戈沙妥组单抗(Sacituzumab govitecan-hziy) - 药物靶点：TOP1 x Trop-2_在研适应症：转移性三阴性乳腺癌，乳腺癌，HR阳性/HER2阴性乳腺癌_专利_临床

概要

基本信息

药物类型

ADC

别名

hRS7-SN38 antibody drug conjugate、Isactuzumab govitecan、Sacituzumab Govitecan

+ [9]

靶点

TOP1 x Trop-2

作用机制

TOP1抑制剂(DNA拓扑异构酶I抑制剂)、Trop-2抑制剂(肿瘤相关钙信号传感器2抑制剂)

治疗领域

肿瘤皮肤和肌肉骨骼疾病呼吸系统疾病+ [7]

在研适应症

转移性三阴性乳腺癌乳腺癌HR阳性/HER2阴性乳腺癌+ [55]

非在研适应症

食管癌多形性胶质母细胞瘤肝细胞癌+ [5]

原研机构

Immunomedics, Inc.

在研机构

BSP Pharmaceuticals SpA

Gilead Sciences, Inc.

GBG Forschungs GmbH

+ [14]

非在研机构

Everest Medicines II Ltd.

最高研发阶段批准上市

首次获批日期

美国 (2020-04-22),

三阴性乳腺癌

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、优先审评 (中国)、附条件批准 (中国)、孤儿药 (韩国)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、快速通道 (韩国)、优先审评 (中国台湾)、优先审评 (美国)

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结构

使用我们的XDC技术数据为新药研发加速。

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序列信息

Sequence Code 27958L

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Sequence Code 319372635H

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关联

94

项与戈沙妥组单抗相关的临床试验

NCT06524544 / Not yet recruiting临床3期IIT

A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitecan vs Sacituzumab Govitecan Alone in Anti-PD(L)1-Resistant Advanced Urothelial Cancer

This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitecan to sacituzumab govitecan alone in treating patients with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitecan. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitecan to kill them. Giving pembrolizumab and sacituzumab govitecan may be more effective than sacituzumab govitecan alone in treating patients with locally advanced or metastatic urothelial cancer.

开始日期2025-02-06

申办/合作机构

National Cancer Institute

NCT06612203 / Not yet recruiting临床1/2期

Phase Ib/II Study to Evaluate Safety and Preliminary Efficacy of the Wee1 Inhibitor Debio 0123 in Combination With Sacituzumab Govitecan in Triple-negative or HR+/HER2- Advanced/ Metastatic Breast Cancer

The WIN-B is an international, multicenter, single-arm, phase Ib/II study to evaluate the safety and activity of the Debio 0123 and Sacituzumab govitecan combination therapy in patients with pre-treated advanced/metastatic TNBC or HR+/HER2- breast cancer. Phase Ib will explore if the addition of increasing doses of Debio 0123 to Sacituzumab govitecan is safe and active in pre-treated advanced/metastatic TNBC and HR+/HER2- breast cancer patients. The Debio 0123's recomendad phase 2 doses (RP2D) obtained during phase Ib will then be administered in combination with Sacituzumab govitecan in phase II of the study.

开始日期2025-01-01

申办/合作机构

Medica Scientia Innovation Research SL

[+2]

NCT06528483 / Not yet recruiting临床2期IIT

Bladder Preservation With Sacituzumab Govitecan + Zimberelimab for Muscle-Invasive Bladder Cancer in Cisplatin-unfit and Unwilling for Cystectomy Patients: Phase II Trial

Patients with MIBC N0/N1 unwilling or unfit for cystectomy will receive SG + Zimberelimab for 3 cycles of treatment prior of first radiological and TURB re-evaluation.
Patients with stable disease or downstaging will continue Zimberelimab up to 1 year. The goal of this trial is to demonstate that Sacituzumab Govitecan + Zimberelimab can avoid cistectomy and can prolong or avoid recurrence to metastatic disease in selected patients with muscle-invasive bladder cancer.
The primary endpoint of this trial is Event Free Survival that is defined as clinical evidence of new or progressing nodal or any distant metastatic disease, radical cystectomy, or death due to any cause from date of inclusion to the first documentation of a EFS event.

开始日期2024-12-02

申办/合作机构

Fondazione Irccs Istituto Nazionale Dei Tumori

[+1]

100 项与戈沙妥组单抗相关的临床结果

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100 项与戈沙妥组单抗相关的转化医学

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100 项与戈沙妥组单抗相关的专利（医药）

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334

项与戈沙妥组单抗相关的文献（医药）

2024-12-01·BREAST

Unveiling the future of breast cancer therapy: Cutting-edge antibody-drug conjugate strategies and clinical outcomes

Review

作者: Wang, Kainan ; Jia, Xiaomeng ; Sun, Lu ; Li, Man

Breast cancer has become the most prevalent malignant tumor worldwide and remains one of the leading causes of cancer-related mortality among women globally. The prognosis for patients with metastatic breast cancer remains poor, necessitating the exploration of novel therapeutic strategies to improve survival rates. In the era of precision medicine, antibody-drug conjugates (ADCs) have gained significant attention as a targeted therapeutic strategy in breast cancer treatment. ADCs, a relatively new treatment for breast cancer, deliver cytotoxic drugs (payloads), directly into the tumor space, turning chemotherapy into a targeted agent, which enables patients to experience significant improvements with manageable drug toxicity. For the treatment of breast cancer, there are three ADCs approved for breast cancer treatment: Trastuzumab emtansine (T-DM1), Trastuzumab Deruxtecan (T-Dxd) targeting HER-2, and Sacituzumab Govitecan (SG) targeting Trop-2. Recent clinical studies have demonstrated that the benefits of ADC therapies extend beyond HER2-positive breast cancer toinclude hormone receptor (HR)-positive breast cancer, triple-negative breast cancer (TNBC), and HER2-low expressing breast cancer. Notably, the DESTINY-Breast series of studies, particularly focusing on T-Dxd, encompass neoadjuvant, adjuvant, and multiple lines of therapy for advanced breast cancer. This marks the advent of a comprehensive ADC era in breast cancer treatment. This review summarizes the efficacy and adverse effects of ADC therapies that have completed or are currently undergoing phase I-III clinical trials. Additionally, it analyzes potential combination strategies to overcome ADC resistance, aiming to provide clinicians with a comprehensive clinical guide to the use of ADCs in breast cancer treatment.

2024-11-07·AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY

Targeted and immunotherapy for the management of advanced urothelial carcinoma of the bladder

Review

作者: Cersosimo, Robert J

Abstract:

Purpose:

The activity of targeted and immunotherapy for the management of advanced bladder cancer is reviewed.

Summary:

Platinum-based chemotherapy is standard first-line treatment for advanced bladder cancer. Pembrolizumab is approved alone as first-line therapy for patients who are ineligible for any platinum-based chemotherapy and with enfortumab for patients ineligible for cisplatin-based chemotherapy. Avelumab is approved for maintenance therapy in patients who have not progressed with first-line platinum-containing therapy. Pembrolizumab, avelumab, and nivolumab are approved second-line therapy in patients who experience progression during or after platinum-containing chemotherapy. Erdafitinib is indicated for advanced disease that has susceptible FGFR2 or FGFR3 genetic alterations and has progressed during or after treatment with at least one line of platinum-containing chemotherapy. Enfortumab vedotin and sacituzumab govitecan are antibody-drug conjugates. They are both approved for patients who have received anti–PD-L1 or anti–PD-1 therapy and treatment with platinum-containing chemotherapy. Enfortumab is also indicated for patients who are ineligible to receive cisplatin-based therapy and have received one or more prior lines of therapy.

Conclusion:

Six targeted and immunotherapeutic agents have been approved for patients with advanced urothelial bladder cancer. They all have demonstrated activity in patients for whom disease has progressed during or after platinum-based therapy. Pembrolizumab, with and without enfortumab, has demonstrated first-line activity, and avelumab is a key maintenance therapy after first-line treatment. The results of additional clinical trials should provide evidence to establish the exact role in therapy of each agent in patients with advanced disease.

2024-11-04·ONCOLOGIST

Genomic, immunologic, and prognostic associations of TROP2 (TACSTD2) expression in solid tumors

Article

作者: Liu, Stephen V ; Algaze, Sandra ; Lopes, Gilberto ; El-Deiry, Wafik S ; Rodriguez, Estelamari ; Morgenstern-Kaplan, Dan ; Ma, Patrick C ; Seeber, Andreas ; Lou, Emil ; Antonarakis, Emmanuel S ; Lenz, Heinz-Josef ; Vanderwalde, Ari M ; Krause, Harris ; Hoon, Dave S B ; Tan, Heng ; Halmos, Balazs ; Trabolsi, Asaad ; Nagasaka, Misako ; Kareff, Samuel A ; Ribeiro, Jennifer R

Abstract:

Background:

TROP2 (TACSTD2) expression is associated with decreased overall survival (OS) in some solid tumors, and the TROP2-targeting antibody-drug conjugate (ADC) sacituzumab govitecan has been approved in breast and urothelial carcinomas. We aimed to explore the multi-omic landscape associated with TACSTD2 gene expression in various solid tumors to identify patients most likely to benefit from this approach.

Methods:

Breast (N = 11 246), colorectal (N = 15 425), hepatocellular (N = 433), pancreatic (N = 5488), and urothelial (N = 4125) tumors were stratified into quartiles by TACSTD2 gene expression, analyzed by next-generation DNA sequencing, whole transcriptome sequencing, and immunohistochemistry at Caris Life Sciences (Phoenix, AZ). Survival data were obtained from insurance claims, and Kaplan-Meier estimates were calculated for molecularly defined cohorts.

Results:

Several pathogenic mutations were associated with TACSTD2-high tumors, including TP53 in breast, colorectal (CRC), pancreatic, and hepatocellular cancers; KRAS in pancreatic and CRC cancers; ARID1A and FGFR3 in urothelial cancer; and CTNNB1 in hepatocellular cancer. TACSTD2-low breast tumors were enriched for copy number amplifications in CCND1 and FGF/R family member genes. TACSTD2 high was generally associated with more immune cell infiltration and greater T-cell inflammation scores. Patients with TACSTD2-high breast, CRC, and pancreatic cancers demonstrated a significantly shorter OS than TACSTD2-low tumors. This was restricted to CRC with microsatellite stable tumors and patients with pancreatic cancer with KRAS-mutant tumors. Patients with breast cancer with TACSTD2-high tumors also experienced significantly worse OS following immune checkpoint inhibitors.

Conclusions:

TACSTD2 expression is associated with key driver alterations and a more active immune microenvironment, suggesting possible combinatorial strategies with TROP2-targeting ADCs plus immunotherapy in various solid tumors.

958

项与戈沙妥组单抗相关的新闻（医药）

2024-11-14

·生物制药小编

Dato-dxd 肺癌“落定”，降维打击ADC赛道

过去几年，Enhertu和SG的崛起带动ADC投资热、研发热，Nectin4-ADC-EV302 OS翻倍成功再将ADC浪推向第二个高潮，紧跟着的，期望着的，其它ADC的突破。 2024年1月22日，吉利德宣布，Trop2 ADC新药Trodelvy用于二线非小细胞肺癌注册三期EVOKE-01未实现主要终点OS统计学显著性；2024年5月30日，吉利德宣布，Trodelvy再折戟UC二线注册III期TROPICS-04，未达主要终点OS。 2024年5月27日，阿斯利康宣布，Trop-2 ADC-Dato-Dxd用于二线非小细胞肺癌注册III期-TROPION-Lung01未实现主要终点OS统计学显著性，但表示非鳞癌亚组OS具有“临床获益”趋势，届时AZ已向FDA提交BLA，原计划PDUFA时间为2024年12月20日。2024年9月23日，阿斯利康宣布，Dato-Dxd用于HR阳性、HER2阴性BC后线注册III期未实现主要终点统计学显著性，需要强调的是，2项折戟的III期都曾先达PFS主要终点。 2024年9月17日，默沙东宣布，HER3 ADC-Patritumab Deruxtecan在经EGFR-TKI治疗失败NSCLC注册III期-HERTHENA-Lung02 达PFS主要终点（6月曾因第三方生产设施问题收到FDA CRL），本次分析时OS尚不成熟。 Dato-dxd肺癌的FDA的决策将影响一众ADC，至少是肺癌这个最大市场的发展，原计划要等到年底，但昨日阿斯利康Q3季度报，我们发现，经过和FDA沟通，公司已撤回非鳞癌二线NSCLC BLA，并基于TROPION-Lung01和TROPION-Lung05汇总分析提交新BLA：用于经EGFR-TKI失败人群，提示将与HER3 ADC-Patritumab Deruxtecan正面交锋。 Dato-Dxd OS折戟，关小猫咪什么事？Dato-Dxd OS再折戟，分析一众ADC 今年5月份三种猜测，FDA给了最坏的情况，所以是全球监管的金字招牌：人群进一步缩小至非鳞癌AGA人群且可能是AA加速审批（带确证III期在做）。当然也再次重申没有失败的药，只有失败的临床艾伯维精分重磅失败，BMS大涨：没有失败的药，只有失败的临床先锋部队ADC在NSCLC里终究是只卷进EGFR驱动基因阳性市场，至于更大的阴性市场，笔者认为晚期一线非常难，早期围术期可能还有机会。同时我们需要注意，前述注册III期届时赛道里TOP2，OS折戟大都还未遇到ADC后ADC情况，面对未来，我们还有多少信心？有多少ADC，有多少瘤肿，有多少适应症可以跑出来？ AZ代表的MNC肺癌策略回首提及：ADC本质是化疗，优势在于缩瘤，不能带来生存延长，最近折戟III期OS Echo当时想法，失败不可怕，反而应该思考谁才是下一个EV-302？哪些瘤肿、哪些适应症、哪些管线有机会？比如早期、TNBC、SCLC、PFS可以获批适应症。

临床3期抗体药物偶联物临床结果

2024-11-13

·ioncology

观点 · 指南塑标准丨樊英教授深度解读2024版ABCC指南，CDK4/6i后时代卡匹色替带来“中国答案”

编者按：随着CDK4/6抑制剂（CDK4/6i）成为HR+/HER2-晚期乳腺癌治疗标准，对于CDK4/6i进展后的治疗优化已成为临床讨论的焦点。在近日举行的2024年乳腺癌规范诊疗与质量控制大会上，中国医学科学院肿瘤医院樊英教授对《中国晚期乳腺癌规范诊疗指南（20204版）》进行解读，并在接受《肿瘤瞭望》的采访中，进一步介绍HR+/HER2-晚期乳腺癌的更新要点。 01 《肿瘤瞭望》：本届大会上，您对新发布的《中国晚期乳腺癌规范诊疗指南（20204版）》（ABCC 2024）进行了解读。作为执笔人，请您重点谈谈指南对晚期HR+/HER2-乳腺癌的治疗领域有哪些重要更新？樊英教授：近年来，HR+/HER2-乳腺癌领域取得了诸多进展。因此，在本次ABCC指南中，针对这一部分的更新内容颇为丰富。首先，指南在生物标记物检测方面进行了重要更新。随着新型靶向药物和内分泌治疗药物的涌现，对生物标记物检测的指导提出了更多新的要求。因此，在ABCC指南中，我们强调了对于HR+/HER2-晚期乳腺癌患者，在药物和检测条件允许的情况下，医生应在HR+患者发现转移或进展的同时尽可能、尽早对患者进行包括PIK3CA/AKT1/PTEN通路等靶点在内的生物标记物检测，以指导后续治疗。其次，指南还更新了治疗药物推荐和循证医学证据。在一线治疗方面，CDK4/6抑制剂（CDK4/6i）联合内分泌治疗依然是标准方案，对于原发内分泌耐药患者，我们推荐优先选择CDK4/6i联合氟维司群；若患者存在PIK3CA突变，且为辅助内分泌治疗中进展或完成辅助内分泌治疗12个月内进展的患者，则可根据INAVO120研究结果，在CDK4/6i基础上加用PI3K抑制剂（PI3Ki）Inavolisib，该药物已在美国获批上市，期待在中国早日可及。对于CDK4/6i进展后的二线及后线治疗中，指南也进行了更新。根据CAPItello-291研究结果，内分泌治疗联合卡匹色替可显著延长患者PFS。FDA已批准该药物用于携带PIK3CA/AKT/PTEN任意一种变异的患者。因此，在新版的ABCC指南中，我们也推荐携带此类基因变异的CDK4/6i经治患者选择卡匹色替；并且作为未经CDK4/6i治疗患者二线及后线治疗的可选方案，因为该药物即将在中国上市。除了靶向治疗以外，指南对二线或后线治疗的其他新型药物选择进行了更新。例如，根据DB-04、DB-06、TROPiCS-02等研究结果，T-DXd和戈沙妥珠单抗已成为CDK4/6抑制剂进展后的后线治疗选择。特别是T-DXd，最新的DB-06研究结果进一步支持其治疗HR+/HER2低表达或超低表达且未接受过化疗的患者。此外，Dato ADC的III期临床研究显示有一定程度的获益，由于这些药物在中国尚未上市，因此我们仅将其作为可选的治疗推荐。最后，值得一提的是，在内分泌治疗方面也有新的成果。例如，艾拉司群（Elacestrant）在CDK4/6i进展且伴有ESR1突变的患者中，其单药使用效果优于传统内分泌治疗。同样地，由于药物尚未在中国上市，我们也将其作为可选的治疗推荐。综上所述，本次ABCC指南在HR+/HER2-晚期乳腺癌方面进行了全面的更新，为临床医生提供了更为详细和实用的指导。 △2024版ABCC指南HR+/HER2-晚期乳腺癌治疗推荐 02 《肿瘤瞭望》：在晚期HR+/HER2-乳腺癌后CDK4/6i时代的用药策略中，PIK3CA/AKT1/PTEN通路抑制剂的地位是怎样的？您对卡匹色替的作用机制及临床应用有何评价？樊英教授：PIK3CA/AKT1/PTEN通路是肿瘤生长、增殖和转移的重要信号通路，与内分泌治疗耐药密切相关。CDK4/6i广泛使用后，部分患者会出现该通路异常活化，导致对CDK4/6i和内分泌治疗耐药。因此，抑制这条通路对于逆转CDK4/6i和内分泌耐药至关重要。在HR+/HER2-晚期乳腺癌中，PIK3CA/AKT1/PTEN通路异常的发生率较高，中国患者中的发生率约为60%乃至更高。既往研究表明，mTOR抑制剂依维莫司可通过抑制该通路的mTOR靶点而逆转内分泌耐药，提高疗效，是首个获批的内分泌加靶向治疗药物。目前，针对该通路又有许多新药取得进展，如抑制PIK3CA突变的Inavolisib以及抑制PIK3CA/AKT1/PTEN多靶点突变的卡匹色替等。以卡匹色替为例，其主要作用机制是抑制PIK3CA/AKT1/PTEN通路中游的关键靶点AKT的异常活化，针对PIK3CA/AKT1/PTEN任何一种变异的患者均有效，覆盖人群更加广泛，能够使更多患者获益于此类靶向治疗；而且国际多中心III期CAPItello-291研究已经证实了卡匹色替的治疗获益，该研究入组人群有大约70%为CDK4/6i经治患者。因此，未来卡匹色替有望在CDK4/6i经治患者的治疗推荐中扮演重要角色。 △III期CAPItello-291研究设计及结果 03 《肿瘤瞭望》：未来，您对《中国晚期乳腺癌规范诊疗指南（20204版）》的落地与实践有怎样的规划？对后CDK4/6i时代HR+/HER2-晚期乳腺癌的治疗水平提升有哪些期待？樊英教授：ABCC指南的特色在于其内容的丰富性，针对每个临床研究、不同场景、各种分子分型的乳腺癌患者，均提供了详尽的治疗推荐与循证医学证据。2024版ABCC指南发布后，我们将加大推广与巡讲力度，确保中国乳腺癌医生能更好地运用指南来指导临床工作。针对CDK4/6i治疗后进展的HR+/HER2-晚期乳腺癌，我们需从以下方面推动诊疗水平的提升：一是强化分子标志物检测的理念。首要任务是提升医生的检测意识，让他们认识到基因检测对精准治疗与用药的重要性。若医生未意识到检测的重要性，则无法为患者提供规范化的诊疗建议。二是提高基因检测的可及性。由于基因检测门槛较高，一些地方医院可能无法开展。因此，我们需在各级医院推广规范化基因检测，确保检测结果的可靠性，从而更好地指导临床工作。三是优化治疗选择。CDK4/6i经治患者有多种治疗选择，包括内分泌加靶向、新型ADC药物、传统化疗及新型内分泌药物等。面对众多选择，临床医生可能感到困惑。因此，我们将通过临床实践病例讨论、临床研究及指南推广等方式，帮助医生更好地选择药物，为患者提供最佳治疗方案。四是探索更多新药及联合治疗。尽管现有治疗选择已相当丰富，但在CDK4/6i经治患者中，除ADC、PIK3CA/AKT1/PTEN通路抑制剂等药物外，其他药物疗效仍有待提高。因此，我们需要研发更多新靶点药物、新作用机制药物，或探索新药组合，以进一步提高患者疗效。樊英教授中国医学科学院肿瘤医院内科乳腺病区主任主任医师硕导协和医科大学八年制博士 2008-2009年英国Royal Marsden医院/ICR访问学者中国医药教育协会临床科研创新发展专业委员会副主任委员秘书长北京乳腺病防治学会青年专委会副主任委员北京肿瘤防治研究会青委会副主任委员北京慢性病防治与健康教育研究会乳腺肿瘤专业委员会副主任委员北京整合医学会中枢神经系统转移瘤多学科整合专委会副主任委员更多精彩内容，请扫码关注“观点”专栏（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。

上市批准

2024-11-08

·BioPharmaDive

Tezspire succeeds in chronic rhinosinusitis; Gilead writes down Trodelvy value

Today, a brief rundown of news from AstraZeneca, Amgen and Jazz Pharmaceuticals, as well as updates from Geron, Gilead Sciences and Avid Bioservices that you may have missed.AstraZeneca and Amgens drug Tezspire reduced nasal congestion and the size of nasal polyps versus placebo in a Phase 3 trial involving people with a form of chronic rhinosinusitis, the companies said Friday. The results, which AstraZeneca and Amgen plan to present at an upcoming medical meeting, could help the two partners expand approval of Tezspire, which is currently cleared for asthma in the U.S. and five dozen other countries. Tezspire could also compete in the future with depemokimab, a drug from GSK that recently succeeded in two Phase 3 studies of people with the same condition. Ned PagliaruloJazz Pharmaceuticals plans to, in the first half of next year, start an early-stage study evaluating an experimental treatment for narcolepsy. Researchers recently tested the drug, called JZP441, in a different Phase 1 clinical trial, but Jazz paused the experiment due to reports of visual disturbances and cardiovascular effects. The drug is designed to target “orexins,“ a class of proteins that regulate important brain activity like wakefulness, arousal, hunger and even mood. On an earnings call Wednesday, Jazz's head of research and development, Robert Iannone, told investors that the new study will not only help the company decide whether to advance JZP441, but also “inform our backup programs. Jacob BellGeron has secured $250 million in funding, and potentially as much as $375 million overall, through agreements with Royalty Pharma and funds managed by Pharmakon Advisors. In the first deal, Geron has sold tiered royalty rights on U.S. net sales of Rytelo, its newly approved drug for anemia in people with myelofibrosis, in exchange for $125 million. The company also secured a 5-year senior secured term loan of up to $250 million from the Pharmakon-associated funds, half of which it has already drawn. Some of the funds have been used to repay loans Geron owed to Hercules Capital and Silicon Valley Bank. The rest will help Geron launch Rytelo and complete further testing of the drug. Ned PagliaruloVenture firm Aditum Bio and China-based Leads Biolabs have formed a new company to develop a tri-specific T cell engager for autoimmune diseases. The new company, dubbed Oblenio Bio, will launch with an exclusive option to develop the drug globally, in exchange for paying Leads $35 million in upfront and near-term fees. Leads will also take an equity stake in Oblenio, the 13th company spun out by Aditum. Ned PagliaruloGilead Sciences will no longer develop its antibody-drug conjugate Trodelvy in second-line non-small cell lung cancer, CEO Daniel ODay told investors Wednesday on an earnings call. The decision followed discussions with regulators after negative results from a lung cancer study earlier this year. As a result, Gilead will take a $1.8 billion write down in the value it ascribes to its in-process R&D. The company continues to develop Trodelvy, which is currently approved for certain kinds of breast tumors, in first-line lung cancer. Ned PagliaruloContract drugmaker Avid Bioservices will be taken private by GHO Capital Partners and Ampersand Capital Partners in a deal worth roughly $1.1 billion. The two investors will pay $12.50 per Avid share, a nearly 14% premium on the stocks closing price Wednesday. The deal comes the same week Ampersand paid $70 million in cash to buy a Nektar Therapeutics drug factory, and follows a pattern of contract development and manufacturing organizations being taken private in recent years. Ned Pagliarulo '

临床3期临床1期抗体药物偶联物上市批准临床2期

100 项与戈沙妥组单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	戈沙妥组单抗	L01	DB12893

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
转移性三阴性乳腺癌	欧盟	Gilead Sciences Ireland UC	2021-11-22
转移性三阴性乳腺癌	冰岛	Gilead Sciences Ireland UC	2021-11-22
转移性三阴性乳腺癌	列支敦士登	Gilead Sciences Ireland UC	2021-11-22
转移性三阴性乳腺癌	挪威	Gilead Sciences Ireland UC	2021-11-22
乳腺癌	瑞士	Gilead Sciences, Inc.	2021-09-09
HR阳性/HER2阴性乳腺癌	澳大利亚	Gilead Sciences Pty Ltd.	2021-09-06
尿路上皮癌	美国	Gilead Sciences, Inc.	2021-04-13
三阴性乳腺癌	美国	Gilead Sciences, Inc.	2020-04-22

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
转移性乳腺癌	申请上市	中国	云顶药业（苏州）有限公司	2021-05-17
子宫内膜癌	临床3期	美国	BSP Pharmaceuticals SpA	2024-08-28
子宫内膜癌	临床3期	美国	Gilead Sciences, Inc.	2024-08-28
子宫内膜癌	临床3期	中国	BSP Pharmaceuticals SpA	2024-08-28
子宫内膜癌	临床3期	中国	Gilead Sciences, Inc.	2024-08-28
子宫内膜癌	临床3期	日本	Gilead Sciences, Inc.	2024-08-28
子宫内膜癌	临床3期	日本	BSP Pharmaceuticals SpA	2024-08-28
子宫内膜癌	临床3期	澳大利亚	BSP Pharmaceuticals SpA	2024-08-28
子宫内膜癌	临床3期	澳大利亚	Gilead Sciences, Inc.	2024-08-28
子宫内膜癌	临床3期	巴西	Gilead Sciences, Inc.	2024-08-28

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临床结果

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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


NCT04639986 (EVER-132-002, Pubmed \| Nat Med) 人工标引	临床3期	转移性乳腺癌 HER2 Negative \| Hormone Receptor Positive	-	Sacituzumab govitecan (Asian patients)	構簾願艱壓觸夢夢願顧(獵蓋鏇鏇鑰構積餘簾夢) = 積觸鹽鏇壓鬱觸醖齋襯蓋壓蓋餘廠顧顧壓襯範 (築構齋繭齋夢觸膚鹽鏇 ) 达到更多	积极	2024-10-01
				Chemotherapy (Asian patients)	構簾願艱壓觸夢夢願顧(獵蓋鏇鏇鑰構積餘簾夢) = 鏇餘膚簾構鬱遞憲獵獵蓋壓蓋餘廠顧顧壓襯範 (築構齋繭齋夢觸膚鹽鏇 ) 达到更多
NCT05101096 (ASCENT-J02, Pubmed \| Int J Clin Oncol) 人工标引	临床1/2期	晚期恶性实体瘤二线	51	Sacituzumab govitecan (Phase 1; intravenous SG 6 mg/kg, escalating to 10 mg/kg)	醖鏇膚願鹽壓繭艱繭襯(壓衊顧淵廠憲餘網築憲) = 積鹹築壓構鏇鏇壓築選憲廠淵簾鑰壓艱淵簾夢 (製餘艱顧壓醖範糧鹽製 ) 更多	积极	2024-09-20
				Sacituzumab govitecan (phase 2; 10 mg/kg)	網膚願築製選衊壓糧醖(積艱願築憲艱夢獵獵餘) = 齋鏇窪艱簾蓋餘網繭膚糧壓壓鹽餘繭顧鏇範蓋 (獵淵蓋遞選鏇積鬱壓糧, 12.1 ~ 42.2) 更多
SARELIFE (ESMO2024) 人工标引	N/A	三阴性乳腺癌 ER Negative \| PR Negative \| HER2 Negative	91	Sacituzumab govitecan (SG)	選蓋鏇繭壓艱鬱鬱廠憲(選積夢餘願衊願壓壓膚) = 蓋觸鏇衊範築網襯範簾蓋築繭繭築齋觸獵簾積 (製築壓艱艱構襯鬱壓鏇 ) 更多	积极	2024-09-16
NCT02574455 (ASCENT, ESMO2024) 人工标引	临床3期	转移性三阴性乳腺癌二线 ER Negative \| HER2 Negative \| PR Negative	-	Sacituzumab govitecan (SG)	衊鑰獵淵蓋顧顧廠積築(淵觸網積積鹽遞範觸蓋) = 憲鹽製範製鹽齋築糧糧餘獵網艱憲願遞艱鑰窪 (簾餘鏇憲醖鬱艱範顧鹽, 7.6 ~ 9.1)	积极	2024-09-16
				Chemotherapy treatment of physician’s choice (TPC)	衊鑰獵淵蓋顧顧廠積築(淵觸網積積鹽遞範觸蓋) = 範醖遞鑰夢蓋獵繭願糧餘獵網艱憲願遞艱鑰窪 (簾餘鏇憲醖鬱艱範顧鹽, 4.3 ~ 5.4)
ESMO2024	N/A	转移性乳腺癌 HER2-negative \| triple-negative \| hormone receptor-positive ... 更多	184	sacituzumab govitecan (Triple-negative breast cancer (TNBC))	壓積夢糧醖廠範膚夢願(鑰鏇選膚膚獵繭襯觸廠) = 簾齋廠壓夢繭願獵顧獵範簾餘獵遞範蓋簾顧遞 (襯築鹽蓋願廠壓憲積簾, 8.0 ~ 13.3) 更多	不佳	2024-09-16
				sacituzumab govitecan (Hormone receptor-positive breast cancer (HR+ BC))	壓積夢糧醖廠範膚夢願(鑰鏇選膚膚獵繭襯觸廠) = 顧夢築鹽觸醖憲壓簾壓範簾餘獵遞範蓋簾顧遞 (襯築鹽蓋願廠壓憲積簾, 7.0 ~ 12.6) 更多
NCT03725761 (ESMO2024) 人工标引	临床2期	转移性去势抵抗性前列腺癌	30	Sacituzumab govitecan (SG) + ARSI	選鬱積鏇醖遞鏇蓋憲蓋(願鏇餘遞遞選觸鬱淵製) = No PSA50 responses were observed with single agent SG. SG and ARSI: 2/3 pts had a PSA50 response by week 9 and continued on treatment past 6 months. 構膚廠網鹹壓鬱衊窪觸 (範網壓願蓋製夢願鏇願 ) 更多	积极	2024-09-15
				Sacituzumab govitecan (SG)
NCT04863885 (ESMO2024) 人工标引	临床1/2期	转移性尿路上皮癌一线	25	Ipilimumab+ Nivolumab+ Sacituzumab govitecan	蓋鏇範製壓廠窪積窪衊(襯築鏇廠夢膚夢艱糧廠) = 鏇構鹽蓋壓糧鹽繭壓淵淵憲衊齋鑰膚壓襯衊衊 (範積積廠構遞憲鹽糧糧, 63.56 ~ 98.5) 更多	不佳	2024-09-15
NCT04724018 (ESMO2024) 人工标引	临床1期	转移性尿路上皮癌二线	24	Sacituzumab govitecan (SG) 8 mg/kg + enfortumab vedotin (EV) 1 mg/kg	網鹹遞築窪蓋鏇醖餘遞(齋獵窪遞齋糧餘鏇積鑰) = There were no new safety signals or unexpected delayed toxicities. 顧壓顧鹹顧繭鏇願憲積 (餘壓艱願衊顧築獵醖遞 )	积极	2024-09-15
				Sacituzumab govitecan (SG) 8 mg/kg + enfortumab vedotin (EV) 1.25 mg/kg
NCT03964727 (TROPiCS-03, ESMO2024) 人工标引	临床2期	子宫内膜癌 MSI-High	41	Sacituzumab govitecan 10 mg/kg	憲觸製壓遞鏇淵壓衊淵(廠鏇淵夢齋鏇願廠夢醖) = 廠襯壓網範網選夢範衊鬱襯衊製鏇積網淵餘積 (鏇鹽餘鹽糧餘憲網憲淵, 14 ~ 43) 更多	积极	2024-09-14
NCT05089734 (EVOKE-01, WCLC2024) 人工标引	临床3期	转移性非小细胞肺癌	-	Sacituzumab Govitecan (In the non-responsive subgroup)	願獵築網淵壓鑰夢觸膚(壓構艱構廠艱繭蓋憲鹹) = 範簾艱蓋醖衊構淵製夢繭網獵顧構鬱窪窪壓遞 (醖壓衊壓構蓋艱鑰遞製 )	积极	2024-09-09
				Docetaxel (In the non-responsive subgroup)	願獵築網淵壓鑰夢觸膚(壓構艱構廠艱繭蓋憲鹹) = 壓觸構遞窪願窪艱窪襯繭網獵顧構鬱窪窪壓遞 (醖壓衊壓構蓋艱鑰遞製 )