紫杉醇(Paclitaxel) - 药物靶点：Tubulin_在研适应症：转移性胰腺腺癌，生殖细胞瘤，食管癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

EmPAC、LDE-paclitaxel、NanoPac

+ [68]

靶点

Tubulin

作用方式

抑制剂

作用机制

微管蛋白抑制剂

治疗领域

肿瘤免疫系统疾病感染+ [12]

在研适应症

转移性胰腺腺癌生殖细胞瘤食管癌+ [229]

非在研适应症

急性淋巴细胞白血病前列腺腺癌腺肉瘤+ [177]

原研机构

National Institutes of Health

在研机构

Hoffmann-La Roche, Inc.

National Cancer Institute

Hoffmann-La Roche Ltd.

+ [38]

非在研机构

Celgene Corp.Norton Healthcare Ltd.

Pfizer Inc.

+ [23]

最高研发阶段批准上市

首次获批日期

美国 (1992-12-29),

艾滋病相关性卡波西肉瘤乳腺癌卵巢癌

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)

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结构/序列

分子式C47H51NO14

InChIKeyRCINICONZNJXQF-MZXODVADSA-N

CAS号33069-62-4

关联

3,098

项与紫杉醇相关的临床试验

NCT06675136

/ Not yet recruiting临床1期IIT

Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases

This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.

开始日期2025-10-17

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06795009

/ Not yet recruiting临床1期IIT

Phase I/IB Study of Zanzalintinib in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

The purpose of this study is to determine the recommended Phase 2 dose of zanzalintinib when given in combination with paclitaxel in patients with recurrent high-grade uterine cancer. Other objectives include overall safety and tolerability as well as rates of response.

开始日期2025-05-31

申办/合作机构

Washington University School of Medicine

[+2]

NCT06904300

/ Not yet recruiting临床2期IIT

A Randomized, Controlled, Multi-center Phase II Study of Ivonescimab (AK112) Plus Paclitaxel Versus Paclitaxel with or Without Ramucirumab As Second-line Therapy in Subjects with Advanced Gastric or Gastroesophageal Junction（G.GEJ）cancer Who Failed Immunochemotherapy

A Randomized, Controlled, Multi-center Phase II Study of Ivonescimab (AK112) plus Paclitaxel versus Paclitaxel with or without Ramucirumab as second-line therapy in subjects with advanced gastric or gastroesophageal junction（G/GEJ）cancer who failed immunochemotherapy

开始日期2025-05-10

申办/合作机构

中山大学

100 项与紫杉醇相关的临床结果

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100 项与紫杉醇相关的转化医学

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100 项与紫杉醇相关的专利（医药）

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66,583

项与紫杉醇相关的文献（医药）

2025-12-31·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Selisistat, a SIRT1 inhibitor, enhances paclitaxel activity in luminal and triple-negative breast cancer: in silico, in vitro, and in vivo studies

Article

作者: Bartuzi, Damian ; Stepulak, Andrzej ; Kalafut, Joanna ; Okon, Estera ; Wawruszak, Anna ; Czerwonka, Arkadiusz ; Luszczki, Jarogniew

Sirtuins (SIRTs) are NAD+-dependent histone deacetylases, which play a key role in cancer progression; however, their prognostic values in breast cancer (BC) remain a subject of debate and controversy. Accumulative evidence suggests that each sirtuin possesses individual character, implicating its role in the regulation of multifaceted biological functions leading to BC initiation, progression and metastasis. Selisistat (EX527) is a potent, cell permeable, highly selective SIRT1 inhibitor. In the study, the tumour-suppressive effects of the SIRT1 inhibitor EX527 (selisistat) alone and in combination with paclitaxel (PAX) in different breast cancer cell lines and zebrafish xenograft models were investigated. The type of pharmacological drug-drug interaction between EX527 and PAX was determined using the isobolographic method. EX527 and PAX used individually inhibited proliferation, induced apoptosis and caused cell cycle arrest in G1 and subG1/G2 phases. Interestingly, the combination of these compounds used in the 1:1 dose-ratio augmented all these effects (IC_50add 29.52 ± 3.29 - 38.45 ± 5.26). The co-treatment of EX527 with PAX generated desirable additive drug-drug interaction. The simultaneous application of EX527 and PAX induced a stronger inhibition of tumour growth compared to individual treatments in zebrafish xenografts. In silico analysis revealed a protein-protein interaction pathway (SIRT1-AKT-S1PR1-GNAI1/GNAO1-Tubulin) connecting molecular targets of both ligands. To summarise, the combination of EX527 and PAX more effectively impairs breast cancer cell growth compared to individual treatments. However, further investigations are required to clarify the specific targets and molecular mechanisms underlying the activity of EX527:PAX in other preclinical models.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare

Article

作者: Bernauer, Mark ; Roth, Joshua A. ; Dorman, Stephanie ; Kratochvil, David

BACKGROUND:

Biosimilars to originator bevacizumab (Avastin), such as bevacizumab-bvzr (Zirabev), can deliver substantial savings and/or expanded access to biologic therapy for patients with metastatic colorectal (mCRC) and non-squamous non-small cell lung cancer (mNSCLC). The objective of this study is to explore the cost-efficiency and budget-neutral expanded access of bevacizumab-bvzr in mCRC and mNSCLC in Medicare.

METHODS:

We developed a Medicare payer perspective simulation model of patients treated for mCRC and mNSCLC to estimate cost-savings from converting bevacizumab (originator) to bevacizumab-bvzr or alternative biosimilars such as bevacizumab-awwb, -maly, and -abcd. The target patient population receiving annual first-line systemic therapy was calculated using Medicare enrollment data, SEER cancer incidence rates in patients age ≥65, and an assumption that 39.3% and 77.2% of new diagnoses receive systemic therapy for mCRC and mNSCLC respectively based on recent evidence. 76.0% of systemically treated mCRC patients and 11.4% of incident mNSCLC patients were expected to be treated with bevacizumab-based regimens based on recent evidence. Costs were derived from the 2024 Average Sales Price (ASP). Results include per-patient per-month (PPPM) cost savings (vs. originator), total monthly savings in the cohort, and number needed to convert (NNC) to biosimilar to fund the treatment of an additional 100 patients.

RESULTS:

PPPM savings from conversion to bevacizumab-bvzr were $4,205 in mCRC and $8,410 in mNSCLC. In 100% conversion scenarios, full cohort monthly savings were $27,664,432 in mCRC (n = 6,579) and $32,319,323 in mNSCLC (n = 3,843), respectively. At 100% conversion, monthly savings from biosimilar conversion could fund up to 13,887 additional mCRC patient-months of treatment with bevacizumab-bvzr + FOLFOX, and up to 8,959 additional mNSCLC patient-months of treatment with bevacizumab-bvzr + paclitaxel + carboplatin. In mCRC and mNSCLC the biosimilar NNC from the originator was 47 and 43, respectively. The biosimilar NNC from other biosimilars ranged from 60-4,564 and 55-4,422 for mCRC and NSCLC, respectively.

CONCLUSION:

In the first cost-efficiency and expanded access study of biosimilar bevacizumab in mCRC and mNSCLC, we find that bevacizumab-bvzr-based regimens can result in substantial cost savings relative to originator-based first line treatment in Medicare. These cost savings could be reinvested to treat a substantial number of additional patients with mCRC or mNSCLC, or fund other costs of care in Medicare, on a budget-neutral basis.

2025-12-31·CANCER BIOLOGY & THERAPY

Sulfatase 2 inhibition sensitizes triple-negative breast cancer cells to paclitaxel through augmentation of extracellular ATP

Article

作者: Schnell, Patrick M. ; Zhang, Xiaoli ; Datta, Jharna ; Rubinstein, Mark P. ; Manouchehri, Jasmine M. ; Marcho, Lynn M. ; Ganju, Ramesh K. ; Mittra, Arjun ; Yue, Yu ; Carson, William E. ; Stover, Daniel ; Cherian, Mathew A. ; Ramaswamy, Bhuvaneswari

The highest incidence and cancer-related mortality rate among women worldwide is due to breast cancer. Triple-negative breast cancers (TNBC) are associated with more inferior outcomes than other breast cancers because of their progressive nature and the deficit in available therapies. Therefore, there is a need for new therapeutic approaches. Our lab determined that chemotherapy induces the release of extracellular adenosine triphosphate (eATP), and, hence, augments TNBC cells' response to chemotherapy. Despite this, eATP concentrations are restricted by a variety of extracellular ATPases. We propose that, as an ATPase inhibitor, heparan sulfate (HS) would augment eATP concentrations and TNBC vulnerability induced by chemotherapy. Sulfatase 2 (SULF2) removes sulfate from HS, the functional group essential for ATPase inhibition. Consequently, we propose that TNBC cell death and eATP release induced by chemotherapy would be intensified by SULF2 inhibitors. We examined eATP and cell viability in paclitaxel-treated TNBC and nontumorigenic immortal mammary epithelial MCF-10A cells in the presence of OKN-007, a selective SULF2 inhibitor, and/or heparan sodium sulfate. Furthermore, sulfatase 1 (SULF1) and SULF2 protein expressions were ascertained. We found that the expression of SULF2 was greater in TNBC cell lines when compared to MCF-10A cells. The release of eATP and loss of TNBC cell viability induced by chemotherapy was enhanced by OKN-007. The co-treatment of chemotherapy and OKN-007 also attenuated cancer-initiating cells. This data implies that the combination of SULF2 inhibitors with chemotherapy augments eATP and decreases cell viability of TNBC greater than chemotherapy alone.

2,786

项与紫杉醇相关的新闻（医药）

23 小时之前

·ioncology

NCCN 2025丨刘继红教授：加强管理，注意免疫联合化疗治疗子宫内膜癌的不良事件

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”NCCN 2025 微专辑扫描二维码可查看更多内容编者按子宫内膜癌是妇科恶性肿瘤中的常见类型，其发病率在全球范围内呈上升趋势。近年来，免疫联合化疗作为一种新兴的治疗策略，已在改善原发性晚期或复发性子宫内膜癌患者的生存期和治疗反应持久性方面展现出显著优势。然而，随着免疫联合化疗的广泛应用，其安全性问题也逐渐受到关注。3月28～30日在美国奥兰多召开的美国国立综合癌症网络（NCCN）2025年会上，一项免疫联合化疗治疗原发性晚期或复发性子宫内膜癌不良事件发生率的荟萃分析入选大会壁报展示。《肿瘤瞭望》荣幸邀请到中山大学肿瘤防治中心刘继红教授就上述研究进行点评，现将内容整理如下，以飨读者。研究背景免疫联合化疗在改善原发性晚期或复发性子宫内膜癌患者生存期及治疗反应持久性方面展现出显著优势，但其免疫相关不良事件（iRAEs），如甲状腺功能减退和皮疹/皮炎，以及静脉血栓栓塞（VTE）等安全问题仍需深入评估。本研究旨在通过荟萃分析明确免疫联合化疗相较于单纯化疗的VTE及iRAEs发生率差异。研究方法文献检索：系统性检索Medline、Embase及Cochrane数据库（截至2024年8月10日），纳入报道甲状腺功能减退、皮疹/皮炎及VTE事件的II/III期随机对照试验（RCT）。数据提取：由两名研究者独立提取数据，如有分歧则由第三方评审者判定。研究终点：主要终点：甲状腺功能减退、皮疹/皮炎及VTE事件的发生率。统计分析：采用随机效应模型及Mantel-Haenszel方法计算危险比（RR）和危险差（RD），并计算95%置信区间（CI）。异质性通过I2统计量和Cochran’s Q检验评估，P<0.05视为具有统计学意义。研究结果纳入研究结果及特征（图1）：共纳入4项III期RCT（AtTEnd、NRG-GY018、RUBY、DUO-E）及1项II期RCT（MITO END-3），涉及2 624例患者。所有试验均比较免疫联合化疗（卡铂+紫杉醇）与安慰剂联合化疗的疗效与安全性。图1. 纳入研究结果及特征不良事件发生率：● 甲状腺功能减退：免疫联合化疗组12.53%，单纯化疗组3.61%（RR：3.27；95% CI: 2.34～4.57；P<0.00001）（图2A）；● 皮疹/皮炎：免疫联合化疗组12.07%，单纯化疗组6.85%（RR：1.80；95% CI: 1.39～2.33；P<0.00001）（图2B）；● VTE：免疫联合化疗组3.56%，单纯化疗组2.07%（RR：1.60；95% CI: 0.97～2.64；P=0.07）（图2C）。图2. 不良反应发生率结果：A.甲状腺功能减退；B.皮疹/皮炎；C.VTE研究结论免疫联合化疗组甲状腺功能减退及皮疹/皮炎的发生率显著高于单纯化疗组，需在临床中加强监测与管理。虽然免疫联合化疗组的VTE发生率更高，但差异无统计学意义，需更大样本研究明确关联性。本研究强调需权衡免疫联合化疗方案的生存获益与潜在风险，建议强化个体化治疗决策及不良事件管理以优化患者结局。大咖点评在肿瘤综合治疗领域，关注免疫治疗联合化疗方案的安全性管理极具临床价值。然而，本荟萃分析将"不良事件发生率"作为核心研究指标存在一定局限性。从药理学机制分析，化疗基础上叠加其他治疗手段（包括免疫治疗或其他抗肿瘤药物）必然导致毒性增加，这一规律本已众所周知。以甲状腺功能减退和皮肤毒性事件为例，其发生率差异本质上源于治疗方案的叠加效应，因此该研究结论的得出缺乏足够的临床创新价值。当然，本研究仍为临床工作者提供了重要的安全性警示，强调在实施联合治疗方案时需建立完善的监测体系与应急预案。刘继红教授中山大学附属肿瘤医院妇科教授、主任医师、博士生导师、首席专家中国抗癌协会子宫体肿瘤专业委员会主任委员中华医学会妇科肿瘤学分会（CSGO）第四、五届委员会副主任委员国家癌症中心国家肿瘤质控中心宫颈癌质控专家委员会副主任委员中国优生科学协会阴道镜和宫颈病理学分会（CSCCP）副主任委员中国医师协会妇产科医师分会常务委员广东省医学会妇科肿瘤学分会主任委员兼青年委员会主任委员广东省医学会妇产科学分会名誉主任委员、妇科肿瘤学组组长中国南方肿瘤临床研究协会妇科肿瘤分子诊疗专业委员会主任委员摘要原文（上下滑动可查看）Meta-Analysis of Randomized Controlled Trials (RCTs) to Evaluate the Incidence of Venous Thromboembolism (VTE) and Immune-Related Adverse Events (iRAEs) in Patients with Primary Advanced or Recurrent Endometrial Cancer Treated with ImmunochemotherapyINTRODUCTION:Immunochemotherapy, combining immune checkpoint inhibitors (ICIs) with platinum-based chemotherapy, has demonstrated improved survival and durable treatment responses for patients with primary advanced or recurrent endometrial cancer (EC). While enhancing treatment efficacy, immunochemotherapy also raises concerns about adverse events, specifically hypothyroidism, rash/dermatitis, and venous thromboembolism (VTE). This meta-analysis evaluates the incidence and relative risk of iRAEs(hypothyroidism and rash/dermatitis) and VTE in patients with primary advanced or recurrent EC treated with immunochemotherapy compared to chemotherapy alone.METHOD: Literature Search: We conducted a comprehensive literature search using Medline, Embase, and Cochrane databases from inception through August 10th, 2024.Eligibility Criteria: Eligible studies included Phase II/III RCTs utilizing immunochemotherapy in primary advanced or recurrent EC reporting hypothyroidism, rash/dermatitis, and VTE (deep vein thrombosis and/or pulmonary embolism) events.Data Extraction: Data extraction was independently conducted by two authors; discrepancies were resolved by a third reviewer.Study Outcome Measures:The primary endpoint of our meta-analysis was the incidence of hypothyroidism, rash/dermatitis, and VTE (deep vein thrombosis and/or pulmonary embolism) events.Data Synthesis and Analysis. The primary meta-analytic approach was a random effects model using the Mantel-Haenszel (MH) method. This method was used to calculate the estimated pooled risk ratio (RR) and risk difference (RD) with 95% confidence intervals (CI). Heterogeneity among the studies was assessed using the I2 statistic and Cochran’s Q-statistic. A p-value of less than 0.05 was considered statistically significant.RESULTS: Search Results: A total of 2624 patients from four Phase III RCTs (AtTEnd, NRG-GY018, RUBY, DUO-E) and one phase II RCT (MITO END-3) were eligible for evaluation of hypothyroidism, rash/dermatitis, and VTE, events.Characteristics of the Studies: All five trials compared immunotherapy combined with chemotherapy versus placebo plus chemotherapy in primary advanced or recurrent EC.Meta-Analysis Results: The incidence of hypothyroidism was 12.53% in the immunochemotherapy arm vs 3.61% in the control arm (RR 3.27; 95% CI: 2.34-4.57; P < 0.00001). The incidence of rash/dermatitis was 12.07% in the immunochemotherapy arm vs 6.85% in the control arm (RR 1.80; 95% CI: 1.39-2.33; P < 0.00001). The incidence of VTE was not statistically significant. 3.56% in the immunochemotherapy arm vs 2.07% in the control arm (RR 1.60; 95% CI: 0.97-2.64; P= 0.07).CONCLUSIONS: Patients with primary advanced or recurrent endometrial cancer treated with immunochemotherapy had a significantly higher incidence of hypothyroidism and rash/dermatitis compared to chemotherapy alone, emphasizing the need for proactive monitoring and management of these immune-related adverse events. While the incidence of venous thromboembolism was higher in the immunochemotherapy group, the difference was not statistically significant, suggesting further studies are needed to confirm this trend. The findings underscore the importance of balancing the therapeutic benefits of immunochemotherapy with its potential risks, reinforcing the need for personalized treatment strategies and vigilant adverse event management to optimize patient outcomes.（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。

临床结果临床3期

2025-04-10

·抗体密码

后线治疗还是要看TCE疗法

在之前的文章中我们介绍了BioNTech的双特异抗体BNT327/PM8002一线治疗ES-SCLC的二期临床数据，从目前的数据看，其还是非常有潜力冲击1线治疗。除此之外，在本次ELCC会议上，BioNTech还公布了BNT327/PM8002治疗SCLC的另外一个Ⅱ期临床，联合紫杉醇2线治疗SCLC，临床结果表明，该疗法在IO-naive和IO治疗后的患者中获得了鼓舞人心的疗效，其中在IO-naïve的患者中，ORR达到72.7%（证实的ORR为50%）,而在IO耐药的患者中，ORR为48.4%（证实的ORR为37.2%），在所有患者中，总体ORR为56.9%（证实的ORR为41.5%）临床设计如下，70位一线经过化疗并且复发的患者入组，其中分为两个亚组：IO-naïve和IO-treated组。所有患者介绍30mg/kg BNT327/PM8002+紫杉醇治疗，后续利用30mg/kg BNT327/PM8002维持治疗。入组患者基线如下，70位患者中，13位有脑转移，21位有肝转移，同时有13位患者接受化疗的间隔期小于30天（这类患者预后较差，后线治疗选择有限）。截至2024年12月20日的截止日期，8例患者仍在接受治疗，中位治疗持续时间为4.7个月（95% CI：3.7–5.4）；中位随访时间为17.9个月（95% CI：15.7–23.1）；无论既往是否接受过IO治疗，患者均表现出鼓舞人心的抗肿瘤活性，总体疾病控制率（DCR）达87.7%。确认的客观缓解率（ORR）为41.5%，未确认的ORR为56.9%。中位总生存期（OS）为14.3个月（95% CI：10.9–19.9），中位无进展生存期（PFS）为5.5个月（95% CI：4.1–7.2），安全性方面，共计69例患者（98.6%）报告了至少1例与 BNT327和/或化疗相关的不良事件（TRAE）。其中，55例患者（78.6%）发生了 ≥3级的TRAEs。最常见的不良事件包括：中性粒细胞计数减少（80%），白细胞计数减少（80%），贫血（63%），血小板计数减少（48.6%）。目前二线标准疗法2020年6月，Zepzelca（lurbinectedin鲁比卡丁）被FDA获批上市，用于治疗在铂类化疗时或化疗后出现疾病进展的成人转移性SCLC患者。这是近30年来首个二线治疗能改善患者生存率的化疗药物。FDA批准Zepzelca基于一项开放标签、多中心、单臂II期单药治疗篮式研究B-005的数据。该试验共入组105例铂类药物化疗后疾病进展的SCLC成人患者（包括铂敏感和铂耐药患者）。由研究者评估的结果显示，lurbinectedin单药治疗复发性SCLC的总缓解率（ORR）为35%、中位缓解持续时间（DOR）为5.3个月；独立审查委员会（IRC）评估的ORR为30%、中位DOR为5.1个月。NCCN指南：将PD-1抑制剂列为复发SCLC的后线选择（2A类推荐），但优先推荐化疗（拓扑替康/鲁比卡丁）或临床试验。其中Opdivo获批用于治疗复发性SCLC（含铂化疗失败后）的患者基于CheckMate-032临床，其客观缓解率ORR为12%，中位缓解持续时间（DoR）17.9个月；生存期：中位总生存期（OS）4.4个月，1年生存率33%。安全性：3-4级治疗相关不良事件（TRAE）发生率13%。Keytruda获批治疗PD-L1阳性（CPS≥1）的复发性SCLC 患者基于KEYNOTE-158临床研究，其临床疗效ORR为19%，中位DoR未达到，中位OS 9.1个月，1年生存率35%。安全性：3-4级TRAE发生率14%。末线TCE疗法作为对比，我们看一下去年Amgen获批的DLL3/CD3的临床疗效。Tarlatamab的批准基于全球性2期临床试验DeLLphi-301的结果。该疗法用于治疗广泛期小细胞肺癌（ES-SCLC）成人患者。这些患者在接受化疗时或之后出现疾病进展，患者在入组前平均接受过2线疗法。临床中共计220例患者接受双抗AMG757的治疗。患者既往接受过的治疗线数中位数为2。在接受治疗并评估的患者中，10 mg组的中位随访时间为10.6个月，100 mg组为10.3个月。10 mg组和100 mg组分别有40%（97.5% [CI]，29~52）和32%（97.5% CI，21~44）的患者达到客观缓解。在这些达到客观缓解的患者中，59%（68例患者中的40例）的缓解持续时间至少为6个月。数据截止时，10 mg组40例患者中22例（55%）和100 mg组28例患者中16例（57%）仍维持客观缓解。10 mg组的中位无进展生存期为4.9个月（95% CI，2.9~6.7），100 mg组为3.9个月（95% CI，2.6~4.4）。9个月总生存率估计值分别为68%和66%。总结对于BNT327/PM8002，联合紫杉醇2线治疗SCLC总体疾病控制率（DCR）达87.7%，确认的客观缓解率（ORR）为41.5%，未确认的ORR为56.9%，与现有标准疗法相比，其ORR具有一定的优势，中位总生存期（OS）为14.3个月，同样优于现有疗法。但是与末线TCE疗法的中位总生存期（OS）14.3 个月相比，BNT327/PM8002没有优势。但同时考虑到TCE疗法的患者群体更难治疗，因此平行比较的话，TCE疗法更具有优势。当然，免疫疗法BNT327/PM8002和TCE靶向疗法是不冲突的，两者也有联用的空间。当然，两者目前都在探索和ADC联用，目前BioNtech已经启动BNT327/PM8002和B7-H3 ADC（BNT324/DB-1311）的联用研究。在和TCE联用方面，第一三共引进了默沙东的MK-6070，并布局与B7-H3 ADC联合用药相关研究。我们已经建立抗体密码读者交流群，有兴趣的可以扫描下方二维码添加微信进群，请主动备注姓名-公司-职位（高校-专业），非诚勿扰！往期精彩回顾抗体密码文章合集双特异抗体平台靶点相关双特异抗体作用机制综述，行业概览抗体筛选技术相关公司技术汇总医药资讯因为你的分享、点赞、在看我足足的精气神儿！声明本公众号所发表文章以宣传知识为目的，因此不构成投资，病人用药等建议。如果文章侵您的权益及时联系小编进行删除！欢迎扫码交流/咨询/合作等参考文献：

临床结果临床2期上市批准临床3期

2025-04-10

·PMLiVE

Compass Therapeutics’ tovecimig shows promise in phase 2/3 biliary tract cancer study

Compass Therapeutics has shared promising results from a phase 2/3 study of its investigational bispecific antibody in biliary tract cancer (BTC). The ongoing COMPANION-002 trial has been evaluating the candidate, tovecimig (formerly CTX-009), alongside paclitaxel in adults with unresectable advanced, metastatic or recurrent BTC who have received one prior systemic chemotherapy regimen. The study met its primary endpoint, with tovecimig plus paclitaxel achieving a 17.1% overall response rate (ORR), including one complete response, compared to an ORR of 5.3% for paclitaxel alone. The tovecimig combination was also associated with progressive disease rates of 16.2% compared to 42.1% in patients on paclitaxel alone, and the safety profile of Compass’ drug was found to be consistent with prior studies. The pre-specified number of events required to inform the analyses of the study’s secondary endpoints, including progression free survival, overall survival and duration of response, have not yet been met and the company said it is expecting to report results for these endpoints in the fourth quarter of 2025. Thomas Schuetz, chief executive officer of Compass and vice chairman of the board of directors, said: “We believe these findings highlight the potential of tovecimig to provide a much-needed treatment option for the majority of patients with BTC who have limited alternatives after first-line therapy. We look forward to discussing this data with regulatory authorities.” Around 23,000 cases of BTC, a rare and aggressive cancer of the bile ducts, are diagnosed in the US every year. Nearly all patients develop progressive disease following first-line treatment with chemotherapy, Compass outlined, underscoring the need for safe and effective therapies in patients with advanced BTC. Tovecimig is designed to block both the Delta-like ligand 4 and vascular endothelial growth factor A signalling pathways, providing anti-tumour activity. “Patients currently have very limited treatment options, with the vast majority in the second-line setting having no approved therapeutic alternative whatsoever,” said Juan Valle, chief medical officer of the Cholangiocarcinoma Foundation. “Each investigative trial helps in this fight to advance new treatment options, and I look forward to following tovecimig’s continued progress.”

临床结果

100 项与紫杉醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00491	紫杉醇	L01CD01	DB01229

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
转移性胰腺腺癌	欧盟	Accord Healthcare SLU	2024-01-05
转移性胰腺腺癌	冰岛	Accord Healthcare SLU	2024-01-05
转移性胰腺腺癌	列支敦士登	Accord Healthcare SLU	2024-01-05
转移性胰腺腺癌	挪威	Accord Healthcare SLU	2024-01-05
铂类耐药性原发性腹膜癌	欧盟	Inceptua SA	2018-11-20
铂类耐药性原发性腹膜癌	冰岛	Inceptua SA	2018-11-20
铂类耐药性原发性腹膜癌	列支敦士登	Inceptua SA	2018-11-20
铂类耐药性原发性腹膜癌	挪威	Inceptua SA	2018-11-20
铂敏感性卵巢上皮癌	欧盟	Inceptua SA	2018-11-20
铂敏感性卵巢上皮癌	冰岛	Inceptua SA	2018-11-20
铂敏感性卵巢上皮癌	列支敦士登	Inceptua SA	2018-11-20
铂敏感性卵巢上皮癌	挪威	Inceptua SA	2018-11-20
铂敏感性输卵管癌	欧盟	Inceptua SA	2018-11-20
铂敏感性输卵管癌	冰岛	Inceptua SA	2018-11-20
铂敏感性输卵管癌	列支敦士登	Inceptua SA	2018-11-20
铂敏感性输卵管癌	挪威	Inceptua SA	2018-11-20
生殖细胞瘤	日本	Clinigen KK	2013-02-21
生殖细胞瘤	日本	Bristol Myers Squibb Co.	2013-02-21
食管癌	日本	Bristol Myers Squibb Co.	2012-03-21
食管癌	日本	Clinigen KK	2012-03-21

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
胰腺癌	申请上市	欧盟	Accord Healthcare SLU	2023-11-09
转移性胰腺癌	临床3期	中国	上海谊众药业股份有限公司	2025-02-01
高级别胶质瘤	临床3期	中国	浙江大学	2024-04-01
HEGF2阴性乳腺癌	临床3期	中国	上海谊众药业股份有限公司	2023-09-25
皮肤鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-06-08
下咽癌	临床3期	美国	National Cancer Institute	2023-06-08
转移性头颈部鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-06-08
下咽部鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-06-08
喉鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-06-08
口腔鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-06-08

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临床结果

适应症

分期

评价

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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


NCT00513786 (CTgov)	临床2期	晚期子宫内膜癌	38	Carboplatin+Paclitaxel+Bevacizumab	觸網齋鑰範憲願築觸網(網艱範蓋遞廠窪衊選窪) = 衊觸製衊壓鬱淵餘繭鏇選積願製製構觸鬱製醖 (窪鑰鏇憲艱遞網構廠鏇, 鏇鏇糧壓網鏇鹹鹽獵夢 ~ 醖醖鑰淵廠簾鬱獵蓋獵) 更多	-	2025-03-28
NCT02684227 (CTgov)	临床2期	子宫内膜样腺癌 \| 复发性子宫内膜癌 \| 复发性子宫体癌	50	Enzalutamide+Carboplatin+Paclitaxel (Part A)	網鏇範淵構鏇鑰遞顧鑰 = 襯繭鬱鹽襯淵鏇鬱衊構積觸鬱網願膚構憲艱獵 (鑰獵鬱廠壓鑰廠積淵齋, 齋遞範襯網膚醖範糧築 ~ 鹽鏇繭衊襯廠鑰憲醖鬱) 更多	-	2025-03-19
				Enzalutamide+Carboplatin+Paclitaxel (Part B)	網鏇範淵構鏇鑰遞顧鑰 = 範鏇鹽鏇膚製範餘選醖積觸鬱網願膚構憲艱獵 (鑰獵鬱廠壓鑰廠積淵齋, 膚鑰獵顧衊齋鹽醖選醖 ~ 艱鹽觸憲構蓋鑰餘廠蓋) 更多
ASCO_GU2025	N/A	-	18	Paclitaxel, Ifosfamide, Cisplatin (TIP) regimen	簾鑰鹽餘廠網齋壓觸淵(齋繭壓鏇顧蓋夢鬱繭廠) = 選膚顧淵鹽襯鑰窪壓獵淵壓糧壓繭範淵憲簾壓 (醖艱選艱遞築衊獵壓觸 ) 更多	积极	2025-02-13
CTR20190050 (ASCO_GI2025) 人工标引	临床3期	晚期胃癌二线	536	Paclitaxel oral solution	夢憲夢齋鏇鬱醖壓艱憲(構夢餘願廠衊壓願觸艱) = 窪壓憲積鹹獵艱遞憲積艱鏇積簾夢鑰繭獵鏇鏇 (獵蓋窪醖衊膚齋廠膚醖, 7.72 ~ 10.97) 更多	非劣	2025-01-23
				Paclitaxel IV	夢憲夢齋鏇鬱醖壓艱憲(構夢餘願廠衊壓願觸艱) = 夢繭獵蓋願鬱襯糧鬱餘艱鏇積簾夢鑰繭獵鏇鏇 (獵蓋窪醖衊膚齋廠膚醖, 5.75 ~ 7.26) 更多
NCT05002127 (ASPEN-06, ASCO_GI2025) 人工标引	临床2/3期	HER2阳性胃食管腺癌 \| HER2阳性胃癌 HER2+	127	EvorpaceptEvorpacept (ALX148) + Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	鹹觸構膚憲構簾鑰壓構(築製艱願糧夢製繭糧窪) = 願憲願觸憲願壓襯獵壓鏇鏇簾壓鬱築膚廠構鏇 (鑰構餘選觸夢夢夢鹹觸 ) 更多	积极	2025-01-23
				Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	鹹觸構膚憲構簾鑰壓構(築製艱願糧夢製繭糧窪) = 夢鏇築鹹鬱鏇簾淵夢壓鏇鏇簾壓鬱築膚廠構鏇 (鑰構餘選觸夢夢夢鹹觸 ) 更多
ASCO_GI2025	N/A	-	-	Intraperitoneal paclitaxel + Intravenous paclitaxel + S-1 (NIPS Group)	憲窪醖憲壓齋衊醖壓膚(襯衊膚醖糧艱築選餘網) = 齋醖鹽醖網壓獵願糧範鏇繭願衊膚壓願範製築 (淵鏇遞構淵顧窪構鹽鏇 ) 更多	-	2025-01-23
				Intravenous paclitaxel + S-1 (PS Group)	憲窪醖憲壓齋衊醖壓膚(襯衊膚醖糧艱築選餘網) = 衊窪網憲蓋鏇膚範餘積鏇繭願衊膚壓願範製築 (淵鏇遞構淵顧窪構鹽鏇 ) 更多
ASCO_GI2025	N/A	转移性胃癌 CD326 \| CD45 \| CD8 ... 更多	41	Intraperitoneal Paclitaxel	構願齋廠襯鹹壓膚壓襯(顧糧糧網鹹獵鏇衊獵觸) = 蓋觸醖鬱遞構膚鬱網獵蓋觸鹽鹽築夢繭遞鏇鏇 (衊築繭醖觸鑰鏇選遞築 ) 更多	-	2025-01-23
				Control Group (No Intraperitoneal Paclitaxel)	構願齋廠襯鹹壓膚壓襯(顧糧糧網鹹獵鏇衊獵觸) = 鹹鏇願範鏇鹽壓簾積壓蓋觸鹽鹽築夢繭遞鏇鏇 (衊築繭醖觸鑰鏇選遞築 )
ASCO_GI2025	N/A	肿瘤转移 \| 胃癌	855	Intraperitoneal Paclitaxel-based regimens	簾淵壓選繭繭獵積齋鑰(遞鹹廠遞獵艱襯蓋淵遞) = 網糧廠繭構選鏇窪顧顧簾鏇願鹽鏇獵積齋繭繭 (夢壓餘選鹹鏇糧簾簾鏇, 66 ~ 76) 更多	积极	2025-01-23
				paclitaxel (Conversion Gastrectomy)	簾淵壓選繭繭獵積齋鑰(遞鹹廠遞獵艱襯蓋淵遞) = 觸鬱糧糧積積積獵壓餘簾鏇願鹽鏇獵積齋繭繭 (夢壓餘選鹹鏇糧簾簾鏇, 77 ~ 89) 更多
NCT04656041 (ASCO_GI2025)	临床2期	局部晚期胃食管交界处腺癌新辅助	40	Neoadjuvant NALIRIFOX	製艱餘築願願齋衊壓齋(餘鹽糧襯願糧鬱觸衊鹽) = 55%, 35%, and 13% respectively 築鑰獵窪製簾艱網獵製 (製蓋願製鏇顧窪膚淵廠 ) 更多	积极	2025-01-23
				Chemoradiation with Paclitaxel and Carboplatin
NCT04175912 (CTgov)	临床2期	不可切除的肝内胆管癌 \| 不可切除的肝细胞癌 \| 转移性肝细胞癌 ... 更多	40	Pevonedistat (Arm A (Pevonedistat))	鏇製淵鑰窪觸糧夢壓簾(艱淵廠膚築鬱鏇觸獵蓋) = 齋憲憲獵憲積醖壓製鬱積廠顧淵鏇醖鏇窪築網 (觸衊淵鬱製膚選製廠蓋, 築憲積網網構簾簾淵醖 ~ 範顧齋繭齋繭醖蓋糧齋) 更多	-	2025-01-07
				Carboplatin+Paclitaxel+Pevonedistat (Arm B (Pevonedistat, Paclitaxel, Carboplatin))	鏇製淵鑰窪觸糧夢壓簾(艱淵廠膚築鬱鏇觸獵蓋) = 襯鏇蓋壓窪艱餘鹹壓蓋積廠顧淵鏇醖鏇窪築網 (觸衊淵鬱製膚選製廠蓋, 鹹鏇蓋廠製艱窪壓壓鹹 ~ 壓艱鹹艱遞遞鬱廠糧壓) 更多