强生公司率先推出首个PARP抑制剂组合，提高HRR改变的mCSPC患者的疗效-动脉网

Johnson & Johnson leads with first PARP inhibitor combo to improve efficacy in patients with HRR-altered mCSPC

强生等信源发布 2025-06-03 04:08

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可切换为仅中文

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Results from the Phase 3 AMPLITUDE study show the potential of AKEEGA

第 3 阶段 AMPLITUDE 研究的结果显示了 AKEEGA 的潜力

(niraparib and abiraterone acetate dual-action tablet) to delay cancer progression and worsening of symptoms

（尼拉帕利和醋酸阿比特龙双效片）以延缓癌症进展和症状恶化

Data show a nearly 50 percent reduction in disease progression in BRCA-altered mCSPC vs. current standard of care

数据显示，在BRCA改变的mCSPC中，疾病进展减少了近50％， vs. 当前的标准治疗方案。

CHICAGO

芝加哥

，

June 3, 2025

2025年6月3日

/PRNewswire/ -- Johnson & Johnson announced today first results from the Phase 3, randomized, double-blind, placebo-controlled AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) genetic alterations including BRCA.

/PRNewswire/ -- 强生公司今天宣布了3期随机、双盲、安慰剂对照的AMPLITUDE研究的首批结果，该研究评估了尼拉帕利与醋酸阿比特龙加泼尼松（AAP）联合治疗携带同源重组修复（HRR）基因改变（包括BRCA）的转移性去势敏感性前列腺癌（mCSPC）患者的效果。

The results show a clinically meaningful and statistically significant improvement in both radiographic progression-free survival (rPFS) and time to symptomatic progression (TSP), with an early trend toward improved overall survival (OS)—highlighting the potential of the combination in this patient population to delay both cancer progression and the worsening of symptoms..

结果表明，在影像学无进展生存期（rPFS）和症状进展时间（TSP）方面均取得了具有临床意义且统计学显著的改善，同时总体生存期（OS）也显示出早期改善趋势——突显了该联合疗法在这一患者群体中延缓癌症进展和症状恶化的潜力。

This marks the first Phase 3 data to show clinical improvement with a PARP-based combination in mCSPC. The findings are being presented as a late-breaking oral presentation (Abstract #LBA5006) at the

这标志着首个在mCSPC中显示基于PARP联合疗法临床改善的三期数据。该研究结果正在作为最新突破性口头报告（摘要编号#LBA5006）展示。

2025 American Society of Clinical Oncology Annual Meeting

2025年美国临床肿瘤学会年会

. The data have also been selected for Best of ASCO and included in the ASCO Press Program.

这些数据还被选为ASCO最佳项目，并纳入了ASCO新闻计划。

'Approximately 25 percent of patients with mCSPC have HRR alterations, with about half being BRCA. These patients typically experience faster disease progression and poorer outcomes,' said Gerhardt Attard*, M.D., Ph.D., FRCP, John Black Charitable Foundation Chair of Medical Oncology, University College London Cancer Institute, Research Department of Oncology and presenting author.

“大约25%的mCSPC患者存在HRR改变，其中约一半为BRCA。这些患者通常疾病进展更快，预后更差，”医学博士、哲学博士、皇家内科医学院院士Gerhardt Attard*表示，他是伦敦大学学院癌症研究所肿瘤学研究部John Black慈善基金会医学肿瘤学主席及报告作者。

'The AMPLITUDE trial is the first to show that combining a PARP inhibitor with an androgen receptor pathway inhibitor both delays disease progression and postpones the onset of symptoms in HRR-altered mCSPC, supporting this combination as a new treatment option for these patients.'.

“AMPLITUDE 试验是首个表明将 PARP 抑制剂与雄激素受体通路抑制剂联合使用，不仅可以延缓 HRR 改变的 mCSPC 患者的疾病进展，还能推迟症状出现时间，这支持了这种联合疗法作为这些患者的新治疗选择。”

'Our aim with the AMPLITUDE study was to determine how long patients could live without their cancer worsening. What we found is that the combination of niraparib, abiraterone acetate, and prednisone is achieving just that, with the goal of offering patients precious quality time before the disease enters a more resistant phase,' said Charles Drake, M.D., Ph.D., FAAP, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, at Johnson & Johnson Innovative Medicine.

“我们的AMPLITUDE研究的目标是确定患者在癌症不恶化的情况下可以存活多久。我们发现尼拉帕利、醋酸阿比特龙和泼尼松的组合正实现了这一目标，旨在为患者提供宝贵的高质量时间，以延缓疾病进入更耐药的阶段，”强生创新医学前列腺癌和免疫治疗领域负责人查尔斯·德雷克（Charles Drake）博士、医学博士、FAAP副总裁表示。

'This breakthrough highlights the need for early initiation of personalized treatment strategies for patients with mCSPC and HRR alterations, particularly BRCA, who typically face more aggressive disease.'.

‘这一突破性进展突显了对于伴有mCSPC和HRR改变（尤其是BRCA）的患者，需要尽早开始个性化的治疗策略，因为这些患者通常面临更具侵袭性的疾病。’

The Phase 3 AMPLITUDE study of 696 patients with mCSPC and HRR alterations met its primary endpoint of rPFS. Patients with BRCA alterations (n=191) showed the greatest benefit of treatment with the combination of niraparib plus AAP, as the median rPFS was not reached compared to 26 months in patients treated with the placebo plus AAP, reducing the risk of radiographic progression or death by 48 percent (hazard ratio [HR] 0.52, 95 percent confidence interval [CI], 0.37-0.72, p<0.0001).

包含696名mCSPC和HRR改变患者的3期AMPLITUDE研究达到了其主要终点rPFS。具有BRCA改变的患者（n=191）在接受尼拉帕利联合AAP治疗中获益最大，因为其中位rPFS未达到，而安慰剂联合AAP治疗组的中位rPFS为26个月，放射学进展或死亡风险降低了48%（风险比[HR] 0.52，95%置信区间[CI]，0.37-0.72，p<0.0001）。

In patients with any HRR alteration treated with the niraparib combination, median rPFS was also not reached in comparison to 29.5 months in patients treated with the placebo plus AAP, with a reduction in risk of progression or death by 37 percent (HR 0.63, 95 percent CI, 0.49-0.80, p=0.0001)..

在任何HRR改变的患者中，接受尼拉帕利联合治疗的患者中位rPFS同样未达到，而接受安慰剂加AAP治疗的患者为29.5个月，疾病进展或死亡风险降低了37%（HR 0.63，95% CI，0.49-0.80，p=0.0001）。

These results also showed that treatment with the niraparib combination reduced the risk of symptomatic progression by 56 percent in patients with BRCA alterations (HR 0.44, 95 percent CI, 0.29-0.68, p=0.0001) and 50 percent in patients with HRR alterations (HR 0.50, 95 percent CI, 0.36-0.69, p<0.0001), meaning that patients experienced a longer delay to worsening symptoms and requiring radiation, surgical intervention, or needing a new anti-cancer therapy.

这些结果还显示，对于BRCA基因改变的患者，使用尼拉帕利联合治疗可将症状进展的风险降低56%（HR 0.44，95% CI，0.29-0.68，p=0.0001），而对于HRR基因改变的患者，这一风险降低了50%（HR 0.50，95% CI，0.36-0.69，p<0.0001）。这意味着患者在症状恶化以及需要放疗、手术干预或新的抗癌治疗上的时间延迟更长。

The first interim analysis showed an early trend toward improved overall survival (OS) favoring the niraparib/AAP combination with a reduction in risk of death of 25 percent (HR 0.75, 95 percent CI, 0.51-1.11, p=0.15) in patients with BRCA alterations and 21 percent in HRR alterations (HR 0.79, 95 percent CI, 0.59-1.04, p=0.10); follow-up is ongoing for maturity of the data..

第一次中期分析显示，在BRCA突变患者中，尼拉帕利/阿比特龙联合治疗组显示出早期总生存期（OS）改善趋势，死亡风险降低25%（HR 0.75，95%置信区间，0.51-1.11，p=0.15），而在HRR突变患者中死亡风险降低21%（HR 0.79，95%置信区间，0.59-1.04，p=0.10）；数据仍在进一步随访以达到成熟。

Grade 3/4 adverse events (AE) were more frequent with the niraparib combination compared to the placebo group (75 percent vs. 59 percent), with anemia and hypertension being the most common; however, treatment discontinuations due to AEs remained low (14.7 percent vs 10.3 percent). To date, the safety profile of niraparib plus abiraterone acetate and prednisone has been consistent with prior experiences..

与安慰剂组相比，尼拉帕利联合治疗的3/4级不良事件（AE）更为频繁（75% vs. 59%），其中贫血和高血压最为常见；然而，因不良事件导致的治疗中断率仍然较低（14.7% vs 10.3%）。迄今为止，尼拉帕利加醋酸阿比特龙和泼尼松的安全性特征与以往经验一致。

New data from the CAPTURE study (Abstract #5094), also being presented at the 2025 ASCO Annual Meeting with simultaneous publication in the

CAPTURE研究（摘要#5094）的新数据，也将在2025年ASCO年会上发表，并同步发表在

Annals of Oncology

肿瘤学年鉴

, reinforce that the presence of HRR, specifically BRCA alterations, among patients with mCSPC are associated with significantly worse prognosis. Despite the availability of life-prolonging ARPIs, patients with HRR-altered mCSPC experience approximately 30 percent faster disease progression and shorter survival, while patients with BRCA-altered mCSPC experience approximately 50 percent faster disease progression and shorter survival—highlighting the importance of genetic testing to inform treatment decisions and the urgent need for novel targeted therapies to improve outcomes and delay progression..

，加强说明在mCSPC患者中，存在HRR（同源重组修复）特别是BRCA改变的患者与显著更差的预后相关。尽管有延长生命的ARPI（雄激素受体信号抑制剂）可用，但携带HRR改变的mCSPC患者疾病进展速度约快30%，生存期更短，而携带BRCA改变的mCSPC患者疾病进展速度约快50%，生存期更短——这凸显了基因检测对于指导治疗决策的重要性，以及对开发新型靶向疗法以改善预后和延缓疾病进展的迫切需求。

Johnson & Johnson has nearly 20 years of leadership in prostate cancer, treating more than 750,000 patients worldwide. With the AMPLITUDE study, Johnson & Johnson becomes the first to show that a PARP inhibitor combination can benefit patients with mCSPC.

强生公司在前列腺癌领域拥有近20年的领导地位，已在全球治疗超过75万名患者。通过AMPLITUDE研究，强生公司成为首家证明PARP抑制剂组合可使mCSPC患者获益的公司。

About AMPLITUDE

关于AMPLITUDE

AMPLITUDE (

幅度（

NCT04497844

) is an ongoing, phase 3, randomized, double-blind, placebo-controlled, international study evaluating the efficacy and safety of niraparib and abiraterone acetate in a dual-action tablet (DAT) formulation with prednisone plus androgen deprivation therapy (ADT) compared to matching oral placebo/abiraterone acetate with prednisone plus ADT in patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).

）是一项正在进行的 III 期随机、双盲、安慰剂对照的国际研究，评估尼拉帕利和醋酸阿比特龙以双效片（DAT）形式联合泼尼松及雄激素剥夺疗法（ADT）对比匹配的口服安慰剂/醋酸阿比特龙加泼尼松及ADT在携带致病性种系或体细胞同源重组修复（HRR）基因改变的转移性去势敏感性前列腺癌（mCSPC）患者中的疗效和安全性。

The primary endpoint is radiographic progression-free survival (rPFS)..

主要终点是影像学无进展生存期 (rPFS)。

About Metastatic Castration-Sensitive Prostate Cancer

关于转移性去势敏感性前列腺癌

Metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that still responds to ADT and has spread to other parts of the body.

转移性去势敏感性前列腺癌 (mCSPC)，也称为转移性激素敏感性前列腺癌 (mHSPC)，指的是仍然对雄激素剥夺治疗 (ADT) 有反应并已扩散到身体其他部位的前列腺癌。

About AKEEGA

关于AKEEGA

(niraparib and abiraterone acetate)

（尼拉帕利和醋酸阿比特龙）

AKEEGA

is a combination, in the form of a dual-action tablet (DAT), of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor. AKEEGA

是一种组合，以双效片剂（DAT）的形式存在，包含高度选择性的聚（ADP-核糖）聚合酶（PARP）抑制剂尼拉帕利和CYP17抑制剂醋酸阿比特龙。AKEEGA

together with prednisone or prednisolone was approved in

与泼尼松或泼尼松龙联合使用已获批准

April 2023

2023年4月

by the European Medicines Agency, and in

由欧洲药品管理局，以及在

August 2023

2023年8月

by the U.S. FDA, for the treatment of patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). Patients are selected for therapy based on an FDA-approved test for genetic alterations. Additional marketing authorization applications are under review across a number of countries globally..

由美国食品药品监督管理局（FDA）批准，用于治疗携带BRCA基因突变的转移性去势抵抗性前列腺癌（mCRPC）患者。患者根据FDA批准的基因变异检测方法来选择治疗方案。其他多个国家的上市授权申请正在审评中。

Additional ongoing studies include the Phase 3 AMPLITUDE study evaluating AKEEGA

其他正在进行的研究包括评估AKEEGA的3期AMPLITUDE研究

with prednisone or prednisolone in a biomarker-selected patient population with metastatic castration-sensitive prostate cancer (mCSPC).

在生物标志物筛选的转移性去势敏感性前列腺癌（mCSPC）患者群体中，使用泼尼松或泼尼松龙。

In April 2016, Janssen Biotech, Inc. entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GlaxoSmithKline [GSK] in 2019) for exclusive rights to niraparib in prostate cancer.

2016年4月，杨森生物技术公司与TESARO公司（2019年被葛兰素史克[GSK]收购）达成了一项全球（日本除外）合作和许可协议，获得了尼拉帕利在前列腺癌领域的独家权利。

For more information visit

更多信息请访问

https://www.akeegahcp.com/.

AKEEGA

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNINGS AND PRECAUTIONS

警告与注意事项

The safety population described in the WARNINGS and PRECAUTIONS reflect exposure to AKEEGA

警告和注意事项中描述的安全人群反映了对AKEEGA的暴露情况。

in combination with prednisone in

与泼尼松联合使用时

BRCA

m patients in Cohort 1 (N=113) of MAGNITUDE.

MAGNITUDE研究中队列1（N=113）的m名患者。

Myelodysplastic Syndrome/Acute Myeloid Leukemia

骨髓增生异常综合征/急性髓系白血病

AKEEGA

may cause myelodysplastic syndrome/acute myeloid leukemia (MDS/AML).

可能导致骨髓增生异常综合征/急性髓系白血病 (MDS/AML)。

MDS/AML, including cases with fatal outcome, has been observed in patients treated with niraparib, a component of AKEEGA

接受过包含尼拉帕利的AKEEGA治疗的患者中，已观察到MDS/AML的发生，包括死亡病例。

。

All patients treated with niraparib who developed secondary MDS/cancer-therapy-related AML had received previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.

所有接受尼拉帕利治疗后出现继发性MDS/癌症治疗相关性AML的患者，均曾接受过含铂药物和/或其他DNA损伤药物（包括放疗）的化疗。

For suspected MDS/AML or prolonged hematological toxicities, refer the patient to a hematologist for further evaluation. Discontinue AKEEGA

对于疑似MDS/AML或长期血液系统毒性，将患者转诊给血液科医生进行进一步评估。停止使用AKEEGA。

if MDS/AML is confirmed.

如果确认为MDS/AML。

Myelosuppression

骨髓抑制

AKEEGA

may cause myelosuppression (anemia, thrombocytopenia, or neutropenia).

可能导致骨髓抑制（贫血、血小板减少或中性粒细胞减少）。

In MAGNITUDE Cohort 1, Grade 3-4 anemia, thrombocytopenia, and neutropenia were reported, respectively in 28%, 8%, and 7% of patients receiving AKEEGA

在MAGNITUDE队列1中，分别有28%、8%和7%接受AKEEGA治疗的患者报告了3-4级贫血、血小板减少和中性粒细胞减少。

. Overall, 27% of patients required a red blood cell transfusion, including 11% who required multiple transfusions. Discontinuation due to anemia occurred in 3% of patients.

总体而言，27%的患者需要输注红细胞，其中11%的患者需要多次输注。因贫血而停药的患者占3%。

Monitor complete blood counts weekly during the first month of AKEEGA

在使用AKEEGA的第一个月内，每周监测全血细胞计数。

treatment, every two weeks for the next two months, monthly for the remainder of the first year and then every other month, and as clinically indicated. Do not start AKEEGA

治疗，每两周一次，持续两个月，之后每月一次，直到第一年结束，然后每隔一个月一次，并根据临床需要进行。不要开始使用AKEEGA。

until patients have adequately recovered from hematologic toxicity caused by previous therapy. If hematologic toxicities do not resolve within 28 days following interruption, discontinue AKEEGA

直到患者从先前治疗引起的血液学毒性中充分恢复。如果在中断治疗后 28 天内血液学毒性仍未解决，则停止使用 AKEEGA。

and refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics.

并将患者转诊给血液科医生进行进一步检查，包括骨髓分析和细胞遗传学的血液样本。

Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions

低钾血症、体液潴留和心血管不良反应

AKEEGA

may cause hypokalemia and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. In post-marketing experience, QT prolongation and Torsades de Pointes have been observed in patients who develop hypokalemia while taking abiraterone acetate, a component of AKEEGA.

可能导致因CYP17抑制引起的盐皮质激素水平升高，从而导致低钾血症和体液潴留。在上市后使用中，观察到服用醋酸阿比特龙（AKEEGA的成分之一）期间出现低钾血症的患者发生QT间期延长和尖端扭转型室性心动过速。

. Hypertension and hypertensive crisis have also been reported in patients treated with niraparib, a component of AKEEGA

接受包含尼拉帕利的AKEEGA治疗的患者也有报道出现高血压和高血压危象。

。

In MAGNITUDE Cohort 1, which used prednisone 10 mg daily in combination with AKEEGA

在MAGNITUDE队列1中，每日使用10毫克泼尼松与AKEEGA联合使用。

, Grades 3-4 hypokalemia was detected in 2.7% of patients on the AKEEGA

，3-4级低钾血症在使用AKEEGA的患者中检出率为2.7%

arm and Grades 3-4 hypertension were observed in 14% of patients on the AKEEGA

在使用AKEEGA的患者中，有14%观察到手臂和3-4级高血压。

arm.

手臂。

The safety of AKEEGA

AKEEGA的安全性

in patients with New York Heart Association (NYHA) Class II to IV heart failure has not been established because these patients were excluded from MAGNITUDE.

在纽约心脏病协会（NYHA）II至IV级心力衰竭患者中尚未确定，因为这些患者被排除在MAGNITUDE研究之外。

Monitor patients for hypertension, hypokalemia, and fluid retention at least weekly for the first two months, then once a month. Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia, or fluid retention, such as those with heart failure, recent myocardial infarction, cardiovascular disease, or ventricular arrhythmia.

在前两个月内，至少每周监测患者是否有高血压、低钾血症和体液潴留，之后每月一次。密切监测那些可能因血压升高、低钾血症或体液潴留而使基础健康状况恶化的患者，例如心力衰竭、近期心肌梗死、心血管疾病或心室心律失常的患者。

Control hypertension and correct hypokalemia before and during treatment with AKEEGA.

在使用AKEEGA治疗前和治疗期间，控制高血压并纠正低钾血症。

。

Discontinue AKEEGA

停止使用AKEEGA

in patients who develop hypertensive crisis or other severe cardiovascular adverse reactions.

在发生高血压危象或其他严重心血管不良反应的患者中。

Hepatotoxicity

肝毒性

AKEEGA

阿基加

may cause hepatotoxicity.

可能引起肝毒性。

Hepatotoxicity in patients receiving abiraterone acetate, a component of AKEEGA

接受阿比特龙乙酸酯（AKEEGA的组成部分）治疗的患者出现肝毒性

, has been reported in clinical trials. In post-marketing experience, there have been abiraterone acetate-associated severe hepatic toxicity, including fulminant hepatitis, acute liver failure, and deaths.

在临床试验中已有报道。在上市后经验中，有报告与醋酸阿比特龙相关的严重肝脏毒性，包括暴发性肝炎、急性肝衰竭和死亡。

In MAGNITUDE Cohort 1, Grade 3-4 ALT or AST increases (at least 5 x ULN) were reported in 1.8% of patients. The safety of AKEEGA

在MAGNITUDE队列1中，报告了1.8%的患者出现3-4级ALT或AST升高（至少为正常上限的5倍）。AKEEGA的安全性

in patients with moderate or severe hepatic impairment has not been established as these patients were excluded from MAGNITUDE.

在中度或重度肝功能损害患者中尚未确定，因为这些患者被排除在MAGNITUDE研究之外。

Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with AKEEGA

在开始使用AKEEGA治疗前，测量血清转氨酶（ALT和AST）和胆红素水平。

, every two weeks for the first three months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient's baseline should prompt more frequent monitoring and may require dosage modifications..

，治疗的前3个月每两周一次，此后每月一次。如果出现提示肝毒性的临床症状或体征，应立即检测血清总胆红素、AST和ALT。如果患者的AST、ALT或胆红素水平较基线升高，应增加监测频率，并可能需要调整剂量。

Permanently discontinue AKEEGA

永久停止使用AKEEGA

for patients who develop a concurrent elevation of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation, or in patients who develop ALT or AST ≥20 x ULN at any time after receiving AKEEGA

对于在无胆汁淤积或其他原因导致同时升高的情况下，ALT升高超过3倍正常上限（ULN）且总胆红素升高超过2倍ULN的患者，或在任何时间接受AKEEGA后出现ALT或AST≥20倍ULN的患者。

。

Adrenocortical Insufficiency

肾上腺皮质功能不全

AKEEGA

may cause adrenal insufficiency.

可能导致肾上腺功能不全。

Adrenocortical insufficiency has been reported in clinical trials in patients receiving abiraterone acetate, a component of AKEEGA

在使用含有醋酸阿比特龙的AKEEGA治疗的患者中，临床试验已报告出现肾上腺皮质功能不全。

, in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Monitor patients for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress.

与泼尼松联合使用时，在中断每日类固醇和/或并发感染或应激情况下。监测患者肾上腺皮质功能不全的症状和体征，特别是当患者停用泼尼松、泼尼松剂量减少或经历异常应激时。

Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with abiraterone acetate. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased doses of corticosteroids may be indicated before, during, and after stressful situations..

肾上腺皮质功能不全的症状和体征可能被与醋酸阿比特龙治疗患者中观察到的盐皮质激素过量相关的不良反应所掩盖。如果临床需要，进行适当的测试以确认肾上腺皮质功能不全的诊断。在压力情况之前、期间和之后，可能需要增加皮质类固醇的剂量。

Hypoglycemia

低血糖症

AKEEGA

may cause hypoglycemia in patients being treated with other medications for diabetes.

可能会导致正在接受其他糖尿病药物治疗的患者出现低血糖。

Severe hypoglycemia has been reported when abiraterone acetate, a component of AKEEGA

当醋酸阿比特龙（AKEEGA的成分）与以下药物合用时，已有严重低血糖的报告

, was administered to patients receiving medications containing thiazolidinediones (including pioglitazone) or repaglinide.

，给予接受含有噻唑烷二酮类药物（包括吡格列酮）或瑞格列奈治疗的患者。

Monitor blood glucose in patients with diabetes during and after discontinuation of treatment with AKEEGA

在糖尿病患者使用AKEEGA治疗期间及停药后监测血糖水平。

. Assess if antidiabetic drug dosage needs to be adjusted to minimize the risk of hypoglycemia.

评估是否需要调整抗糖尿病药物的剂量，以尽量减少低血糖的风险。

Increased Fractures and Mortality in Combination with Radium 223 Dichloride

与镭223二氯化物联合使用时骨折和死亡率增加

AKEEGA

with prednisone is not recommended for use in combination with Ra-223 dichloride outside of clinical trials.

与泼尼松联合使用时不建议在临床试验之外与Ra-223二氯化物联合使用。

The clinical efficacy and safety of concurrent initiation of abiraterone acetate plus prednisone/prednisolone and radium Ra 223 dichloride was assessed in a randomized, placebo-controlled multicenter study (ERA-223 trial) in 806 patients with asymptomatic or mildly symptomatic castration-resistant prostate cancer with bone metastases.

在一项随机、安慰剂对照的多中心研究（ERA-223试验）中，评估了806名无症状或轻度症状的去势抵抗性前列腺癌伴骨转移患者同时开始使用醋酸阿比特龙加泼尼松/泼尼松龙和镭Ra 223二氯化物的临床疗效和安全性。

The study was unblinded early based on an Independent Data Monitoring Committee recommendation..

基于独立数据监查委员会的建议，该研究提前揭盲。

At the primary analysis, increased incidences of fractures (29% vs 11%) and deaths (39% vs 36%) have been observed in patients who received abiraterone acetate plus prednisone/prednisolone in combination with radium Ra 223 dichloride compared to patients who received placebo in combination with abiraterone acetate plus prednisone..

在初步分析中，与接受安慰剂联合醋酸阿比特龙加泼尼松/泼尼松龙的患者相比，接受醋酸阿比特龙加泼尼松/泼尼松龙联合镭-223二氯化物治疗的患者骨折（29% vs 11%）和死亡（39% vs 36%）的发生率有所增加。

It is recommended that subsequent treatment with Ra-223 not be initiated for at least five days after the last administration of AKEEGA

建议在最后一次给予AKEEGA后，至少5天内不要开始使用Ra-223进行后续治疗。

, in combination with prednisone.

，与泼尼松联合使用。

Posterior Reversible Encephalopathy Syndrome

后部可逆性脑病综合征

AKEEGA

may cause Posterior Reversible Encephalopathy Syndrome (PRES).

可能导致可逆性后部脑病综合征 (PRES)。

PRES has been observed in patients treated with niraparib as a single agent at higher than the recommended dose of niraparib included in AKEEGA

在使用高于AKEEGA中推荐剂量的尼拉帕利单药治疗的患者中，已观察到PRES。

。

Monitor all patients treated with AKEEGA

监测所有使用AKEEGA治疗的患者

for signs and symptoms of PRES. If PRES is suspected, promptly discontinue AKEEGA

如果怀疑出现PRES的体征和症状，请立即停止使用AKEEGA。

and administer appropriate treatment. The safety of reinitiating AKEEGA

并给予适当的治疗。重新开始使用AKEEGA的安全性

in patients previously experiencing PRES is not known.

以前经历过PRES的患者中是否会发生这种情况尚不清楚。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

The safety and efficacy of AKEEGA

AKEEGA的安全性和有效性

have not been established in females. Based on animal reproductive studies and mechanism of action, AKEEGA

在女性中尚未确立。根据动物生殖研究和作用机制，AKEEGA

can cause fetal harm and loss of pregnancy when administered to a pregnant female.

可能对胎儿造成伤害，并导致孕妇流产。

Niraparib has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow).

尼拉帕利具有致畸性和/或胚胎-胎儿死亡的潜在风险，因为尼拉帕利具有基因毒性，并且在动物和患者中会作用于活跃分裂的细胞（例如，骨髓）。

In animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (AUC) at the recommended dose.

在动物生殖研究中，于器官发生期对怀孕大鼠口服给予醋酸阿比特龙，在母体暴露量约为推荐剂量下人体暴露量（AUC）的0.03倍或更高时，会导致不良发育影响。

Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of AKEEGA

建议有生育潜力的女性伴侣的男性在治疗期间及服用AKEEGA最后一剂后4个月内使用有效避孕措施。

. Females who are or may become pregnant should handle AKEEGA

可能或已经怀孕的女性应谨慎处理AKEEGA。

with protection, e.g., gloves.

使用保护措施，例如手套。

Based on animal studies, AKEEGA

基于动物研究，AKEEGA

may impair fertility in males of reproductive potential.

可能损害具有生殖潜力的男性的生育能力。

ADVERSE REACTIONS

不良反应

The safety of AKEEGA

AKEEGA的安全性

in patients with

患者中

BRCA

m mCRPC was evaluated in Cohort 1 of MAGNITUDE.

m mCRPC 在 MAGNITUDE 的队列 1 中进行了评估。

The most common adverse reactions (≥10%), including laboratory abnormalities, are decreased hemoglobin, decreased lymphocytes, decreased white blood cells, musculoskeletal pain, fatigue, decreased platelets, increased alkaline phosphatase, constipation, hypertension, nausea, decreased neutrophils, increased creatinine, increased potassium, decreased potassium, increased AST, increased ALT, edema, dyspnea, decreased appetite, vomiting, dizziness, COVID-19, headache, abdominal pain, hemorrhage, urinary tract infection, cough, insomnia, increased bilirubin, weight decreased, arrhythmia, fall, and pyrexia..

最常见的不良反应（≥10%），包括实验室异常，为血红蛋白减少、淋巴细胞减少、白细胞减少、肌肉骨骼疼痛、疲劳、血小板减少、碱性磷酸酶升高、便秘、高血压、恶心、中性粒细胞减少、肌酐升高、钾升高、钾减少、AST升高、ALT升高、水肿、呼吸困难、食欲减退、呕吐、头晕、COVID-19、头痛、腹痛、出血、尿路感染、咳嗽、失眠、胆红素升高、体重减轻、心律失常、跌倒和发热。

Serious adverse reactions reported in >2% of patients included COVID-19 (7%), anemia (4.4%), pneumonia (3.5%), and hemorrhage (3.5%). Fatal adverse reactions occurred in 9% of patients who received AKEEGA

在超过2%的患者中报告的严重不良反应包括新冠肺炎（7%）、贫血（4.4%）、肺炎（3.5%）和出血（3.5%）。在接受AKEEGA治疗的患者中，有9%发生了致命的不良反应。

, including COVID-19 (5%), cardiopulmonary arrest (1%), dyspnea (1%), pneumonia (1%), and septic shock (1%).

，包括 COVID-19（5%）、心肺骤停（1%）、呼吸困难（1%）、肺炎（1%）和脓毒性休克（1%）。

DRUG INTERACTIONS

药物相互作用

Effect of Other Drugs on AKEEGA

其他药物对AKEEGA的影响

Avoid coadministration with strong CYP3A4 inducers.

避免与强效CYP3A4诱导剂联合使用。

Abiraterone is a substrate of CYP3A4. Strong CYP3A4 inducers may decrease abiraterone concentrations, which may reduce the effectiveness of abiraterone.

阿比特龙是CYP3A4的底物。强效CYP3A4诱导剂可能会降低阿比特龙的浓度，从而可能降低其疗效。

Effects of AKEEGA

AKEEGA的效果

on Other Drugs

其他药物

Avoid coadministration unless otherwise recommended in the Prescribing Information for CYP2D6 substrates for which minimal changes in concentration may lead to serious toxicities. If alternative treatments cannot be used, consider a dose reduction of the concomitant CYP2D6 substrate drug.

除非处方信息中另有建议，对于浓度的微小变化可能导致严重毒性的CYP2D6底物，应避免联合给药。如果无法使用替代治疗，考虑减少同时使用的CYP2D6底物药物的剂量。

Abiraterone is a CYP2D6 moderate inhibitor. AKEEGA

阿比特龙是一种CYP2D6中度抑制剂。AKEEGA

increases the concentration of CYP2D6 substrates, which may increase the risk of adverse reactions related to these substrates.

增加CYP2D6底物的浓度，这可能会增加与这些底物相关的不良反应的风险。

Monitor patients for signs of toxicity related to a CYP2C8 substrate for which a minimal change in plasma concentration may lead to serious or life-threatening adverse reactions.

监测患者是否出现与CYP2C8底物相关的毒性迹象，其血浆浓度的微小变化可能导致严重或危及生命的不良反应。

Abiraterone is a CYP2C8 inhibitor. AKEEGA

阿比特龙是一种CYP2C8抑制剂。AKEEGA

increases the concentration of CYP2C8 substrates, which may increase the risk of adverse reactions related to these substrates.

增加CYP2C8底物的浓度，这可能会增加与这些底物相关的不良反应的风险。

Please see the full

请参阅完整内容

Prescribing Information

处方信息

for AKEEGA

适用于AKEEGA

。

About Johnson & Johnson

关于强生公司

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

在强生，我们相信健康就是一切。我们在医疗保健创新方面的优势使我们能够构建一个世界，在这个世界里，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且更少侵入性，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们有能力在当今整个医疗保健解决方案领域进行创新，以实现明天的突破，并对人类健康产生深远影响。

Learn more at .

了解更多，请访问。

https://www.jnj.com/

or at

或在

www.innovativemedicine.jnj.com

. Follow us at

关注我们

@JNJInnovMed

. Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, and Janssen Scientific Affairs, LLC are Johnson & Johnson companies.

杨森研发有限责任公司、杨森生物科技有限公司、杨森全球服务有限责任公司和杨森科学事务有限责任公司均为强生公司旗下企业。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of AKEEGA

本新闻稿包含《1995年私人证券诉讼改革法案》中定义的关于产品开发以及AKEEGA潜在益处和治疗影响的“前瞻性声明”。

(niraparib/abiraterone). The reader is cautioned not to rely on these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson.

（尼拉帕利/阿比特龙）。读者应注意不要依赖这些前瞻性声明。读者应注意不要依赖这些前瞻性声明。这些声明基于对未来事件的当前预期。如果基本假设被证明不准确或已知或未知的风险或不确定性变为现实，实际结果可能与强生公司的预期和预测大不相同。

Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.

风险和不确定性包括但不限于：产品研究和开发中固有的挑战和不确定性，包括临床成功的不确定性以及获得监管批准的不确定性；商业成功的不确定性；生产困难和延误；竞争，包括技术进步、竞争对手的新产品和专利；专利挑战；产品功效或安全性问题导致的产品召回或监管行动；医疗卫生产品和服务购买者的行为和支出模式的变化；适用法律法规的变更，包括全球医疗改革；以及控制医疗成本的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.

这些风险、不确定性和其他因素的进一步列表和描述可以在强生公司最近的年度报告 Form 10-K 中找到，特别是标题为“关于前瞻性陈述的警示声明”和“Item 1A. 风险因素”的部分，以及强生公司随后的季度报告 Form 10-Q 和提交给证券交易委员会的其他文件中。

Copies of these filings are available online at .

这些文件的副本可在线获取，网址为。

www.sec.gov

，

www.jnj.com

or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

或应Johnson & Johnson的要求。Johnson & Johnson不承担因新信息或未来事件或发展而更新任何前瞻性声明的义务。

*Dr. Attard has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

阿塔尔德博士为强生公司提供过咨询、顾问和演讲服务；他未因任何媒体工作获得报酬。

Media contact:

媒体联系人：

Oncology Media Relations

肿瘤学媒体关系

Oncology_media_relations@its.jnj.com

肿瘤学媒体关系@its.jnj.com

Investor contact:

投资者联系方式：

Lauren Johnson

劳伦·约翰逊

investor-relations@its.jnj.com

投资者关系@its.jnj.com

U.S. medical inquiries:

美国医学询问：

+1 800 526-7736

Attard, G., et al. (2025, May). Phase 3 AMPLITUDE trial: Niraparib and abiraterone acetate plus prednisone for metastatic castration-sensitive prostate cancer patients with alterations in homologous recombination repair genes. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL..

阿塔尔德，G. 等（2025年5月）。第三阶段AMPLITUDE试验：尼拉帕利联合醋酸阿比特龙和泼尼松用于同源重组修复基因改变的转移性去势敏感性前列腺癌患者。在美国临床肿瘤学会（ASCO）年会上发表，会议地点：伊利诺伊州芝加哥。

Olmos, D. (2025, May). Impact of somatic/germline homologous recombination repair (HRR) alterations on metastatic hormone-sensitive prostate cancer (mHSPC) outcomes by disease volume. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025.

奥尔莫斯，D.（2025年5月）。体细胞/生殖系同源重组修复（HRR）改变对不同病灶体积的转移性激素敏感性前列腺癌（mHSPC）结果的影响。在2025年美国临床肿瘤学会（ASCO）年会上发表。

Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Özgüroğlu M, Ye D, Feyerabend S, Protheroe A, Sulur G, Luna Y, Li S, Mundle S, Chi KN. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial.

Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Özgüroğlu M, 叶定伟, Feyerabend S, Protheroe A, Sulur G, Luna Y, 李善福, Mundle S, Chi KN。醋酸阿比特龙联合泼尼松治疗新诊断的高危转移性去势敏感性前列腺癌（LATITUDE）：一项随机、双盲、III 期试验的最终总生存分析。

Lancet Oncol. 2019 May;20(5):686-700. doi: 10.1016/S1470-2045(19)30082-8. Epub 2019 Apr 12. PMID: 30987939..

《柳叶刀·肿瘤学》2019年5月；20(5):686-700。doi: 10.1016/S1470-2045(19)30082-8。电子版发表于2019年4月12日。PMID: 30987939。

American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2018).

美国临床肿瘤学会。ASCO 回答：前列腺癌（2018）。

http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf

. Accessed May 2025.

. 2025年5月访问。

View original content to download multimedia:

查看原始内容以下载多媒体：

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https://www.prnewswire.com/news-releases/强生公司率先推出首个PARP抑制剂组合，提高HRR改变的mCSPC患者的疗效-302471320.html

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