Combination Therapy of Senaparib and Bevacizumab for First-line Maintenance Therapy in Newly Diagnosed Advanced Homologous Recombination Proficient Ovarian Cancer Based on Exosome Protein Marker: a Single Arm, Prospective Clinical Study

This study is a Prospective, Single-arm, Phase II clinical trial. The purpose of this study is to find out if taking combination therapy of Senaparib and Bevacizumab is safe and works well for people with first-line maintenance therapy in newly diagnosed advanced homologous recombination proficient ovarian cancer, and explore relevant biomarkers for evaluating the efficacy of maintenance therapy through exosome. Researchers will look at the Progression-Free Survival, Overall Survival, safety, and any side effects.

开始日期2025-10-10

申办/合作机构

复旦大学

NCT06617923

/ Recruiting临床2期IIT

A Phase 2 Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer

This is a phase 2 study to test the effectiveness (anti-tumor activity) of the combination of the study drugs, Senaparib and Temozolomide, in patients with clear cell or endometrioid ovarian cancers that have ARID1A pathologic variants.

开始日期2025-02-06

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT07019194

/ Completed临床1期

An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study to Compare Two Strengths (10 mg and 20 mg) of Senaparib Capsules in Healthy Chinese Subjects Following Oral Administration Under Fasting Condition

开始日期2024-06-21

申办/合作机构

上海瑛派药业有限公司

100 项与塞纳帕利相关的临床结果

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100 项与塞纳帕利相关的转化医学

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100 项与塞纳帕利相关的专利（医药）

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项与塞纳帕利相关的文献（医药）

2025-05-01·JOURNAL OF CONTROLLED RELEASE

Multifunctional nanoparticle-mediated targeting of metabolic reprogramming and DNA damage response pathways to treat drug-resistant triple-negative breast cancer

Article

作者: Wang, Jue ; Wang, Cheng ; Cai, Zimin ; Sun, Chao ; Zhu, Sifeng ; Wu, Jibin ; Han, Xu

Multi-drug resistance and immunosuppressive triple-negative breast cancer (TNBC) is triggered by the Warburg effect, which promotes homologous recombination repair (HRR) and upregulates expression of P-glycoprotein (P-gp), in turn preventing DNA damage from chemotherapy and creating an immunosuppressive microenvironment. It is therefore of clinical relevance to develop an effective delivery system that targets metabolic reprogramming and DNA damage response pathways for the treatment of drug-resistant TNBC. Herein, a P-gp-inhibiting and GSH-responsive multifunctional drug carrier targeting integrin αvβ3 was synthesised for the delivery of Lonidamine-prodrug (M1, glycolysis inhibitor) and Senaparib (Se, Poly [ADP-ribose] polymerase inhibitor). The nanodrug delivery system (iPR@M1/Se nanoparticles) exhibit effective tumour penetration and P-gp inhibition, effectively inducing DNA damage and apoptosis in Olaparib-resistant TNBC cells in vitro, as well as a higher tumour inhibitory rate compared with that of Se (81.82 % ± 2.31 % vs 43.91 % ± 4.65 %) in vivo. Mechanistically, iPR@M1/Se nanoparticles not only reshaped the immunosuppressive microenvironment resulting from tumour glycolysis, but also downregulated the expression of HRR-related protein, fostering the cytoplasmic accumulation of DNA damage fragments, which induced activation of the cyclic GMP-AMP synthase (cGAS)/stimulator of interferon gene (STING) pathway. Experimental results show that iPR@M1/Se nanoparticles effectively promote dendritic cell maturation and T lymphocyte activation, which elicits long-term immune memory responses, and prevents tumour recurrence and lung metastasis. Therefore, these multifunctional nanoparticles have great potential and provide a clinically relevant and valuable option for Olaparib-resistant TNBC.

2025-04-01·JOURNAL OF BIOLOGICAL CHEMISTRY

Duplexed CeTEAM drug biosensors reveal determinants of PARP inhibitor selectivity in cells

Article

作者: Alam, Seher ; Rotili, Dante ; Altun, Mikael ; Lovric, Alen ; Fabbrizi, Emanuele ; Pires, Maria J ; Valerie, Nicholas C K

Poly (ADP-ribose) polymerase (PARP) inhibitors (PARPi) targeting PARP1 and PARP2 have revolutionized cancer therapy by selectively killing cancer cells with defective DNA repair. However, achieving PARP1 or PARP2-selective inhibitors is difficult due to structural homology. Selectivity profiling is typically done with purified proteins, but these lack the complexity of intracellular environments and could therefore be inaccurate. Here, we duplex PARP1 L713F-GFP and PARP2 L269A-mCherry cellular target engagement by accumulation of mutant (CeTEAM) drug biosensors to systematically characterize binding and cell cycle alterations of 27 PARPi. Our results reveal that most PARPi are equipotent for both PARPs, including the next-generation drug, senaparib. However, benzimidazole carboxamide (niraparib) derivatives demonstrated PARP1-selective tendencies, while phthalazinones (olaparib) favored PARP2. AZD5305, a reported PARP1-selective inhibitor with characteristics of both series, was the exception and appears ∼1600-fold more potent toward PARP1. In agreement with current understanding, we see that trapping-associated S/G2-phase transitions positively correlate with PARP1/2 binding potency, while some potent binders, such as veliparib, did not - likely reflecting their allosteric influence on DNA retention. We also assessed the effect of the PARP1/2 active site component, histone PARylation factor 1, on intracellular PARPi binding and see that its depletion elicits slight deviations in apparent binding potency, while contributing additively to trapping-like phenotypes. The PARP1/2 CeTEAM platform thus provides a structural roadmap for the development of selective PARPi and should facilitate the discovery of targeted therapies. Furthermore, our results highlight that multiplexing CeTEAM biosensors and layered genetic perturbations can systematically profile determinants of intracellular drug selectivity.

2025-01-02·MOLECULAR CANCER THERAPEUTICS

The Discovery of a Potent PARP1 Inhibitor Senaparib

Article

作者: Guo, Mingchuan ; Cai, Sui X. ; Tian, Ye E. ; Jiang, Yangzhen ; Ma, Ning ; Wang, Xiaozhu

Abstract:

PARP1 is a critical enzyme involved in DNA damage repair. It belongs to a superfamily of proteins and catalyzes poly(ADP-ribosyl)ation (PARylation). PARP1 inhibitors are effective to treat tumors that have homologous recombination deficiency such as those with BRCA1/2 mutations. The PARP1 inhibitors that have been approved by FDA inhibit both PARP1 and PARP2. PARP2 has also been suggested to play a similar function in DNA repair as PARP1. In addition to inhibiting PARP1 enzymatic activities, PARP1 inhibitors cause the PARP1 enzyme to be “trapped” on DNA, stalling the DNA replication fork and eventually causing double-strand DNA breaks and cell death. Here, we report a PARP1 inhibitor, Senaparib, which has a novel chemical structure and high potency inhibiting PARP1/2 enzymes. Senaparib was highly potent in cell viability tests against tumor cells with BRCA1/2 mutations. It was efficacious in cell line-derived and patient-derived xenograft models in tumors harboring BRCA1/2 mutations. In combination studies, Senaparib used with temozolomide had shown strong synergistic cytotoxicity in both in vitro and in vivo experiments. Senaparib represents a novel class of PARP1 inhibitors that can be used for the treatment of cancer. A phase III clinical study of Senaparib for maintenance treatment following first-line chemotherapy in patients with advanced ovarian cancer has met its primary endpoint, and a new drug application of Senaparib has been accepted by the National Medical Products Administration of China for review.

121

项与塞纳帕利相关的新闻（医药）

2025-09-03

·医药观澜

破局之路：从50%死亡率，到生存率接近翻倍，卵巢癌治疗如何实现历史性跨越

编者按：卵巢癌是死亡率最高的妇科癌症之一。从手术到放化疗，再到创新靶向疗法，医学的进步持续为广泛的卵巢癌患者带来新的治疗选择。然而，临床挑战仍在：晚期卵巢癌患者的五年生存率仍未突破50%的大关。目前，全球有数百新药管线项目处于临床研究阶段，不断探索卵巢癌治疗的更多可能性。作为医药创新的赋能者，药明康德凭借一体化、端到端的CRDMO平台，持续助力全球合作伙伴加速包括卵巢癌在内的各类癌症创新药物的研发进程，致力于将更多突破性治疗方案带给癌症患者，为战胜癌症贡献力量。在全球女性癌症谱系中，卵巢癌一直以“难治”著称。难治的原因之一是其早期症状十分隐匿，约70%的患者在确诊时已处于晚期。再加上复发率高、预后较差等因素，卵巢癌也成为了主要的“妇女杀手”之一。卵巢癌的治疗策略经历了漫长的演变。从19世纪早期的开创性手术起步，当时卵巢切除术因缺乏有效的技术支持而风险极高；但在十九世纪后期，随着无菌技术和麻醉的应用，该手术的死亡率从惊人的50%大幅降至11%，成为治疗史上的重要转折。此后，医学的进步持续推动治疗策略的演进：20世纪中期引入放射治疗，70-80年代铂类与紫杉烷类化疗药物问世，直再到21世纪靶向治疗创新，每一步都为卵巢癌的治疗带来了深刻改变。近十余年来，随着靶向治疗时代的开启和新型分子疗法的不断涌现，卵巢癌的治疗格局迎来了新的转机。回望整个卵巢癌治疗的发展史，各类治疗手段的迭代演进，全球各界协同创新，共同推动着卵巢癌治疗领域的每一次重大突破。图片来源：123RF 从“无差别杀伤”到“精准打击” 自从基于铂类药物的组合化疗成为标准治疗后，晚期卵巢癌患者的5年生存率提高到了约25%，但仍然不是一个令人满意的数字。约80%的患者在接受一线治疗后有望获得完全缓解，然而残酷的是，60%~80%患者会在18个月内因化疗耐药复发，即便二线治疗有效，85%患者仍会在两年内再次出现疾病进展。临床上仍然存在着巨大的未竟医疗需求。 21世纪初，靶向治疗时代拉开了帷幕，也为卵巢癌的治疗带来了突破——开始从“无差别杀伤”的传统化疗模式，转向针对肿瘤特定分子特征的“精准打击”策略。 2011年，欧洲率先批准了抗血管生成药物Avastin（bevacizumab，贝伐珠单抗）与铂-紫杉烷类化疗的联合方案，用于晚期卵巢癌的一线治疗及维持治疗。该药物通过抑制肿瘤血管生成来“饿死”癌细胞，与化疗联用可显著延长无进展生存期。三年后，美国FDA也批准了该药在铂类耐药复发性卵巢癌二线治疗中的应用。作为一类在卵巢癌领域取得突破的生物制品，贝伐珠单抗能暂时延缓疾病进展，但难以显著延长患者的总生存时间，加上该药有可能引发一些不良反应，医学界希望找到更安全有效的新疗法。 “合成致死”，针对卵巢癌的常见突变 2014年，随着首款PARP抑制剂的问世为卵巢癌治疗带来了革命性转变。这一突破可追溯至1922年，当时哥伦比亚大学Calvin Bridges博士发现了“合成致死”现象——既两个基因同时发生突变时会导致细胞死亡，而单独突变却不会。近一个世纪后，这一机制成为了抗癌药物开发的新思路。2005年，《自然》杂志同期发表两项里程碑研究首次证实：PARP抑制剂与BRCA突变存在“合成致死”效应。其原理在于，BRCA突变会破坏癌细胞修复DNA双链断裂的能力，而PARP抑制剂则能阻断另一条修复单链断裂的通路。当两种机制同时被抑制时，癌细胞就会因无法修复DNA损伤而死亡。约15%的卵巢癌患者携带BRCA基因突变，这为PARP抑制剂的应用提供了理想靶点。经过近十年的临床探索，2014年12月，FDA批准了首款PARP抑制剂Lynparza（olaparib，奥拉帕利），用于治疗携带BRCA种系突变的晚期卵巢癌患者。奥拉帕利的成功推动了更多PARP抑制剂的研发。2016年，Zejula（niraparib，尼拉帕利）证实其对同源重组修复缺陷（HRD）阳性的非BRCA突变患者同样有效，进一步扩大了受益人群。截至目前，全球已有7款PARP抑制剂获批，其中6款可用于治疗卵巢癌，包括奥拉帕利、尼拉帕利，塞纳帕利、帕米帕利、氟唑帕利，以及和Rubraca（rucaparib）。它们通过精准打击癌细胞的DNA修复缺陷，显著延长了患者的无进展生存期。随着PARP抑制剂广泛应用于在一线维持治疗，卵巢癌患者的生存率持续提升。例如，在一项临床试验中，晚期高风险患者的5年生存率已超过40%。这一进步源于多方面的协同进展：更彻底的手术肿瘤减灭，更有效的化疗方案，PARP抑制剂的维持治疗的精准应用，以及其他靶向药物的合理组合，共同延缓了疾病复发的进程。从靶向药到免疫疗法在PARP抑制剂取得显著临床成果的同时，多种机制各异的卵巢癌创新疗法也陆续问世，为患者提供了更加丰富的治疗选择。以叶酸受体α（FRα）为例，尽管该靶点在35-40%的卵巢癌中存在高表达，但长期以来缺乏有效靶向药物。2022年11月，FDA加速批准了首个靶向FRα的抗体偶联药物（ADC）Elahere（mirvetuximab soravtansine）。该药物通过将FRα单抗与细胞毒性分子DM4偶联，实现了对铂类耐药卵巢癌的杀伤打击。值得一提的是，该疗法是首个在铂类耐药卵巢癌患者上显示带来总生存期（OS）获益的疗法：在其关键3期临床中，Elahere组患者的中位OS为16.46个月，较研究者选择（IC）化疗组的12.75个月延长近4个月。针对化疗应答率较低的卵巢癌亚型，2025年5月，FDA加速批准了RAF/MEK抑制剂avutometinib联合FAK抑制剂defactinib方案（Avmapki Fakzynja Co-Pack）用于KRAS突变型复发性低级别浆液性卵巢癌（LGSOC）。Avutometinib可同时抑制RAF和MEK，克服了传统MEK抑制剂的代偿性激活问题。在抗血管生成治疗方面，新一代重组人源化抗血管内皮生长因子（VEGF）抗体苏维西塔单抗于今年7月获中国NMPA批准，可与紫杉醇、多柔比星脂质体或拓扑替康联用治疗铂耐药后接受过不超过1种系统治疗的成人复发性卵巢癌、输卵管癌或原发性腹膜癌的治疗。在一项3期临床试验中，与对照组相比，苏维西塔单抗组显示出总生存期获益趋势（16.07个月 vs 14.88个月）。此外，该药物的临床应用不受前线VEGF通路治疗和PARP抑制剂靶向治疗的限制，与化疗联用也不受化疗种类限制。除上述靶点外，约1-2%的卵巢癌患者携带NTRK基因融合突变，该突变会驱动异常细胞生长和癌症进展。Vitrakvi（larotrectinib，拉罗替尼）和Rozlytrek（entrectinib，恩曲替尼）能够阻断突变NTRK基因产生异常蛋白质，适用于那些经治后进展、携带NTRK基因突变的晚期卵巢癌患者。在靶向疗法不断突破的同时，免疫治疗也为卵巢癌患者带来新的希望。癌细胞常利用免疫“检查点”机制逃避免疫监视，以PD-1/PD-L1抑制剂为代表的免疫检查点抑制剂，通过阻断这一逃逸通路，能够重新激活T细胞对癌细胞的杀伤作用。目前，包括Keytruda（pembrolizumab，帕博利珠单抗）、Jemperli（dostarlimab）和百泽安（替雷利珠单抗）在内的多种PD-1抑制剂已获得监管批准，用于治疗不可切除或转移性微卫星高度不稳定型（MSI-H）或错配修复基因缺陷型（dMMR）的晚期实体瘤患者，其中也包括卵巢癌患者。靶向治疗与免疫疗法的持续涌现，正推动卵巢癌治疗迈向精准化和个体化的新时代。随着对卵巢癌分子机制理解的深入以及创新药物的不断研发，临床医生得以依据患者的分子特征，选择更加匹配的治疗策略，为不同亚型的卵巢癌患者提供更具针对性的治疗选择。一体化平台赋能卵巢癌新药开发从十九世纪的卵巢切除术发展至如今的精准靶向治疗，人类对抗卵巢癌的征程已走过一条漫长而艰辛的道路。一方面看，治疗手段不断革新，给患者带来了新的希望。然而另一方面，晚期卵巢癌患者的五年生存率至今仍未突破50%。这一现实始终提醒我们：与卵巢癌这一“沉默杀手”的较量，依然任重而道远。根据公开资料，目前有数百卵巢癌疗法研发管线已进入临床开发阶段。长期以来，药明康德都在支持全球合作伙伴从药物研究（R）、开发（D）到商业化生产（M）各个阶段的需求，通过独特的一体化、端到端CRDMO模式，助力突破性疗法加速研发进程、早日惠及患者。我们很高兴能赋能来自全球客户的卵巢癌新药的开发，也将继续与全球合作伙伴携手同行，共同推动卵巢癌治疗的突破，让更多患者迎来曙光！免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。

放射疗法

2025-08-18

·impacttherapeutics.com

英派药业宣布欧洲药品管理局已受理塞纳帕利胶囊用于卵巢癌一线维持治疗的上市许可申请

中国上海，2025年8月15日 - 英派药业，一家专注于发现和开发基于合成致死作用机制的靶向抗癌治疗药物的生物技术公司，欣然宣布，塞纳帕利 (Senaparib)用于晚期卵巢癌一线维持治疗的上市许可申请（MAA）已获得欧洲药品管理局（EMA）受理。这是继 2025 年 1 月中国国家药品监督管理局（NMPA）批准塞纳帕利作为适用于晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者在一线含铂化疗达到完全缓解或部分缓解后的维持治疗之后的又一里程碑。此次申报是基于一项随机、双盲、安慰剂对照、多中心III期临床研究（FLAMES研究）。其研究结果显示塞纳帕利维持治疗能够显著延长晚期卵巢癌患者的无进展生存期（PFS），无论患者是否伴有乳腺癌易感基因（BRCA）突变，均能从塞纳帕利治疗中获益。同时，塞纳帕利耐受性良好，安全性可控。该研究数据已于2024年5月在Nature Medicine 上发表。1 英派药业首席执行官蔡遂雄博士表示：“我们很高兴塞纳帕利的上市许可申请获得欧洲药品管理局的受理。这是英派药业走向国际化的重要里程碑。我们期待塞纳帕利能尽快进入海外市场，惠及全球患者。” 【关于卵巢癌】卵巢癌是最常见的致死性女性生殖道恶性肿瘤之一。据GLOBOCAN 2020数据，，全球卵巢癌的年新发病例数达31万，死亡病例数达21万2。由于卵巢癌早期症状隐匿且非特异，约80%的患者确诊时已为晚期，5年生存率仅有40%3。尽管卵巢癌经过初始含铂化疗后可以得到缓解，但大多数患者都不可避免面临复发4。近年来，PARP抑制剂正在改变卵巢癌的治疗格局，其维持治疗可延长一线含铂化疗后的缓解时间，延缓复发5。 1. 本材料旨在传递前沿信息，无意向您做任何产品的推广，不作为临床用药指导。 2. 若您想了解具体疾病诊疗信息，请遵从医疗卫生专业人士的意见与指导。【关于FLAMES研究】 FLAMES研究（IMP4297-301，NCT04169997）是一项随机、双盲、安慰剂对照、多中心的Ⅲ期临床研究，旨在评价一线含铂化疗达到完全缓解（CR）或部分缓解（PR）后塞纳帕利单药维持治疗FIGO III-IV期卵巢癌患者的有效性和安全性。FLAMES研究结果显示，塞纳帕利维持治疗能够显著延长晚期卵巢癌患者的中位无进展生存期（mPFS）（未达到 vs 13.6月, HR 0.43， P < 0.0001），且不论患者的BRCA基因表达如何，均能从塞纳帕利治疗中获益。同时，塞纳帕利耐受性良好，安全性可控。此外，塞纳帕利在具有同源重组缺陷(HRD)和同源重组修复正常（HRR）亚组的患者中均显示出显著PFS获益，突显其广泛的临床应用潜力。此研究结果有力支持了塞纳帕利单药作为新诊断卵巢癌患者一线全人群维持治疗的标准方案。该研究数据于2023年欧洲肿瘤内科学会（ESMO）大会和2024年中国临床肿瘤学会（CSCO）大会等重要学术会议上，通过口头报告的形式展示，并发表在国际顶级医学期刊《Nature Medicine》上。1 【关于 Senaparib（派舒宁®）】塞纳帕利是英派药业研发的一种强效、新型PARP 1/2抑制剂。其独特的分子结构具有较高的体外和体内活性、优异的靶点选择性和较宽的安全窗。FLAMES研究为塞纳帕利获得NMPA批准提供了支持。【关于英派药业】英派药业是一家处于商业化阶段的全球性、创新驱动型生物技术公司，也是全球少数专注于合成致死（synthetic lethality）原理开发新型精准肿瘤疗法的公司之一。我们的愿景是打造全球领先的合成致死平台，提供更优的靶向癌症治疗方案，显著改善实体瘤治疗现状。我们的产品管线处于全球合成致死领域前沿，旨在解决重大未满足的医疗需求，树立新的治疗标准。公司管线包括PARP抑制剂塞纳帕利（Senaparib/IMP4297）、ATR抑制剂（IMP9064）、Wee1抑制剂（IMP7068）、PARP1选择性抑制剂 (IMP1734及IMP1707，与美国Eikon Therapeutics合作开发)以及多个其他合成致死靶点抑制剂。更多信息请浏览www.impacttherapeutics.com 投资者关系及媒体英派药业 +86 21 6841 1121 IR@impacttherapeutics.com PR@impacttherapeutics.com 【参考文献】 1.Nature Medicine | Volume 30 | June 2024 | 1612–1621 2.Sung H, et al. CA Cancer J Clin. 2021; 71(3):209-49 3.Morgan RJ Jr, et al. J Natl Compr Canc Netw. 2016; 14:1134-63. 4.Jayson GC, et al. Lancet. 2014;384(9951):1376–88. 5. Khalique S, et al. Curr Opin Oncol. 2014;26(5):521–8.

临床3期上市批准

2025-08-15

·英派药业

EMA Accepts MAA of Senaparib for 1L Maintenance Therapy in OC

NEWS SHANGHAI, August 15th, 2025 - IMPACT Therapeutics (“IMPACT”), a biotechnology company focused on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, is pleased to announce that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Senaparib, a next-generation PARP1/2 inhibitor discovered and developed by IMPACT, as a first-line maintenance treatment for advanced ovarian cancer. This milestone follows Senaparib’s approval by the China National Medical Products Administration (NMPA) in January 2025 as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. This MAA submission is based on the randomized, double-blind, placebo-controlled, multicenter phase III FLAMES study (FLAMES Study). The results of the FLAMES Study showed that Senaparib demonstrated significant improvement in median progression-free survival (mPFS) compared to placebo, irrespective of BRCA status. Meanwhile, Senaparib was well-tolerated with a manageable safety profile. The results were published in May 2024 in the internationally renowned medical journal Nature Medicine.1 Dr. Sui Xiong Cai, CEO of IMPACT, said: “We are delighted that the MAA for Senaparib has been accepted by the EMA. This marks a pivotal milestone in IMPACT’s journey toward globalization. With this acceptance, we anticipate expedited entry into overseas markets to deliver this innovative therapy to patients worldwide.” - This material is intended to provide cutting-edge information, and is not meant to promote any products or serve as clinical medication guidance. - If you wish to obtain specific disease diagnosis and treatment information, please follow the advice and guidance of medical and healthcare professionals. About Ovarian Cancer Ovarian cancer is one of the most common lethal female reproductive malignancies. According to GLOBOCAN 2020 data, the global incidence of ovarian cancer is amounted to 310,000 cases and mortality is amounted to 210,000.2 Due to the insidious and non-specific early symptoms of ovarian cancer, about 80% of patients are already in advanced stage when they are diagnosed, and the 5-year survival rate is only 40%.3 Although ovarian cancer may be resolved after initial platinum-based chemotherapy, most patients face recurrence, highlighting a significant unmet clinical need for treatment in the ovarian cancer patient population.4 In recent years, PARP inhibitors have transformed the therapeutic landscape for ovarian cancer, with maintenance therapy extending the duration of sustained remission after platinum-based chemotherapy and delaying disease recurrence.5 About the FLAMES Study The FLAMES Study (IMP4297-301, NCT04169997) is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study designed to evaluate the efficacy and safety of Senaparib as a single-agent maintenance treatment for patients with FIGO Stage III-IV ovarian cancer who have achieved a complete response (CR) or partial response (PR) following first-line platinum-based chemotherapy. The results of the FLAMES Study showed that Senaparib demonstrated significant improvement in median PFS compared to placebo (PFS not reached vs 13.6 months, HR 0.43, P < 0.0001), irrespective of BRCA status. Senaparib demonstrated a tolerable safety profile, with no noticeable safety issues. 1 The results also indicated that both homologous recombination deficiency (HRD) positive and HRD negative populations derived benefit from Senaparib maintenance therapy, highlighting the potential of Senaparib for broad clinical application. The results of this study will strongly support Senaparib as the Standard of Care for first-line maintenance therapy in patients with newly diagnosed ovarian cancer. The top-line results of the study were initially presented as a late-breaking oral presentation at ESMO in 2023 and at CSCO 2024, and published in the international renowned medical journal Nature Medicine. 1 About Senaparib (派舒宁®) Senaparib is a potent and novel PARP 1/2 inhibitor discovered and developed by IMPACT. Its unique molecular structure provides high in vitro and in vivo activity, exceptional target selectivity and wide safety window. Senaparib’s approval by the NMPA was supported by the FLAMES Study. About IMPACT Therapeutics IMPACT Therapeutics is a globally focused, innovation-driven biotechnology company at the commercial stage, and one of the few biotechnology companies worldwide dedicated to the discovery and development of novel precision oncology therapeutics based on the synthetic lethality approach. IMPACT’s vision is to build a leading global synthetic lethality franchise that delivers better targeted cancer therapies and makes a meaningful impact on the treatment of solid tumors. IMPACT’s pipeline is among the most advanced in the synthetic lethality field globally, with product candidates designed to address significant unmet medical needs and poised to set new standards of care. IMPACT’s pipeline includes the PARP1/2 inhibitor Senaparib (IMP4297), ATR inhibitor (IMP9064), Wee1 inhibitor (IMP7068), PARP1 selective inhibitors (IMP1734 and IMP1707, co-developed with Eikon Therapeutics), and multiple other synthetic lethality target inhibitors. For additional information, please visit www.impacttherapeutics.com IMPACT Therapeutics Contact: +86 21 6841 1121 IR@impacttherapeutics.com PR@impacttherapeutics.com References 1. Nature Medicine | Volume 30 | June 2024 | 1612–1621 2. Sung H, et al. CA Cancer J Clin. 2021; 71(3):209-49 3. Morgan RJ Jr, et al. J Natl Compr Canc Netw. 2016; 14:1134-63. 4. Jayson GC, et al. Lancet. 2014;384(9951):1376–88. 5. Khalique S, et al. Curr Opin Oncol. 2014;26(5):521–8.

CSCO会议临床结果

100 项与塞纳帕利相关的药物交易

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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
输卵管癌	中国	上海英派药业有限公司	2025-01-14
卵巢上皮癌	中国	上海英派药业有限公司	2025-01-14
原发性腹膜癌	中国	上海英派药业有限公司	2025-01-14

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
卵巢癌	申请上市	欧盟	南京英派药业股份有限公司	2025-08-15
转移性去势抵抗性前列腺癌	临床2期	美国	上海瑛派药业有限公司	2021-12-31
转移性去势抵抗性前列腺癌	临床2期	中国	上海瑛派药业有限公司	2021-12-31
转移性去势抵抗性前列腺癌	临床2期	澳大利亚	上海瑛派药业有限公司	2021-12-31
晚期恶性实体瘤	临床2期	美国	上海英派药业有限公司	2021-09-28
晚期恶性实体瘤	临床2期	澳大利亚	上海英派药业有限公司	2021-09-28
晚期恶性实体瘤	临床2期	韩国	上海英派药业有限公司	2021-09-28
广泛期小细胞肺癌	临床2期	美国	上海英派药业有限公司	2021-09-28
广泛期小细胞肺癌	临床2期	澳大利亚	上海英派药业有限公司	2021-09-28
广泛期小细胞肺癌	临床2期	韩国	上海英派药业有限公司	2021-09-28

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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


NCT04169997 (FLAMES, Nat Med) 人工标引	临床3期	卵巢癌一线 BRCA1 Mutation \| BRCA2 Mutation	404	senaparib 100 mg	衊簾繭鹽醖蓋鏇膚糧願(壓糧觸簾遞襯繭壓製簾) = 製願鬱範齋鹹構鹽糧壓鬱餘網觸衊艱鬱淵簾鬱 (膚範醖齋夢範廠膚鑰鬱 ) 更多	积极	2024-05-15
				placebo	衊簾繭鹽醖蓋鏇膚糧願(壓糧觸簾遞襯繭壓製簾) = 糧獵鏇築淵選憲繭窪襯鬱餘網觸衊艱鬱淵簾鬱 (膚範醖齋夢範廠膚鑰鬱 ) 更多
NCT04089189 (SABRINA, ESMO 12023 \| ESMO 22023) 人工标引	临床2期	卵巢癌 BRCA1 Mutation \| BRCA2 Mutation	93	Senaparib 100 mg	築糧憲蓋鏇簾餘積遞觸(膚簾窪遞膚糧壓夢憲廠) = 鏇繭鏇膚鑰構艱鏇窪膚衊膚簾鏇夢構鑰範衊製 (夢鏇醖鏇獵膚齋淵夢積, 86.2 ~ 97.5) 更多	积极	2023-10-22
NCT04169997 (FLAMES, ESMO2023) 人工标引	临床3期	卵巢癌维持	404	Senaparib	壓艱窪齋觸齋顧壓獵願(製簾繭憲廠網築鏇艱廠) = 餘願積網願鏇鹽鬱鬱餘鹽餘選製鹽膚齋廠衊觸 (築鏇餘襯選衊構觸願窪 ) 更多	积极	2023-10-20
				Placebo	壓艱窪齋觸齋顧壓獵願(製簾繭憲廠網築鏇艱廠) = 襯網窪製艱齋夢選範鬱鹽餘選製鹽膚齋廠衊觸 (築鏇餘襯選衊構觸願窪 ) 更多
FLAMES study (ESGO2023)	临床3期	卵巢癌维持 high-grade serous \| endometrioid tumors	404	Senaparib	範網鬱願製淵餘觸衊糧(範鹹選衊顧襯製築窪齋) = 選餘壓餘窪範遞壓糧壓廠艱膚淵蓋鬱醖鑰遞鹽 (積廠衊鬱鬱簾膚糧廠憲 )	积极	2023-09-28
				Placebo	範網鬱願製淵餘觸衊糧(範鹹選衊顧襯製築窪齋) = 襯淵襯齋願壓壓簾鏇觸廠艱膚淵蓋鬱醖鑰遞鹽 (積廠衊鬱鬱簾膚糧廠憲 )
NCT04434482 (WCLC2023) 人工标引	临床1/2期	广泛期小细胞肺癌	42	Senaparib + Temozolomide	襯蓋鏇窪齋蓋蓋鏇淵獵(淵鏇鹹遞鏇構構壓遞夢) = 鹹蓋夢艱糧廠構憲鏇淵齋遞艱齋襯膚觸壓夢網 (夢網醖範蓋膚簾艱鏇網, 5.4 ~ 28.5) 更多	积极	2023-09-12
				Senaparib + Temozolomide (Platinum sensitive)	襯蓋鏇窪齋蓋蓋鏇淵獵(淵鏇鹹遞鏇構構壓遞夢) = 築廠範衊獵鬱淵艱築簾齋遞艱齋襯膚觸壓夢網 (夢網醖範蓋膚簾艱鏇網, 2.4 ~ 30.2) 更多
NCT03508011 (Pubmed)	临床1期	晚期恶性实体瘤	57	Senaparib	選鹽齋夢鏇鑰網餘蓋壓(廠鹽遞衊製糧鏇壓觸構) = 醖壓網積窪構齋糧膚選積製廠淵窪鏇選憲衊鏇 (鏇醖廠齋窪蓋夢鏇夢構 ) 更多	-	2023-06-20
NCT03507543 (Pubmed)	临床1期	晚期恶性实体瘤	39	Senaparib	憲觸憲構壓夢憲醖齋襯(鹽簾願網壓壓糧積簾廠) = Most treatment-emergent adverse events were grade 1-2 (91%). Seven patients (17.9%) reported hematologic treatment-emergent adverse events. Treatment-related adverse events occurred in eight patients (20.5%), and the most frequent was nausea (7.7%). Two deaths were reported after the end of study treatment, one of which was considered a complication from senaparib-related bone marrow failure. 積觸淵鏇憲鬱遞範鏇網 (齋積觸願淵選鬱膚築艱 )	-	2023-01-31
NCT04434482 (ASCO2022) 人工标引	临床1期	广泛期小细胞肺癌 \| HR阳性/HER2低表达实体瘤	14	Senaparib+Temozolomide	鹽鹽積願襯鬱襯製醖廠(廠壓遞壓簾餘淵夢製積) = The MTD and RP2D were determined as: senaparib 80 mg plus temozolomide 20 mg. 艱獵構願壓積鏇膚淵窪 (糧糧膚鹹積構淵餘齋衊 ) 更多	积极	2022-06-02