甲苯磺酸他拉唑帕利(Talazoparib Tosylate) - 药物靶点：PARP x PARP1 x PARP2_在研适应症：乳腺癌，BRCA突变去势抵抗性前列腺癌，转移性去势抵抗性前列腺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Talazoparib、talazoparib、Talazoparib Tosilate

+ [13]

靶点

PARP x PARP1 x PARP2

作用方式

抑制剂

作用机制

PARP抑制剂(聚腺苷二磷酸核糖聚合酶抑制剂)、PARP1抑制剂(聚腺苷二磷酸核糖聚合酶1抑制剂)、PARP2抑制剂(聚腺苷二磷酸核糖聚合酶2抑制剂)

治疗领域

肿瘤皮肤和肌肉骨骼疾病泌尿生殖系统疾病+ [7]

在研适应症

乳腺癌BRCA突变去势抵抗性前列腺癌转移性去势抵抗性前列腺癌+ [34]

非在研适应症

晚期子宫内膜癌儿童恶性实体瘤慢性淋巴细胞白血病+ [18]

原研机构

BioMarin Pharmaceutical, Inc.

在研机构

Pfizer Inc.Pfizer Europe MA EEIG

Zenith Epigenetics Ltd.

+ [5]

非在研机构

Calithera Biosciences, Inc.MediVation, Inc.

权益机构

Nektar Therapeutics

Strata Oncology, Inc.

Medivation LLC (California)

+ [4]

最高研发阶段批准上市

首次获批日期

美国 (2018-10-16),

gBRCA突变/HER2阴性乳腺癌

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)

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结构/序列

分子式C26H22F2N6O4S

InChIKeyQUQKKHBYEFLEHK-QNBGGDODSA-N

CAS号1373431-65-2

关联

115

项与甲苯磺酸他拉唑帕利相关的临床试验

NCT04982848

/ Not yet recruitingN/A

A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Talzenna(Registered)

Talzenna will be approved for the treatment of gBRCA advanced breast cancer in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Talzenna after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Talzenna will be observed.

开始日期2025-12-31

申办/合作机构

Pfizer Inc.

NCT05873192

/ Not yet recruiting临床2期IIT

Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in de Novo Metastatic to Lymph Nodes Prostate Cancer

To learn about the effectiveness of adding talazoparib to the standard of care treatment combination of androgen ablation therapy (hormone therapy, also known as ADT) and enzalutamide in patients with prostate cancer that has spread into the lymph nodes.

开始日期2025-09-30

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT06762808

/ Not yet recruiting临床2期

Phase II Trial of Atezolizumab and Tiragolumab for Patients With Detectable Circulating Tumor DNA After Definitive Treatment for HPV-positive Squamous Cell Carcinoma

A single-arm, phase II study for patients with detectable HPV CtDNA at 12 weeks or longer after completion of definitive therapy for non-metastatic, HPV+ squamous cell carcinoma.

开始日期2025-06-01

申办/合作机构

Genentech, Inc.

100 项与甲苯磺酸他拉唑帕利相关的临床结果

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100 项与甲苯磺酸他拉唑帕利相关的转化医学

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100 项与甲苯磺酸他拉唑帕利相关的专利（医药）

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953

项与甲苯磺酸他拉唑帕利相关的文献（医药）

2025-06-01·JOURNAL OF MOLECULAR STRUCTURE

Design, synthesis and pharmacological evaluation of triazolopyrimidines derivatives as novel agonists for benzodiazepine receptor

作者: Yi, Shijia ; Li, Mengjiao ; Liu, Zheng ; Yan, Hui ; Hu, Lina ; Lei, Kang ; Wang, Xuekun ; Wang, Shiben

In this paper, two series of triazolopyrimidines derivatives were designed, synthesized, and all the target compounds were structurally confirmed using ¹H NMR, ¹³C NMR and HRMS methods.Pharmacol. experiments were carried out using maximal electroshock (MES), s.c. pentylenetetrazole (scPTZ) and rotating rod (ROT) models for activity and neurotoxicity screening, and potential compounds were screened out for further determination of ED₅₀, TD₅₀ and in vitro binding experimentsFinally, compound 5,7-Bis(pentyloxy)-[1,2,4]triazolo[1,5-a]pyrimidine (6b) with best activity and lowest toxicity was obtained.The pharmacol. results showed that the ED₅₀ of compound 6b was MES = 11.3 mg/kg, PTZ = 9.5 mg/kg, which was superior to that of the carbamazepine (MES = 6.3 mg/kg) and ethosuximide (PTZ = 3.6 mg/kg).The IC₅₀ of compound 6b binding affinity toward the GABA_A receptor was 0.15 μM, and the GABA content experiments showed that compound 6b significantly increased the GABA content in the rat brain.In elevated plus maze (EPM) assay, compound 6b possessed anxiolytic effects.In silico studies, most of the target compounds have suitable physicochem. and pharmacokinetic data with the possibility of drug-forming properties, mol. docking results showed that compound 6b could generate more interactions with the amino acid residues of diazepam active site of GABA_A receptor.

2025-05-04·Expert Opinion On Drug Safety

Detection and analysis of the safety profile of talazoparib based on FAERS database

Article

作者: Chen, Jinjin ; Tang, Mufei ; Li, Yuanyuan ; Li, Yang ; Liu, Peiyan ; Du, Linzhe

BACKGROUND:

Talazoparib was approved for the treatment of breast cancer. However, the safety of talazoparib in a large population sample over an extended period remained uncertain. The objective of this study is to offer guidance for the secure utilization of talazoparib in clinical settings.

METHODS:

Four algorithms were used to quantify the signals of talazoparib associated adverse events(AEs), using data from the food and drug administration adverse event reporting system(FAERS) between fourth quater of 2018 and second quater of 2023.

RESULTS:

A total of 7,186,517 records were reported, with 737 indicating talazoparib as the primary suspected (PS) AEs. A total of 40 significant preferred terms (PTs) that adhere to the four algorithms were simultaneously retained. There is a possibility of experiencing unforeseen and noteworthy AEs, including embolism(0.46%), pulmonary embolism(1.06%), hyponatremia(0.46%), hypokalemia(0.40%), hematuria(0.33%), and pericardial effusion(0.26%). Most of the AEs related to talazoparib occurred within the initial month of starting the medication, with a median onset time of 79 days (IQR: 22-207 days).

CONCLUSION:

Results of our study were consistent with clinical observations, and we also found potential new and unexpected AEs signals for talazoparib, suggesting prospective clinical studies were needed to confirm these results and illustrate their relationship. Our results may provide valuable evidence for further safety studies of talazoparib.

2025-05-01·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Discovery of dual PARP/NAMPT inhibitors for the treatment of BRCA wild-type triple-negative breast cancer

Article

作者: Liao, Zepeng ; Miao, Qi ; Zhang, Wanheng ; Zhang, Zhiyi ; Jiang, Sheng ; Tong, Jun ; Wang, Kaizhen ; Mao, Jie ; Shen, Guoqing ; Zhang, Kuojun ; Wang, Dexiang

Simultaneous inhibition of poly(ADP-ribose) polymerase (PARP) and nicotinamide phosphoribosyltransferase (NAMPT) has been shown to be synergistically effective against breast cancer susceptibility (BRCA) wild-type triple-negative breast cancer (TNBC) through synthetic lethality, which may be explored to broaden the clinical utility of PARP inhibitors. Herein, we report the discovery of dual PARP/NAMPT inhibitors through a pharmacophore linking approach. The lead compound 13j with potent inhibitory activity against both PARP1 and NAMPT (IC₅₀ = 0.8 and 18 nM, respectively) effectively inhibited the proliferation of TNBC MDA-MB-231 cells with wild-type BRCA at submicromolar level. Mechanically, 13j disrupted the homologous recombination repair (HRR) pathway, caused the accumulation of DNA double-strand breaks (DSBs) and ultimately induced apoptotic cell death. In addition, this compound exhibited potent inhibitory potency on the migration of MDA-MB-231 cells. This study demonstrates that compound 13j is a promising lead compound for the development of better PARP/NAMPT inhibitors to treat TNBC with wild-type BRCA.

271

项与甲苯磺酸他拉唑帕利相关的新闻（医药）

2025-05-07

·ioncology

泌尿生殖肿瘤中国之声亮相ASCO 2025，最新成果瞭望聚焦丨ASCO 2025

编者按：美国临床肿瘤学会（ASCO）年会将在芝加哥以线上线下结合的形式盛大召开（5月30日~6月3日）。作为全球规模最大、学术水平最高、最具权威性的国际肿瘤会议之一，2025年ASCO年会汇聚了肿瘤领域前沿进展，带领临床医生及科研学者走向灵感澎湃、进展迭出的新世界。今天，2025 ASCO摘要标题（包括Late-Breaking Abstracts）已发布。摘要具体内容将在2025年5月22日发布，Late-breaking摘要内容将在会议当天发布。肿瘤瞭望-泌尿时讯特别整理泌尿肿瘤领域中国专家入选口头报告及壁报，包括1篇口头报告+21篇壁报。01肾癌及膀胱癌快速口头报告专场当地时间：5月31日13:15-14:33报告地点：Arie Crown Theater摘要号：4519英文标题：9MW2821, a novel Nectin-4 antibody-drug conjugate (ADC), combined with toripalimab in treatment-naïve patients with locally advanced or metastatic urothelial carcinoma (la/mUC)： Results from a phase 1b/2 study.中文标题：9MW2821是一种新型Nectin-4抗体偶联药物，与特瑞普利单抗联合用于治疗初治局部晚期或转移性尿路上皮癌患者：1b/2期研究结果讲者：盛锡楠教授北京大学肿瘤医院02肾癌及膀胱癌壁报专场当地时间：6月2日09：00报告地点：Hall A - Posters and Exhibits摘要号：4524英文标题：Comparison of 68Ga-NY104 PET/CT with 18F-FDG PET/CT in patients with metastatic clear cell renal cell carcinoma (NYCRM)： A prospective, comparative phase II study.中文标题：转移性透明细胞肾细胞癌（NYCRM）患者使用68Ga-NY104 PET/CT与18F-FDG PET/CT的比较：一项前瞻性、比较性II期研究讲者：朱文佳教授中国医学科学院北京协和医学院肿瘤医院摘要号：4525英文标题：Anlotinib plus everolimus as first-line treatment for advanced non–clear cell renal cell carcinoma： 1 year updated results from UC-001, a single-center, single-arm, phase II trial.中文标题：安罗替尼联合依维莫司作为晚期非透明细胞肾细胞癌的一线治疗：单中心、单组、II期试验UC-001的1年更新结果讲者：徐文浩教授复旦大学附属肿瘤医院摘要号：4526英文标题：Anlotinib combined with sintilimab as first-line treatment in patients with advanced non-clear cell renal cell carcinoma (nccRCC)： Preliminary results from an exploratory prospective multicentre clinical study.中文标题：安罗替尼联合信迪利单抗一线治疗晚期非透明细胞肾细胞癌（nccRCC）患者：一项探索性前瞻性多中心临床研究的初步结果讲者：董培教授中山大学肿瘤防治中心摘要号：4534英文标题：Early detection of renal cell carcinoma： A novel cfDNA fragmentomics-based liquid biopsy assay.中文标题：肾细胞癌的早期检测：一种基于cfDNA片段组学的新型液体活检检测方法讲者：彭毓璐教授中山大学肿瘤防治中心摘要号：4535英文标题：Efficacy and safety of neoadjuvant toripalimab plus axitinib in renal cell carcinoma with tumor thrombus： A combined analysis of two phase II trials.中文标题：特瑞普利单抗联合阿昔替尼新辅助方案治疗肾细胞癌伴癌栓的疗效和安全性：两项II期临床试验的综合分析讲者：顾良友教授中国人民解放军总医院摘要号：4536英文标题：First-line benmelstobart plus anlotinib versus sunitinib in advanced renal cell carcinoma： Subgroup analysis from the phase 3 ETER100 trial.中文标题：贝莫苏拜单抗联合安罗替尼对比舒尼替尼一线治疗晚期肾细胞癌的疗效：来自III期ETER100试验的亚组分析讲者：盛锡楠教授北京大学肿瘤医院摘要号：4551英文标题：Vasculogenic mimicry as a potential indicator of drug resistance and prognosis in renal cell carcinoma.中文标题：血管生成拟态是肾细胞癌耐药性和预后的潜在指标讲者：崔心刚教授上海交通大学医学院附属新华医院摘要号：4584英文标题：Revolutionizing bladder cancer follow-up： Personalized urinary ctDNA analysis for detecting minimal residual disease.中文标题：革命性的膀胱癌随访：个性化尿液ctDNA分析用于检测微小残留疾病讲者：万学斌博士深圳市海普洛斯生物科技有限公司摘要号：4585英文标题：An exploratory study of clostridium butyricum combined with neoadjuvant chemoimmunotherapy in urothelial carcinoma.中文标题：丁酸梭菌联合新辅助化学免疫治疗治疗尿路上皮癌的探索性研究讲者：杨潇教授南京医科大学第一附属医院（江苏省人民医院）摘要号：4586英文标题：Updated efficacy and safety results from ReBirth, a phase II study of risk-based bladder-sparing therapy for MIBC.中文标题：ReBirth临床研究的最新疗效和安全性结果，ReBirth是一项针对MIBC的基于风险的膀胱保留治疗的II期研究讲者：沈益君教授复旦大学附属肿瘤医院摘要号：4587英文标题：Postoperative assessment using urinary tumor DNA (utDNA) to identify potential candidates for repeat transurethral resection of bladder tumor (re-TURBT) in non-muscle invasive bladder cancer (NMIBC)： A retrospective analysis.中文标题：术后使用尿液肿瘤DNA（utDNA）评估以确定非肌层浸润性膀胱癌（NMIBC）再次经尿道膀胱肿瘤切除术（re-TURBT）的潜在获益患者：一项回顾性分析讲者：Zihan Xue 天津医科大学第二医院摘要号：4588英文标题：Updated results from a phase II study of perioperative disitamab vedotin (RC48-ADC) plus cadonilimab (AK104) for HER2-expressing muscle-invasive bladder cancer (MIBC).中文标题：围手术期维迪西妥单抗（RC48-ADC）联合卡度尼利单抗（AK104）治疗HER2表达的肌层浸润性膀胱癌的II期研究最新结果讲者：韩苏军教授国家癌症中心/中国医学科学院肿瘤医院，中国医学科学院北京协和医学院肿瘤医院摘要号：4590英文标题：Efficacy and safety of disitamab vedotin (RC48) combined with toripalimab as adjuvant therapy after radical surgery for patients with HER2-overexpression upper tract urothelial cancer (UTUC)： A single-arm, prospective, phase 2 clinical trial.中文标题：维迪西妥单抗（RC48）联合特瑞普利单抗作为HER2过表达上尿路尿路上皮癌（UTUC）患者根治术后辅助治疗的疗效和安全性：一项单臂、前瞻性、2期临床试验讲者：Shouyong Liu 南京大学医学院附属金陵医院摘要号：4592英文标题：Prognostic impact of histological subtypes in non-muscle-invasive UTUC： Propensity matched analysis.中文标题：组织学亚型对非肌层侵袭性UTUC预后的影响：倾向匹配分析讲者：Yunkai Qie 天津医科大学第二医院摘要号：4606英文标题：IL-15RαFc superagonist SHR-1501 with or without bacille Calmette Guerin (BCG) for high-risk non-muscle invasive bladder cancer (NMIBC)： A phase 1/2 study.中文标题：IL-15RαFc超激动剂SHR-1501联合或不联合卡介苗治疗高危非肌层浸润性膀胱癌（NMIBC）：一项1/2期研究讲者：Yuke Chen 北京大学第一医院摘要号：4607英文标题：Results of BH011 after intravesical administration in patients with CIS and/or papillary non-muscle invasive bladder cancer (NMIBC) after BCG failure： Interim results from a phase I/II clinical trial.中文标题：BH011在BCG失败后的CIS和/或乳头状非肌层浸润性膀胱癌患者中膀胱内给药后的结果：I/II期临床试验的中期结果讲者：叶定伟教授复旦大学附属肿瘤医院摘要号：TPS4617英文标题：Clinical effectiveness of urine DNA for minimal residual disease (MRD) monitoring of urothelial carcinoma in urine： A multicenter, prospective, observational study.中文标题：尿液DNA对尿路上皮癌微小残留病灶（MRD）监测的临床效果：一项多中心、前瞻性、观察性研究讲者：郭璇骏教授北京大学第一医院摘要号：TPS4624英文标题：PUNCH03： A phase II study of disitamab vedotin combined with tislelizumab and bacillus Calmette-Guerin (BCG) in Her2-positive high-risk non-muscle-invasive bladder cancer (HR NMIBC).中文标题：PUNCH03：维迪西妥单抗联合替雷利珠单抗和卡介苗治疗HER2阳性高危非肌层浸润性膀胱癌（HR NMIBC）的II期研究讲者：王宗任教授中山大学附属第一医院03前列腺癌、睾丸癌及阴茎癌壁报专场当地时间：6月2日09：00报告地点：Hall A - Posters and Exhibits摘要号：5038英文标题：Spatial transcriptional dynamics of CD74⁺ B cells in tertiary lymphoid structures and effects on immune evolution in penile squamous cell carcinoma.中文标题：CD74⁺ B细胞在三级淋巴结构中的空间转录动态及其对阴茎鳞状细胞癌免疫进化的影响讲者：Zaishang Li 深圳市人民医院摘要号：5047英文标题：Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as an initial treatment in unselected patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) in the China cohort of the phase 3 TALAPRO-2 trial.中文标题：在3期TALAPRO-2试验的中国队列中，未经选择的转移性去势抵抗性前列腺癌患者使用他拉唑帕利+恩扎卢胺作为初始治疗的最终总生存期讲者：卞晓洁教授复旦大学附属肿瘤医院摘要号：5075英文标题：Exploring PSMA heterogeneity and alternative targets expression in PSMA-negative prostate cancer.中文标题：探索PSMA阴性前列腺癌中的PSMA异质性和替代靶标表达讲者：Yelin Mulati 北京大学第一医院（来源：《肿瘤瞭望-泌尿时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果ASCO会议抗体药物偶联物临床2期

2025-04-30

·求实药社

辉瑞发布2025年第一季度财报，收入/支出双降，计划2027年前节省77亿美元

来源：新猎药人笔记2025年4月29日，美国制药巨头辉瑞公司（Pfizer）公布了其2025年第一季度的财务报告，并重申了2025年全年的财务指引。尽管面临新冠相关产品需求下降的挑战，辉瑞通过有效的成本管理和运营效率提升，实现了超出市场预期的业绩表现。第一季度财务表现• 收入：第一季度总收入为137亿美元，较市场预期的139.1亿美元略低。• 每股收益：调整后每股收益为0.92美元，显著高于市场预期的0.66美元。• 研发费用：第一季度研发费用为21.73亿美元，较去年同期下降12%，主要得益于研发管线的优化和重点聚焦。• 运营支出：调整后总运营支出为52.1亿美元，较去年同期下降13%。尽管第一季度收入略低于预期，辉瑞仍重申了其2025年全年的财务指引，预计总收入将在610亿至640亿美元之间，调整后摊薄每股收益预计在2.80至3.00美元之间。主要产品市场表现• Vyndaqel家族：全球销售额同比增长33%，主要得益于美国和国际发达市场的强劲需求。• Comirnaty（新冠疫苗）：全球销售额同比增长62%，主要由于美国市场的份额增长和国际市场的合同交付增加。• Padcev：全球销售额同比增长25%，主要由于在一线转移性尿路上皮癌（mUC）中的市场份额增加。• Nurtec ODT/Vydura：全球销售额同比增长40%，主要由于美国市场的强劲需求和国际市场的近期上市。• Lorbrena：全球销售额同比增长39%，主要由于在美国、中国和部分国际市场的市场份额增长。• Paxlovid：销售额同比下降75%，主要由于全球新冠感染人数减少和国际政府采购量下降辉瑞Q1核心管线进展• Padcev（enfortumab vedotin-ejfv）：2025年2月，辉瑞和安斯泰来（Astellas Pharma）公布了Padcev联合Keytruda（pembrolizumab）治疗局部晚期或转移性尿路上皮癌（la/mUC）的III期EV-302临床试验的额外随访结果。结果显示，联合治疗在总生存期（OS）和无进展生存期（PFS）方面具有持续的益处，且未发现新的安全信号。• Talzenna（talazoparib）：2025年2月，辉瑞宣布Talzenna联合Xtandi（enzalutamide）治疗转移性去势抵抗性前列腺癌（mCRPC）的III期TALAPRO-2研究取得了积极的总生存期（OS）结果，与安慰剂联合Xtandi相比，具有统计学意义和临床意义的改善。• Sasanlimab：2025年4月，辉瑞公布了sasanlimab（一种抗PD-1单克隆抗体）联合卡介苗（BCG）治疗高危非肌层浸润性膀胱癌（NMIBC）的III期CREST试验结果。研究显示，sasanlimab联合BCG治疗组与单独BCG治疗组相比，疾病相关事件的风险降低了32%。• Vepdegestrant：2025年3月，辉瑞和Arvinas宣布了vepdegestrant单药治疗雌激素受体阳性、人表皮生长因子受体2阴性（ER+/HER2-）晚期或转移性乳腺癌的III期VERITAC-2临床试验结果。在雌激素受体1突变（ESR1m）人群中，vepdegestrant组的无进展生存期（PFS）显著优于氟维司群（fulvestrant）组。• Danuglipron：2025年4月，辉瑞宣布停止开发danuglipron（一种口服GLP-1受体激动剂），该药物原本用于慢性体重管理。这一决定是在综合考虑所有临床数据和监管机构的反馈后做出的。• 2025年2月，宣布美国食品和药物管理局（FDA）批准Adcetris联合来那度胺和一种利妥昔单抗产品用于治疗复发或难治性大b细胞淋巴瘤（LBCL）的成人患者的补充生物制剂许可申请（sBLA），包括未另行指定的弥漫性大b细胞淋巴瘤（DLBCL）、由惰性淋巴瘤引起的DLBCL或高级别b细胞淋巴瘤。成本削减计划辉瑞宣布在此前公布的45亿美元成本削减计划基础上进一步扩大其成本削减计划，预计到2027年底实现总计77亿美元的成本节省。具体措施包括：• 销售、信息和行政费用（SI&A）：预计到2027年底实现约12亿美元的额外节省，主要通过数字化转型、自动化和人工智能技术的应用以及简化业务流程。• 研发重组：预计到2026年底通过研发部门的重组实现约5亿美元的成本节省，这些节省将被重新投入到公司的研发管线中。• 制造优化：公司现有的制造优化项目预计到2027年底实现约15亿美元的成本节省，初步节省预计将在2025年下半年开始显现。财报公布后，辉瑞股价上涨3.21%，显示出投资者对其未来前景的信心。辉瑞董事长兼首席执行官阿尔伯特·博尔拉博士（Albert Bourla）表示：“我们继续专注于战略优先事项，包括加强研发组织和提高生产力。凭借我们业务的潜在实力，我们相信可以在不确定和动荡的外部环境中保持灵活性。”免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们ISO 2025展位火热预定中！扫码立即咨询电话：13816031174（同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩！

抗体药物偶联物财报临床3期疫苗临床结果

2025-04-30

·Pharmaceutical Technology

GSK’s Zejula reduces risk of progression and death in mesothelioma study

Mesothelioma is a type of cancer that develops in the lining that covers the outer surface of some of the body’s organs and is usually linked to asbestos exposure. Image credit: Shutterstock / Wirestock Creators. GSK’s Zejula (niraparib) has reduced the risk of death or progression by 27% in patients with mesothelioma in an investigator-led Phase II trial. The NERO study (NCT05455424) investigated the efficacy of Zejula in 88 mesothelioma patients who relapsed after previously receiving platinum-based systemic therapy. The study is sponsored by the University Hospital Southampton NHS Foundation Trust and funded by Asthma + Lung UK, with support from Mesothelioma UK and the Mavis Nye Foundation. Mesothelioma is a highly aggressive cancer that forms in the protective lining surrounding certain internal organs, most commonly the lungs, and is usually linked to asbestos exposure. Treatments are limited, and the standard of care (SOC) includes surgery, chemotherapy, radiation therapy, and immunotherapy. Those treated with Zejula benefited from an average of 1.5 months progression-free survival (PFS) compared to SOC – marking a 27% reduction in the risk of the cancer progressing or death. Professor Gareth Griffiths, director of the Southampton Clinical Trials Unit and co-lead of the trial, said: “Although this increase may seem small, for this group of patients who have very few treatment options and a generally poor prognosis, this is a significant step forward. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “We have shown for the first time that this kind of drug can improve progression-free survival for mesothelioma patients compared with their usual treatment in the NHS. This gives enormous hope to those patients and their families and means we can now carry out further research to find out more about how these treatments could be tailored and enhanced to stimulate an even better response in more people.” The data was presented at the American Association of Cancer Research (AACR) Annual Meeting 2025 in Chicago, US, on 29 April. The University Hospital Southampton NHS Foundation Trust is now keen to initiate a new study, SELECTmeso, which will be a Phase II platform trial in patients with confirmed histological diagnosis of mesothelioma with evidence of MTAP loss on immunohistochemistry, and evidence of disease progression following prior standard systemic therapy on CT scan. Griffiths added: “This trial will see patients tested for certain biomarkers, or genetic signals, in their tumours and then given the drug that is most likely to work for them. We really hope this step into more personalised medicine could further help these patients who desperately need better treatment options.” Other PARP inhibitors being investigated in mesothelioma Zejula is an oral poly-ADP ribose polymerase (PARP) inhibitor that was approved on 27 March 2017 by the US Food and Drug Administration (FDA) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Other PARP inhibitors being investigated in patients with mesothelioma include AstraZeneca’s Lynparza (olaparib), which is currently in a Phase II trial (NCT04515836); and Pfizer’s Talzenna (talazoparib), which is also in a Phase II study (NCT04462809). AstraZeneca is also studying volrustomig , a bispecific antibody immunotherapy that targets and blocks PD-1 and CTLA-4. The drug is currently being evaluated in a Phase III trial for malignant pleural mesothelioma (NCT06097728). In September 2024, the FDA approved MSD’s Keytruda in combination with chemotherapy as a treatment for unresectable advanced or metastatic malignant pleural mesothelioma, based on data from the KEYNOTE-483 (NCT02784171) study.

临床2期临床结果免疫疗法上市批准临床3期

100 项与甲苯磺酸他拉唑帕利相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	甲苯磺酸他拉唑帕利	L01XX60	DB11760

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
乳腺癌	美国	Pfizer Inc.	2024-03-07
BRCA突变去势抵抗性前列腺癌	日本	Pfizer Japan, Inc.	2024-01-18
转移性去势抵抗性前列腺癌	欧盟	Pfizer Inc.	2024-01-08
转移性去势抵抗性前列腺癌	冰岛	Pfizer Inc.	2024-01-08
转移性去势抵抗性前列腺癌	列支敦士登	Pfizer Inc.	2024-01-08
转移性去势抵抗性前列腺癌	挪威	Pfizer Inc.	2024-01-08
HRR 基因突变去势抵抗性前列腺癌	澳大利亚	Pfizer Australia Pty Ltd.	2019-11-18
转移性乳腺癌	加拿大	PF Consumer Healthcare Canada ULC	2019-09-06
HR阳性乳腺癌	欧盟	Pfizer Europe MA EEIG	2019-06-20
HR阳性乳腺癌	冰岛	Pfizer Europe MA EEIG	2019-06-20
HR阳性乳腺癌	列支敦士登	Pfizer Europe MA EEIG	2019-06-20
HR阳性乳腺癌	挪威	Pfizer Europe MA EEIG	2019-06-20
gBRCA突变/HER2阴性乳腺癌	美国	Pfizer Inc.	2018-10-16

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
去势抵抗性前列腺癌	申请上市	美国	Pfizer Inc.	2023-02-17
去势敏感前列腺癌	临床3期	美国	Pfizer Inc.	2021-05-12
去势敏感前列腺癌	临床3期	中国	Pfizer Inc.	2021-05-12
去势敏感前列腺癌	临床3期	日本	Pfizer Inc.	2021-05-12
去势敏感前列腺癌	临床3期	阿根廷	Pfizer Inc.	2021-05-12
去势敏感前列腺癌	临床3期	澳大利亚	Pfizer Inc.	2021-05-12
去势敏感前列腺癌	临床3期	比利时	Pfizer Inc.	2021-05-12
去势敏感前列腺癌	临床3期	保加利亚	Pfizer Inc.	2021-05-12
去势敏感前列腺癌	临床3期	加拿大	Pfizer Inc.	2021-05-12
去势敏感前列腺癌	临床3期	捷克	Pfizer Inc.	2021-05-12

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


TAPUR (AACR2025)	临床2期	-	29	Talazoparib 1 mg	窪廠憲蓋鏇鹹膚鏇選鹽(鏇遞夢遞艱遞廠構築膚) = 糧鏇願顧衊鬱願糧網壓襯衊製鑰糧膚鹹膚範構 (築鬱範製鹽簾顧積膚獵, 29 ~ 100) 更多	积极	2025-04-29
NCT03395197 (TALAPRO-2, AACR2025)	临床3期	转移性去势抵抗性前列腺癌一线 TMPRSS2-ERG \| TP53 \| PTEN ... 更多	687	Talazoparib + Enzalutamide	廠餘鏇鑰艱鹽製壓夢夢(鬱鬱艱遞顧蓋糧蓋蓋積) = 膚獵襯獵壓簾廠憲繭繭膚網糧簾繭鑰願製願憲 (醖鑰願選鹹齋壓鏇膚製 ) 更多	积极	2025-04-28
				Placebo + Enzalutamide	廠餘鏇鑰艱鹽製壓夢夢(鬱鬱艱遞顧蓋糧蓋蓋積) = 鬱膚蓋顧選膚簾淵壓膚膚網糧簾繭鑰願製願憲 (醖鑰願選鹹齋壓鏇膚製 ) 更多
NCT03395197 (TALAPRO-2, AACR2025)	临床3期	转移性去势抵抗性前列腺癌一线 homologous recombination repair gene alterations \| ARa	681	Talazoparib + Enzalutamide	蓋鑰衊鑰選繭鹹鏇製艱(範糧觸鹹願憲壓選蓋壓) = 糧窪築襯顧觸構網廠夢遞願蓋蓋築鑰築繭鏇艱 (餘膚觸製壓築壓鏇繭簾 )	积极	2025-04-27
				Placebo + Enzalutamide	蓋鑰衊鑰選繭鹹鏇製艱(範糧觸鹹願憲壓選蓋壓) = 繭齋醖簾鹽範網膚鏇範遞願蓋蓋築鑰築繭鏇艱 (餘膚觸製壓築壓鏇繭簾 )
NCT04693468 (TalaCom, ESMO_TAT2025) 人工标引	临床1期	腹膜恶性间皮瘤 \| 卵巢癌 \| 肿瘤 ... BRCA2 Gene Mutation Negative \| BRCA1 Gene Mutation Negative 更多	28	Talazoparib 1mg QD + Axitinib 5 mg BID	願鑰壓製簾顧蓋網構鹽(鹽淵願餘製蓋獵鑰壓製) = 選製簾鑰獵獵鏇願簾遞窪襯憲淵衊鏇鬱鏇築憲 (憲鹽憲蓋獵蓋夢繭壓鹹 ) 更多	积极	2025-03-03
NCT04337970 (Phase 1b/2 Study of Talazoparib and Axitinib, Pubmed \| Eur Urol Oncol)	临床1/2期	局部晚期透明细胞肾细胞癌	23	Talazoparib	鏇鹹簾衊醖糧窪簾選蓋(艱製淵夢獵窪築蓋積鏇) = 製願觸製廠鬱遞網鏇鬱構簾膚艱淵繭糧網衊窪 (構憲顧鬱觸構簾選憲築, 3.5 ~ 8.4) 更多	不佳	2025-03-01
NCT03395197 (ASCO_GU2025) 人工标引	临床3期	HRR 基因突变去势抵抗性前列腺癌同源重组修复缺陷	399	Talazoparib + Enzalutamide	簾積夢觸壓繭廠蓋艱觸(獵糧選築糧膚艱顧蓋構) = 鑰鑰願壓顧獵鑰鏇鹹觸簾顧觸夢夢製觸顧遞餘 (窪艱鹹繭夢願醖選蓋襯 ) 更多	积极	2025-02-13
				Placebo + Enzalutamide	簾積夢觸壓繭廠蓋艱觸(獵糧選築糧膚艱顧蓋構) = 積積遞餘餘觸網醖製夢簾顧觸夢夢製觸顧遞餘 (窪艱鹹繭夢願醖選蓋襯 ) 更多
NCT03395197 (TALAPRO-2, ASCO_GU2025) 人工标引	临床3期	转移性去势抵抗性前列腺癌	805	Talazoparib + Enzalutamide	繭積齋餘餘鹹鹽餘蓋構(選遞製糧糧簾鹽簾願衊) = 餘觸襯糧膚範壓襯餘窪鹹壓鏇艱齋遞築餘憲鹹 (鬱構鬱網蓋築獵簾窪憲 ) 更多	积极	2025-02-13
				Placebo + Enzalutamide	繭積齋餘餘鹹鹽餘蓋構(選遞製糧糧簾鹽簾願衊) = 製繭壓糧衊選顧製網鏇鹹壓鏇艱齋遞築餘憲鹹 (鬱構鬱網蓋築獵簾窪憲 ) 更多
NCT04187833 (CTgov)	临床2期	转移性黑色素瘤 \| 不可切除的黑色素瘤	8	Nivolumab+Talazoparib	顧膚膚觸餘遞構築鏇繭 = 構遞醖醖簾鑰鑰膚觸製糧網選襯糧築廠鏇壓築 (憲艱糧餘鬱淵願齋構製, 鏇蓋淵遞憲衊觸蓋選繭 ~ 簾積齋築齋壓淵鹽壓齋) 更多	-	2025-01-14
NCT03395197 (TALAPRO-2, Pubmed \| Cancer Med)	临床3期	转移性去势抵抗性前列腺癌 homologous recombination repair (HRR) gene alterations \| BRCA1/2 gene alterations	116	Talazoparib plus Enzalutamide	觸鹽製淵鏇糧窪範繭遞(窪糧顧獵顧淵鏇夢製鬱) = 艱觸淵網淵製齋鹽構選築簾簾艱積衊選觸窪夢 (淵顧糧範壓蓋遞範餘繭 )	积极	2025-01-01
				Placebo plus Enzalutamide	觸鹽製淵鏇糧窪範繭遞(窪糧顧獵顧淵鏇夢製鬱) = 糧築襯蓋鹽醖膚繭淵繭築簾簾艱積衊選觸窪夢 (淵顧糧範壓蓋遞範餘繭 )
NCT04068831 (CTgov)	临床2期	转移性肾细胞癌 \| 富马酸水合酶缺乏型肾细胞癌 \| 线粒体复合体II缺乏	18	Avelumab+Talazoparib (Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual))	蓋襯鬱艱壓範簾鏇襯淵(鏇製範觸願積膚選齋淵) = 獵艱艱窪鹽網選鬱憲壓鏇艱憲餘襯夢淵壓襯願 (鏇範憲構簾選願遞夢餘, 選鹹鹽遞鬱齋鑰蓋顧顧 ~ 鑰鹹壓遞醖窪鬱製願襯) 更多	-	2024-12-27
				Avelumab+Talazoparib (Talazoparib and Avelumab (FH- or SDH-deficiency))	蓋襯鬱艱壓範簾鏇襯淵(鏇製範觸願積膚選齋淵) = 繭觸遞艱窪齋鹽廠繭顧鏇艱憲餘襯夢淵壓襯願 (鏇範憲構簾選願遞夢餘, 糧醖鑰鹽鏇顧築觸淵築 ~ 窪獵衊繭積齋鏇壓齋鹹) 更多