞维利亚橙）共同给药，因为这会增加卢比内克汀的全身暴露，可能增加ZEPZELCA不良反应的发生率和严重程度。如果无法避免共同给药，请适当减少ZEPZELCA的剂量。

Avoid coadministration with a strong CYP3A inducer as it may decrease systemic exposure to lurbinectedin, which may decrease the efficacy of ZEPZELCA.

避免与强效CYP3A诱导剂联合使用，因为它可能会降低lurbinectedin的全身暴露量，从而可能降低ZEPZELCA的疗效。

GERIATRIC USE

老年患者使用

ZEPZELCA with Intravenous Atezolizumab

ZEPZELCA联合静脉注射阿特珠单抗

Of the 242 patients with ES-SCLC treated with ZEPZELCA and atezolizumab in IMforte, 124 (51%) patients were 65 years of age and older, while 29 (12%) patients were 75 years of age and older. No overall differences in effectiveness were observed between older and younger patients. There was no overall difference in the incidence of serious adverse reactions in patients ≥65 years of age and patients <65 years of age (33% vs.

在 IMforte 中接受 ZEPZELCA 和 atezolizumab 治疗的 242 名 ES-SCLC 患者中，124 名（51%）患者年龄为 65 岁及以上，而 29 名（12%）患者年龄为 75 岁及以上。老年患者与年轻患者之间未观察到总体疗效差异。≥65 岁患者和＜65 岁患者严重不良反应的发生率无总体差异（33% 对比）。

29%, respectively). There was a higher incidence of Grade 3 or 4 adverse reactions in patients ≥65 years of age compared to younger patients (45% vs. 31%, respectively)..

29%，分别）。与年轻患者相比，≥65岁的患者发生3级或4级不良反应的几率更高（分别为45% vs. 31%）。。

ZEPZELCA as a Single Agent

ZEPZELCA作为单一药物

Of the 105 patients with SCLC administered ZEPZELCA in clinical studies, 37 (35%) patients were 65 years of age and older, while 9 (9%) patients were 75 years of age and older. No overall difference in effectiveness was observed between patients aged 65 and older and younger patients.

在临床研究中，105名接受ZEPZELCA治疗的小细胞肺癌（SCLC）患者中，有37名（35%）患者年龄在65岁及以上，而9名（9%）患者年龄在75岁及以上。在65岁及以上的患者和较年轻的患者之间，未观察到总体疗效的差异。

There was a higher incidence of serious adverse reactions in patients ≥65 years of age than in patients <65 years of age (49% vs. 26%, respectively). The serious adverse reactions most frequently reported in patients ≥65 years of age were related to myelosuppression and consisted of febrile neutropenia (11%), neutropenia (11%), thrombocytopenia (8%), and anemia (8%).

年龄≥65岁的患者发生严重不良反应的频率高于年龄<65岁的患者（分别为49%和26%）。在年龄≥65岁的患者中，报告最多的严重不良反应与骨髓抑制相关，包括发热性中性粒细胞减少症（11%）、中性粒细胞减少症（11%）、血小板减少症（8%）和贫血（8%）。

There was a higher incidence of Grade 3 or 4 adverse reactions in patients ≥65 years of age compared to younger patients (76% vs. 50%, respectively)..

在≥65岁的患者中，3级或4级不良反应的发生率高于年轻患者（分别为76％和50％）。

HEPATIC IMPAIRMENT

肝功能损害

Avoid administration of ZEPZELCA in patients with severe hepatic impairment. If administration cannot be avoided, reduce the dose. Monitor for increased adverse reactions in patients with severe hepatic impairment.

避免对严重肝功能不全的患者使用ZEPZELCA。如果无法避免用药，应减少剂量。监测严重肝功能不全患者是否出现不良反应增加的情况。

Reduce the dose of ZEPZELCA in patients with moderate hepatic impairment. Monitor for increased adverse reactions in patients with moderate hepatic impairment.

对中度肝功能不全患者减少ZEPZELCA的剂量。监测中度肝功能不全患者的不良反应是否增加。

No dose adjustment of ZEPZELCA is recommended for patients with mild hepatic impairment.

对于轻度肝功能不全的患者，不建议调整ZEPZELCA的剂量。

The full Prescribing Information for ZEPZELCA is available

ZEPZELCA的完整处方信息可查阅

at:

在：

https://pp.jazzpharma.com/pi/zepzelca.en.USPI.pdf

Tevimbra (tislelizumab) is a registered trademark of BeOne Medicines.

百泽安（替雷利珠单抗）是贝一医药公司的注册商标。

Zepzelca 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 根据许可使用。

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

Tecentriq（阿特珠单抗）是罗氏集团成员基因泰克的注册商标。

About Jazz Pharmaceuticals

关于Jazz制药公司

Jazz Pharmaceuticals plc (Nasdaq:

Jazz Pharmaceuticals plc（纳斯达克：

JAZZ

爵士乐

) 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 rare disease — often with limited or no therapeutic options. We have a diverse portfolio of medicines, including leading therapies addressing epilepsies, cancers and sleep disorders.

是一家全球生物制药公司，其宗旨是通过创新来改变患者及其家人的生活。我们致力于为罕见病患者开发改变生活的药物，这些患者通常面临有限或没有治疗选择的困境。我们拥有多样化的药物组合，包括针对癫痫、癌症和睡眠障碍的前沿疗法。

Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.

我们以患者为中心、以科学为驱动的方法，推动了我们在创新治疗药物的强大研发管线中取得突破性的研究和开发进展。Jazz 总部位于爱尔兰都柏林，在多个国家设有研发实验室、生产设施和员工，致力于为全球患者服务。

Please visit .

请访问。

www.jazzpharmaceuticals.com

for more information.

更多信息，请参阅。

Cautionary Note Concerning Forward-Looking Statements

关于前瞻性陈述的警告声明

This press release contains forward-looking statements, including, but not limited to, statements related to the potential therapeutic benefits of zanidatamab in HER2+ first-line GEA, and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties.

本新闻稿包含前瞻性声明，包括但不限于与扎尼达单抗在HER2+一线GEA中的潜在治疗益处相关的声明，以及其他非历史事实的声明。这些前瞻性声明基于Jazz Pharmaceuticals当前的计划、目标、估计、预期和意图，本质上涉及重大风险和不确定性。

Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the successful completion of regulatory activities and uncertain regulatory approval, risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients and other risks and uncertainties affecting Jazz Pharmaceuticals and its development programs, including those described from time to time under the caption 'Risk Factors' and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports, including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2025, and future filings and reports by Jazz Pharmaceuticals.

实际结果和事件的时间可能会因这些风险和不确定性而与前瞻性声明中的预期存在重大差异，这些风险和不确定性包括但不限于：与监管活动成功完成相关的风险及不确定的监管批准、未能或延迟成功启动或完成临床试验及评估患者的风险，以及其他影响Jazz Pharmaceuticals及其开发项目的风险和不确定性，其中包括Jazz Pharmaceuticals不时在其证券和交易委员会文件及报告中（包括标题为“风险因素”部分及其他地方）所描述的内容，例如Jazz Pharmaceuticals截至2025年12月31日的年度报告Form 10-K，以及Jazz Pharmaceuticals未来的其他文件和报告。

Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise.

Jazz Pharmaceuticals目前尚未知晓的其他风险和不确定性也可能影响其前瞻性声明，并可能导致实际结果和事件发生的时间与预期有重大差异。本前瞻性声明仅截至本日期或前瞻性声明中注明的日期作出，即使此后Jazz Pharmaceuticals在其网站或其他渠道提供这些声明。

Jazz Pharmaceuticals un.

爵士制药公司。

Contacts:

联系人：

Media Contact:

媒体联系人：

[email protected]

电子邮件地址

Ireland +353 1 637 2141

爱尔兰 +353 1 637 2141

U.S. +1 215 867 4948