Study of JAK Inhibition in Stem-Like Prostate Cancer (JASPER): A Phase 1b/2a Multicenter Study of Ruxolitinib and Enzalutamide in Castration Resistant Prostate Cancer

This phase I/II tests the safety, side effects and best dose of ruxolitinib in combination with enzalutamide and how well it works in treating patients with prostate cancer that remains despite blocking hormone production (castration-resistant) and that has spread from where it first started to other places in the body (metastatic). Ruxolitinib, a kinase inhibitor, slows down the growth of the tumor by blocking the proteins, JAK1 and JAK2, tumors use to grow. Enzalutamide, an androgen receptor inhibitor, works by blocking the effects of androgen (a male reproductive hormone). This may help stop the growth and spread of tumor cells that need testosterone to grow. Giving ruxolitinib in combination with enzalutamide may be safe, tolerable, and/or effective in treating metastatic castration-resistant prostate cancer.

开始日期2025-03-01

申办/合作机构

Rogel Cancer Center: University of Michigan

[+1]

NCT06592924

/ Not yet recruiting临床3期IIT

A Randomized Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer Without Deep PSA Response

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?
This study would like to find out if this approach is better or worse than the usual approach for prostate cancer.
The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

开始日期2025-01-15

申办/合作机构

Canadian Cancer Trials Group

[+4]

CTR20244950

/ RecruitingN/A

恩扎卢胺软胶囊空腹及餐后人体生物等效性研究

以山东新时代药业有限公司生产的恩扎卢胺软胶囊（规格：40mg）为受试制剂，Astellas Pharma Europe B.V.持证的恩扎卢胺软胶囊（商品名：Xtandi/安可坦，规格：40mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药吸收速度和程度的差异，评价两制剂是否具有生物等效性。

开始日期2025-01-12

申办/合作机构

山东新时代药业有限公司

100 项与恩扎卢胺相关的临床结果

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100 项与恩扎卢胺相关的转化医学

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100 项与恩扎卢胺相关的专利（医药）

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3,429

项与恩扎卢胺相关的文献（医药）

2025-02-01·Clinical Genitourinary Cancer

Development and Validation of Prognostic Model for Metastatic Castration-Resistant Prostate Cancer Patients Treated With First-Line Abiraterone or Enzalutamide

Article

作者: Basso, Umberto ; Farinea, Giovanni ; Veccia, Antonello ; Kinspergher, Stefania ; Lai, Eleonora ; Lay, Ludovica ; Samuelly, Alessandro ; Cani, Massimiliano ; Pierantoni, Francesco ; Crespi, Veronica ; Alberti, Martina ; Maruzzo, Marco ; Bimbatti, Davide ; Ermacora, Paola ; Cattrini, Carlo ; Kadrija, Dzenete ; Mennitto, Alessia ; Anesi, Cecilia ; Buttigliero, Consuelo ; Caffo, Orazio ; Urban, Susanna ; Maines, Francesca

INTRODUCTION:

Over the years, several prognostic models were developed in patients receiving chemotherapy for metastatic castration resistant prostate cancer (mCRPC), while data on androgen-receptor signaling inhibitors (ARSI) in a real-world setting are limited.

PATIENTS AND METHODS:

We compared a consecutive series of 565 mCRPC patients receiving first-line ARSI at 4 high-volume Italian Centers (development set) to an external series of 180 patients receiving the same treatment at another Italian high-volume Center (training set), between 2011 and 2022. Sixteen clinical and baseline laboratory variables were selected to develop a prognostic model. Patients were categorized into risk groups according to the number of independent factors positively associated with overall survival (OS).

RESULTS:

In the development cohort, after a median follow-up of 21.1 months, the median OS was 30.4 months (95% CI 27.5-33.4). At the multivariate analysis, 7 variables [age, prostate specific antigen (PSA) doubling time, baseline levels of hemoglobin, PSA, time to castration resistance, ECOG PS and bone metastases number) were included into the final model. The median OS was 13.4, 25.7 and 46.4 months in poor (0-2 factors), intermediate (3-4 factors) and good (≥ 5 factors) prognosis group, respectively. The application of the model to the validation set confirmed its ability to prognosticate for OS. The model c-indexes were 0.68 (95% CI 0.64-0.72) and 0.75 (95% CI 0.68-0.81) in the development and validation cohort, respectively.

CONCLUSIONS:

Our model, based on clinical and laboratory variables readily assessable in clinical practice, might prognosticate the OS of mCRPC patients receiving first-line ARSI.

2025-02-01·Clinical Genitourinary Cancer

Central Nervous System Toxicity in Prostate Cancer Patients Treated with Androgen Receptor Signaling Inhibitors: A Systematic Review, Meta-analysis, and Network Meta-analysis

Review

作者: Laukhtina, Ekaterina ; Parizi, Mehdi Kardoust ; Kimura, Takahiro ; Rajwa, Pawel ; Matsukawa, Akihiro ; Klemm, Jakob ; Yanagisawa, Takafumi ; Chiujdea, Sever ; Kimura, Shoji ; Miki, Jun ; Shariat, Shahrokh F. ; Tsuboi, Ichiro ; Mancon, Stefano ; Karakiewicz, Pierre I. ; Shariat, Shahrokh F ; Mori, Keiichiro ; Miszczyk, Marcin ; Fazekas, Tamás ; Karakiewicz, Pierre I

BACKGROUND:

Androgen-receptor signaling inhibitors (ARSIs) significantly improve survival in systemic therapy for advanced/metastatic prostate cancer (PCa) patients; however possible central nervous system (CNS) toxicity is an unaddressed concern. We aimed to assess and compare the incidence of CNS-related adverse events (AEs) secondary to the treatment of PCa patients with different ARSIs.

MATERIALS:

In August 2023, a comprehensive seach was conducted in three databases for randomized controlled trials (RCTs) of PCa patients receiving ARSIs plus ADT. The primary endpoints included mental impairment, cognitive impairment, seizure, fatigue, and falls.

RESULTS:

Twenty-six RCTs, comprising 20,328 patients, were included in meta-analyses and network meta-analyses (NMAs). ARSIs increased the risk of mental impairment (RR: 1.72; 95% CI, 1.09-2.71), cognitive impairment (RR: 2.25; 95% CI, 1.78-2.86), seizure (RR: 2.20, 95% CI, 1.09-4.45), fatigue (RR: 1.31, 95% CI, 1.20-1.43), and falls (RR: 2.07, 95% CI, 1.60-2.67) compared to standard of care (SOC). Based on NMAs, Enzalutamide showed a significant increase in risk for all assessed CNS-related AEs, while Abiraterone demonstrated significant risk increases in cognitive impairment, fatigue, and falls. Conversely, Darolutamide did not exhibit significant increases in risk for any CNS-related AEs, except for fatigue.

CONCLUSIONS:

The addition of ARSIs to ADT increased all examined CNS-related AEs compared to SOC. Each ARSI is associated with a distinct profile of CNS-related AEs. Careful patient selection and monitoring for CNS sequelae is necessary to achieve the best quality of life in patients on ARSI + ADT for PCa.

2025-02-01·PROSTATE

Comparison of abiraterone, enzalutamide, and apalutamide for metastatic hormone‐sensitive prostate cancer: A multicenter study

Article

作者: Kimura, Takahiro ; Yanagisawa, Takafumi ; Urabe, Fumihiko ; Katsumi, Kouta ; Iwatani, Kosuke ; Habuchi, Tomonori ; Tashiro, Kojiro ; Takahashi, Hidetsugu ; Mori, Keiichiro ; Shimomura, Tatsuya ; Narita, Shintaro ; Hatakeyama, Shingo ; Muramoto, Katsuki ; Fukuokaya, Wataru

Abstract:

Purpose:

We aimed to assess the differential efficacy and safety of androgen receptor pathway inhibitors (ARPI), such as abiraterone, enzalutamide, and apalutamide, in patients with metastatic hormone‐sensitive prostate cancer (mHSPC) in a real‐world practice setting.

Methods:

We retrospectively reviewed the records of consequent 668 patients with mHSPC treated with ARPI plus androgen deprivation therapy between September 2015 and December 2023. Based on the LATITUDE criteria, the comparison among abiraterone, enzalutamide, and apalutamide was exclusively conducted in high‐risk patients. Prostate‐specific antigen (PSA) responses such as the achievement of 95% and 99% PSA decline, overall survival (OS), cancer‐specific survival (CSS), time to castration‐resistant prostate cancer (CRPC), and the incidence of adverse events (AEs) were compared. All two‐group comparisons relied on propensity score matching (PSM) to minimize the effect on possible confounders.

Results:

In total, 297 patients with high‐risk mHSPC treated with abiraterone, 127 with enzalutamide, and 142 with apalutamide were compared. There were no differences in time to CRPC (p = 0.13), OS (p = 0.7), and CSS (p = 0.5) among the three ARPIs. No differences were observed in the achievement rates for 95% PSA decline at 3 months among the three ARPIs, while abiraterone was significantly better in 99% PSA decline achievement compared to apalutamide (72% vs. 57%, p = 0.003). The aforementioned oncologic outcomes were sustained even when performing PSM analyzes. Although skin rash for APA (34%) was the highest incidence of AEs, there were no differences in the rates of severe AEs across the three ARPIs. Enzalutamide resulted in the lowest treatment discontinuation rates (10%) other than disease progression compared to the other regimens.

Conclusions:

Abiraterone, enzalutamide, and apalutamide have comparable oncologic outcomes in terms of OS, CSS, and time to CRPC in patients with high‐risk mHSPC. Our data on differential treatment discontinuation rates, PSA response, and AE profiles can help guide clinical decision‐making.

887

项与恩扎卢胺相关的新闻（医药）

2025-01-22

·echemi

U.S. Government to Negotiate Prices for 15 High-Cost Medications by 2027

The U.S. government announced on Friday that 15 medications, including Wegovy for weight loss and Ozempic for diabetes, will be part of the Medicare price negotiation plan set to take effect in 2027. This initiative stems from the Inflation Reduction Act signed by the Biden administration in 2022 and aims to reduce Medicare's spending on expensive drugs. Key Medications Involved Among the 15 drugs targeted for negotiation are: Ibrance and Xtandi (cancer treatments from Pfizer) Trelegy Ellipta (treatment for asthma and COPD from GlaxoSmithKline) Austedo (for Huntington’s disease from Teva) Linzess (for irritable bowel syndrome from AbbVie) These medications are among the highest expenditures for Medicare, particularly for individuals aged 65 and older or those with disabilities. President Biden emphasized that these 15 drugs, alongside 10 others negotiated last year, account for nearly one-third of Medicare Part D prescription drug spending. Negotiation Participation and Penalties Pharmaceutical manufacturers must decide by February 28 whether to participate in the negotiations. Those opting out may face penalties of up to 95% of their drug sales or be required to withdraw their products from Medicare and Medicaid. Historical data suggests that the price reductions implemented in 2026 could range from 38% to 79%, significantly reducing Medicare's drug expenditure. For instance, Wegovy costs approximately $1,350 per month, while Ozempic is about $935. Despite Novo Nordisk's claims of offering discounts, Medicare's spending on these drugs exceeded $4.6 billion in 2022. Financial Implications Government researchers warn that if Ozempic and Wegovy are used at their current prices, they could contribute to an increase in the U.S. deficit over the next decade. By October 2024, around 2.3 million Medicare Part D beneficiaries were reported to be using Novo Nordisk’s semaglutide drugs, leading to total expenditures of over $14 billion for Medicare Part D. Future Considerations It remains uncertain whether a future Trump administration would alter the negotiation process. However, Biden administration officials have indicated that any successor might find it challenging to change the negotiation framework, as the law outlines specific criteria for participation. The inclusion of these 15 high-cost drugs in Medicare's price negotiation plan represents a significant step toward controlling pharmaceutical costs in the U.S. As negotiations commence, the outcomes could reshape the landscape of drug pricing and accessibility for millions of Americans.

2025-01-18

·CPHI制药在线

奥赛康药业1类新药利厄替尼片获批上市；强生146亿美元收购Intra-Cellular | CPHI制药在线一周药闻复盘

点击蓝字关注我们本周，热点不少。首先看审评审批方面，多个药获批，很值得一提的就是，奥赛康药业1类新药利厄替尼片获批上市；其次是研发方面，多个药取得重要进展，其中，全球第2款PROTAC药物BMS-986365进入Ⅲ期阶段；最后是交易及投融资方面，有不少交易尘埃落定，最大金额的是，强生146亿美元收购Intra-Cellular。本期盘点包括审评审批、研发、交易及投融资三大板块，统计时间为2025.1.13-1.17，包含23条信息。审评审批 NMPA 上市批准 1、1月13日，NMPA官网显示，和黄医药的赛沃替尼片（Savolitinib、商品名：沃瑞沙）获批新适应症，用于治疗初治MET外显子14跳跃突变非小细胞肺癌（NSCLC）患者。赛沃替尼是一种口服的高选择性小分子c-Met抑制剂，最初由和黄医药开发。2011年，和黄医药与阿斯利康达成一项全球许可协议，将共同开发沃瑞沙并促进其商业化。 2、1月13日，NMPA官网显示，强生的厄达替尼片（商品名：博珂）获批上市，用于治疗携带易感型FGFR3基因变异，且既往接受至少一线含抗PD-1或抗PD-L1期间或之后出现疾病进展的手术不可切除的局部晚期或转移性尿路上皮癌（UC）成人患者。厄达替尼片是一款新型靶向治疗药物，可显著改善携带FGFR3基因变异患者的总生存期和无进展生存期。 3、1月13日，NMPA官网显示，上海生物制品研究所3.3类生物制品贝伐珠单抗注射液生物类似药获批上市，用于治疗非小细胞肺癌、转移性结直肠癌、胶质母细胞瘤、肝细胞癌、卵巢癌和宫颈癌等适应症。贝伐珠单抗是一款抗血管内皮生长因子（VEGF）人源化单克隆抗体。 4、1月16日，NMPA官网显示，英派药业的塞纳帕利胶囊（senaparib、商品名：派舒宁）获批上市，用于国际妇产科联盟（“FIGO”）Ⅲ-Ⅳ期上皮性卵巢癌、输卵管癌或原发性腹膜癌患者在一线含铂化疗达到完全或部分缓解后的维持治疗。塞纳帕利是一款PARP抑制剂，获得“十三五”国家重大新药创制专项的立项支持并顺利完成验收。 5、1月16日，NMPA官网显示，奥赛康药业1类新药利厄替尼片（limertinib、商品名：奥壹新）获批上市，用于治疗既往接受表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗时或治疗后出现疾病进展的EGFR T790M突变阳性局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。利厄替尼由奥赛康药业与上海药物所、广州健康院合作开发，是一款高选择性、不可逆第三代EGFR-TKI。申请 6、1月14日，CDE官网显示，智翔金泰瑞的斯乐韦米单抗注射液（GR1801）申报上市，用于治疗成人疑似狂犬病病毒暴露后的被动免疫。斯乐韦米单抗是一款由智翔金泰自主研发的重组全人源抗狂犬病病毒（Rabies Virus、RABV）双特异性抗体，注册分类为治疗用生物制品1类，作用靶点为RABV的包膜糖蛋白（Glycoprotein、G蛋白）。 7、1月15日，CDE官网显示，勃林格殷格翰的宗格替尼（Zongertinib）申报上市，用于治疗携带HER2（ERBB2）激活突变且既往接受过系统治疗的不可切除或转移性非小细胞肺癌（NSCLC）成人患者。宗格替尼是一种选择性HER2抑制剂，2024年4月，BI与中国生物制药签署了战略合作协议。 8、1月15日，CDE官网显示，第一三共（Daiichi Sankyo）5.1类新药盐酸吡昔替尼胶囊（PLX3397）申报上市，用于治疗伴有重度病变或功能受限且无法通过手术改善的症状性腱鞘巨细胞瘤（TGCT）成年患者。吡昔替尼（pexidartinib）是一款CSF1R小分子抑制剂，该产品已经于2024年10月被CDE正式纳入优先审评。 9、1月15日，CDE官网显示，美纳里尼和赛生药业的5.1类新药注射用美罗培南韦博巴坦申报上市，这是一款抗生素复方制剂（商品名：Vaborem），为新型抗菌药物。赛升药业在2022年8月与美纳里尼亚太公司达成许可及合作协议，从而可在中国境内独家开发和商业化该产品。临床批准 10、1月15日，CDE官网显示，阿斯利康1类新药AZD0022获批临床，拟开发治疗携带KRAS G12D突变的晚期实体瘤。这是一款KRAS G12D抑制剂，目前在国际范围内处于Ⅰ/Ⅱ期临床试验阶段。阿斯利康在2023年11月与祐森健恒达成授权合作，获得AZD0022。 11、1月15日，CDE官网显示，金赛药业1类新药GenSci120注射液获批两项适应症，拟开发治疗系统性红斑狼疮（SLE）、原发性干燥综合征（pSS）。GenSci120注射液是一款PD-1激动剂。全球范围内已有十几款PD-1激动剂类产品正在研发，但多数尚处于临床前阶段。进展较快的产品包括Anaptys Bio公司开发的激活性PD-1单克隆抗体rosnilimab，正Ⅱ期。 12、1月15日，CDE官网显示，赛诺菲1类新药Itepekimab注射液获批临床，拟用于治疗慢性鼻窦炎不伴鼻息肉（CRSsNP）患者。这是一款靶向IL33的单克隆抗体，由赛诺菲与再生元（Regeneron）合作开发。该产品此前已经在中国获得多项临床，适应症包括治疗非囊性纤维化支气管扩张症（NCFB）、中度至重度慢性阻塞性肺疾病（COPD）患者的添加维持治疗。 FDA 上市批准 13、1月15日，FDA官网显示，礼来的Mirikizumab（商品名:Omvoh）获批第2项适应症，用于治疗成人中度至重度活动性克罗恩病。Mirikizumab继2023年10月被批准为治疗中度至重度活动性成人溃疡性结肠炎（UC）的同类首创疗法之后，现在又被批准用于治疗两种类型的炎症性肠病（IBD）。Mirikizumab通过靶向IL-23p19这一特定蛋白来减轻胃肠道内的炎症。 14、1月17日，FDA官网显示，阿斯利康的Calquence（阿可替尼）获批新适应症，用于联合苯达莫司汀和利妥昔单抗治疗既往未经治疗且不适合自体造血干细胞移植的套细胞淋巴瘤（MCL）成人患者。该药物是首个获准用于一线治疗MCL的BTK抑制剂。研发临床状态 15、1月13日，Clinicaltrials官网显示，Celgene启动了蛋白降解靶向嵌合体（PROTAC）BMS-986365的首个Ⅲ期临床试验，该临床是一项随机、开放标签、适应性研究（n=960），旨在评估BMS-986365对比研究者选择（恩杂鲁胺+阿比特龙+泼尼松/泼尼松龙或多西他赛+泼尼松/泼尼松龙）治疗转移性去势抵抗性前列腺癌（mCRPC）患者的安全性和有效性。研究的主要终点为第4年患者的放射学无进展生存期（rPFS）变化。 16、1月13日，Clinicaltrials官网显示，石药集团启动了SYH9056（马来酸左旋氨氯地平+缬沙坦）的Ⅲ期临床试验。该研究是一项多中心、随机、双盲、平行对照临床试验（n=606），旨在评估SYH9056治疗接受4周马来酸左旋氨氯地平单药或缬沙坦单药治疗后血压仍未得到控制的中重度原发性高血压成年患者的疗效和安全性。研究的主要终点是第12周患者的坐位收缩压相较于基线的变化。临床数据 17、1月13日，Biohaven宣布，BHV-1400的首个I期研究取得了初步的积极数据。数据显示，BHV-1400可以在单次给药4h内迅速、强效、选择性降低IgA肾病患者的致病性半乳糖缺陷型IgA1（Gd-IgA1）抗体水平，同时将IgA等免疫球蛋白的水平保持在正常范围内。BHV-1400是Biohaven基于其胞外蛋白分子降解剂（MoDE）技术平台开发的一款靶向去除异常蛋白（TRAP）降解剂。 18、1月14日，恒瑞医药宣布，其与Kailera Therapeutics正在共同开发的GLP-1/GIP双受体激动剂HRS9531注射液8mg在减重Ⅱ期临床研究（HRS9531-203）中显著减低体重，同时安全性、耐受性良好。HRS9531是恒瑞医药研发的一种新型GLP-1/GIP双受体激动剂，减重与降糖适应症均已进入于Ⅲ期研发阶段。交易及投融资 19、1月13日，GSK宣布，收购IDRx。根据协议，GSK将支付10亿美元的预付款，并有可能根据监管批准情况再支付1.5亿美元的里程碑款项。此次收购的核心资产为IDRX-42，该药是一种高度选择性的KIT酪氨酸激酶抑制剂（TKI），旨在用于胃肠道间质瘤的一线和二线治疗。胃肠道间质瘤通常发生在胃肠道，80%的病例由KIT基因突变驱动。 20、1月13日，三生制药附属公司沈阳三生宣布，与映恩生物就HER2 ADC药物DB-1303达成合作协议。协议约定，沈阳三生将获得映恩生物开发的HER2 ADC药物 DB-1303多个适应症在中国大陆、中国香港和中国澳门的商业化权利。映恩生物将获得2500万美元不可退回首付款，未来映恩生物有资格获得至高4200万美元的研发里程碑、以及潜在额外的销售里程碑付款。同时，映恩生物将继续负责推进相关适应症在合作区域的临床开发和注册等工作。 21、1月13日，强生宣布，已与Intra-Cellular达成协议，将以每股132美元的价格收购后者所有流通股份，总交易额约为146亿美元。通过协议，强生获得了Intra-Cellular的每日1次口服抗精神病产品Lumateperone（商品名：Caplyta、卢美哌隆）。该药物是一款5-羟色胺2A（5-HT2A）受体拮抗剂和多巴胺受体D2调节剂，已于2019年12月被FDA批准用于治疗精神分裂症成人患者。 22、1月13日，先声药业宣布，与艾伯维订立许可选择权协议。根据协议，艾伯维将拥有候选药物SIM0500的许可权益。SIM0500正在中美两国针对复发或难治性多发性骨髓瘤（MM）患者进行临床I期研究。SIM0500是一款人源化GPRC5D/BCMA/CD3三特异性抗体，由先声药业通过其专有的T细胞衔接器多特异性抗体技术平台开发。 23、1月14日，阿斯利康宣布，与宜联生物签署临床研究合作协议。双方将基于在临床前研究中展现出的联用协同效应，共同探索阿斯利康免疫检查点抑制剂度伐利尤单抗联合宜联生物靶向B7H3的抗体偶联药物YL201治疗多种实体瘤的潜力。双方将共同启动一项多中心、开放性、Ⅰ/Ⅰb期研究，旨在评估两款药物联合治疗在实体肿瘤患者中的安全性、有效性和药代动力学。扫码领取CPHI & PMEC China 2025展会门票【智药研习社近期直播】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

上市批准临床3期并购生物类似药蛋白降解靶向嵌合体

2025-01-17

·辉瑞制药

泰泽纳®首批处方成功落地，加速惠及更多晚期前列腺癌患者

近日，辉瑞前列腺癌创新药物泰泽纳®（TALZENNA®，通用名：甲苯磺酸他拉唑帕利胶囊）在北京、上海、天津、济南、石家庄、郑州、沈阳、温州、东莞、成都等多地开出全国首批处方，并将同步在30个省市的70个城市推动临床应用，为中国HRR突变的晚期前列腺癌患者带来更加个性化的精准治疗选择。泰泽纳®是具有独特双重作用机制的PARP抑制剂，已于去年年底获得中国国家药品监督管理局（NMPA）批准，与恩扎卢胺联合用于HRR（同源重组修复）基因突变的转移性去势抵抗性前列腺癌 (mCRPC) 成人患者，也是中国目前唯一获批HRR基因突变的mCRPC治疗的PARP抑制剂。辉瑞中国区总裁、RDPAC执行委员会主席、中国外商投资企业协会副会长Jean-Christophe Pointeau表示：“泰泽纳®在中国的快速获批及落地临床应用为国内众多前列腺癌患者提供了国际同步的精准治疗选择，这是辉瑞‘中国速度’的体现，也是辉瑞‘为患者带来改变其生活的突破创新’的又一实践。包括前列腺癌在内的泌尿系统肿瘤是中国男性常见恶性肿瘤，也是辉瑞重点聚焦的疾病领域之一，我们将持续加大研发投入，推动更多肿瘤治疗的科学突破，并进一步缩短创新药物在国内上市的窗口期，帮助肿瘤患者延长生命、改善生活质量，真正地‘Outdo Cancer’！” 辉瑞中国区总裁 Jean-Christophe Pointeau 前列腺癌是全球最常见的恶性肿瘤之一，在男性群体中的发病率仅次于肺癌[1]。然而，由于前列腺癌早期症状不明显，我国前列腺癌初诊病例以临床中晚期居多，晚期前列腺癌患者在接受过雄激素剥夺治疗后出现治疗抵抗，并出现转移，进入转移性去势抵抗性前列腺癌阶段，而mCRPC是前列腺癌的终末阶段，具有高度异质性和致死性，如果缺乏有效的治疗，mCRPC患者的中位生存时间一般不会超过3年[3]。约有25%的mCRPC患者携带HRR基因突变[4]，而这类患者肿瘤的恶性程度更高，疾病进展也更加迅速，在临床上存在巨大的未满足需求。国内外指南均建议对转移性前列腺癌患者进行基因检测，以指导用药, 尤其强调了检测HRR基因突变的重要性[5][6]。而基于精准检测后的PARP抑制剂联合新型内分泌药物也已成为各项权威指南推荐的mCRPC一线治疗方案。泰泽纳®具有抑制PARP酶及PARP捕获的双重作用机制，与雄激素受体抑制剂恩扎卢胺联用，可诱导携带HRR基因突变导致的肿瘤细胞死亡。临床研究数据证实，泰泽纳®联合恩扎卢胺治疗可显著改善HRR基因突变的mCRPC患者的临床结局[7]。泰泽纳®加速落地临床应用，将进一步助力中国前列腺癌的精准诊疗及患者生存结局的改善。 2024年9月，欧洲肿瘤内科学会（ESMO）年会期间，辉瑞公布了全球多中心III期注册临床研究TALAPRO-2的中国人群数据，进一步证实了泰泽纳®为患者带来的临床获益。而在今年2月即将举行的2025年美国临床肿瘤学会泌尿生殖肿瘤研讨会（ASCO GU 2025）期间，辉瑞将进一步公布TALAPRO-2研究的更多最新数据。关于泰泽纳® (通用名：甲苯磺酸他拉唑帕利胶囊) 滑动阅览泰泽纳®（通用名：甲苯磺酸他拉唑帕利胶囊) 是一种聚腺苷二磷酸核糖聚合酶（PARP，包括PARP1和PARP2）抑制剂，该酶在DNA修复中发挥作用。2023年6月，美国食品药品监督管理局（FDA）批准泰泽纳®联合恩扎卢胺用于同源重组修复（HRR）基因突变的转移性去势抵抗性前列腺癌（mCRPC）成人患者的治疗。2024年1月，欧洲药品管理局(EMA)批准泰泽纳®与恩扎卢胺联用治疗无临床化疗指征的mCRPC成人患者。2024年10月，中国国家药品监督管理局（NMPA）批准泰泽纳®联合恩扎卢胺用于HRR基因突变的转移性去势抵抗性前列腺癌 (mCRPC) 成人患者。关于辉瑞肿瘤滑动阅览在辉瑞肿瘤，我们身处癌症治疗新纪元的最前沿。我们拥有行业领先的产品组合和广泛的产品管线，覆盖抗体偶联药物（ADC）、小分子药物、双特异性抗体和其他免疫疗法，通过颠覆性的作用机制，从多个方向着手攻克癌症。我们致力于为乳腺癌、泌尿系统肿瘤、血液肿瘤、消化道肿瘤、妇科肿瘤和包括肺癌在内的胸部肿瘤等全球高发癌种提供变革性的治疗方案。在科学的驱动下，辉瑞致力于加快突破性创新的步伐，帮助肿瘤患者延长生命、改善生活质量。免责声明滑动阅览本新闻稿仅在于传递科学前沿信息，不构成对任何药物或治疗方案的推荐或推广。如您有药物或治疗方面的问题，请咨询医疗卫生专业人士。 [1] IARC. (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Retrieved from https://gco.iarc.fr/today. [2]国家癌症中心, 国家肿瘤质控中心前列腺癌质控专家委员会. 中国前列腺癌规范诊疗质量控制指标(2022版) [J] . 中华肿瘤杂志, 2022, 44(10) : 1011-1016. [2] National Cancer Center, Prostate Cancer Quality Control Expert Committee of the National Cancer Quality Control Center. Quality control index for standardized diagnosis and treatment of prostate cancer in China (2022 edition) [J]. Chinese Journal of Oncology, 2022, 44(10): 1011-1016. [3] Chen JR, Zhang YW, Zhang XM, et al. Comparison of systemic treatments for metastatic castration-resistant prostate cancer after docetaxel failure: a systematic review and network meta-analysis[J]. Front Pharmacol, 2022, 12:789319. DOI:10.3389/fphar.2021.789319. [4] Chung, J. H., Dewal, N., Sokol, E., Mathew, P., Whitehead, R., Millis, S. Z., Frampton, G. M., Bratslavsky, G., Pal, S. K., Lee, R. J., Necchi, A., Gregg, J. P., Lara, P., Jr, Antonarakis, E. S., Miller, V. A., Ross, J. S., Ali, S. M., & Agarwal, N. (2019). Prospective Comprehensive Genomic Profiling of Primary and Metastatic Prostate Tumors. JCO precision oncology, 3, PO.18.00283. [5] National Comprehensive Cancer Network. (2024). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Prostate Cancer. Version 3.2024. [6] 中国临床肿瘤学会指南工作委员会. (2023). 中国临床肿瘤学会（CSCO）前列腺癌诊疗指南2023. 人民卫生出版社. [6] Chinese Society of Clinical Oncology Guidance Working Committee (2023). Chinese Society of Clinical Oncology (CSCO). 2023 Guidelines for the Diagnosis and Treatment of Prostate Cancer. People's Medical Publishing House. [7] Fizazi, K., Azad, A. A., Matsubara, N., Carles, J., Fay, A. P., De Giorgi, U., Joung, J. Y., Fong, P. C. C., Voog, E., Jones, R. J., Shore, N. D., Dunshee, C., Zschäbitz, S., Oldenburg, J., Ye, D., Lin, X., Healy, C. G., Di Santo, N., Laird, A. D., Zohren, F., … Agarwal, N. (2024). First-line talazoparib with enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer: the phase 3 TALAPRO-2 trial. Nature medicine, 30(1), 257–264. 往期 · 推荐博遏制耐药，拯救生命，我们在行动！疗创新引领全面守护 | 为血液病患者带去更多希望辉瑞创新药物 HYMPAVZI™（马塔西单抗/marstacimab-hncq）获FDA批准用于治疗血友病A及血友病B 【一键通达】药品问询不再难，医学信息解忧烦!

临床研究上市批准

100 项与恩扎卢胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10218	恩扎卢胺	L02BB04	DB08899

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
前列腺癌	韩国	Astellas Pharma Korea, Inc.	2024-12-03
去势敏感前列腺癌	美国	Astellas Pharma US, Inc.	2023-11-16
HRR 基因突变去势抵抗性前列腺癌	美国	Pfizer Inc.	2023-06-20
去势抵抗性前列腺癌	欧盟	Astellas Pharma Europe Ltd.	2013-06-21
去势抵抗性前列腺癌	冰岛	Astellas Pharma Europe Ltd.	2013-06-21
去势抵抗性前列腺癌	列支敦士登	Astellas Pharma Europe Ltd.	2013-06-21
去势抵抗性前列腺癌	挪威	Astellas Pharma Europe Ltd.	2013-06-21
激素依赖性前列腺癌	欧盟	Astellas Pharma Europe Ltd.	2013-06-21
激素依赖性前列腺癌	冰岛	Astellas Pharma Europe Ltd.	2013-06-21
激素依赖性前列腺癌	列支敦士登	Astellas Pharma Europe Ltd.	2013-06-21
激素依赖性前列腺癌	挪威	Astellas Pharma Europe Ltd.	2013-06-21
转移性去势抵抗性前列腺癌	美国	Astellas Pharma US, Inc.	2012-08-31

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
阿尔茨海默症	临床3期	中国	安斯泰来制药（中国）有限公司	2019-09-02
阿尔茨海默症	临床3期	中国	Astellas Pharma Global Development, Inc.	2019-09-02
晚期三阴性乳腺癌	临床3期	美国	Astellas Pharma, Inc.	2016-09-01
晚期三阴性乳腺癌	临床3期	美国	MediVation, Inc.	2016-09-01
晚期三阴性乳腺癌	临床3期	美国	Pfizer Inc.	2016-09-01
前列腺腺癌	临床3期	美国	Astellas Pharma US, Inc.	2014-01-22
前列腺腺癌	临床3期	美国	MediVation, Inc.	2014-01-22
前列腺腺癌	临床3期	加拿大	MediVation, Inc.	2014-01-22
前列腺腺癌	临床3期	加拿大	Astellas Pharma US, Inc.	2014-01-22
前列腺腺癌	临床3期	波多黎各	MediVation, Inc.	2014-01-22

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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


JPRN-UMIN000015529 (ENABLE, ESMO_ASIA2024) 人工标引	临床3期	去势抵抗性前列腺癌	107	Enzalutamide	鏇壓窪醖觸糧餘顧餘繭(築構獵壓繭糧衊鹽蓋廠) = 艱醖簾醖壓襯積憲艱廠觸顧艱獵遞衊醖選製艱 (鹹築繭積簾觸夢鑰膚衊 ) 更多	积极	2024-12-07
				Abiraterone plus prednisolone	鏇壓窪醖觸糧餘顧餘繭(築構獵壓繭糧衊鹽蓋廠) = 醖淵淵淵蓋廠簾顧壓網觸顧艱獵遞衊醖選製艱 (鹹築繭積簾觸夢鑰膚衊 ) 更多
NCT04076059 (China ARCHES, ESMO_ASIA2024) 人工标引	临床3期	激素依赖性前列腺癌	180	ADT + Enzalutamide	鬱淵網糧網衊觸憲鏇簾(鏇獵鬱醖觸願顧鬱鑰糧) = 壓繭築顧壓積艱艱簾餘醖窪憲網憲齋範繭築衊 (遞廠壓鬱顧壓夢膚醖壓 ) 更多	不佳	2024-12-07
				ADT + Placebo	鬱淵網糧網衊觸憲鏇簾(鏇獵鬱醖觸願顧鬱鑰糧) = 壓壓壓鹽網築齋鑰願窪醖窪憲網憲齋範繭築衊 (遞廠壓鬱顧壓夢膚醖壓 ) 更多
NCT03464201 (GETHI2016-01, Pubmed \| Gynecol Oncol)	临床2期	卵巢颗粒细胞瘤 hormone receptors	16	Enzalutamide 160 mg	窪積繭願願醖獵獵網艱(鹽願遞簾鹹鏇範築餘膚) = 窪醖繭構廠積窪鹽鏇獵糧襯顧製遞齋淵齋憲糧 (夢積廠鑰窪醖顧繭簾艱, 46 ~ 91.5)	积极	2024-12-01
NCT02213107 (phase II trial of enzalutamide (Enz) with 5-alpha reductase inhibitors (5-ARI), CTgov)	临床2期	前列腺癌	43	Enzalutamide+Dutasteride or finasteride	範醖網襯顧蓋網蓋齋簾(鹽鏇餘蓋窪繭築遞網築) = 鏇齋廠願鹽觸壓獵艱艱顧簾製淵構糧繭願鬱鹽 (窪膚鏇齋顧鏇製網糧鏇, 顧遞齋網鬱網鹽選醖製 ~ 選觸鹹鑰簾網繭壓遞鬱) 更多	-	2024-11-13
NCT05075577 (PRNewswire) 人工标引	临床2期	转移性去势抵抗性前列腺癌	120	Enzalutamide 160mg QD	衊艱簾獵構襯獵鹹鏇襯(願醖網淵膚顧繭鑰築膚) = 齋獵觸襯鹹膚廠衊觸膚遞餘構蓋鏇窪蓋鹹製餘 (獵積憲襯醖淵膚觸夢觸 ) 未达到更多	不佳	2024-10-31
				Masofaniten 600mg BID + enzalutamide 160mg QD	衊艱簾獵構襯獵鹹鏇襯(願醖網淵膚顧繭鑰築膚) = 獵繭窪鑰製顧積獵構蓋遞餘構蓋鏇窪蓋鹹製餘 (獵積憲襯醖淵膚觸夢觸 ) 未达到更多
NCT03395197 (TALAPRO-2, PipelineReview) 人工标引	临床3期	转移性去势抵抗性前列腺癌	-	talazoparib + enzalutamide	製獵醖膚鏇遞齋簾憲衊(鏇膚構積製淵蓋範衊衊) = Results showed a statistically significant and clinically meaningful improvement in the final OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to XTANDI alone. 鹹簾鏇醖鬱廠遞鏇繭鹹 (觸糧醖鬱膚觸遞遞築獵 )	积极	2024-10-10
NCT03395197 (TALAPRO-2, ESMO2024) 人工标引	临床3期	转移性去势抵抗性前列腺癌一线	125	Talazoparib + Enzalutamide	築鏇選廠齋衊餘廠壓膚(艱膚窪網醖範鹽淵艱繭) = 襯廠膚顧積範淵壓艱醖簾獵製壓獵鏇遞願構膚 (範淵製淵壓遞醖鏇範鹹 ) 更多	积极	2024-09-15
				Placebo + Enzalutamide	築鏇選廠齋衊餘廠壓膚(艱膚窪網醖範鹽淵艱繭) = 遞襯遞糧夢網艱積製窪簾獵製壓獵鏇遞願構膚 (範淵製淵壓遞醖鏇範鹹 ) 更多
NCT04179864 (EZH-1101, ESMO2024) 人工标引	临床1/2期	转移性去势抵抗性前列腺癌	81	TAZ 1200 mg BID plus ENZ 160 mg QD	製糧觸膚遞製餘鹹憲醖(蓋淵鏇餘鑰淵鬱積廠遞) = 選蓋鏇顧壓鹽製壓窪範壓廠獵繭齋獵鹹網鬱衊 (艱簾醖醖廠鏇衊糧網繭, 8.5 ~ NE) 更多	不佳	2024-09-15
				ENZ 160 mg QD	製糧觸膚遞製餘鹹憲醖(蓋淵鏇餘鑰淵鬱積廠遞) = 積糧艱網網構齋憲夢顧壓廠獵繭齋獵鹹網鬱衊 (艱簾醖醖廠鏇衊糧網繭, 6.6 ~ NE) 更多
NCT02319837 (EMBARK, ESMO2024)	临床3期	非转移性前列腺癌 prostate-specific antigen (PSA) doubling time	-	Enzalutamide + Leuprolide	遞繭蓋遞築襯蓋築鏇淵(觸鹽遞鹽構繭網範願鏇) = Serious adverse events (AEs) were more common in older pts, but were low regardless of age. 構壓繭淵鹽膚壓廠顧顧 (餘構選衊醖膚築顧願餘 ) 更多	积极	2024-09-15
				Leuprolide alone