Eribulin mesylate

First global approval based on TROPION-Breast01 where DATROWAY significantly reduced the risk of disease progression or death by 37% versus chemotherapy Second DXd antibody drug conjugate approved in Japan based on Daiichi Sankyo’s DXd technology TOKYO, Japan I December 27, 2024 I Daiichi Sankyo’s (TSE:4568) DATROWAY® (datopotamab deruxtecan) has been approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy. In Japan, breast cancer is the most common cancer in women.1 Approximately 92,000 cases of breast cancer were diagnosed in Japan in 2022, with approximately 17,600 deaths.1 It is estimated that 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2 DATROWAY is the first ever TROP-2 directed medicine to be approved in Japan for HR positive, HER2 negative breast cancer and is the second DXd antibody drug conjugate (ADC) approved based on Daiichi Sankyo’s DXd ADC Technology. The approval of DATROWAY by the Japan Ministry of Health, Labour and Welfare (MHLW) is based on results from the TROPION-Breast01 phase 3 trial. In this trial, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63, 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with DATROWAY compared to 4.9 months in those treated with chemotherapy. “This first global approval of DATROWAY provides patients in Japan with metastatic HR positive, HER2 negative breast cancer a new alternative to conventional chemotherapy, which is often associated with poor response rates,” said Wataru Takasaki, PhD, Senior Advisor, Daiichi Sankyo. “DATROWAY also is the second DXd antibody drug conjugate approved in Japan based on technology invented by Daiichi Sankyo, emphasizing our commitment to creating new, innovative standards of care for patients with cancer.” In TROPION-Breast01, adverse reactions occurred in 93.6% (337/360 patients) of the 360 patients (including 31 Japanese patients) in the DATROWAY (6 mg/kg) arm. The most common adverse reactions included nausea (51.1%), stomatitis (50.0%), alopecia (36.4%), fatigue (23.6%), and dry eye (21.7%). In Japanese patients, interstitial lung disease (ILD) occurred in 6.5% of patients treated with DATROWAY. DATROWAY is approved in Japan with a Warning for ILD. As cases of ILD, including fatal cases, have occurred in DATROWAY-treated patients. DATROWAY is to be used in close collaboration with a respiratory disease expert. Patients should be closely observed during therapy by monitoring for early signs or symptoms of ILD (such as dyspnea, cough or fever) and performing periodical percutaneous oxygen saturation (SpO2) tests, chest X-ray scans and chest CT scans. If abnormalities are observed, discontinue administration of DATROWAY and take appropriate measures, such as corticosteroid administration. Prior to initiation of DATROWAY therapy, a chest CT scan should be performed and medical history taken to confirm the absence of any comorbidity or history of ILD with the patient and carefully consider the eligibility of the patient for DATROWAY therapy. Additional regulatory submissions for DATROWAY in breast cancer are under review in the EU, China, U.S. and other regions. About TROPION-Breast01 TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one additional systemic therapy for unresectable or metastatic disease. Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted. The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and overall survival. Key secondary endpoints include overall response rate, duration of response, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology . TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov. About Hormone Receptor Positive, HER2 Negative Breast Cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.3 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.3 In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.2 Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2 Endocrine therapies are widely given consecutively in the early lines of treatment for HR positive metastatic breast cancer.4 However, after initial treatment, further efficacy from endocrine therapy is often limited.4 The current standard of care following endocrine therapy is chemotherapy, which is associated with poor response rates and outcomes.4,5,6,7 About DATROWAY DATROWAY (datopotamab deruxtecan) is a TROP-2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP-2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. DATROWAY (6 mg/kg) is approved in Japan for the treatment of adult patients with HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy based on results from the TROPION-Breast01 trial. About the DATROWAY Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including non-small cell lung cancer, triple negative breast cancer, and HR positive, HER2 low or negative breast cancer. The program includes seven phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU® in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP-2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com . References: 1 World Health Organization. Global Cancer Observatory: Japan. Accessed December 2024. 2 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed December 2024. 3 Bray F, et al. CA Cancer J Clin. 2024; 10.3322/caac.21834. 4 Manohar P, et al. Cancer Biol Med. 2022 Feb 15; 19(2):202–212. 5 Cortes J, et al. Lancet. 2011;377:914-923. 6 Yuan P, et al. Eur J Cancer. 2019;112:57-65. 7 Jerusalem G, et al. JAMA Oncol. 2018;4(10):1367–1374. SOURCE: Daiichi Sankyo

导读 2024年12月21日，在第十六届上海市乳腺癌专业研讨会暨上海市抗癌协会乳腺癌专业委员会年会上，《2025年CBCS&CSOBO乳腺癌诊治指南与规范精要本》（以下简称“2025版小红书”）正式发布，为乳腺癌临床决策提供了新的指导。值得注意的是，此次更新将我国首款自主研发的TROP2 ADC药物——芦康沙妥珠单抗纳入TNBC解救治疗推荐列表，为晚期TNBC患者带来了新的治疗选择，表明我国在乳腺癌诊疗领域的自主创新能力正在逐步提升。据此，医脉通特邀复旦大学附属肿瘤医院张剑教授就2025版小红书的更新内容进行深入解读，并展望芦康沙妥珠单抗在乳腺癌领域的应用前景。 医脉通：乳腺癌小红书是乳腺癌诊疗领域的重要参考，获得临床医生广泛认可。今年，2025版小红书展现了与往年不同的特色，并且引入了许多新的内容，能否请您谈谈2025版小红书中更新了哪些内容，相比往年更新有什么特点？ 张剑教授 复旦大学附属肿瘤医院 2025版小红书对乳腺癌的检测与诊疗进行了全面更新[1]。在TNBC领域，早期新辅助、辅助治疗策略和晚期TNBC的治疗方案均有所更新，其中一项非常重要的更新，即国产自研的新型TROP2 ADC芦康沙妥珠单抗被纳入晚期TNBC的解救治疗。在HR阳性乳腺癌领域，2025版小红书对辅助化疗、内分泌治疗、二线及后线治疗推荐方案进行了更新，进一步巩固了精准治疗在临床实践中的重要地位，并且特别关注了在难治性HR阳性患者、未经化疗的患者以及超低表达患者中，DESTINY-Breast06结果的应用价值。在HER2阳性乳腺癌领域，2025版小红书更新了总体治疗原则和一线治疗策略，尤其是伴有脑转移的患者，特别引入了艾立布林的EMERALD临床研究数据，以指导一线治疗决策。 与既往版本的小红书相比，2025版小红书加入了更多新的诊疗理念，倡导通过综合治疗手段给予患者全面支持。本次更新特别强调了多学科合作的重要性，病理科医生、影像科医生和临床医生之间的紧密合作对于实现精准治疗至关重要；并指出精准诊疗和分层治疗都是乳腺癌诊疗的未来发展趋势，生物标志物如HER2、Ki67在临床中扮演着关键角色，这要求我们在临床实践中要识别患者的个体特征，并据此为患者制定个性化的治疗方案。此外，2025版小红书新增了心理社会康复和不良反应管理相关内容，表明乳腺癌诊疗中不仅要关注治疗效果，更要注重疗效与生活质量之间的平衡。例如卵巢功能的保护、手术方法的选择（如保乳手术）和生育能力的保护都得到了更多的关注。 与国际的NCCN指南、ASCO指南相比，2025版小红书的不同之处在于，本次更新中纳入了更多中国创新药物，凸显了中国的创新能力，为中国患者提供了更具针对性的治疗方案，同时也表明中国在乳腺癌诊疗领域的国际地位正在逐步提升。 医脉通：TNBC是乳腺癌中“最难治”的乳腺癌亚型，尤其是晚期TNBC患者，治疗选择有限且预后极差。我们看到，2025版小红书在晚期TNBC二线推荐列表中新增了芦康沙妥珠单抗，结合您对这一产品的了解情况，请您谈谈这一更新对晚期TNBC诊疗有什么意义和价值？ 张剑教授 复旦大学附属肿瘤医院 芦康沙妥珠单抗是国内首款自主研发的靶向TROP2的新型ADC药物，目前已经获批上市，其核心Ⅲ期研究OptiTROP-Breast01是一项随机对照、开放标签的中国多中心研究，旨在对比芦康沙妥珠单抗与医生选择的化疗用于既往接受≥2种化疗（至少一种针对晚期或转移性阶段）后复发或难治性晚期TNBC患者的疗效和安全性。 在2024年ASCO大会上，该研究公布了主要研究数据[2]。结果表明，中位随访10.4个月后，研究达到了主要终点无进展生存期（PFS），芦康沙妥珠单抗组和化疗组患者的中位无进展生存期（mPFS）分别为6.7个月和2.5个月。相比化疗，芦康沙妥珠单抗可将疾病进展或死亡风险显著降低68%（HR=0.32，95%CI：0.22-0.44，P<0.00001）。芦康沙妥珠单抗和化疗组的9个月的PFS率分别为34%和5.9%，这一结果令人瞩目。 图1. 芦康沙妥珠单抗组与化疗组的PFS 此外，所有亚组均显示出一致的PFS获益趋势。无论TROP2表达水平如何，芦康沙妥珠单抗均能带来获益。在TROP2 H评分＞200的患者中，芦康沙妥珠单抗组和化疗组的mPFS分别为8.3个月和2.3个月(HR 0.29；95%CI：0.19-0.46)。在TROP2 H评分≤200的患者中，芦康沙妥珠单抗组和化疗组的mPFS分别为5.7个月和2.6个月(HR 0.35；95%CI：0.21-0.56)，提示未来的临床应用中，不必通过TROP2评分限制芦康沙妥珠单抗的使用。 图2.不同TROP2表达水平亚组的PFS 在总生存期（OS）方面，芦康沙妥珠单抗也具有显著获益。相比化疗组，芦康沙妥珠单抗组相比化疗组的mOS具有显著统计学意义（未达到 vs 9.4个月，HR=0.53，95% CI：0.36-0.78，P=0.0005)，疾病死亡风险下降了47%。 图3. 芦康沙妥珠单抗组与化疗组的OS 在肿瘤缓解方面，芦康沙妥珠单抗组相比化疗组的客观缓解率（ORR）提升了约3倍（45.4% vs 12.0%），中位缓解持续时间（mDOR）分别为7.1个月和3.0个月（HR 0.50; 95%CI：0.22-1.13）。 在安全性方面，芦康沙妥珠单抗整体安全性良好，没有发现新的安全性的信号。中位治疗持续15.4周，因治疗相关不良事件（TRAE）导致治疗终止的比例为1.5%，因TRAE导致减量的比例是25.4%，导致减量的最常见TRAE是贫血 (13.8%) 和口腔黏膜炎(5.4%)。值得关注的不良事件中，口腔黏膜炎的发生率为44%，≥3级发生率仅9%，可通过预防措施和及时干预缓解。 图4.安全性总结 随后，该研究在2024年的ESMO大会公布了新的亚组分析数据[3]，结果表明，在PD-(L)1抑制剂经治患者中，芦康沙妥珠单抗组与化疗组的mPFS分别为5.6个月和2.7个月（HR 0.31）；ORR分别为56.3%和5.6%。在未接受过PD-(L)1抑制剂治疗的患者中，两组的mPFS分别为7.2个月和2.3个月（HR 0.34），ORR分别为41.8%和14.4%；提示TNBC患者无论是否接受过PD-(L)1抑制剂治疗，都能从芦康沙妥珠单抗治疗中获益，与总体人群观察到的趋势一致。 总体而言，OptiTROP-Breast01研究证实了芦康沙妥珠单抗治疗晚期TNBC具有优异的疗效和可控的安全性，可为患者带来新的治疗选择；并且OptiTROP-Breast01研究聚焦于中国TNBC患者，其数据更能真实反映中国人群的疗效和安全性，对中国的晚期TNBC治疗决策具有较高参考价值。 本次芦康沙妥珠单抗被纳入2025版小红书具有重要的临床和社会意义。从晚期TNBC的治疗现状来看，一直以来，晚期TNBC的治疗选择相对有限，主要依赖于化疗，患者预后不佳，存在巨大的未满足临床需求。TROP2在TNBC中高表达，比例高达95%[4]，是其预后不良的影响因素，TROP2 ADC芦康沙妥珠单抗的问世为改善晚期TNBC患者的预后带来了新的希望。OptiTROP-Breast01研究的数据表明，作为中国首个自主研发的TROP2 ADC药物，芦康沙妥珠单抗能够满足TNBC临床需求，改善患者生存，为中国晚期TNBC后线治疗提供安全有效的新选择，并且有助于优化TNBC二线治疗格局，提升晚期乳腺癌整体诊疗水平。此外，芦康沙妥珠单抗的卓越表现也为中国原创新药的发展起到了较好的示范作用，有助于推动中国创新药物的快速进步。 医脉通：芦康沙妥珠单抗是乳腺癌领域首款中国自主研发、达到国际品质的TROP2 ADC，在晚期TNBC患者中显示出卓越疗效和可控的安全性，这得益于芦康沙妥珠单抗独特的药物设计和抗肿瘤方式。能否请您从药物结构和作用机制的角度，阐述芦康沙妥珠单抗与其他同类型药物相比的主要优势？ 张剑教授 复旦大学附属肿瘤医院 芦康沙妥珠单抗具有独特而精巧的分子结构设计，该药物通过优化的连接子CL2A与自主研发的新型拓扑异构酶Ⅰ抑制剂T030偶联而成，将新型不可逆的抗体偶联技术、毒素双重释放机制和药物抗体比高达7.4的中等活性毒素相结合，确保在肿瘤部位能够释放更多毒素，实现疗效和安全性的平衡[5]。 相较于其他TROP2 ADC药物，芦康沙妥珠单抗的结构设计具有差异化优势。首先，芦康沙妥珠单抗采用新一代偶联技术，确保抗体与连接子之间的不可逆偶联，避免了逆迈克尔加成反应的发生。其次，T030作为一种全新的拓扑异构酶Ⅰ抑制剂，其甲基砜结构与连接子的结合稳定性更高。此外，连接子CL2A具有更高的亲水性和稳定性，同时具备pH敏感性和酶促毒素释放的双重机制。 芦康沙妥珠单抗主要通过三重机制精准杀伤肿瘤细胞。第一重机制是芦康沙妥珠单抗与肿瘤细胞表面的TROP2抗原结合后被肿瘤细胞内吞，被溶酶体裂解释放T030，杀伤肿瘤细胞。第二重机制是T030释放之后穿透细胞膜，发挥旁观者效应（bystander效应），进一步杀伤周围肿瘤细胞。第三重机制是芦康沙妥珠单抗能够在肿瘤微环境中释放毒素，杀伤更多的肿瘤细胞。 众所周知，药物在临床实践中的卓越表现与其结构设计密切相关。从芦康沙妥珠单抗的药物结构与作用机制来看，该药物能够精准有效地杀伤肿瘤细胞，同时兼顾安全性和有效性，实现两者之间的平衡。临床研究也进一步证实，芦康沙妥珠单抗在结构和技术上的优势能够成功转化为临床上更好的疗效和安全性，为乳腺癌患者带来更多生存机会。 医脉通：基于OptiTROP-Breast01研究的卓越疗效和可控的安全性，芦康沙妥珠单抗已于11月27日获得NMPA批准上市，目前又被纳入2025版小红书，为我国晚期TNBC患者带来了全新的治疗选择与希望，对于芦康沙妥珠单抗的临床实践和未来发展，您有哪些建议和期望？ 张剑教授 复旦大学附属肿瘤医院 随着对TNBC的深入理解，我们越来越倾向于在临床治疗中先使用疗效好、副作用小的药物，遵循“好药先用”原则。芦康沙妥珠单抗作为国内首个创新的靶向TROP2 ADC，在晚期TNBC二线治疗中展现出显著的疗效和可控的安全性，为临床医生提供了一个有力的治疗选择，并且该适应症已获得MMPA上市批准，对TNBC二线治疗格局产生了积极影响。今年更新的2025版小红书也将芦康沙妥珠单抗纳入晚期TNBC的二线治疗推荐列表，进一步证实了芦康沙妥珠单抗的临床应用价值。因此，建议临床医生在诊疗中遵循指南制定治疗策略，推广使用创新药物，让更多患者能用上“好药”，同时也有助于推动新版指南的落地实施，提升整体乳腺癌诊疗水平。 当然，在临床用药过程中不仅要关注疗效，安全性同样不容忽视。诊疗过程中需要规范用药，定期监测如中性粒细胞减少、口腔黏膜炎等不良反应。通过尽早预防和及时干预，确保患者在获得良好疗效的同时，也能保障甚至提升生活质量。 对于芦康沙妥珠单抗的未来发展，我们抱有高度期待。首要目标是推动该药物尽快纳入国家医保目录，以医保准入为手段，增强患者对药物的可及性，从而提高其使用率。此外，作为中国创新药的代表，芦康沙妥珠单抗在全球临床应用场景中具有广阔前景，期待芦康沙妥珠单抗能够作为中国原创新药的典型名片走向国际，成为全球新药创新的中国标志。 就研究布局而言，芦康沙妥珠单抗在TNBC领域的探索并未局限于二线及后线，在前线治疗中也有所布局。SKB264单药一线治疗TNBC患者的中国Ⅲ期研究（SKB264-11）以及SKB264±A167（PD-L1抑制剂）一线治疗TNBC患者的中国Ⅱ期研究（SKB264-07）正在进行；在辅助治疗阶段，还有一项SKB264+帕博利珠单抗对比帕博利珠单抗±卡培他滨治疗TNBC的全球Ⅲ期研究（MK-2870-012）正在进行。 除了TNBC领域，芦康沙妥珠单抗在HR+/HER2-领域也进行了探索。2023年ESMO大会上公布的数据显示，芦康沙妥珠单抗治疗既往接受二线化疗的HR+/HER2-乳腺癌患者，mPFS达11.1个月，ORR为36.8%[6]，与同类产品相比具有一定的优势。此外，探索SKB264±A167（PD-L1抑制剂）一线治疗HR+/HER2-患者的中国Ⅱ期研究（SKB264-07），以及对比SKB264 vs SKB264+帕博利珠单抗 vs TPC一线治疗既往内分泌治疗失败但未接受化疗的HR+/HER2-转移性乳腺癌的全球Ⅲ期研究（MK-2870-010）正在开展。 总的来看，芦康沙妥珠单抗在乳腺癌诊疗领域有着巨大的应用潜力。目前该药物在TNBC二线治疗领域的适应症已经成功获批，并被纳入最新的2025版小红书指南，这标志着芦康沙妥珠单抗在乳腺癌治疗领域获得了权威认可，能够惠及更广泛的乳腺癌患者群体。未来随着临床研究的不断深入，我们期待芦康沙妥珠单抗能够继续改善患者的生存和生活质量，为乳腺癌患者提供更多样化、更有效的治疗方案！ 参考文献： [1]. 中国抗癌协会乳腺癌专业委员会, 上海市抗癌协会.CBCS&CSOBO乳腺癌诊治指南与规范精要本（2025版）. [2]. Binghe Xu, et al. Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study.2024 ASCO. Abstract 104. [3]. Yongmei Yin, et al.Exploratory analysis of patients with or without prior PD-(L)1 inhibitors in phase III OptiTROP-Breast01 study of sacituzumab tirumotecan (sac-TMT) versus chemotherapy for previously treated advanced triple-negative breast cancer (TNBC). 2024 ESMO.Abstract 386P. [4]. Seligson JM, Patron AM, Berger MJ, Harvey RD, Seligson ND. Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Ann Pharmacother. 2021;55(7):921-931.  [5]. Cheng Y, Yuan X, Tian Q, et al. Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132. Front Oncol. 2022;12:951589.  [6]. Q. Ouyang, et al.SKB264 (MK-2870) in previously treated hormone receptor-positive (HR+)/ HER2-negative metastatic breast cancer (mBC): Results from a phase I/II, single-arm, basket trial. 2023 ESMO. Abstract 380MO. 本文转载自：医脉通 专家简介 张剑 教授 复旦大学附属肿瘤医院 肿瘤内科/一期临床研究病房主任医师、博导 复旦大学附属肿瘤医院福建医院临床研究中心主任/肿瘤内科常务副主任/肿瘤内科主任医师 上海“医苑新星”杰青人才获得者 中国医药教育协会肿瘤药物临床研究专业委员会主委 中国老年保健协会肿瘤防治与临床研究专业委员会主委 长江学术带乳腺联盟 YBCSG主委 上海市抗癌协会肿瘤药物临床研究专业委员会候任主委 中国抗癌协会乳腺癌专业委员会常委 中国抗癌协会乳腺癌专业委员会青委会副召集人 中国研究型医院协会乳腺专业委员会青委会副主委 中国妇幼健康研究会乳腺癌防治研究专业委员会副主委 国家抗肿瘤药物临床应用监测青委会副主委 上海市抗癌协会 肿瘤心脏病学专业委员会副主委 CSCO肿瘤支持与康复治疗专家委员会常委 中国康复医学会肿瘤康复专业委员会常委 CSCO乳腺癌专家委员会委员 中国抗癌协会 肿瘤临床研究管理学专业委员会委员 国家食品药品监督管理总局CDE首批化药临床兼职审评员 获2023 十大医学先锋专家、2023“人民好医生”杰出贡献奖 《Diseases ＆ Research》副主编、人卫《肿瘤综合治疗电子杂志》副主编 第一/共一/通讯SCI论文80篇（Lancet Oncol、Ann Oncol、Nat Commun、Clin Cancer Res、J Hematol Oncol、STTT、ACS Nano等）