A Multicenter, Open-label, Single-arm, Phase II Clinical Trial to Evaluate the Preventive Effect of Pegylated G-CSF (PG) on Neutropenia in Patients With Metastatic Triple-negative Breast Cancer (mTNBC) Receiving Sacituzumab Govitecan (SG)

Prevention of Sacituzumab Govitecan-related Neutropenia in Patients with metastatic Triple Nagative Breast Cancer who have received at least one, and no more than two, prior standard of care chemotherapy regimens

开始日期2025-01-31

申办/合作机构

Samsung Medical Center

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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364

项与戈沙妥组单抗相关的文献（医药）

2025-12-01·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

作者: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

2025-02-01·BREAST

Safety profile of sacituzumab govitecan in patients with breast cancer: A systematic review and meta-analysis

Review

作者: Vilbert, Maysa ; Michelon, Isabella ; Ravani, Lis Victória ; Ernesto do Rego Castro, Caio ; Rossato de Almeida, Guilherme ; Dacoregio, Maria Inez ; Barros Costa, Ricardo Lima ; Cezar Aquino de Moraes, Francisco

BACKGROUND:

Sacituzumab Govitecan (SG), a first-in-class anti-trophoblast cell surface antigen-2-directed antibody-drug conjugate (ADC), has shown clinically meaningful improvement in outcomes of patients with breast cancer (BC). However, it has also been accompanied by significant toxicity. Thus, we conducted a systematic review and meta-analysis to evaluate the safety and tolerability of SG in this patient population.

METHODS:

We comprehensively searched PubMed, Embase, and Cochrane databases, and ASCO and ESMO websites for clinical trials (CTs) assessing the safety of SG in BC patients. All analyses were performed in R software (v.4.2.2) using random effects models. Heterogeneity was assessed using I² test.

RESULTS:

Seven studies - three randomized clinical trials (RCTs) and four single-arm phase I/II - were included, comprising 928 patients receiving SG and 576 on treatment of physician's choice (TPC). Most patients had triple negative BC (54.4 %, n = 505), metastatic disease (89.8 %, n = 833), and were heavily pretreated (at least two lines of prior therapy). Most common all-grade adverse events (AEs) were: neutropenia (70 %, 95 % CI, 64-76 %), followed by nausea (62 %, 95 % CI, 55-68 %), diarrhea (54 %, 95 % CI 47-60 %) and anemia (51 %, 95 % CI, 38-65 %). Regarding high-grade AEs, 46 % of patients developed grade ≥3 neutropenia. Compared to TPC, we observed a higher risk of neutropenia (OR 3.11, 95 % CI 1.62-5.99, I² = 81 %; p < 0.001), diarrhea (OR 6.82, 95 % CI 3.99-11.66, I² = 64 %; p < 0.001) and anemia (OR 2.26, 95 % CI 1.20-4.27, I² = 78 %; p = 0.012) for those on SG. Dose reductions and treatment discontinuation were reported in 22 % and 4 % of patients, respectively, and 19 deaths (2 %) were documented. Most of them were not deemed to be treated-related.

CONCLUSION:

This systematic review and meta-analysis provides extensive data on the safety and management of SG toxicity in BC patients across clinical trials. Concerning rates of neutropenia, nausea diarrhea, and anemia were reported. We highlight the need for protocols establishing prophylactic measures and strategies to mitigate SG-related toxicity.

2024-12-02·MOLECULAR PHARMACEUTICS

Trop2-Targeted Molecular Imaging in Solid Tumors: Current Advances and Future Outlook

Review

作者: Saladin, Rachel J. ; Kang, Lei ; Hsu, Jessica C. ; Huang, Wenpeng ; Cai, Weibo ; Liu, Yongshun

Trophoblast cell surface antigen 2 (Trop2), a transmembrane glycoprotein, plays a dual role in physiological and pathological processes. In healthy tissues, Trop2 facilitates development and orchestrates intracellular calcium signaling. However, its overexpression in numerous solid tumors shifts its function toward driving cell proliferation and metastasis, thus leading to a poor prognosis. The clinical relevance of Trop2 is underscored by its utility as both a biomarker for diagnostic imaging and a target for therapy. Notably, the U.S. Food and Drug Administration (FDA) has approved sacituzumab govitecan (SG), a novel Trop2-targeted agent, for treating triple-negative breast cancer (TNBC) and refractory urothelial cancer, highlighting the significance of Trop2 in clinical oncology. Molecular imaging, a powerful tool for visualizing and quantifying biological phenomena at the molecular and cellular levels, has emerged as a critical technique for studying Trop2. This approach encompasses various modalities, including optical imaging, positron emission tomography (PET), single photon emission computed tomography (SPECT), and targeted antibodies labeled with radioactive isotopes. Incorporating Trop2-targeted molecular imaging into clinical practice is vital for the early detection, prognostic assessment, and treatment planning of a broad spectrum of solid tumors. Our review captures the latest progress in Trop2-targeted molecular imaging, focusing on both diagnostic and therapeutic applications across diverse tumor types, including lung, breast, gastric, pancreatic, prostate, and cervical cancers, as well as salivary gland carcinomas. We critically evaluate the current state by examining the relevant applications, diagnostic accuracy, therapeutic efficacy, and inherent limitations. Finally, we analyze the challenges impeding widespread clinical application and offer insights into strategies for advancing the field, thereby guiding future research endeavors.

1,019

项与戈沙妥组单抗相关的新闻（医药）

2024-12-20

·癌度

《癌度早报2024年12月20日》

一、新药快讯 1、恩沙替尼在美国上市获批，中国原研药物走向国际 2024年12月19日，靶向ALK融合基因突变非小细胞肺癌的第二代靶向药恩沙替尼，获得美国食品药品监督管理局正式批准，恩沙替尼在美国上市申请于2024年3月12日获得受理，获批的依据是基于一项全球三期临床试验，恩沙替尼治疗ALK突变肺癌的中位无进展生存时间为31.3个月，脑部病灶治疗缓解率达到了63.6%，是对照组克唑替尼的3倍。 2、贝莫苏拜单抗联合安罗替尼申报新适应症 2024年12月19日，国产抗癌药贝莫苏拜单抗联合安罗替尼提交新适应症上市申请，用于治疗晚期腺泡状软组织肉瘤，在今年的美国临床肿瘤学年会上，一项临床试验入组了29名患者，28名患者可评估治疗效果，治疗应答率达到了79.3%，其中3名患者可评估肿瘤病灶完全消失，20名患者病灶缩小超过30%，中位无进展生存时间尚未达到。 3、戈沙妥珠单抗临床试验数据表现非凡，83.7%患者病情得到控制近日，美国食品药品监督管理局FDA授予抗体偶联药戈沙妥珠单抗突破性疗法资格，适用于治疗铂类化疗后病情进展的晚期小细胞肺癌，基于一项二期临床试验结果，43名患者中的18名患者肿瘤病灶显著缩小，也就是对超过40%的晚期小细胞肺癌有较好的治疗效果，超过80%的患者在二线治疗使用戈沙妥珠单抗能获得病情控制，平均肿瘤控制时间为4.7个月。二、新药快讯 1、HER2阳性乳腺癌脑转移预防专家共识公布 HER2阳性乳腺癌出现脑转移的概率在30%到55%，显著影响患者的生存期，近日通过专家最终投票达成了34条共识，囊括脑转移一级和二级预防的定义、筛查流程、症状和治疗疗效评估以及预防脑转移的发生和进展，为临床实践中HER2阳性乳腺癌脑转移的预防提供参考。

突破性疗法临床2期快速通道临床3期上市批准

2024-12-19

·ioncology

SABCS 2024丨如何做好“精”和“序”的文章？王晓稼教授解读DB-03生物标志物分析及T-DXd真实世界研究

编者按：新型抗体偶联药物（ADC）T-DXd的乳腺癌“命运交响曲”（DESTINY-Breast）系列研究已取得许多具有里程碑意义的突破进展，如DB-03研究树立HER2+晚期乳腺癌二线治疗新标准，DB-04和DB-06研究拓展了HER2低表达和超低表达的ADC治疗。在近日举行的2024年圣安东尼奥国际乳腺癌研讨会（SABCS 2024）上，DB-03研究首次公布了生物标志物探索分析，T-DXd又有来自不同地区的真实世界研究披露。这些研究对HER2表达乳腺癌的治疗优化有怎样的启示呢？《肿瘤瞭望》特邀浙江省肿瘤医院王晓稼教授总结如下。精准施治有的放矢 DB-03研究生物标志物分析 2022年SABCS大会上更新的III期DESTINY-Breast03（DB-03）显示，T-DXd用于HER2+晚期乳腺癌二线治疗的PFS是T-DM1的4倍（28.8 vs 6.8个月，HR，0.33）[1]，今年ASCO大会公布的更长随访数据则显示T-DXd治疗的OS长达52.6个月，死亡风险降低27%（HR 0.73）[2]。目前，T-DXd已经成为国内外权威指南推荐的二线治疗优选方案。时隔2年，再次回到圣安东尼奥现场，DB-03研究首次公布了生物标志物的探索性分析[3]，可为HER2+ABC患者的精准治疗带来一些启示。这次基因组分析使用涵盖＞700个基因点的面板，检测样本则来自两组患者基线和疾病进展时的循环肿瘤DNA（ctDNA）。首先，研究检测到的突变与HER2+ABC常见突变大致相同，包括：TP53（73%）、HER2（ERBB2；61%）、CDK12（52%）和PIK3CA（48%）的单核苷酸变异、扩增和插入/缺失。以下是不同基因组状态的疗效分析。 HER2基因扩增两组患者的HER2基因拷贝（CN）高、低或未检测到（ND）的比例如下表所示。总体上，无论是HER2 CN高、低或ND，T-DXd均相较于T-DM1有更高的ORR和更长的PFS。在接受T-DXd治疗的患者中，HER2 CN高或低的患者ORR（87.1% vs 81.4%）和PFS（23.9 vs 21.1个月）相似，而ND患者的中位PFS长达37.3个月。当然，ctDNA检测HER2扩增水平不代表肿瘤的HER2蛋白表达水平，而是反映肿瘤MRD（最小残余疾病负荷）的指标。从这些数据可见，不同HER2扩增水平的患者均可从T-DXd治疗中获得一致的、较好的治疗效果，且均优于T-DM1。 △不同HER2扩增水平T-DXd和T-DM1治疗的ORR和PFS △不同HER2扩增水平T-DXd和T-DM1治疗的PFS K-M曲线 PI3K通路变异两组均有超过40%的患者检测到PI3K通路变异。无论是否检测到PI3K通路变异，T-DXd治疗的ORR和PFS均优于T-DM1。此外，在接受T-DXd治疗的患者中，PI3K通路变异和ND患者的ORR和PFS差异不大，表明PI3K通路变异对T-DXd的疗效几乎没有影响。TP3突变状态也表现如此。 △不同PI3K和TP53突变状态T-DXd和T-DM1治疗的ORR和PFS HRD和BRCA1/2状态两组均有超过11%的患者检测到同源重组修复缺陷（HRD）。无论是否检测到HRD，T-DXd治疗的ORR和PFS均数倍于T-DM1。在接受T-DXd治疗的患者中，HRD+和HRD-患者的ORR差异不大，但HRD+患者的PFS仅为HRD-患者的三分之一（12.4 vs 37.3个月）；T-DM1治疗患者也有相同趋势（2.8 vs 7.1个月），表明同时存在HER2+和HRD+的患者预后较差，单独接受ADC治疗的效果不佳。BRCA1/2突变状态也有类似表现。 △不同HRD状态和BRCA1/2突变T-DXd和T-DM1治疗的ORR和PFS △不同基因组状态T-DXd相较于T-DM1治疗的PFS森林图从上述生物标志物分析可见，T-DXd在不同基因组变异人群中的疗效均优于T-DM1，HER2基因扩增水平、PI3K突变与否对T-DXd疗效影响不大；而HRD+患者接受T-DXd或T-DM1的疗效均较差，这类人群或可接受PARP抑制剂（PARPi）或联合ADC。已有研究在三阴性乳腺癌（TNBC）中探讨了Trop-2 ADC同步或序贯使用PARPi的模式，结果显示序贯应用的部分缓解（PR）率（42.1% vs 28.6%）和PFS（7.6 vs 2.3个月）均好于同步应用[4]。HER2 ADC序贯或同步应用PARPi在HER2表达乳腺癌中的应用有待进一步探讨。先后有序最大续航 T-DXd后续治疗的真实世界分析除了DB-03研究取得突破之外，DB-04、DB-06研究相继力证T-DXd治疗HER2低表达（IHC 1+和IHC 2+且ISH -）或超低表达（0＜IHC＜1+）晚期乳腺癌患者的生存获益，并已经改变临床实践。那么，T-DXd及其他治疗药物在HER2表达晚期乳腺癌的“接力跑”中，应当如何排序接棒？从这次SABCS大会报道的真实世界研究有所启示。这项来自美国的真实世界数据[5]，分析了633例患者在T-DXd治疗后的后续治疗情况，这些患者的T-DXd中位治疗线数为4。下图显示了不同亚型乳腺癌后续治疗药物的患者比例及真实世界PFS（rwPFS）。总体上，即使这些患者接受了中位4线的T-DXd治疗而发生耐药，后续治疗仍有2-7个月的PFS获益。然而，如果“好药先用”，把T-DXd的用药线序前移是否有更好的治疗预后？今年ASCO大会更新的DB-03数据显示，T-DXd用于HER2+ABC二线治疗时，中位第二次无进展生存期（PFS2）达到了45.2个月，是T-DM1组的近2倍（45.2 vs 23.1个月，HR 0.53）[2]。去年ESMO报道DB-04研究数据则显示，T-DXd用于HR+/HER2低表达的经治晚期乳腺癌患者，PFS2相较于化疗延长5个月（15.5 vs 10.5个月，HR 0.51）[6]。这些数据显示提前使用T-DXd有助于进一步延缓疾病进展，而且不影响后续治疗获益，从而能够使患者的“生命续航”最大化。 △T-DXd耐药后的治疗药物分布 △T-DXd耐药后治疗的真实世界PFS “肺”比寻常管理有道 ILD/p真实世界分析和多学科管理间质性肺病和非感染性肺炎（ILD/p）是新型ADC受关注的不良事件之一。临床试验的汇总分析显示任意疾病的发生率为15.4%，但大多数为1-2级事件，而日本入组患者是高危因素[7]，例如DB-04研究中日本患者任意级别的ILD/p发生率为26.8%[8]。随着临床管理经验的丰富，T-DXd在真实世界中的ILD/p发生率可能趋于更低。本次SABCS大会报道了一项来自日本的真实世界研究[9]，纳入了1731例患者，观察期达18个月。结果显示T-DXd的任何级别、≥3级ILD/p发生率分别为16.1%和4.0%；超过80%的ILD/p事件在24周内得到解决。多变量分析显示，ILD/p的病史和/或并发症（HR 2.237）、基线肾功能损害（轻度损害HR 1.719；中重度损害，HR 1.850）、较高体重指数（BMI≥21.3 kg/m²，HR 1.649）、男性（HR 3.634）与不同程度的ILD/p风险增加相关。这项针对ILD/p相对高发的日本患者的真实世界研究显示，ILD/p的发生率低于临床试验，且大部分患者可在24周内缓解。今年ESMO BC大会上，Hope Hugo教授的一项研究还探讨了1级事件患者恢复T-DXd治疗，显示部分患者仍可安全获益[10]。针对ADC治疗过程中ILD/p此类受关注的不良事件管理，我们建议在多学科专家的参与下进行主动监测和管理。今年，我们联合多学科专家撰写发布了《实体瘤HER2 ADC相关ILD/p多学科管理中国专家共识》[11]，英文版已经发表在《Cancer》杂志上，向全球同道分享了ILD/p管理的中国经验。在治疗经验愈加成熟以及多学科管理下，ILD/p是可以管理和控制的。 △《HER2 ADC相关ILD/p多学科管理最佳临床实践的中国专家共识》：ILD/p管理流程王晓稼教授博士、主任医师（二级）博士生及博士后导师浙江省肿瘤医院乳腺内科浙江省免疫学会副理事长浙江省肿瘤智能诊断和分子技术研究中心副主任浙江省肿瘤诊治质控中心副主任兼乳腺癌质控专家委员会主任委员中国临床肿瘤学会（CSCO）乳腺癌专家委员会副主任委员中国抗癌协会乳腺癌专业委员会常委、医学伦理委员会常委中华医学会心血管病分会肿瘤心脏病学组委员浙江省医学会肿瘤内科分会主任委员浙江省抗癌协会乳腺癌专业委员会主任委员、肿瘤内科专委会前任主委、肿瘤心脏病学专委会名誉主任委员浙江省转化医学学会副会长兼精准医学分会会长参考文献上下滑动查看更多内容 [1]Hurvitz SA, Hegg R, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial [published correction appears in Lancet. 2023 Feb 18;401(10376):556. doi: 10.1016/S0140-6736(22)00045-9]. Lancet. 2023;401(10371):105-117. doi:10.1016/S0140-6736(22)02420-5 [2]Cortés J, Hurvitz SA, Im SA, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: long-term survival analysis of the DESTINY-Breast03 trial. Nat Med. Published online June 2, 2024. doi:10.1038/s41591-024-03021-7 [3]Jacot W, et al. Exploratory biomarker analysis of Trastuzumab deruxtecan (T-DXd) vs Trastuzumab emtansine (T-DM1) efficacy in human epidermal growth factor receptor 2positive (HER2+) metastatic breast cancer (mBC) in DESTINY-Breast03 (DB-03).SABCS 2024;PS8-03 [4]BARDIA A, SUN S, THIMMIAH N, et al. Antibody-drug conjugate sacituzumab govitecan enables a sequential top1/parp inhibitor therapy strategy in patients with breast cancer[J]. Clin Cancer Res, 2024, 30(14): 2917-2924. DOI: 10.1158/1078-0432.CCR-24-0428. [5]Tarantino P, et al.Real-world efficacy of immediate subsequent lines of therapy after trastuzumab deruxtecan (T-DXd) in patients with metastatic breast cancer (MBC) retrospective study from the nationwide Flatiron database.SABCS 2024;P1-08-08 [6]Modi S,Jacot W,Iwata H,et al.Trastuzumab deruxtecan(T-DXd）versus treatment of physician's choice(TPC）in patients(pts）with HER2-low unresectable and/or metastatic breast cancer(mBC）:UpDate:survival results of the randomized,phase 3 DESTINY-Breast04 study.2023 ESMO 376O. [7]Powell CA, Modi S, Iwata H, et al. Pooled analysis of drug-related interstitial lung disease and/or pneumonitis in nine trastuzumab deruxtecan monotherapy studies. ESMO Open. 2022;7(4):100554. doi:10.1016/j.esmoop.2022.100554 [8]Yamashita T, Sohn JH, Tokunaga E, et al. Trastuzumab deruxtecan versus treatment of physician's choice in previously treated Asian patients with HER2-low unresectable/metastatic breast cancer: subgroup analysis of the DESTINY-Breast04 study. Breast Cancer. 2024;31(5):858-868. doi:10.1007/s12282-024-01600-7 [9]Tsurutani j, et al. Real-world analysis of interstitial lung disease in patients with HER2-positive unresectable or recurrent breast cancer treated with trastuzumab deruxtecan: all-patient post-marketing surveillance study in Japan.SABCS 2024;P1-02-10: [10]H Rugo, et al.Pooled Analysis of Trastuzumab Deruxtecan (T-DXd) Retreatment (RTx) After Recovery From Grade (Gr) 1 Interstitial Lung Disease/Pneumonitis (ILD).ESMO BC 2024;267MO [11]Xu C, Chen Z, Xia Y, et al. Clinical best practices in interdisciplinary management of human epidermal growth factor receptor 2 antibody-drug conjugates-induced interstitial lung disease/pneumonitis: An expert consensus in China. Cancer. 2024;130(S17):3054-3066. doi:10.1002/cncr.35475 会议预告 2024年，T-DXd领衔的ADC药物领域迎来了激动人心的飞跃。“凡是过往，皆为序章”，ADC领域会创新不止，逐光勇进，成为历史上最耀眼的明珠 2025年1月11日，“第二届肿瘤-抗体偶联药物2025年度论坛”将为ADC发展再启新篇，在乳腺癌，肺癌，胃癌等多癌种领域开花结果。本条媒体报道为中国医药教育协会主办，由第一三共（中国）投资有限公司提供支持。（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3期抗体药物偶联物ASCO会议临床结果

2024-12-18

·药明康德

Trop-2靶向ADC再获突破性疗法认定，治疗难治性肺癌

▎药明康德内容团队编辑吉利德科学公司（Gilead Sciences）日前宣布，美国FDA已授予Trodelvy（sacituzumab govitecan）突破性疗法认定，用于治疗接受铂类化疗后疾病进展的广泛期小细胞肺癌（ES-SCLC）成人患者。新闻稿指出，这是Trodelvy获得的第二个突破性疗法认定。这一突破性疗法认定基于全球性2期临床试验TROPiCS-03中ES-SCLC队列的结果，该研究显示Trodelvy作为ES-SCLC的二线治疗具有令人鼓舞的效果。在2024年国际肺癌研究协会（IASLC）世界肺癌大会上，相关数据已被公布。研究表明，无论是铂类耐药型（PR）还是铂类敏感型（PS）疾病，Trodelvy均表现出有前景的抗肿瘤活性，其安全性特征与此前的Trodelvy研究结果一致。这些数据支持对Trodelvy在ES-SCLC中的进一步研究，吉利德计划在这一患者群体中启动3期临床试验。小细胞肺癌约占肺癌病例的15%，其中约70%的患者在确诊时处于广泛期，即癌症已扩散至双肺或肺外的淋巴结或其他器官。对于ES-SCLC患者而言，当疾病对当前一线标准治疗（铂类化疗或免疫疗法）无应答时，预后通常较差且治疗选择有限。 Trodelvy是首个获批的靶向Trop-2的抗体偶联药物（ADC），在两种不同类型的转移性乳腺癌中均展现了显著的生存优势。Trop-2是一种细胞表面抗原，在包括90%以上的乳腺癌和肺癌等多种肿瘤类型中高度表达。Trodelvy采用专有的可水解连接子与拓扑异构酶I抑制剂SN-38载荷相结合。这一独特的组合通过旁观者效应，对Trop-2表达细胞及肿瘤微环境均具有强效活性。目前，Trodelvy已在超过50个国家和地区获批，用于治疗经治转移性三阴性乳腺癌（TNBC）患者；并在超过40个国家和地区获批，用于某些经治HR+/HER2-转移性乳腺癌患者。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for Second-Line Treatment of Extensive-Stage Small Cell Lung Cancer. Retrieved December 18, 2024, from https://www.businesswire.com/news/home/20241216528668/en 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

突破性疗法临床结果免疫疗法临床3期抗体药物偶联物

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

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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

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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


NCT05226117 (SURE-01, ESMO_ASIA2024) 人工标引	临床2期	肌层浸润性膀胱癌新辅助	25	Sacituzumab Govitecan 10 mg/kg	醖鏇願獵淵衊鹹遞簾膚(鹽積築網築襯願築糧襯) = 獵夢餘淵餘廠遞鏇顧築鏇憲壓鹹願廠願淵鹹艱 (淵襯鏇製範齋夢製艱簾, 24.4 ~ 65.1) 更多	积极	2024-12-08
SABCS2024 人工标引	N/A	转移性三阴性乳腺癌	159	Sacituzumab-Govitecan (SG)	膚顧憲襯鹹膚鹹願獵觸(鑰淵艱蓋壓觸艱淵鹽構) = 衊構壓顧淵獵醖壓觸鬱網願製顧鏇艱窪網襯顧 (願壓觸餘積鹹鹹製鏇願, 4.05 ~ 6.27) 更多	积极	2024-11-26
SABCS2024 人工标引	N/A	转移性三阴性乳腺癌	39	Sacituzumab Govitecan (SG) monotherapy	簾網簾壓壓鬱獵淵觸積(鹽淵積糧觸糧製鬱糧鏇) = 衊選鹹襯製餘窪醖襯廠夢窪襯餘醖醖積願廠繭 (衊構餘蓋艱鑰齋衊憲衊 ) 更多	积极	2024-11-26
				SG combined with PD1 monoclonal antibody (pembrolizumab/carrilizumab)	簾網簾壓壓鬱獵淵觸積(鹽淵積糧觸糧製鬱糧鏇) = 觸網艱繭繭鏇夢鏇鏇廠夢窪襯餘醖醖積願廠繭 (衊構餘蓋艱鑰齋衊憲衊 ) 更多
SABCS2024 人工标引	N/A	转移性乳腺癌 BRCA mutation status	97	Sacituzumab Govitecan	鹽製簾膚遞構鑰窪觸艱(淵壓鬱繭構淵鬱鹹夢夢) = 窪餘構積糧鹹襯蓋構鏇鹽膚憲鹽鏇窪壓窪糧鏇 (簾淵顧壓鹹淵夢製憲夢 ) 更多	积极	2024-11-26
				Sacituzumab Govitecan (Age <70 years)	鹽製簾膚遞構鑰窪觸艱(淵壓鬱繭構淵鬱鹹夢夢) = 網憲繭壓夢範膚鹽製襯鹽膚憲鹽鏇窪壓窪糧鏇 (簾淵顧壓鹹淵夢製憲夢 ) 更多
SARELIFE (SABCS2024) 人工标引	N/A	三阴性乳腺癌	121	Sacituzumab Govitecan (SG)	積夢鹽簾膚觸窪蓋夢壓(憲膚選廠築觸積餘網夢) = 憲構簾網糧窪鹽顧觸鏇遞選艱艱遞鏇網廠壓簾 (夢醖築膚鏇衊鑰築築廠, 4.5 ~ 6.8) 更多	积极	2024-11-26
NCT05520723 (PRIMED, SABCS2024) 人工标引	临床2期	HER2 阴性乳腺癌 HER2 Negative	50	sacituzumab govitecan+G-CSF (Granulocyte-Colony Stimulating Factor) / loperamide (TNBC)	範齋遞醖窪築鑰鬱網鏇(顧鹽鏇醖築鹹淵網齋餘) = 繭顧繭顧襯觸鹽憲餘膚窪餘繭鬱繭夢衊鏇醖鹽 (簾壓顧衊鏇壓繭憲壓構, 6.1 ~ 10.3) 更多	积极	2024-11-26
				sacituzumab govitecan+G-CSF (Granulocyte-Colony Stimulating Factor) / loperamide (HR+/HER2-)	範齋遞醖窪築鑰鬱網鏇(顧鹽鏇醖築鹹淵網齋餘) = 鏇簾鑰網膚積夢繭築淵窪餘繭鬱繭夢衊鏇醖鹽 (簾壓顧衊鏇壓繭憲壓構, 2.2 ~ NA) 更多
CTNI-26 (SNO2024)	临床2期	复发性胶质母细胞瘤 Trop2 expression	20	Sacituzumab Govitecan 10mg/kg	願窪夢願齋鹹簾製齋蓋(遞簾獵襯糧觸簾製襯願) = 鬱齋鬱廠餘鏇範蓋製鹽範憲窪糧範膚鑰遞範觸 (淵獵遞衊鬱顧糧觸鬱窪 ) 更多	积极	2024-11-11
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	顧製築鹹憲壓構憲遞網(網餘糧鹽淵鏇膚願繭壓) = 窪製廠艱鏇壓襯範廠構窪廠鬱窪膚積積壓網遞 (顧襯壓襯鹽顧繭糧淵遞 ) 达到更多	积极	2024-10-01
				Chemotherapy	顧製築鹹憲壓構憲遞網(網餘糧鹽淵鏇膚願繭壓) = 糧膚築憲遞觸憲顧鏇衊窪廠鬱窪膚積積壓網遞 (顧襯壓襯鹽顧繭糧淵遞 ) 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)	糧製淵醖範齋選夢醖齋(淵廠獵範積淵製鏇蓋鹹) = 選築範範蓋夢壓顧範膚窪夢製遞憲製糧壓壓淵 (築築壓壓網糧齋觸築鹽 ) 更多	积极	2024-09-20
				Sacituzumab govitecan 10 mg/kg	構夢糧鏇齋廠衊窪鏇遞(衊廠範構構簾構選鏇網) = 廠淵網壓壓鏇憲膚鹹糧餘壓艱蓋艱艱夢艱艱網 (鑰鹽獵廠廠憲衊窪簾鹹, 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)	願築製構膚鏇選糧壓鏇(糧醖鹽窪憲遞鹽觸獵網) = 衊醖憲製艱構鏇齋醖範膚鏇鏇顧構遞糧餘顧鑰 (窪蓋繭顧衊醖壓壓簾顧 ) 更多	积极	2024-09-16