PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced statistically significant and clinically meaningful overall survival (OS) results from Part 1 and progression-free survival (PFS) results from Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial in adult patients with primary advanced or recurrent endometrial cancer.

费城--（商业新闻短讯）--葛兰素史克股份有限公司（LSE/NYSE:GSK）今天宣布了RUBY/ENGOT-EN6/GOG3031/NSGO III期临床试验成人原发性晚期或复发性子宫内膜癌患者第1部分的统计学显着性和临床意义的总生存期（OS）结果和第2部分的无进展生存期（PFS）结果。

These data were presented today in a late-breaking plenary session at the Society of Gynecologic Oncology 2024 Annual Meeting on Women’s Cancer (March 16-18)..

这些数据今天在妇科肿瘤学会2024年女性癌症年会（3月16日至18日）的一次最新全体会议上公布。

The goal of the RUBY phase III trial program is to evaluate which patients with primary advanced or recurrent endometrial cancer could potentially benefit from treatment with Jemperli (dostarlimab-gxly) plus chemotherapy, with or without the addition of Zejula (niraparib) maintenance. Part 1 of the RUBY phase III trial is investigating dostarlimab-gxly plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab-gxly compared to chemotherapy plus placebo followed by placebo.

RUBY III期试验计划的目标是评估哪些原发性晚期或复发性子宫内膜癌患者可能受益于Jemperli（dostarlimab gxly）加化疗，加或不加Zejula（niraparib）维持治疗。RUBY III期试验的第1部分正在研究dostarlimab gxly加标准治疗化疗（卡铂-紫杉醇），然后是dostarlimab gxly，与化疗加安慰剂，然后是安慰剂相比。

Part 2 of the RUBY phase III trial is evaluating dostarlimab-gxly plus standard-of-care chemotherapy, followed by dostarlimab-gxly plus niraparib as maintenance therapy compared to chemotherapy plus placebo followed by placebo. The safety and tolerability profiles of dostarlimab-gxly plus carboplatin-paclitaxel and dostarlimab-gxly plus carboplatin-paclitaxel followed by dostarlimab-glxy plus niraparib were generally consistent with the known safety profiles of the individual medicines..

RUBY III期试验的第2部分是评估dostarlimab gxly加标准护理化疗，然后是dostarlimab gxly加niraparib作为维持治疗，与化疗加安慰剂和安慰剂相比。dostarlimab gxly加卡铂-紫杉醇和dostarlimab gxly加卡铂-紫杉醇，然后是dostarlimab glxy加niraparib的安全性和耐受性概况通常与个体药物的已知安全性概况一致。

Previous data showed a statistically significant and clinically meaningful improvement in PFS with Jemperli plus chemotherapy versus chemotherapy alone in frontline mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. These data led to regulatory approvals for this patient population in the US, EU and certain other countries.

先前的数据显示，在一线错配修复缺陷型（dMMR）/微卫星不稳定性高（MSI-H）原发性晚期或复发性子宫内膜癌中，Jemperli加化疗与单纯化疗相比，PFS有统计学意义和临床意义的改善。这些数据导致了美国，欧盟和某些其他国家对该患者人群的监管批准。

Data presented today show additional potential benefit of dostarlimab-gxly plus chemotherapy, with or without the addition of niraparib, in the overall population of patients with primary advanced or recurrent endometrial cancer, including patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, for which there are currently no approved immuno-therapy-based regimens..

今天提供的数据显示，在原发性晚期或复发性子宫内膜癌患者（包括错配修复熟练（MMRp）/微卫星稳定（MSS）肿瘤患者）的总体人群中，dostarlimab gxly加化疗（加或不加niraparib）的额外潜在益处，目前还没有批准的基于免疫治疗的方案。

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK said: “The positive data presented today further show how dostarlimab-gxly-based regimens could benefit a broader set of patients with endometrial cancer. The results we’ve seen to date comprise the growing body of evidence supporting the role of dostarlimab-gxly as the backbone of our immuno-oncology development program.

葛兰素史克公司研发全球肿瘤学负责人高级副总裁Hesham Abdullah表示：“今天提供的积极数据进一步表明，基于dostarlimab gxly的方案可以使更广泛的子宫内膜癌患者受益。迄今为止，我们看到的结果包括越来越多的证据支持dostarlimab gxly作为我们免疫肿瘤学发展计划的支柱。

Our goal is to continue to identify ways to use dostarlimab-gxly alone and in combination with other therapies to help improve outcomes for patients with limited treatment options.”.

我们的目标是继续确定单独使用dostarlimab gxly并与其他疗法联合使用的方法，以帮助改善治疗选择有限的患者的预后。”

RUBY Part 1: a statistically significant and clinically meaningful improvement in OS was observed for dostarlimab-gxly plus chemotherapy versus placebo plus chemotherapy, meeting a primary endpoint of the study.

RUBY第1部分：dostarlimab gxly加化疗与安慰剂加化疗相比，OS有统计学意义和临床意义的改善，符合研究的主要终点。

Dostarlimab-gxly plus chemotherapy versus chemotherapy alone showed:

Dostarlimab gxly加化疗与单纯化疗相比显示：

In the overall population:

在总人口中：

a statistically significant reduction in the risk of death by 31% (Hazard Ratio [HR]: 0.69; [95% CI: 0.539–0.890])

死亡风险在统计学上显着降低了31%（危险比[HR]：0.69；[95%置信区间：0.539-0.890]）

a clinically meaningful improvement of 16.4 months in median OS (44.6 months vs 28.2 months)

中位OS的临床意义改善为16.4个月（44.6个月vs 28.2个月）

In a prespecified exploratory analysis of the MMRp/MSS population:

在对MMRp/MSS人群的预先指定的探索性分析中：

a clinically meaningful trend in reduced risk of death by 21% (HR: 0.79; [95% CI: 0.602–1.044])

临床上有意义的死亡风险降低21%（HR:0.79；[95%置信区间：0.602-1.044]）

a clinically meaningful improvement of seven months in median OS (34.0 months vs 27.0 months)

中位OS有临床意义的改善7个月（34.0个月vs 27.0个月）

Full OS summaries are shown below.

完整的操作系统摘要如下所示。

dostarlimab-gxly +

dostarimab gxly+

carboplatin-paclitaxel

卡铂-紫杉醇

placebo +

安慰剂+

carboplatin-paclitaxel

卡铂-紫杉醇

Overall population, Number (N)

总人口，数字（N）

245

245

249

249

OS, HR (95% CI)

OS，HR（95%置信区间）

0.69 (0.539–0.890)

0.69 (0.539–0.890)

P-value1

P值1

0.002

0.002

OS, median (95% CI), mo.

OS，中位数（95%CI），mo。

44.6 (32.6–NR)

44.6（32.6–NR）

28.2 (22.1–35.6)

28.2 (22.1–35.6)

dMMR/MSI-H population2, N

dMMR/MSI-H人口2，N

53

53

65

65

OS, HR (95% CI)

OS，HR（95%置信区间）

0.32 (0.166–0.629)

0.32 (0.166–0.629)

OS, median3 (95% CI), mo.

OS，中位数3（95%置信区间），mo。

NR (NR–NR)

NR（NR–NR）

31.4 (20.3–NR)

31.4（20.3–NR）

MMRp/MSS2, N

MMRp/MSS2，N

192

192

184

184

OS, HR (95% CI)

OS，HR（95%置信区间）

0.79 (0.602–1.044)

0.79 (0.602–1.044)

OS, median (95% CI), mo.

OS，中位数（95%CI），mo。

34.0 (28.6–NR)

34.0（28.6–NR）

27.0 (21.5–35.6)

27.0 (21.5–35.6)

1 One-sided p-value based on stratified log-rank test.

1基于分层对数秩检验的单侧p值。

2 Exploratory analyses of OS in dMMR/MSI-H and OS in MMRp/MSS populations were pre-specified with no planned hypothesis testing.

2 dMMR/MSI-H中OS和MMRp/MSS人群中OS的探索性分析是预先指定的，没有计划的假设检验。

3 Although the median OS was not reached, at 30 months the estimated reduction in the risk of death was 82.8% for patients who received dostarlimab plus chemotherapy vs. 54.1% for patients who received chemotherapy alone.

3虽然未达到中位OS，但在30个月时，接受dostarlimab加化疗的患者死亡风险估计降低了82.8%，而单独接受化疗的患者死亡风险降低了54.1%。

Matthew Powell, MD, Division of Gynecologic Oncology, Washington University School of Medicine, and US principal investigator of the RUBY trial said: “RUBY Part 1 is the first clinical trial to show a statistically significant and clinically meaningful improvement in overall survival for an immuno-oncology therapy in combination with chemotherapy in the overall population of patients with primary advanced or recurrent endometrial cancer.

华盛顿大学医学院妇科肿瘤科医学博士马修·鲍威尔，RUBY试验的美国首席研究员表示：“RUBY第1部分是第一个在原发性晚期或复发性子宫内膜癌患者总体人群中显示免疫肿瘤学治疗联合化疗的总体生存率有统计学意义和临床意义的改善的临床试验。

As a clinician, I celebrate the results of the RUBY Part 1 trial presented today, which show how dostarlimab-gxly added to chemotherapy could potentially benefit a broader set of patients with this type of cancer.”.

作为一名临床医生，我庆祝今天介绍的RUBY第1部分试验的结果，该试验表明，将dostarlimab gxly添加到化疗中可能会使更广泛的此类癌症患者受益。”。

In RUBY Part 1, grade 3 or higher and serious treatment-emergent adverse events (AEs) were approximately 12% higher in the dostarlimab-gxly plus carboplatin-paclitaxel arm (treatment arm) compared with the placebo plus carboplatin-paclitaxel arm (control arm). The nature and types of immune-related AEs in the dostarlimab-gxly plus chemotherapy safety profile were consistent with the mechanism of action of dostarlimab-gxly and similar to those reported for other PD-(L)1 inhibitors.

在RUBY第1部分中，与安慰剂加卡铂-紫杉醇组（对照组）相比，dostarlimab gxly加卡铂-紫杉醇组（治疗组）的3级或更高级别和严重治疗紧急不良事件（AE）高约12%。dostarlimab gxly加化疗安全性中免疫相关AE的性质和类型与dostarlimab gxly的作用机制一致，与其他PD-（L）1抑制剂的报道相似。

In the trial, 40.7% of participants in the treatment arm and 16.3% of participants in the control arm had immune-related AEs assessed by the investigator as related to dostarlimab-gxly or placebo, respectively. Discontinuation of dostarlimab-gxly or placebo due to a treatment-emergent AE occurred in 19.1% of patients in the treatment arm and 8.1% of patients in the control arm..

在该试验中，40.7%的治疗组参与者和16.3%的对照组参与者分别有研究者评估的与dostarlimab gxly或安慰剂相关的免疫相关AE。治疗组19.1%的患者和对照组8.1%的患者因治疗出现AE而停止服用dostarlimab gxly或安慰剂。。

GSK expects US Food and Drug Administration regulatory submission acceptance based on RUBY Part 1 data for an expanded indication in the overall population in the first half of this year.

葛兰素史克预计，今年上半年，美国食品和药物管理局（FDA）将根据RUBY第1部分的数据接受监管提交，以扩大总体人口的适应症。

RUBY Part 2: addition of niraparib to dostarlimab-gxly in maintenance setting significantly improved PFS in first-line primary advanced or recurrent endometrial cancer compared to chemotherapy alone, meeting the primary endpoint of the trial.

RUBY第2部分：与单独化疗相比，在维持治疗中向dostarlimab gxly中添加niraparib显着改善了一线原发性晚期或复发性子宫内膜癌的PFS，达到了试验的主要终点。

Dostarlimab-gxly plus chemotherapy followed by dostarlimab-gxly plus niraparib compared to placebo plus chemotherapy followed by placebo showed:

与安慰剂加化疗后安慰剂相比，Dostarlimab gxly加化疗后Dostarlimab gxly加niraparib显示：

In the overall population:

在总人口中：

a statistically significant reduction in the risk of disease progression or death by 40% (HR: 0.60 [95% CI: 0.43–0.82])

疾病进展或死亡风险在统计学上显着降低40%（HR:0.60[95%CI:0.43-0.82]）

a clinically meaningful improvement of 6.2 months in median PFS (14.5 months vs 8.3 months)

中位PFS的临床意义改善为6.2个月（14.5个月vs 8.3个月）

In the MMRp/MSS population:

在MMRp/MSS人群中：

a statistically significant reduction in the risk of disease progression or death by 37% (HR: 0.63 [95% CI: 0.44–0.91])

疾病进展或死亡风险在统计学上显着降低了37%（HR:0.63[95%CI:0.44-0.91]）

a clinically meaningful improvement of 6.0 months in median PFS (14.3 months vs 8.3 months)

中位PFS的临床意义改善为6.0个月（14.3个月vs 8.3个月）

Dr Mansoor Raza Mirza, Chief Oncologist, Copenhagen University Hospital, Denmark, and RUBY principal investigator said: “In RUBY Part 2, we observed that the use of dostarlimab-gxly in combination with niraparib in the maintenance therapy setting further improved progression-free survival versus placebo for patients with primary advanced or recurrent endometrial cancer.

丹麦哥本哈根大学医院首席肿瘤学家Mansoor Raza Mirza博士和RUBY首席研究员说：“在RUBY第二部分中，我们观察到在维持治疗环境中使用dostarlimab gxly联合niraparib进一步提高了原发性晚期或复发性子宫内膜癌患者的无进展生存率。

These findings are particularly important for patients who have MMRp/MSS tumors as the data help build on the initial benefit observed with an immuno-oncology plus chemotherapy regimen, reflecting the potential for the addition of niraparib maintenance to address unmet medical need for these patients.”.

这些发现对于患有MMRp/MSS肿瘤的患者尤其重要，因为这些数据有助于建立在免疫肿瘤学加化疗方案观察到的初始益处的基础上，反映了增加尼拉帕利维持治疗以解决这些患者未满足的医疗需求的潜力。”。

In RUBY Part 2, grade 3 or higher and serious treatment-emergent AEs were approximately 36% and 24% higher, respectively, in the dostarlimab-gxly plus chemotherapy followed by dostarlimab-gxly plus niraparib arm (treatment arm) compared with the placebo plus chemotherapy followed by placebo arm (control arm).

在RUBY第2部分中，与安慰剂加化疗相比，dostarlimab gxly加化疗后dostarlimab gxly加niraparib组（治疗组）的3级或更高级别和严重治疗出现的AE分别高约36%和24%，其次是安慰剂组（对照组）。

In the trial, 36.6% of participants in the treatment arm and 6.3% of participants in the control arm had immune-related AEs assessed by the investigator as related to dostarlimab-gxly or placebo, respectively. No cases of myelodysplastic syndrome/acute myeloid leukemia were reported; other secondary primary malignancies occurred in 1 patient each in both treatment arms.

在试验中，36.6%的治疗组参与者和6.3%的对照组参与者分别有研究者评估的与dostarlimab gxly或安慰剂相关的免疫相关AE。没有骨髓增生异常综合征/急性骨髓性白血病的报道；两个治疗组各有1例患者发生其他继发性原发性恶性肿瘤。

Discontinuation of dostarlimab-gxly or placebo due to a TEAE occurred in 24.1% of patients in the treatment arm and 5.2% of patients in the control arm. Discontinuation of niraparib or placebo due to a treatment-emergent AE occurred in 15.7% of patients in the treatment arm and 4.2% of patients in the control arm..

治疗组24.1%的患者和对照组5.2%的患者因TEAE停止服用dostarlimab gxly或安慰剂。治疗组15.7%的患者和对照组4.2%的患者因治疗紧急AE而停用尼拉帕利或安慰剂。。

About endometrial cancer

关于子宫内膜癌

Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynecologic cancer in developed countries, with approximately 417,000 new cases reported each year worldwide1, and incidence rates are expected to rise by almost 40% between 2020 and 2040.2,3 Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.4.

子宫内膜癌发现于子宫内膜，称为子宫内膜。子宫内膜癌是发达国家最常见的妇科癌症，全球每年报告约417000例新病例1，2020年至2040年期间发病率预计将上升近40%.2,3大约15-20%的子宫内膜癌患者在诊断时将被诊断为晚期疾病。

About RUBY

关于RUBY

RUBY is a two-part global, randomized, double-blind, multicenter phase III trial of patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab-gxly plus carboplatin-paclitaxel followed by dostarlimab-gxly versus carboplatin-paclitaxel plus placebo followed by placebo.

RUBY是一项针对原发性晚期或复发性子宫内膜癌患者的两部分全球，随机，双盲，多中心III期临床试验。第1部分是评估dostarlimab gxly加卡铂-紫杉醇，然后是dostarlimab gxly与卡铂-紫杉醇加安慰剂，然后是安慰剂。

Part 2 is evaluating dostarlimab-gxly plus carboplatin-paclitaxel followed by dostarlimab-gxly plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo..

第2部分是评估dostarlimab gxly加卡铂-紫杉醇，然后是dostarlimab gxly加niraparib与安慰剂加卡铂-紫杉醇，然后是安慰剂。

In Part 1, the dual-primary endpoints are investigator-assessed PFS based on the Response Evaluation Criteria in Solid Tumors v1.1 and OS. The statistical analysis plan included pre-specified analyses of PFS in the dMMR/MSI-H and overall populations and OS in the overall population. Pre-specified exploratory analyses of PFS and OS in the MMRp/MSS population and OS in the dMMR/MSI-H populations were also performed.

在第1部分中，双重主要终点是基于实体瘤v1.1和OS中的反应评估标准的研究者评估的PFS。统计分析计划包括对dMMR/MSI-H中PFS以及总体人群和总体人群中OS的预先指定分析。还对MMRp/MSS人群中的PFS和OS以及dMMR/MSI-H人群中的OS进行了预先指定的探索性分析。

RUBY Part 1 included a broad population, including histologies often excluded from clinical trials and had approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma..

RUBY第1部分包括广泛的人群，包括通常被排除在临床试验之外的组织学，大约有10%的癌肉瘤患者和20%的浆液性癌患者。

In Part 2, the primary endpoint is investigator-assessed PFS in the overall population, followed by PFS in the MMRp/MSS population, and OS in the overall population is a key secondary endpoint. Additional secondary endpoints in Part 1 and Part 2 include PFS per blinded independent central review, PFS2, overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability..

在第2部分中，主要终点是总体人群中研究者评估的PFS，其次是MMRp/MSS人群中的PFS，总体人群中的OS是关键的次要终点。第1部分和第2部分的其他次要终点包括每个盲法独立中央审查的PFS，PFS2，总体缓解率，缓解持续时间，疾病控制率，患者报告的结果以及安全性和耐受性。

RUBY is part of an international collaboration between the European Network of Gynaecological Oncological Trial groups (ENGOT), a research network of the European Society of Gynaecological Oncology (ESGO) that consists of 22 trial groups from 31 European countries that perform cooperative clinical trials, and the GOG Foundation, a non-profit organization dedicated to transforming the standard of care in gynecologic oncology..

RUBY是欧洲妇科肿瘤试验小组网络（ENGOT）和GOG基金会之间国际合作的一部分，该网络是欧洲妇科肿瘤学会（ESGO）的研究网络，由来自31个欧洲国家的22个进行合作临床试验的试验小组组成，一家致力于改变妇科肿瘤学护理标准的非营利组织。

About Jemperli (dostarlimab-gxly)

关于Jemperli（dostarlimab gxly）

Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.5

Jemperli是一种程序性死亡受体-1（PD-1）阻断抗体，与PD-1受体结合并阻断其与PD-1配体PD-L1和PD-L2.5的相互作用

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialization, and manufacturing of Jemperli, and cobolimab (GSK4069889), a TIM-3 antagonist..

Jemperli是由AnaptysBio，Inc.发现的，并根据2014年3月签署的合作和独家许可协议授权给TESARO，Inc。根据该协议，GSK负责Jemperli和TIM-3拮抗剂cobolimab（GSK4069889）的持续研究，开发，商业化和制造。

Indications and Important Safety Information for JEMPERLI (dostarlimab-gxly)

JEMPERLI（dostarlimab gxly）的适应症和重要安全信息

JEMPERLI, in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H)..

JEMPERLI联合卡铂和紫杉醇，然后是JEMPERLI作为单一药物，用于治疗成人原发性晚期或复发性子宫内膜癌（EC），其错配修复缺陷（dMMR），由FDA批准的测试确定，或微卫星不稳定性高（MSI-H）。

JEMPERLI, as a single agent, is indicated for the treatment of adult patients with dMMR recurrent or advanced:

JEMPERLI作为一种单一药物，适用于治疗dMMR复发或晚期的成年患者：

EC, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation, or

根据FDA批准的测试确定，EC在任何情况下均已在含铂方案的先前治疗中或之后取得进展，并且不适合进行根治性手术或放射治疗，或者

solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)..

通过FDA批准的测试确定的实体瘤，在先前的治疗或之后已经进展，并且没有令人满意的替代治疗选择。根据肿瘤反应率和反应持久性，该适应症在加速批准下获得批准。是否继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。

Important Safety Information

重要安全信息

Severe and Fatal Immune-Mediated Adverse Reactions

严重致命的免疫介导的不良反应

Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue and can occur at any time during or after treatment with a PD-1/PD-L1–blocking antibody, including JEMPERLI.

免疫介导的不良反应可能是严重或致命的，可能发生在任何器官系统或组织中，并且可能在用PD-1/PD-L1阻断抗体（包括JEMPERLI）治疗期间或之后的任何时间发生。

Monitor closely for signs and symptoms of immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. For suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection.

密切监测免疫介导的不良反应的体征和症状。在基线和治疗期间定期评估肝酶，肌酐和甲状腺功能测试。对于疑似免疫介导的不良反应，启动适当的检查以排除其他病因，包括感染。

Institute medical management promptly, including specialty consultation as appropriate..

及时进行医疗管理，包括适当的专业咨询。

Based on the severity of the adverse reaction, withhold or permanently discontinue JEMPERLI. In general, if JEMPERLI requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to ≤Grade 1. Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue to taper over at least 1 month.

根据不良反应的严重程度，停止或永久停用JEMPERLI。一般来说，如果JEMPERLI需要中断或停用，则给予全身皮质类固醇（1至2 mg/kg/天泼尼松或等效药物），直至改善至≤1级。在改善至≤1级后，开始减少皮质类固醇激素，并在至少1个月内继续减少。

Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids..

考虑在免疫介导的不良反应不受皮质类固醇控制的患者中使用其他全身免疫抑制剂。

Immune-Mediated Pneumonitis

免疫介导性肺炎

JEMPERLI can cause immune-mediated pneumonitis, which can be fatal. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Pneumonitis occurred in 2.3% (14/605) of patients, including Grade 2 (1.3%), Grade 3 (0.8%), and Grade 4 (0.2%) pneumonitis..

JEMPERLI可引起免疫介导的肺炎，这可能是致命的。在接受其他PD-1/PD-L1阻断抗体治疗的患者中，接受过胸部放疗的患者肺炎的发生率更高。肺炎发生率为2.3%（14/605），包括2级（1.3%），3级（0.8%）和4级（0.2%）肺炎。

Immune-Mediated Colitis

免疫介导的结肠炎

Colitis occurred in 1.3% (8/605) of patients, including Grade 2 (0.7%) and Grade 3 (0.7%) adverse reactions. Cytomegalovirus infection/reactivation have occurred in patients with corticosteroid-refractory immune-mediated colitis. In such cases, consider repeating infectious workup to exclude alternative etiologies..

结肠炎发生率为1.3%（8/605），包括2级（0.7%）和3级（0.7%）不良反应。皮质类固醇难治性免疫介导的结肠炎患者发生巨细胞病毒感染/再激活。在这种情况下，考虑重复感染性检查以排除其他病因。

Immune-Mediated Hepatitis

免疫介导的肝炎

JEMPERLI can cause immune-mediated hepatitis, which can be fatal. Grade 3 hepatitis occurred in 0.5% (3/605) of patients.

JEMPERLI可以引起免疫介导的肝炎，这可能是致命的。0.5%（3/605）的患者发生3级肝炎。

Immune-Mediated Endocrinopathies

免疫介导的内分泌病

Adrenal Insufficiency

肾上腺皮质功能不全

Adrenal insufficiency occurred in 1.2% (7/605) of patients, including Grade 2 (0.5%) and Grade 3 (0.7%). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity..

肾上腺功能不全发生率为1.2%（7/605），包括2级（0.5%）和3级（0.7%）。对于2级或更高级别的肾上腺功能不全，根据机构指南开始对症治疗，包括临床指示的激素替代。根据严重程度扣留或永久停用JEMPERLI。

Hypophysitis

垂体炎

JEMPERLI can cause immune-mediated hypophysitis. Grade 3 hypophysitis occurred in 0.4% (1/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel. Grade 2 hypophysitis occurred in 0.2% (1/605) of patients receiving JEMPERLI as a single agent. Initiate hormone replacement as clinically indicated.

JEMPERLI可引起免疫介导的垂体炎。接受JEMPERLI联合卡铂和紫杉醇治疗的患者中有0.4%（1/241）发生3级垂体炎。接受JEMPERLI作为单一药物的患者中有0.2%（1/605）发生2级垂体炎。根据临床指示开始激素替代。

Withhold or permanently discontinue JEMPERLI depending on severity..

根据严重程度扣留或永久停用JEMPERLI。

Thyroid Disorders

甲状腺疾病

Grade 2 thyroiditis occurred in 0.5% (3/605) of patients. Grade 2 hypothyroidism occurred in 12% (28/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel. Grade 2 hypothyroidism occurred in 8% (46/605) of patients receiving JEMPERLI as a single agent. Hyperthyroidism occurred in 3.3% (8/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel, including Grade 2 (2.9%) and Grade 3 (0.4%).

0.5%（3/605）的患者发生2级甲状腺炎。接受JEMPERLI联合卡铂和紫杉醇治疗的患者中有12%（28/241）发生2级甲状腺功能减退症。接受JEMPERLI作为单一药物的患者中有8%（46/605）发生2级甲状腺功能减退症。接受JEMPERLI联合卡铂和紫杉醇治疗的患者中，甲状腺功能亢进发生率为3.3%（8/241），包括2级（2.9%）和3级（0.4%）。

Hyperthyroidism occurred in 2.3% (14/605) of patients receiving JEMPERLI as a single agent, including Grade 2 (2.1%) and Grade 3 (0.2%). Initiate thyroid hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity..

接受JEMPERLI作为单一药物的患者中有2.3%（14/605）发生甲状腺功能亢进，包括2级（2.1%）和3级（0.2%）。根据临床指示，开始甲状腺激素替代或甲状腺功能亢进的医疗管理。根据严重程度扣留或永久停用JEMPERLI。

Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis

1型糖尿病，可伴有糖尿病酮症酸中毒

JEMPERLI can cause type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Grade 3 type 1 diabetes mellitus occurred in 0.4% (1/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel. Grade 3 type 1 diabetes mellitus occurred in 0.2% (1/605) of patients receiving JEMPERLI as a single agent.

JEMPERLI可引起1型糖尿病，可伴有糖尿病酮症酸中毒。接受JEMPERLI联合卡铂和紫杉醇治疗的患者中，有0.4%（1/241）发生3级1型糖尿病。接受JEMPERLI作为单一药物的患者中有0.2%（1/605）发生3级1型糖尿病。

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity..

监测患者的高血糖或其他糖尿病体征和症状。根据临床指示开始胰岛素治疗。根据严重程度扣留或永久停用JEMPERLI。

Immune-Mediated Nephritis with Renal Dysfunction

免疫介导性肾炎伴肾功能不全

JEMPERLI can cause immune-mediated nephritis, which can be fatal. Grade 2 nephritis, including tubulointerstitial nephritis, occurred in 0.5% (3/605) of patients.

JEMPERLI可引起免疫介导的肾炎，这可能是致命的。0.5%（3/605）的患者发生2级肾炎，包括肾小管间质性肾炎。

Immune-Mediated Dermatologic Adverse Reactions

免疫介导的皮肤病不良反应

JEMPERLI can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred with PD-1/PD-L1–blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes.

JEMPERLI可引起免疫介导的皮疹或皮炎。PD-1/PD-L1阻断抗体已发生大疱性和剥脱性皮炎，包括史蒂文斯-约翰逊综合征（SJS），中毒性表皮坏死松解症（TEN）以及伴有嗜酸性粒细胞增多和全身症状的药疹（DRESS）。局部润肤剂和/或局部皮质类固醇可能足以治疗轻度至中度非大疱性/剥脱性皮疹。

Withhold or permanently discontinue JEMPERLI depending on severity..

根据严重程度扣留或永久停用JEMPERLI。

Other Immune-Mediated Adverse Reactions

其他免疫介导的不良反应

The following clinically significant immune-mediated adverse reactions occurred in <1% of the 605 patients treated with JEMPERLI or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.

在接受JEMPERLI治疗或使用其他PD-1/PD-L1阻断抗体治疗的605例患者中，有不到1%发生了以下临床上显着的免疫介导的不良反应。据报道，其中一些不良反应有严重或致命的病例。

Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy

神经系统：脑膜炎、脑炎、脊髓炎和脱髓鞘、肌无力综合征/重症肌无力、格林-巴利综合征、神经麻痹、自身免疫性神经病

Cardiac/Vascular: Myocarditis, pericarditis, vasculitis

心脏/血管：心肌炎，心包炎，血管炎

Ocular: Uveitis, iritis, other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur

眼部：葡萄膜炎，虹膜炎，其他眼部炎症毒性。有些病例可能与视网膜脱离有关。可能会出现各种程度的视力障碍，包括失明

Gastrointestinal: Pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis

胃肠道：胰腺炎，包括血清淀粉酶和脂肪酶水平升高，胃炎，十二指肠炎

Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica

肌肉骨骼和结缔组织：肌炎/多发性肌炎，横纹肌溶解症和相关后遗症，包括肾衰竭，关节炎，风湿性多肌痛

Endocrine: Hypoparathyroidism

内分泌：甲状旁腺功能减退

Other (Hematologic/Immune): Autoimmune hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.

其他（血液学/免疫）：自身免疫性溶血性贫血，再生障碍性贫血，噬血细胞淋巴组织细胞增多症，全身炎症反应综合征，组织细胞坏死性淋巴结炎（菊池淋巴结炎），结节病，免疫性血小板减少症，实体器官移植排斥反应，其他移植（包括角膜移植）排斥反应。

Infusion-Related Reactions

输液相关反应

Severe or life-threatening infusion-related reactions have been reported with PD-1/PD-L1–blocking antibodies. Severe infusion-related reactions (Grade 3) occurred in 0.2% (1/605) of patients receiving JEMPERLI. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue JEMPERLI based on severity of reaction..

据报道，PD-1/PD-L1阻断抗体会导致严重或危及生命的输注相关反应。接受JEMPERLI治疗的患者中有0.2%（1/605）发生严重的输液相关反应（3级）。监测患者输液相关反应的体征和症状。根据反应的严重程度，中断或减慢输注速度或永久停止JEMPERLI。

Complications of Allogeneic HSCT

同种异体造血干细胞移植的并发症

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after treatment with a PD-1/PD-L1–blocking antibody, which may occur despite intervening therapy. Monitor patients closely for transplant-related complications and intervene promptly..

在用PD-1/PD-L1阻断抗体治疗之前或之后接受异基因造血干细胞移植（HSCT）的患者可能会发生致命和其他严重并发症，尽管进行了干预治疗，但仍可能发生这种情况。密切监测患者的移植相关并发症，并及时干预。

Embryo-Fetal Toxicity and Lactation

胚胎-胎儿毒性和哺乳

Based on its mechanism of action, JEMPERLI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with JEMPERLI and for 4 months after their last dose. Because of the potential for serious adverse reactions from JEMPERLI in a breastfed child, advise women not to breastfeed during treatment with JEMPERLI and for 4 months after their last dose..

根据其作用机制，JEMPERLI可引起胎儿伤害。告知孕妇对胎儿的潜在风险。建议有生殖潜力的女性在接受JEMPERLI治疗期间和最后一次服用后4个月内使用有效的避孕措施。由于JEMPERLI可能会对母乳喂养的孩子产生严重的不良反应，因此建议女性在接受JEMPERLI治疗期间以及最后一次服用后的4个月内不要母乳喂养。

Common Adverse Reactions

常见不良反应

The most common adverse reactions (≥20%) in patients with dMMR/MSI-H EC who received JEMPERLI in combination with carboplatin and paclitaxel were rash, diarrhea, hypothyroidism, and hypertension. The most common Grade 3 or 4 laboratory abnormalities (≥10%) were decreased neutrophils, decreased hemoglobin, decreased white blood cell count, decreased lymphocytes, increased glucose, decreased sodium, and decreased platelets..

接受JEMPERLI联合卡铂和紫杉醇治疗的dMMR/MSI-H EC患者最常见的不良反应（≥20%）是皮疹，腹泻，甲状腺功能减退和高血压。最常见的3级或4级实验室异常（≥10%）是中性粒细胞减少，血红蛋白减少，白细胞计数减少，淋巴细胞减少，葡萄糖增加，钠减少和血小板减少。

The most common adverse reactions (≥20%) in patients with dMMR EC who received JEMPERLI as a single agent were fatigue/asthenia, anemia, nausea, diarrhea, constipation, vomiting, and rash. The most common Grade 3 or 4 laboratory abnormalities (>2%) were decreased lymphocytes, decreased sodium, increased alanine aminotransferase, increased creatinine, decreased neutrophils, decreased albumin, and increased alkaline phosphatase..

接受JEMPERLI作为单一药物的dMMR-EC患者最常见的不良反应（≥20%）是疲劳/虚弱，贫血，恶心，腹泻，便秘，呕吐和皮疹。最常见的3级或4级实验室异常（>2%）是淋巴细胞减少，钠减少，丙氨酸氨基转移酶增加，肌酐增加，中性粒细胞减少，白蛋白减少和碱性磷酸酶增加。

The most common adverse reactions (≥20%) in patients with dMMR solid tumors who received JEMPERLI as a single agent were fatigue/asthenia, anemia, diarrhea, and nausea. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased sodium, increased alkaline phosphatase, and decreased albumin..

接受JEMPERLI作为单一药物的dMMR实体瘤患者最常见的不良反应（≥20%）是疲劳/虚弱，贫血，腹泻和恶心。最常见的3或4级实验室异常（≥2%）是淋巴细胞减少，钠减少，碱性磷酸酶增加和白蛋白减少。

Please see the full US Prescribing Information for JEMPERLI.

请参阅JEMPERLI的完整美国处方信息。

About Zejula (niraparib)

关于Zejula（niraparib）

Zejula is an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor.

Zejula是一种口服，每日一次的聚（ADP-核糖）聚合酶（PARP）抑制剂。

Indication and Important Safety Information for ZEJULA (niraparib)

ZEJULA（niraparib）的适应症和重要安全信息

ZEJULA (niraparib) tablets 100 mg/200 mg/300 mg are indicated:

ZEJULA（niraparib）片剂100 mg/200 mg/300 mg如下所示：

for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy

用于对一线铂类化疗完全或部分缓解的晚期上皮性卵巢癌，输卵管癌或原发性腹膜癌成年患者的一线维持治疗

for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA.

用于维持治疗对铂类化疗完全或部分反应的有害或疑似有害生殖系BRCA突变的复发性上皮性卵巢癌，输卵管癌或原发性腹膜癌的成年患者。根据FDA批准的ZEJULA伴随诊断选择患者进行治疗。

Important Safety Information

重要安全信息

Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), including cases with a fatal outcome, have been reported in patients who received ZEJULA. In PRIMA, MDS/AML occurred in 6 out of 484 (1.2%) patients treated with ZEJULA, and in 3 out of 244 (1.2%) patients treated with placebo. The duration of therapy with ZEJULA in patients who developed secondary MDS/cancer therapy-related AML varied from 3.7 months to 2.5 years.

据报道，接受ZEJULA治疗的患者出现了骨髓增生异常综合征/急性髓细胞白血病（MDS/AML），包括致命结局的病例。在PRIMA中，484名接受ZEJULA治疗的患者中有6名（1.2%）发生MDS/AML，244名接受安慰剂治疗的患者中有3名（1.2%）发生MDS/AML。发生继发性MDS/癌症治疗相关AML的患者接受ZEJULA治疗的持续时间从3.7个月到2.5年不等。

In NOVA, of patients within the gBRCAmut cohort, MDS/AML occurred in 10 out of 136 (7%) patients treated with ZEJULA and in 2 out of 65 (3%) patients treated with placebo. The duration of therapy with ZEJULA in patients who developed secondary MDS/cancer therapy-related AML varied from 3.6 months to 5.9 years.

在NOVA，gBRCAmut队列中的患者中，136例（7%）接受ZEJULA治疗的患者中有10例发生MDS/AML，65例（3%）接受安慰剂治疗的患者中有2例发生MDS/AML。发生继发性MDS/癌症治疗相关AML的患者接受ZEJULA治疗的持续时间从3.6个月到5.9年不等。

All patients who developed secondary MDS/cancer therapy-related AML had received previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy. For suspected MDS/AML or prolonged hematological toxicities, refer the patient to a hematologist for further evaluation.

所有发生继发性MDS/癌症治疗相关AML的患者都曾接受过铂类药物和/或其他DNA损伤剂（包括放疗）的化疗。对于疑似MDS/AML或长期血液学毒性，请将患者转介给血液学家进行进一步评估。

Discontinue ZEJULA if MDS/AML is confirmed..

如果MDS/AML得到确认，停止使用ZEJULA。

Hematologic adverse reactions (thrombocytopenia, anemia, neutropenia, and/or pancytopenia) have been reported in patients receiving ZEJULA. The overall incidence of Grade ≥3 thrombocytopenia, anemia, and neutropenia were reported, respectively, in 39%, 31%, and 21% of patients receiving ZEJULA in PRIMA and 29%, 25%, and 20% of patients receiving ZEJULA in NOVA.

据报道，接受ZEJULA治疗的患者出现了血液学不良反应（血小板减少症，贫血，中性粒细胞减少症和/或全血细胞减少症）。据报道，在PRIMA接受ZEJULA治疗的患者中，有39%，31%和21%的患者发生≥3级血小板减少症，贫血和中性粒细胞减少症的总发生率，在NOVA接受ZEJULA治疗的患者中，有29%，25%和20%的患者发生率。

Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 4%, 2%, and 2% of patients in PRIMA and 3%, 1%, and 2% of patients in NOVA. In patients who were administered a starting dose of ZEJULA based on baseline weight or platelet count in PRIMA, Grade ≥3 thrombocytopenia, anemia, and neutropenia were reported, respectively, in 22%, 23%, and 15% of patients receiving ZEJULA.

PRIMA患者中有4%，2%和2%的患者以及NOVA患者中有3%，1%和2%的患者因血小板减少症，贫血和中性粒细胞减少症而停药。在根据PRIMA基线体重或血小板计数服用起始剂量ZEJULA的患者中，接受ZEJULA治疗的患者中，分别有22%，23%和15%报告了≥3级血小板减少症，贫血和中性粒细胞减少症。

Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 3%, 3%, and 2% of patients. Do not start ZEJULA until patients have recovered from hematological toxicity caused by prior chemotherapy (≤Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months, and periodically thereafter.

分别有3%，3%和2%的患者因血小板减少，贫血和中性粒细胞减少而停药。在患者从先前化疗引起的血液学毒性（≤1级）恢复之前，不要开始使用ZEJULA。第一个月每周监测全血细胞计数，接下来的11个月每月监测一次，之后定期监测。

If hematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA, and refer the patient to a hematologist for further investigations..

如果血液学毒性在中断后28天内没有解决，请停用ZEJULA，并将患者转介给血液学家进行进一步调查。

Hypertension and hypertensive crisis have been reported in patients receiving ZEJULA. Grade 3-4 hypertension occurred in 6% of patients receiving ZEJULA vs 1% of patients receiving placebo in PRIMA, with no reported discontinuations. Grade 3-4 hypertension occurred in 9% of patients receiving ZEJULA vs 2% of patients receiving placebo in NOVA, with discontinuation occurring in <1% of patients.

据报道，接受ZEJULA治疗的患者患有高血压和高血压危象。接受ZEJULA治疗的患者中有6%发生3-4级高血压，而PRIMA中接受安慰剂治疗的患者中有1%发生高血压，没有报告停药。接受ZEJULA治疗的患者中有9%发生3-4级高血压，而NOVA接受安慰剂治疗的患者中有2%发生3-4级高血压，停药率低于1%。

Monitor blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

前两个月至少每周监测一次血压和心率，第一年每月监测一次，之后在用ZEJULA治疗期间定期监测。密切监测心血管疾病患者，尤其是冠状动脉功能不全、心律失常和高血压患者。

Manage hypertension with antihypertensive medications and adjustment of the ZEJULA dose if necessary..

使用抗高血压药物治疗高血压，必要时调整ZEJULA剂量。

Posterior reversible encephalopathy syndrome (PRES) occurred in 0.1% of 2,165 patients treated with ZEJULA in clinical trials and has also been described in postmarketing reports. Monitor all patients for signs and symptoms of PRES, which include seizure, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.

在临床试验中，用ZEJULA治疗的2165例患者中，有0.1%发生了后部可逆性脑病综合征（PRES），上市后报告中也有描述。监测所有患者的PRES体征和症状，包括癫痫发作，头痛，精神状态改变，视力障碍或皮质盲，伴或不伴高血压。

Diagnosis requires confirmation by brain imaging. If suspected, promptly discontinue ZEJULA and administer appropriate treatment. The safety of reinitiating ZEJULA is unknown..

诊断需要通过脑部成像进行确认。如果怀疑，立即停用ZEJULA并进行适当的治疗。重新启动ZEJULA的安全性尚不清楚。

Embryo-fetal toxicity and lactation: Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months after receiving their final dose of ZEJULA. Because of the potential for serious adverse reactions from ZEJULA in breastfed infants, advise lactating women not to breastfeed during treatment with ZEJULA and for 1 month after receiving the last dose..

胚胎-胎儿毒性和哺乳期：根据其作用机制，ZEJULA可引起胎儿伤害。建议女性注意对胎儿的潜在风险的生殖潜力，并在治疗期间和接受最终剂量的ZEJULA后6个月内使用有效的避孕方法。由于ZEJULA可能会对母乳喂养的婴儿产生严重的不良反应，因此建议哺乳期妇女在服用ZEJULA期间以及服用最后一剂后1个月内不要母乳喂养。

First-line Maintenance Advanced Ovarian Cancer

一线维持治疗晚期卵巢癌

Most common adverse reactions (Grades 1-4) in ≥10% of all patients who received ZEJULA in PRIMA were thrombocytopenia (66%), anemia (64%), nausea (57%), fatigue (51%), neutropenia (42%), constipation (40%), musculoskeletal pain (39%), leukopenia (28%), headache (26%), insomnia (25%), vomiting (22%), dyspnea (22%), decreased appetite (19%), dizziness (19%), cough (18%), hypertension (18%), AST/ALT elevation (14%), and acute kidney injury (12%)..

在PRIMA接受ZEJULA治疗的所有患者中，≥10%的最常见不良反应（1-4级）是血小板减少症（66%），贫血（64%），恶心（57%），疲劳（51%），中性粒细胞减少症（42%），便秘（40%），肌肉骨骼疼痛（39%），白细胞减少症（28%），头痛（26%），失眠（25%），呕吐（22%），呼吸困难（22%），食欲下降（19%），头晕（19%），咳嗽（18%），高血压（18%），AST/ALT升高（14%）和急性肾损伤（12%）。

Common lab abnormalities (Grades 1-4) in ≥25% of all patients who received ZEJULA in PRIMA included: decreased hemoglobin (87%), decreased platelets (74%), decreased leukocytes (71%), increased glucose (66%), decreased neutrophils (66%), decreased lymphocytes (51%), increased alkaline phosphatase (46%), increased creatinine (40%), decreased magnesium (36%), increased AST (35%), and increased ALT (29%)..

在PRIMA接受ZEJULA治疗的所有患者中，≥25%的常见实验室异常（1-4级）包括：血红蛋白降低（87%），血小板减少（74%），白细胞减少（71%），葡萄糖增加（66%），中性粒细胞减少（66%），淋巴细胞减少（51%），碱性磷酸酶增加（46%），肌酐增加（40%），镁减少（36%），AST增加（35%），ALT升高（29%）。

Maintenance Recurrent Germline BRCA-mutated Ovarian Cancer

维持复发性生殖系BRCA突变的卵巢癌

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received ZEJULA in NOVA gBRCAmut Cohort were nausea (77%), thrombocytopenia (71%), fatigue (61%), anemia (52%), vomiting (40%), constipation (38%), headache (35%), neutropenia (31%), decreased appetite (22%), hypertension (21%), insomnia (18%), dizziness (18%), dyspnea (17%), dyspepsia (17%), back pain (16%), cough (16%), nasopharyngitis (13%), dry mouth (13%), dysgeusia (13%), urinary tract infection (11%), rash (10%), and anxiety (10%)..

在NOVA gBRCAmut队列中接受ZEJULA治疗的患者中，≥10%的患者最常见的不良反应（1-4级）是恶心（77%），血小板减少（71%），疲劳（61%），贫血（52%），呕吐（40%），便秘（38%），头痛（35%），中性粒细胞减少（31%），食欲下降（22%），高血压（21%），失眠（18%），头晕（18%），呼吸困难（17%），消化不良（17%），背痛（16%），咳嗽（16%），鼻咽炎（13%），口干（13%），味觉障碍（13%），尿路感染（11%），皮疹（10%）和焦虑（10%）。

Common lab abnormalities (Grades 1-4) in ≥25% of patients who received ZEJULA in NOVA gBRCAmut Cohort included: decrease in hemoglobin (85%), decrease in platelet count (81%), decrease in white blood cell count (71%), decrease in absolute neutrophil count (56%), increase in AST (35%), and increase in ALT (25%)..

在NOVA gBRCAmut队列中接受ZEJULA治疗的患者中，≥25%的患者常见实验室异常（1-4级）包括：血红蛋白减少（85%），血小板计数减少（81%），白细胞计数减少（71%），绝对中性粒细胞计数减少（56%），AST增加（35%），ALT增加（25%）。

Please see the US Prescribing Information for ZEJULA tablets.

请参阅美国ZEJULA片剂的处方信息。

GSK in oncology

葛兰素史克与肿瘤学

Oncology is an emerging therapeutic area for GSK where we are committed to maximizing patient survival with a current focus on hematologic malignancies, gynecologic cancers and other solid tumors through breakthroughs in immuno-oncology and tumor-cell targeting therapies.

肿瘤学是GSK的一个新兴治疗领域，我们致力于通过免疫肿瘤学和肿瘤细胞靶向治疗的突破，最大限度地提高患者的生存率，目前专注于血液恶性肿瘤，妇科癌症和其他实体瘤。

About GSK

GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at us.gsk.com.

葛兰素史克是一家全球性生物制药公司，旨在将科学、技术和人才团结起来，共同战胜疾病。更多信息请访问us.gsk.com。