First-line maintenance combination therapy reduced the risk of disease progression or death by 46%, with a median overall survival of 13.2 months vs 10.6 months

一线维持联合治疗使疾病进展或死亡风险降低了46%，中位总生存期为13.2个月 vs 10.6个月。

for atezolizumab alone from the point of randomization

从随机分组开始单独使用阿特珠单抗

First Phase 3 study to demonstrate statistically significant and clinically meaningful improvements in both progression-free and overall survival in ES-SCLC first-line maintenance

第一个在ES-SCLC一线维持治疗中证明无进展生存期和总生存期均有统计学意义和临床意义改善的3期研究

Results presented at the ASCO 2025 Annual Meeting and simultaneously published in

在2025年ASCO年会上公布并同时发表在

The Lancet

柳叶刀

Jazz to host investor webcast on

Jazz 将举办投资者网络直播

Tuesday, June 10

6月10日，星期二

to review Zepzelca data

审查Zepzelca数据

For U.S. media and investors only

仅限美国媒体和投资者

DUBLIN

都柏林

,

，

June 2, 2025

2025年6月2日

/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq:

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

JAZZ

爵士乐

) today announced positive results from the Phase 3 IMforte study of Zepzelca

）今天宣布了Zepzelca的3期IMforte研究的积极结果

®

®

(lurbinectedin) in combination with atezolizumab (Tecentriq

(lurbinectedin)联合阿特珠单抗(Tecentriq)

®

®

) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and atezolizumab. The study met both primary endpoints, demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to atezolizumab alone..

作为广泛期小细胞肺癌（ES-SCLC）患者在使用卡铂、依托泊苷和阿特珠单抗诱导治疗后的首选维持治疗。该研究达到了两个主要终点，与单独使用阿特珠单抗相比，在无进展生存期（PFS）和总生存期（OS）方面均显示出统计学上的显著改善。

IMforte is the first global Phase 3 trial to demonstrate clinically meaningful PFS and OS benefits in the first-line maintenance setting for ES-SCLC and supports maintenance therapy with

IMforte是全球首个在ES-SCLC一线维持治疗中证明具有临床意义的PFS和OS益处的III期试验，并支持维持治疗。

Zepzelca

泽普泽卡

plus atezolizumab as a new standard of care for patients. The data were presented today in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in

加上阿特珠单抗作为患者护理的新标准。这些数据在2025年美国临床肿瘤学会（ASCO）年会上的口头报告环节中发布，会议地点为

Chicago

芝加哥

and published simultaneously in

同时在...发布

The Lancet

柳叶刀

. Data from the trial served as the basis for the supplemental New Drug Application (sNDA) submission to the U.S. Food and Drug Administration (FDA).

该试验的数据作为补充新药申请（sNDA）提交给美国食品药品监督管理局（FDA）的基础。

Following induction therapy with carboplatin, etoposide and atezolizumab, patients who did not have disease progression were randomized to receive

在使用卡铂、依托泊苷和阿特珠单抗进行诱导治疗后，病情未进展的患者被随机分配接受

Zepzelca

泽普赛卡

plus atezolizumab or atezolizumab alone. From the point of randomization, the median PFS was 5.4 months for the

加上阿特珠单抗或单独使用阿特珠单抗。从随机化开始，中位无进展生存期为5.4个月。

Zepzelca

泽普泽卡

plus atezolizumab combination versus 2.1 months for atezolizumab alone (stratified HR = 0.54, 95% CI: 0.43–0.67; p < 0.0001), and median OS was 13.2 months versus 10.6 months (stratified hazard ratio [HR] = 0.73; 95% CI: 0.57–0.95; p = 0.0174). The combination reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to atezolizumab alone.

联合使用atezolizumab的中位无进展生存期为对比单独使用atezolizumab的2.1个月（分层HR = 0.54，95% CI：0.43-0.67；p < 0.0001），中位总生存期为13.2个月对比10.6个月（分层风险比[HR] = 0.73；95% CI：0.57-0.95；p = 0.0174）。与单独使用atezolizumab相比，联合疗法使疾病进展或死亡风险降低了46%，死亡风险降低了27%。

The .

。

Zepzelca

泽普泽卡

plus atezolizumab combination had no new or unexpected safety signals.

加上阿特珠单抗的组合没有出现新的或意外的安全信号。

'Small cell lung cancer is an aggressive and devastating disease; at the time of diagnosis, the large majority of patients have already progressed to extensive-stage disease and only one out of five survive longer than two years,

小细胞肺癌是一种侵袭性强、危害极大的疾病；在诊断时，大多数患者已经进展为广泛期疾病，只有五分之一的患者能存活两年以上，

1

1

' said

`说`

Luis Paz-Ares

路易斯·帕兹-阿雷斯

, M.D., Ph.D., Head of Medical Oncology at the Hospital Universitario 12 de Octubre in

，医学博士，哲学博士，10月12日大学医院肿瘤内科主任

Madrid, Spain

西班牙马德里

, and IMforte trial principal investigator. 'The IMforte results are very encouraging showing a potentially practice-changing option that could improve survival for patients with a very high unmet need.'

“,IMforte试验的首席研究员。‘IMforte试验的结果非常令人鼓舞，展示了一个可能改变临床实践的选择，可以为那些有非常高未满足需求的患者改善生存率。’”

'In the U.S., approximately 30,000 new cases of small cell lung cancer are diagnosed each year, and the IMforte results demonstrate a combination treatment approach that can meaningfully extend the survival benefit for people with extensive-stage small cell lung cancer who complete induction therapy without progression,.

“在美国，每年大约有30,000例新的小细胞肺癌病例被诊断出来，而IMforte研究结果表明，一种组合治疗方法可以为那些在完成诱导治疗后病情未进展的广泛期小细胞肺癌患者带来显著的生存获益。

2,3

2,3

' said

‘说

Stephen V. Liu

刘斯蒂芬

, M.D., Associate Professor of Medicine, Lombardi Comprehensive Cancer Center,

医学博士，医学副教授，隆巴迪综合癌症中心，

Georgetown University

乔治敦大学

, and IMforte trial investigator. 'Unfortunately, a significant number of patients are not able to receive any therapy at the time of progression. This combination gives oncologists a new evidence-based option to help patients before progression occurs and improve outcomes in a setting where options have been limited.'.

`,以及IMforte试验的研究者。“不幸的是，在病情进展时，许多患者无法接受任何治疗。这种组合为肿瘤学家提供了一种新的循证选择，可以在病情恶化之前帮助患者，并在治疗选择有限的情况下改善结果。`

'The IMforte trial results underscore the potential of

“IMforte试验结果强调了潜力

Zepzelca

泽普泽卡

with atezolizumab to deliver clinically meaningful benefit as a first-line maintenance option for patients with extensive-stage small cell lung cancer and is a significant advance for these patients,' said

与阿特珠单抗联合使用，为广泛期小细胞肺癌患者提供了一线维持治疗的临床意义益处，是这些患者的重大进展，”

Rob Iannone

罗伯·伊安诺内

, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. 'These results represent important progress in expanding

医学博士、硕士、执行副总裁、全球研发主管及Jazz Pharmaceuticals首席医疗官。“这些结果代表了在扩展方面取得的重要进展

Zepzelca's

Zepzelca的

potential utility earlier in the treatment journey. We look forward to engaging with the FDA to bring this indication to market as quickly as possible.'

在治疗过程的早期就展现出了潜在的效用。我们期待与FDA合作，尽快将这一适应症推向市场。

Phase 3 IMforte Trial Results

第三阶段IMforte试验结果

These primary results are from the global Phase 3 IMforte trial, which evaluated

这些主要结果来自全球三期 IMforte 试验，该试验评估了

Zepzelca

泽普泽卡

plus atezolizumab as a first-line maintenance therapy in patients with ES-SCLC. 483 patients were randomized after completion of 4 cycles of induction therapy with atezolizumab plus carboplatin and etoposide. From the point of randomization, the median OS for the

在广泛期小细胞肺癌（ES-SCLC）患者中，将阿特珠单抗作为一线维持治疗。483名患者在接受了4个周期的阿特珠单抗联合卡铂和依托泊苷诱导治疗后被随机分组。从随机分组开始，中位总生存期（OS）为

Zepzelca

Zepzelca

plus atezolizumab regimen was 13.2 months versus 10.6 months for atezolizumab alone (stratified hazard ratio [HR] = 0.73; 95% CI: 0.57–0.95; p = 0.0174). From the point of randomization, the median PFS by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR = 0.54, 95% CI: 0.43–0.67; p < 0.0001).

加用阿特珠单抗方案的中位总生存期为13.2个月，而单独使用阿特珠单抗为10.6个月（分层风险比 [HR] = 0.73；95% 置信区间 [CI]：0.57–0.95；p = 0.0174）。从随机化开始，独立评估的中位无进展生存期分别为5.4个月和2.1个月（分层 HR = 0.54，95% CI：0.43–0.67；p < 0.0001）。

Treatment duration for patients in the .

患者的治疗持续时间。

Zepzelca

泽普赛卡

plus atezolizumab arm was twice as long as the atezolizumab arm, with a median maintenance treatment duration of 4.2 months versus 2.1 months, respectively.

加上阿特珠单抗组的治疗时间是阿特珠单抗组的两倍，中位维持治疗时间分别为4.2个月和2.1个月。

The

The

Zepzelca

泽普泽卡

plus atezolizumab combination as maintenance therapy was generally well tolerated with no new safety signals identified. In the

加上阿特珠单抗组合作为维持治疗通常耐受性良好，未发现新的安全信号。在

Zepzelca

泽普泽卡

plus atezolizumab and atezolizumab arms, respectively, treatment-related adverse events (TRAEs) occurred in 83.5% versus 40.0% of patients, with Grade 3-4 TRAEs in 25.6% versus 5.8% and Grade 5 TRAEs in 0.8% (two patients with sepsis and febrile neutropenia) versus 0.4% (one patient with sepsis). AEs led to treatment discontinuation in 6.2% of patients in the .

分别为83.5%和40.0%的患者发生治疗相关不良事件（TRAEs），其中3-4级TRAEs分别为25.6%和5.8%，5级TRAEs分别为0.8%（两名患者因败血症和发热性中性粒细胞减少）和0.4%（一名患者因败血症）。在联合治疗组中，不良事件导致6.2%的患者停止治疗。

Zepzelca

泽普泽卡

plus atezolizumab arm and 3.3% of patients in the atezolizumab arm.

加上阿特珠单抗组和阿特珠单抗组的3.3%的患者。

The Company will host an investor webcast on June 10 at 4:30 p.m. ET / 9:30 p.m. IST to review

公司将于东部时间6月10日下午4点30分/印度标准时间晚上9点30分举办投资者网络直播，以回顾相关内容。

Zepzelca

泽普泽卡

data. The webcast will include commentary from a leading small cell lung cancer expert and Company senior management. The webcast may be accessed from the Investors section of the Jazz Pharmaceuticals website at

数据。网络直播将包括一位领先的小细胞肺癌专家和公司高层管理的评论。网络直播可以通过 Jazz Pharmaceuticals 网站的投资者部分访问，网址是

www.jazzpharmaceuticals.com

www.jazzpharmaceuticals.com

.

。

About the IMforte Phase 3 Trial

关于IMforte第三阶段试验

IMforte (

IMforte (

NCT05091567

NCT05091567

) is an ongoing Phase 3, randomized, multicenter maintenance trial evaluating the efficacy, safety and pharmacokinetics of

) 是一项正在进行的 III 期、随机、多中心维持试验，评估其有效性、安全性和药代动力学特性。

Zepzelca

泽普泽卡

plus atezolizumab, compared with standard-of-care first-line maintenance with atezolizumab alone, in adults (≥18 years) with ES-SCLC, following induction therapy with carboplatin, etoposide and atezolizumab. The primary endpoints for this study are OS and independent review facility (IRF)-assessed PFS in the maintenance phase..

在成人（≥18岁）广泛期小细胞肺癌（ES-SCLC）患者中，对比标准一线维持治疗单独使用阿特珠单抗与联合使用阿特珠单抗的效果，这些患者在接受卡铂、依托泊苷和阿特珠单抗的诱导治疗后。本研究的主要终点是维持阶段的总生存期（OS）和独立审查机构（IRF）评估的无进展生存期（PFS）。

The trial consists of two phases: an induction phase and a maintenance phase. Participants were required to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 after the induction phase of four cycles of carboplatin, etoposide, and atezolizumab to be considered for eligibility screening for the maintenance phase.

试验分为两个阶段：诱导阶段和维持阶段。参与者在四个周期的卡铂、依托泊苷和阿特珠单抗诱导阶段后，必须根据实体瘤疗效评价标准（RECIST）v1.1 保持持续反应或疾病稳定，才有资格进入维持阶段的筛选。

Eligible participants were randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase..

符合条件的参与者以1:1的比例随机分配，在维持阶段接受lurbinectedin联合atezolizumab或单独使用atezolizumab。

The trial is sponsored by Roche and co-funded by Jazz Pharmaceuticals. Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at:

该试验由罗氏公司赞助，Jazz制药公司共同资助。有关该试验的更多信息，包括资格标准和临床试验地点列表，可以在以下网址找到：

ClinicalTrials.gov

临床试验.gov

(Identifier: NCT05091567).

（标识符：NCT05091567）。

About Small Cell Lung Cancer

关于小细胞肺癌

In the U.S., approximately 13 percent of lung cancers are small cell.

在美国，大约13%的肺癌是小细胞癌。

2

2

Approximately 30,000 new cases of small cell lung cancer (SCLC) are reported in the U.S. each year.

美国每年报告的小细胞肺癌 (SCLC) 新发病例大约为 30,000 例。

2

2

,

，

3

3

The risk for developing SCLC is much higher among current or former tobacco smokers; however, SCLC can also be caused by exposure to secondhand smoke, asbestos, some inhaled chemicals, radiation and air pollution. People with a family history of lung cancer may also be at a higher risk, too.

目前或曾经吸烟的人患小细胞肺癌的风险要高得多；然而，小细胞肺癌也可能由接触二手烟、石棉、某些吸入的化学物质、辐射和空气污染引起。有肺癌家族史的人可能也面临更高的风险。

4

4

SCLC is the most aggressive form of lung cancer and it tends to spread quickly to other parts of the body including the brain, liver and bone.

小细胞肺癌是肺癌中最具侵袭性的形式，它往往会迅速扩散到身体的其他部位，包括大脑、肝脏和骨骼。

5,6

5,6

A large percentage of SCLC patients on treatment briefly achieve a response, although the cancer often returns and is usually more aggressive and resistant to regimens that were previously effective.

大部分接受治疗的小细胞肺癌患者会短暂地出现缓解，尽管癌症经常复发并且通常更具侵袭性，对以前有效的治疗方案产生抵抗。

5

5

About Zepzelca

关于Zepzelca

®

®

(lurbinectedin)

(卢比奈定)

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，导致细胞周期的中断以及可能的细胞死亡。

4

4

The FDA approved

FDA批准

Zepzelca

泽普泽卡

under accelerated approval in June 2020 for the treatment of adult patients with metastatic small cell lung cancer (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. In December 2021, Jazz and PharmaMar announced the initiation of LAGOON, a confirmatory Phase 3 clinical trial of .

于2020年6月获得加速批准，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。该批准基于一项开放标签、单药治疗临床试验中展现的总体缓解率（ORR）和缓解持续时间。2021年12月，Jazz与PharmaMar宣布启动LAGOON，这是一项确证性的3期临床试验。

Zepzelca

泽普赛卡

for the treatment of patients with relapsed small cell lung cancer. If positive, LAGOON could confirm the benefit of

用于治疗复发性小细胞肺癌患者。如果结果积极，LAGOON可以证实其益处。

Zepzelca

泽普泽卡

in the treatment of SCLC when patients progress following 1L treatment with a platinum-based regimen and support full approval in the U.S.

在SCLC的治疗中，当患者在接受含铂方案的一线治疗后出现进展时，并在美国获得完全批准。

Zepzelca

泽普泽卡

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.

是一种用于治疗已扩散到身体其他部位（转移性）的小细胞肺癌（SCLC）成人患者的处方药，这些患者曾接受含铂化疗，但该治疗无效或不再有效。

Zepzelca

泽普泽卡

is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of

基于响应率和响应持续时间获得批准。更多的研究将进一步评估

Zepzelca

泽普泽卡

for this use.

用于此用途。

Important Safety Information

重要安全信息

Myelosuppression

骨髓抑制

ZEPZELCA can cause myelosuppression. In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA, 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.

ZEPZELCA 可能导致骨髓抑制。在 554 名接受 ZEPZELCA 治疗的晚期实体瘤患者的临床研究中，41% 的患者出现了 3 级或 4 级中性粒细胞减少症，中位发病时间为 15 天，中位持续时间为 7 天。7% 的患者出现发热性中性粒细胞减少症。

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

2% 的患者发生了脓毒症，其中 1% 患者因此死亡（所有病例均发生在非小细胞肺癌的实体瘤患者中）。10% 的患者发生了 3 级或 4 级血小板减少症，中位发病时间为 10 天，中位持续时间为 7 天。17% 的患者发生了 3 级或 4 级贫血。

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。

3

3

and platelet count of at least 100,000/mm

血小板计数至少为100,000/mm

3

3

.

。

Monitor blood counts including neutrophil count and platelet count prior to each administration. For neutrophil count less than 500 cells/mm

在每次给药前监测包括中性粒细胞计数和血小板计数在内的血细胞计数。当中性粒细胞计数低于500个细胞/mm

3

3

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、减少剂量或永久停止使用ZEPZELCA。

Hepatotoxicity

肝毒性

ZEPZELCA can cause hepatotoxicity. In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA, 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.

ZEPZELCA可能引起肝毒性。在554名接受ZEPZELCA治疗的晚期实体瘤患者的临床研究中，分别有6%和3%的患者观察到3级ALT和AST升高，分别有0.4%和0.5%的患者观察到4级ALT和AST升高。

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..

转氨酶升高至3级或以上的中位发病时间为8天（范围：3至49天），中位持续时间为7天。

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

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

Extravasation Resulting in Tissue Necrosis

渗漏导致组织坏死

Extravasation of ZEPZELCA resulting in skin and soft tissue injury, including necrosis requiring debridement, can occur. 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。

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，给予支持性护理，并根据需要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之前和治疗期间定期监测肌酸磷酸激酶（CPK），根据临床需要。根据严重程度暂停或减少剂量。

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 6 months after the last dose.

ZEPZELCA 在给孕妇使用时可能会对胎儿造成伤害。请告知孕妇对胎儿的潜在风险。建议有生育潜力的女性患者在使用 ZEPZELCA 治疗期间以及最后一剂后的 6 个月内使用有效的避孕措施。

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.

建议有生育潜力的女性伴侣的男性患者在使用ZEPZELCA治疗期间及最后一剂后4个月内采取有效的避孕措施。

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在人乳中是否存在的数据，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。

MOST COMMON ADVERSE REACTIONS

最常见的不良反应

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抑制剂和诱导剂的作用效果

Avoid coadministration with a strong or a moderate CYP3A inhibitor (including grapefruit and

避免与强效或中效CYP3A抑制剂（包括葡萄柚和

Seville

塞维利亚

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.

橙子），因为这会增加卢比内克丁的系统暴露，可能会增加ZEPZELCA不良反应的发生率和严重程度。如果不能避免联合使用，应适当减少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诱导剂共同给药，因其可能降低lurbinectedin的全身暴露量，从而可能降低ZEPZELCA的疗效。

GERIATRIC USE

老年使用

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，接受ZEPZELCA治疗的105名小细胞肺癌（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。未观察到65岁及以上患者与较年轻患者之间的总体疗效差异。

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%)..

≥65岁的患者发生严重不良反应的频率高于<65岁的患者（分别为49%和26%）。≥65岁患者中最常报告的严重不良反应与骨髓抑制有关，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%）。

Please see accompanying full

请参阅随附的完整内容

Prescribing Information

处方信息

.

。

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

ZEPZELCA 是 Pharma Mar, S.A. 的商标，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 potentially life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

）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。我们致力于为患有严重疾病的人群开发可能改变生命的药物——这些疾病往往缺乏或没有任何治疗选择。我们拥有多种已上市的药物组合，包括针对睡眠障碍和癫痫的领先疗法，并且我们的癌症治疗药物组合也在不断扩展。

Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. 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，推动了我们在肿瘤学和神经科学领域强大的创新治疗管道的开创性研发进展。Jazz 总部位于爱尔兰都柏林，在多个国家设有研发实验室、制造设施和员工，致力于为全球患者服务。

Please visit .

请访问 。

www.jazzpharmaceuticals.com

www.jazzpharmaceuticals.com

for more information.

更多信息，请参阅。

Jazz Pharmaceuticals plc

爵士制药公司

Caution 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 Zepzelca's potential as a first-line maintenance therapy for extensive-stage small cell lung cancer, the potential for Zepzelca in combination with atezolizumab to become a new standard of care for patients with ES-SCLC and other statements that are not historical facts.

本新闻稿包含前瞻性声明，包括但不限于关于Zepzelca作为广泛期小细胞肺癌一线维持治疗的潜力、Zepzelca与atezolizumab联合使用可能成为ES-SCLC患者的新护理标准，以及其他非历史事实的声明。

These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. 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, 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 plc's Securities and Exchange Commission filings and reports (Commission File No.

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。由于这些风险和不确定性，实际结果和事件的时间可能与此类前瞻性声明中预期的存在重大差异，这些风险和不确定性包括但不限于：与监管活动成功完成及不确定的监管批准相关的风险和不确定性，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 plc 在美国证券交易委员会文件和报告中不时在“风险因素”标题下及其他部分描述的内容（档案号：Commission File No.）。

001-33500), including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended .

001-33500），包括Jazz Pharmaceuticals的年度报告表格10-K，截至年份。

December 31, 2024

2024年12月31日

, as supplement by Jazz Pharmaceuticals' Quarterly Report on Form 10-Q for the quarter ended

，作为Jazz制药公司截至该季度的10-Q表季度报告的补充

March 31, 2025

2025年3月31日

, and future filings and reports by Jazz Pharmaceuticals. 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.

，并且Jazz Pharmaceuticals未来的文件和报告也可能影响。Jazz Pharmaceuticals尚未意识到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的时间与预期有重大差异。

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 undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made..

本前瞻性声明仅于本文件发布之日或前瞻性声明中指明的日期作出，即使其后 Jazz Pharmaceuticals 通过其网站或其他方式提供。Jazz Pharmaceuticals 没有义务更新或补充任何前瞻性声明，以反映实际结果、新信息、未来事件、期望的变化或其他在前瞻性声明作出日期之后存在的情况。

Contacts:

联系人：

Media Contact:

媒体联系人：

Kristin Bhavnani

克里斯汀·巴夫纳尼

Head of Global Corporate Communications

全球企业传播主管

Jazz Pharmaceuticals plc

爵士制药公司

CorporateAffairsMediaInfo@jazzpharma.com

企业事务媒体信息@jazzpharma.com

Ireland

爱尔兰

+353 1 637 2141

+353 1 637 2141

U.S. +1 215 867 4948

美国 +1 215 867 4948

Investors:

投资者：

Jeff Macdonald

杰夫·麦克唐纳

Executive Director, Investor Relations

投资者关系执行董事

Jazz Pharmaceuticals plc

爵士制药公司

investorinfo@jazzpharma.com

投资者信息@爵士制药.com

Ireland

爱尔兰

+353 1 634 3211

+353 1 634 3211

U.S. +1 650 496 2717

美国 +1 650 496 2717

1

1

Murray, Nevin, and

默里、内文，和

Andrew T. Turrisi III.

安德鲁·T·图里西三世。

A review of first-line treatment for small-cell lung cancer. Journal of Thoracic Oncology 1.3 (2006): 270-278.

小细胞肺癌一线治疗的综述。《胸部肿瘤学杂志》1.3（2006）：270-278。

2

2

Alvarado-Lunda G, Morales-Espinosa D. Treatment for small cell lung cancer, where are we now? – A review. Transl Lung Cancer Res. 2016;5(1):26-38.

阿尔瓦拉多-伦达 G，莫拉莱斯-埃斯皮诺萨 D。小细胞肺癌的治疗，我们现在处于什么阶段？——综述。《转化性肺癌研究》。2016年；5(1): 26-38。

3

3

SEER Explorer Lung and Bronchus Cancer, Recent Trends in SEER Incidence Rates, 2000-2016, by Age,

SEER Explorer 肺与支气管癌，2000-2016年SEER发病率近期趋势，按年龄划分，

https://seer.cancer.gov/explorer

https://seer.cancer.gov/explorer

Updated

更新时间

June 27, 2024

2024年6月27日

. Accessed

. 已访问

May 30, 2025

2025年5月30日

.

。

4

4

American Cancer Society. Small cell lung cancer causes, risk factors, and prevention.

美国癌症协会。小细胞肺癌的病因、风险因素和预防。

https://www.cancer.org/content/dam/CRC/PDF/Public/8709.00.pdf

https://www.cancer.org/content/dam/CRC/PDF/Public/8709.00.pdf

. Updated

. 已更新

May 16, 2016

2016年5月16日

. Accessed

. 已访问

May 30, 2025

2025年5月30日

.

。

5

5

American Cancer Society. What is lung cancer?

美国癌症协会。什么是肺癌？

https://www.cancer.org/cancer/lung-cancer/about/what-is.html

https://www.cancer.org/cancer/lung-cancer/about/what-is.html

. Updated

. 已更新

October 1, 2019

2019年10月1日

. Accessed

. 已访问

May 30, 2025

2025年5月30日

.

。

6

6

American Cancer Society. Small cell lung cancer stages.

美国癌症协会。小细胞肺癌分期。

https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/staging-sclc.html

https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/staging-sclc.html

. Updated

. 已更新

October 1, 2019

2019年10月1日

. Accessed

. 已访问

May 30, 2025

2025年5月30日

.

。

SOURCE Jazz Pharmaceuticals plc

来源：Jazz Pharmaceuticals plc

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