DAROSTEP: Evaluating Step Counts as a Biomarker and Its Relationship on Treatment Outcomes in Vulnerable Patients With Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy

This prospective clinical trial aims to investigate the impact of darolutamide in combination with standard-of-care androgen deprivation on physical activity, specifically step count, and its correlation with important markers of safety in vulnerable adults who screen positive by a brief geriatric assessment (GA) and metastatic hormone-sensitive prostate cancer.

开始日期2025-11-01

申办/合作机构

The University of Chicago

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]

NCT06625970 / Not yet recruiting临床3期IIT

A Randomized Phase III Trial With a Factorial Design Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse, From the Prostate Cancer Consortium in Europe (PEACE)

PEACE 7 is an international, multicenter, randomized, open-label phase III study that aims at evaluating the efficacy and safety of darolutamide and of stereotactic dose escalated prostate radiotherapy in patients with localised prostate cancer and high-risk features of relapse (defined as patients with at least 2 high-risk criteria from National Comprehensive Cancer Network (NCCN) classification) using a factorial (2x2) design.
The primary objective of this study is to assess the efficacy of darolutamide and of a stereotactic dose escalated radiotherapy targeting prostate in combination with ADT and pelvic nodal radiotherapy in terms of metastasis-free survival (MSF).
Patients will be randomized (1:1:1:1) to receive either:
* Arm A (Standard arm): ADT + conventional fractionated or moderately hypo-fractionated prostate radiotherapy including pelvic nodal radiotherapy
* Arm B (Experimental arm): ADT + conventional fractionated or moderately hypo-fractionated prostate radiotherapy including pelvic nodal radiotherapy + darolutamide
* Arm C (Experimental arm): ADT + conventional fractionated or moderately hypo-fractionated pelvic nodal radiotherapy + Prostate SBRT
* Arm D (Experimental arm): ADT + conventional fractionated or moderately hypo-fractionated pelvic nodal radiotherapy + Prostate SBRT + darolutamide
Patient will receive systemic treatments (ADT and/or darolutamide) during 2 years where visits on site are planned at D45, D90, D180 and then every 3 months for checkups and follow prostate specific antigen (PSA) level.
Metastasis-free survival (MFS) is defined as the time interval from randomization to the date of the appearance of metastasis (on next generation imaging) or death (from any cause), whichever occurs first. Radiographic evaluation will be carried out at the time of biochemical failure (Phoenix criteria) or in case of clinical suspicion. After biochemical failure (Phoenix criteria) radiographic evaluation on next generation imaging (prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan (any European Medicines Agency (EMA) approved PSMA tracer)) will be performed every 6 months until a metastatic site of relapse is identified and will be repeated at each subsequent PSA progression.

开始日期2025-01-01

申办/合作机构

UNICANCER

[+1]

100 项与达罗他胺相关的临床结果

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100 项与达罗他胺相关的转化医学

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100 项与达罗他胺相关的专利（医药）

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308

项与达罗他胺相关的文献（医药）

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 ; Matsukawa, Akihiro ; Rajwa, Pawel ; 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.

2024-12-01·Prostate cancer and prostatic diseases

Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer

Article

作者: Vjaters, Egils ; Kuss, Iris ; Aspegren, John ; Tammela, Teuvo L ; Garcia, Jorge A ; Bono, Petri ; James, Nicholas D ; Protheroe, Andrew ; Shore, Neal ; Kataja, Vesa ; Fizazi, Karim ; Priou, Frank ; Joensuu, Heikki ; Jones, Robert Hugh ; Fiala-Buskies, Sabine ; Matsubara, Nobuaki ; Lesimple, Thierry ; Beuzeboc, Philippe

Abstract:

Background:

In patients with metastatic castration-resistant prostate cancer, darolutamide was well tolerated for 25 months, but minimal long-term safety data are available.

Methods:

Treatment-emergent adverse events (TEAEs) for patients receiving darolutamide for a median of 38 months (n = 13) are described in this pooled analysis of individual patient data from phase 1/2 studies.

Results:

All patients reported TEAEs (mostly grade 1/2). The most common TEAEs were diarrhea, abdominal pain, and nausea. Serious TEAEs were reported in six patients (none related to darolutamide). All treatment-related TEAEs (n = 5) were grade 1.

Conclusions:

Long-term darolutamide treatment was well tolerated; no new safety signals observed.

Tweetable abstract:

In patients with mCRPC, long-term darolutamide treatment was well tolerated and no new safety signals were observed. These findings are consistent with previous reports, demonstrating a favorable safety and tolerability profile of darolutamide.

2024-12-01·Actas urologicas espanolas

Controversies in prostate cancer management: Consensus recommendations from experts in northern Spain

Article

作者: Domínguez, M ; Álvarez, C ; Gómez Caamaño, A ; Willisch, P ; Pérez Fentes, D ; Anido, U ; Martínez Breijoo, S

In recent years, various aspects of prostate cancer (PC) management have undergone significant changes, including the implementation of therapeutic strategies such as the use of new hormonal agents like abiraterone, apalutamide, enzalutamide or darolutamide and the incorporation of next generation imaging techniques (NGI). However, the evidence regarding the role of NGI and the therapeutic decision-making based on their findings is not solid. Following the methodology of the Advanced Prostate Cancer Consensus Conference (APCCC), a multidisciplinary expert consensus was developed to address controversial questions concerning the use of NGI and clinical management in four priority scenarios: localized PC, PC after radical prostatectomy, PC after radiotherapy with curative intent, and metastatic hormone-sensitive PC. This consensus represents the opinions of medical oncology, radiation oncology and urology physicians and provides useful recommendations for clinical practice.

262

项与达罗他胺相关的新闻（医药）

2024-12-17

·戊戌数据

【品种报告】阿帕他胺片

一品种概述 1、基本情况阿帕他胺（商品名：安森珂®）是强生旗下杨森制药公司研发的一款强效、选择性口服雄激素受体（AR）抑制剂，属于第二代非甾体雄激素受体拮抗剂。阿帕他胺片在中国获批的适应症为：有高危转移风险的非转移性去势抵抗性前列腺癌（NM-CRPC）和转移性内分泌治疗敏感性前列腺癌（mHSPC）。本品已被收录于国家医保乙类目录（2024），属协议期内谈判药品，协议有效期：2024年1月1日至 2025年12月31日。国内：目前仅有原研杨森制药和齐鲁制药的阿帕他胺片在国内获批上市。原研杨森制药的阿帕他胺获批时间为2019年9月，成为中国首个用于NM-CRPC患者的新—代AR抑制剂。2020年8月，阿帕他胺在华获批新适应症，用于治疗mHSPC成年患者。齐鲁制药的阿帕他胺片获批时间为2024年12月1日，为国内首个获批的仿制药。国外：阿帕他胺由美国加利福尼亚大学首先研制，2009年授权美国Aragon公司（已被强生收购）独家开发。阿帕他胺片（商品名：ERLEADA®）于2018年2月通过加速审批通道获得美国FDA批准，是全球首个治疗非转移性去势抵抗性前列腺癌（NM-CRPC）的药物，也是首个FDA批准的依据无转移生存期的临床重点获批上市的抗前列腺癌新药。该药已在欧盟、日本、加拿大、澳大利亚等国家获批上市。 2、疾病的相关介绍临床上，可将前列腺癌的疾病过程大致分为：局限性前列腺癌 → mHSPC 或 NM-CRPC → mCRPC（转移性去势抵抗性前列腺癌）→ 疾病终末期（死亡）。前列腺癌是雄激素依赖性的，所以前列腺癌最重要治疗方法之一就是雄激素剥夺治疗（ADT），包括手术去势和药物去势。ADT是转移性前列腺癌患者的主要全身性基础治疗，也是各种新型联合治疗方案的基础。然而，前列腺癌会对激素疗法产生抵抗，就会转变为“去势抵抗性前列腺癌（CRPC）”。去势抵抗性前列腺癌（CRPC）：经过初次持续雄激素剥夺治疗（ADT）后疾病依然进展的前列腺癌。具体诊断要求：睾酮达到去势水平后（＜50 ng/dl 或1.7nmol/L），出现下面情况的1种：1.间隔1周以上连续3次PSA上升，2次升高均在PSA低点50%以上，并且PSA＞2 ng/ml。2.影像学进展：新发病灶的出现，包括骨扫描提示2处或以上的新发骨转移病灶，或者是应用实体瘤临床疗效评价标准评价的新发软组织病灶。非转移性去势抵抗性前列腺癌（NM-CRPC）：指药物去势或手术去势后出现生化进展且通过传统影像学检查未发现远处转移病灶的前列腺癌。具体诊断要求：①血清睾酮维持在去势水平以下：即血清睾酮水平＜50ng/dl或1.7nmol/L；②PSA 进展：PSA值＞2ng/ml，间隔1周，连续3次较基础升高＞50%；③传统影像学检查包括CT、MRI及骨扫描未发现远处转移。转移性内分泌治疗敏感性前列腺癌（mHSPC）：指对雄激素剥夺治疗（ADT）有疗效应答的转移性前列腺癌，患者发现病灶转移时，尚未给予内分泌治疗方案。采用CHAARTED标准进行分层评估，临床将mHSPC划分为高瘤负荷和低瘤负荷。 3、作用机制和优势作用机制：阿帕他胺是对恩杂鲁胺结构优化筛选而得到的，为第二代非甾体雄激素受体拮抗剂。阿帕他胺可直接与AR的配体结合域结合；可通过抑制AR核转位以及DNA与雄激素反应元件（ARE）的结合，拮抗AR的信号传递，最终有效延缓前列腺癌的疾病进展。优势：（1）口服吸收快，代谢产物仍具有抗肿瘤活性：阿帕他胺口服生物利用度接近100%，主要代谢产物（N-甲基阿帕他胺）仍然具有一定抗肿瘤活性。（2）无 “类雄激素作用”，可持续发挥抗肿瘤作用。（3）对AR的受体亲和力较强：优于恩杂鲁胺，是比卡鲁胺的7-10倍，疗效更强。（4）AR的强效选择性拮抗：阿帕他胺与其他核激素受体（如孕酮受体、雌激素受体或糖皮质激素受体）无显著结合作用，避免了药物选择性不高而引起的不良反应。（5）疗效显著：多个临床研究的结果显示，安森珂可以显著延长患者的生存期，延缓患者的疾病进展，提高患者的生活质量。 4、国内上市药品专利情况阿帕他胺片的专利信息主要包括：化合物专利（2027-03-26到期）和药物组合专利（2035-12-02到期）。图：阿帕他胺片的中国上市药品专利信息 5、国内上市情况除原研杨森制药外，仅有齐鲁制药的阿帕他胺片获批上市。图：国内阿帕他胺片的上市信息 6、国内注册情况截至目前，共3家企业（南京正大天晴、成都宛东生物制药、四川科伦）进行了阿帕他胺片的注册申请（化药4类），均暂未获批。图：阿帕他胺片的部分注册申请信息 7、国内临床试验情况截至目前，除齐鲁制药、南京正大天晴、成都宛东生物制药、四川科伦外，还有9家企业进行了阿帕他胺片BE试验的登记。图：阿帕他胺片的部分临床试验信息二市场可行性分析 1、适应症的流行病学全球：根据WHO分布的数据显示，2020年全球新发前列腺癌1 414 259例（全球年龄标化发病率30.7/10万），占全身恶性肿瘤的7.3%，发病率仅次于乳腺癌和肺癌，位于第3位；前列腺癌死亡病例375 304例（全球年龄标化死亡率7.7/10万），占全身恶性肿瘤的3.8%，死亡率位居第8位。中国：根据国家癌症中心发布的数据显示，2020年中国新发的前列腺癌病例数为12万，位于第9位；前列腺癌的死亡病例数为5万。2022年前列腺癌的发病人数为13.42万人，位于第9位；前列腺癌的死亡病人数为4.75万，位居第11位；2022年前列腺癌的发病率为9.68/10万（标化率），死亡率为3.26/10万（标化率）。2000年-2018年，前列腺癌的发病率和死亡率均呈明显上升趋势。 2、临床指南/共识转移性内分泌治疗敏感性前列腺癌（mHSPC）：新型内分泌治疗（NHT） + ADT已经成为无论高瘤、低瘤mHSPC的标准治疗方案，三联疗法纳入高瘤负荷mHSPC一级推荐治疗。非转移性去势抵抗性前列腺癌（NM-CRPC）：治疗首要目标是延缓疾病进展。目前临床nmCRPC治疗Ⅰ级推荐为二代AR拮抗剂（恩扎鲁胺、阿帕他胺和达罗他胺），从临床数据来看，ADT联合二代AR拮抗剂可显著延长nmCRPC无转移生存期（MFS），延缓nmCRPC进展至mCRPC状态。表：前列腺癌相关指南/共识推 3、同类型产品比较雄激素能够刺激癌细胞生长，因此前列腺癌有雄激素依赖的生长特性，因此雄激素受体（AR）拮抗剂在前列腺癌的治疗中产生重要的作用。目前AR拮抗剂主要有两代，而根据化学结构的不同，又分为甾体类和非甾体类。表：常见雄激素受体（AR）拮抗剂的对比 4、前列腺癌全球市场情况 2020年，G7预测前列腺癌市场规模约112亿美元（美国、法国、德国、意大利、西班牙、英国和日本等 7 个主要市场），其中这些发达国家主要AR靶向药物和ADT治疗为主，AR靶向药物（以AR拮抗剂为主）约占销售总额的 56.3%。尽管后期专利到期潮来临会有来自仿制药的竞争，但预测到2029年前列腺市场将会达到301亿美元。未来10年，AR拮抗剂仍然将会是市场上销售额最大的品种。到2029年，AR 靶向药物销售额预计达到174亿美元，约占总额58%。预计恩扎卢胺、阿帕他胺等AR拮抗剂将在2029年成为抗前列腺癌药物领域市场份额最大的产品。恩扎卢胺作为第2代AR拮抗剂的首个上市品种，2022年全球销售额已高达59.6亿美元。2022年阿帕他胺片全球销售额达到18.81亿美元，同比增长45.7%，随着药物市场推广及用药人群增多，第2代AR拮抗剂市场会有更大的增长空间。图：抗前列腺癌药物全球市场规模情况信息来源：药学进展 5、前列腺癌中国市场情况国内前列腺癌市场销售仍以GnRH为主，第2代AR拮抗剂应用处于放量早期。2022年我国前列腺癌治疗药物市场规模为81亿元，2018年-2022年复合增长率为11%。2022年我国前列腺癌治疗药物中亮丙瑞林市占率最高（31.3%），其次为戈舍瑞林（27.7%），第三为阿比特龙（14.8%）。图：中国前列腺癌样本医院药物销售额及市占率信息来源：平安证券研究所 6、AR拮抗剂中国市场情况目前国内第1代AR拮抗剂仅氟他胺片、比卡鲁胺片、比卡鲁胺胶囊在售，整体的销售额近几年呈下降趋势，全年销售额已从2019 年巅峰时期的 17.9 亿元人民币降至 2022 年的8.6 亿元人民币。目前国内第2代AR拮抗剂有恩杂鲁胺/恩扎卢胺软胶囊、阿帕他胺片以及达罗他胺片在售。第2代AR拮抗剂正在逐渐取代第1代AR拮抗剂，国内销售额呈快速上升趋势。2020 年销售额仅 700 万元人民币，2022 年销售额已达到 6.0 亿元人民币，增长率为 8471%。在2022年，恩杂鲁胺/恩扎卢胺软胶囊和阿帕他胺片占据绝大多数市场份额（超过90%）。图：第1代AR拮抗剂国内销售情况（医院数据，单位：亿元）图：第2代AR拮抗剂国内销售情况（医院数据，单位：亿元）信息来源：药学进展 7、中国阿帕他胺片市场情况阿帕他胺片近几年中国市场规模处于快速增长阶段，增速惊人。到了2022年，其市场规模达到了4.84亿元，增长率较上一年更是增加到了996.34%。3年年复合增长率为497.45% (2020年-2022年) 。从销售终端来看，2021年及之前，均是由全国零售贡献了主要的销售额。但是到了2022年，公立医院占据了绝对主导地位，占比超过80%。数据来源：米内网 END ★ 点击下方卡片，发现更多精彩

上市批准并购申请上市

2024-12-12

·ioncology

恩扎卢胺mHSPC适应症成功准入医保，惠及晚期前列腺癌患者全人群

点击蓝字，关注我们 2024年6月25日，中国国家药品监督管理局批准恩扎卢胺软胶囊（安可坦®）治疗转移性激素敏感性前列腺癌（mHSPC），这是恩扎卢胺在中国获批的第三项适应症[1]。至此，恩扎卢胺成为唯一一款适用于mHSPC和CRPC阶段全人群的雄激素受体通路抑制剂（ARPI）[2]。同年11月28日，国家医保局正式公布的《2024版国家医保目录》中，恩扎卢胺的mHSPC新适应症也实现医保准入，将会造福更多前列腺癌患者[3]。 01 荆棘载途转移性前列腺癌患者占比高、预后差，亟需新型治疗方案前列腺癌是中国男性第七大癌症死亡原因，国家癌症中心公布的最新数据显示中国估计有134,200例新发和47,500例死亡病例。同时，其发病率和死亡率均呈持续上升趋势，患者基数大、增长快[4]。目前，mHSPC的治疗方案以雄激素剥夺疗法（ADT）联合ARPI为主，但部分ARPI存在获益人群有限等问题[5, 6]。同时，mHSPC主要为老年患者，存在基础状况差和合并症等情况，疾病管理更加复杂[7, 8]。现有ARPI或存在药物相关不良事件和他汀类药物相互作用，可能会进一步影响患者疗效、安全性和生活质量[9-11]。 02 披荆斩棘恩扎卢胺强效缩瘤，延缓疾病进展，延长总生存期，成为mHSPC全人群的最优选择恩扎卢胺作为全新ARPI，通过“三重阻断”机制（抑制雄激素与雄激素受体（AR）结合，抑制AR核移位以及AR与DNA的相互作用）有效控制肿瘤生长和疾病进展[12]。 2019年ASCO GU大会中首次公布的全球ARCHES研究显示，恩扎卢胺+ADT治疗mHSPC达到主要终点——影像学无进展生存期（rPFS）[13]。与安慰剂+ADT相比，恩扎卢胺+ADT显著降低mHSPC患者61%的影像学进展或死亡风险（HR 0.39，P＜0.001）；同时，恩扎卢胺+ADT可显著缩小瘤体，客观缓解率达到83.1%，36.9%的患者病灶完全消失（83.1% vs 63.7%，P＜0.001）；此外，恩扎卢胺+ADT组患者PSA不可检出应答率（PSA＜0.2 ng/ml）达到68.1%，显著降低87%的PSA进展风险[13]。最终OS分析显示，恩扎卢胺+ADT可显著延长患者生存期，降低34%的死亡风险（HR 0.66，P＜0.0001）[13, 14]。 2023年ESMO大会上首次公布中国ARCHES研究结果，这是目前唯一一项针对中国全人群mHSPC患者展开的III期临床研究[15]。研究结果显示，与安慰剂+ADT相比，恩扎卢胺+ADT可显著降低中国mHSPC患者87%的PSA进展风险（HR 0.13，P＜0.001）[15]。次要终点结果显示，恩扎卢胺+ADT可显著延长影像学无进展生存期，延缓进展至去势抵抗的时间，PSA不可检出应答率高达76.3%，并降低78.6%开始后续新抗肿瘤治疗风险（HR 0.214；P<0.0001）[15]。同时，全球ARCHES研究和中国ARCHES的安全性结果均显示，两个治疗组的治疗期间不良事件发生率相似，无新的安全性信号[13-15]。 03 全面覆盖恩扎卢胺三大联合治疗方案均纳入医保，惠及更多晚期前列腺癌患者本次恩扎卢胺mHSPC新适应症的获批和快速纳入医保也体现了国家对前列腺癌治疗的高度重视。随着医保目录的动态调整，恩扎卢胺覆盖了mHSPC、非转移性去势抵抗性前列腺癌（nmCRPC）、未经化疗的转移性去势抵抗性前列腺癌（mCRPC）三大阶段治疗方案，全球惠及超过1000000患者。恩扎卢胺进入医保，为中国广大晚期前列腺癌患者的治疗和全病程管理提供了更多的选择方案；同时也进一步减轻患者经济负担，惠及更多晚期患者人群[3, 14, 16-18]。参考文献：（滑动查看） [1] 中国医疗保障局. 2024年国家医保药品目录调整申报材料（公示版）. 20241205版. https://www.nhsa.gov.cn/attach/Ypsn2024/YPSN202400193/YPSN202400193.pdf [Z]. [2] 安可坦转移性激素敏感性前列腺癌适应症获批.（20241202）. https://www.astellas.com.cn/zh-hans/news/14671 [Z]. [3] 国家基本医疗保险、工伤保险和生育保险药品目录（2024年） [Z]. [4] HAN B, ZHENG R, ZENG H, et al. Cancer incidence and mortality in China, 2022 [J]. Journal of the National Cancer Center, 2024, 4（1）: 47-53. [5] GU W, HAN W, LUO H, et al. Rezvilutamide versus bicalutamide in combination with androgen-deprivation therapy in patients with high-volume, metastatic, hormone-sensitive prostate cancer （CHART）: a randomised, open-label, phase 3 trial [J]. The Lancet Oncology, 2022, 23（10）: 1249-60. [6] 中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会（CSCO）前列腺癌诊疗指南 [M]. 北京: 人民卫生出版社, 2024. [7] GOEBELL P J, RAINA R, CHEN S, et al. Real-world treatment of metastatic hormone-sensitive prostate cancer in the USA, Europe and Asia [J]. Future Oncol, 2024, 20（14）: 903-18. [8] BOYLE H J, ALIBHAI S, DECOSTER L, et al. Updated recommendations of the International Society of Geriatric Oncology on prostate cancer management in older patients [J]. Eur J Cancer, 2019, 116: 116-36. [9] BRETAGNE M, LEBRUN-VIGNES B, PARIENTE A, et al. Heart failure and atrial tachyarrhythmia on abiraterone: A pharmacovigilance study [J]. Arch Cardiovasc Dis, 2020, 113（1）. [10] 阿帕他胺片（分包）说明书（202408版）. [Z]. [11] 达罗他胺片说明书（20230315版）. [Z]. [12] HE Y, XU W, XIAO Y-T, et al. Targeting signaling pathways in prostate cancer: mechanisms and clinical trials [J]. Signal Transduction and Targeted Therapy, 2022, 7（1）. [13] ARMSTRONG A J, SZMULEWITZ R Z, PETRYLAK D P, et al. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer [J]. Journal of Clinical Oncology, 2019, 37（32）: 2974-86. [14] ARMSTRONG A J, AZAD A A, IGUCHI T, et al. Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer [J]. Journal of Clinical Oncology, 2022, 40（15）: 1616-22. [15] ZHOU F, GONGQIAN Z, GUO H, et al. 1795P China ARCHES: A multicenter phase III randomized double-blind placebo （PBO）-controlled efficacy and safety trial of enzalutamide （ENZA） + androgen deprivation therapy （ADT） vs PBO + ADT in Chinese patients （pts） with metastatic hormone-sensitive prostate cancer （mHSPC） [J]. Annals of Oncology, 2023, 34: S971. [16] Internal data from Astella Pharma Inc. [Z]. [17] ARMSTRONG A J, LIN P, TOMBAL B, et al. Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial [J]. European Urology, 2020, 78（3）: 347-57. [18] STERNBERG C N, FIZAZI K, SAAD F, et al. Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer [J]. New England Journal of Medicine, 2020, 382（23）: 2197-206. （来源：《肿瘤瞭望》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。

ASCO会议临床3期临床结果

2024-12-11

·GlobeNewswire-Health Care

Celcuity Presents Overall Survival Data from Phase 1b Study Evaluating Gedatolisib in Combination with Palbociclib and Endocrine Therapy at the 2024 San Antonio Breast Cancer Symposium

Median overall survival (OS) among patients with HR+, HER2- advanced breast cancer who were treatment-naïve in the advanced setting was 77.3 months Median OS among patients previously treated with a CDK4/6 inhibitor was 33.9 months MINNEAPOLIS, Dec. 11, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced overall survival (OS) data from two patient cohorts evaluated in a Phase 1b trial with gedatolisib, a pan-PI3K/mTORC1/2 inhibitor, in combination with palbociclib and either letrozole or fulvestrant, in patients with HR+, HER2-advanced or metastatic breast cancer. Results will be presented in a poster session at the San Antonio Breast Cancer Symposium (SABCS) being held December 10-13 at the Henry B. Gonzalez Convention Center in San Antonio, Texas. The poster presents overall survival data among patients with HR+, HER2- advanced breast cancer who were either treatment-naïve (N=41) or whose disease progressed during prior treatment with a CDK4/6 inhibitor (N=27). For the treatment-naïve patient cohort (Escalation Arm A and Expansion Arm A), median OS was 77.3 months (95% CI, 50.3 to 89.0). For the patients previously treated with a CDK4/6 inhibitor and who received the Phase 3 dose of gedatolisib (Expansion Arm D), median OS was 33.9 months (95% CI, 17.8 to 52.3). “The median OS results reported for gedatolisib in combination with palbociclib and endocrine therapy are encouraging and compare favorably to published data for currently available first- or second-line standard-of-care regimens for patients with HR+/HER2- advanced breast cancer,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “These results highlight the promising clinical development strategy of simultaneously blocking the ER, CDK4/6, and PAM (PI3K/AKT/mTOR) signaling pathways. This approach provided the rationale for our two Phase 3 clinical trials, the ongoing VIKTORIA-1 and planned VIKTORIA-2, which are and will be evaluating this treatment strategy in patients with HR+, HER2- advanced breast cancer in the second- and first-line setting, respectively.” This poster, and two additional posters presenting nonclinical data for gedatolisib at the SABCS, are available on the publications page of the Celcuity website. About Gedatolisib Gedatolisib is a potent, reversible inhibitor that selectively targets all Class I PI3K isoforms and mTORC1 and mTORC2 to blockade PI3K/AKT/mTOR signaling activity. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K, AKT, or mTOR alone or together. Inhibiting all four Class I PI3K isoforms and mTORC1/2 limits the potential development of drug resistance compared with isoform-specific PI3K, AKT or mTOR specific inhibitors. A robust response rate and a manageable side effect profile were reported for the Phase 1b clinical trial that evaluated gedatolisib in combination with palbociclib and endocrine therapy in patients with HR+/HER2- advanced breast cancer. Gedatolisib, in combination with palbociclib and fulvestrant, has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of HR+/HER2- advanced breast cancer that has progressed following treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor. About Celcuity Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is enrolling patients. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is expected to begin enrolling patients in the second quarter of 2025. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and Twitter. Forward-Looking Statements This press release contains statements that constitute "forward-looking statements" including, but not limited to, the design of our clinical trials; the timing of initiating and enrolling patients in, and receiving results and data from, our clinical trials; the costs and expected results from any ongoing or planned clinical trials; the market opportunity for gedatolisib; revenue expectations; our strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to Celcuity's lead product candidate, gedatolisib, and its CELsignia platform; our anticipated use of cash; and the strength of our balance sheet. In some cases, you can identify forward-looking statements by terminology such as "may," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "intends" or "continue," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward-looking statements are subject to numerous risks, uncertainties, and conditions, many of which are beyond the control of Celcuity. These include, but are not limited to, unforeseen delays in our clinical trials, our ability to obtain and maintain regulatory approvals to commercialize our products, and the market acceptance of such products, the development of therapies and tools competitive with our products, our ability to access capital upon favorable terms or at all, and those risks set forth in the Risk Factors section in Celcuity's Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 27, 2024. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as required by law. View source version of release on GlobeNewswire.com Contacts: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.comVicky Hahne, vhahne@celcuity.com(763) 392-0123 ICR HealthcarePatti Bank, patti.bank@icrhealthcare.com (415) 513-1284

临床1期临床3期突破性疗法临床结果临床2期

100 项与达罗他胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11045	达罗他胺	L02BB06	DB12941

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
转移性前列腺癌	日本	Bayer AG	2023-02-24
转移性去势抵抗性前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2022-08-05
前列腺癌	巴西	Bayer AG	2020-01-01
去势抵抗性前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2019-07-30

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
去势敏感前列腺癌	申请上市	美国	Bayer AG	2024-09-26
局限性前列腺癌	临床3期	-	Bayer AG	2025-01-01
复发性前列腺癌	临床3期	美国	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	中国	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	日本	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	澳大利亚	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	奥地利	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	比利时	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	巴西	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	加拿大	Bayer AG	2023-04-03

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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


NCT04736199 (ARANOTE, ESMO2024 \| NEWS) 人工标引	临床3期	激素依赖性前列腺癌	669	darolutamide+androgen-deprivation therapy	餘遞願觸鹹壓膚遞醖觸(憲獵築膚壓簾願構範膚): HR = 0.54 (95% CI, 0.41 ~ 0.71), P-Value = <0.0001 更多	积极	2024-09-16
				Placebo+androgen-deprivation therapy
NCT04736199 (ARANOTE, PipelineReview) 人工标引	临床3期	激素依赖性前列腺癌	669	darolutamide	簾鬱夢壓憲選艱淵醖鹹(繭獵遞範顧鏇範鹽觸衊) = Has met its primary endpoint of radiological progression-free survival (rPFS). 鹹繭遞簾襯範衊簾繭糧 (蓋襯餘齋襯構衊齋鹽襯 ) 达到更多	积极	2024-07-17
ASCO2024	N/A	去势敏感前列腺癌	10	Darolutamide + Chemotherapy + ADT	淵餘選餘餘製遞網範醖(衊壓鹽蓋選鏇鑰鑰獵壓) = 5 patients (50%) presented asthenia 膚衊鏇獵襯衊築膚襯築 (願襯遞積糧糧蓋觸願醖 ) 更多	积极	2024-05-24
NCT02799602 (ARASENS, ASCO2024)	临床3期	激素依赖性前列腺癌	1,305	Darolutamide 600 mg	鏇糧壓鬱鹹願鹽製壓壓(鏇範蓋衊顧網積獵鏇選) = 範衊獵鬱範鹹積鹽窪鑰選蓋鹽範願廠願憲構遞 (膚鏇鹽觸壓衊鑰蓋構廠 )	积极	2024-05-24
				Placebo	鏇糧壓鬱鹹願鹽製壓壓(鏇範蓋衊顧網積獵鏇選) = 選淵鏇簾醖襯艱齋淵選選蓋鹽範願廠願憲構遞 (膚鏇鹽觸壓衊鑰蓋構廠 )
NCT04122976 (DAROL, AUA2024) 人工标引	N/A	去势抵抗性前列腺癌	550	Darolutamide	醖廠膚蓋膚襯衊膚衊範(顧鏇壓鏇築鏇餘製鏇願) = 鏇網範蓋淵鏇製鬱範顧構艱膚淵繭積醖餘壓遞 (觸齋餘築齋鬱鬱夢選糧 ) 更多	积极	2024-05-01
MP60-18 (AUA2024)	N/A	去势敏感前列腺癌	319	DARO plus ADT (doublet therapy [DT])	壓鹽餘範鹽壓繭膚窪築(餘窪製鏇餘憲憲繭壓製) = 鹹齋觸築築鹹醖膚淵淵淵鬱鬱鬱鑰遞範蓋網觸 (顧願糧範鏇夢廠繭簾簾 ) 更多	积极	2024-05-01
ARASENS (ASCO_GU2024) 人工标引	临床3期	去势敏感前列腺癌	-	DarolutamiDocetaxeltaxel + ADT	製築遞構壓構醖積顧糧(積獵糧選網簾遞簾築觸) = 製簾繭製積憲鹹壓網膚繭蓋壓淵衊範製選願獵 (壓簾淵淵膚顧製繭鬱衊, 6.54 ~ 9.14) 更多	积极	2024-01-25
				DarolutamidecetDocetaxelT	製築遞構壓構醖積顧糧(積獵糧選網簾遞簾築觸) = 構鏇顧繭簾蓋廠鬱醖夢繭蓋壓淵衊範製選願獵 (壓簾淵淵膚顧製繭鬱衊, 4.92 ~ 6.96) 更多
ARASENS (ESMO_ASIA2023)	临床3期	转移性去势抵抗性前列腺癌	1,305	Darolutamide 600 mg	構蓋餘構網壓遞壓艱蓋(願簾齋願窪膚艱範壓鬱): HR = 0.64 (95% CI, 0.41 ~ 0.99) 更多	积极	2023-12-02
				Placebo
NCT02799602 (ARASENS, ESMO2023)	临床3期	去势敏感前列腺癌	1,306	Darolutamide 600 mg	餘築鹹遞鏇艱構繭壓廠(醖鬱鬱製醖願廠襯觸選): HR = 0.2 (95% CI, 0.15 ~ 0.27) 更多	-	2023-10-22
				Placebo
NCT04157088 (DaroAcT, CTgov)	临床2期	去势抵抗性前列腺癌 \| 转移性去势抵抗性前列腺癌	30	Darolutamide (Nubeqa, BAY1841788)	選鏇觸糧觸構糧顧膚蓋(範選壓壓繭壓鏇遞齋鹹) = 選築膚遞網蓋糧獵範膚夢憲膚願獵顧淵淵簾膚 (蓋獵蓋顧構簾壓築襯網, 膚壓獵窪廠選齋獵願糧 ~ 膚鹽壓夢鹽構餘醖廠獵) 更多	-	2023-08-04