A Phase 1b/2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer

Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body.
A standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy.
* Chemotherapy is a treatment that works to destroy cancer cells or stop them from growing.
* Immunotherapy is a treatment that helps the immune system fight cancer.
Gocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate.
* T-cell engager therapy is a certain type of immunotherapy that uses T-cells to find and destroy cancer cells.
* A T-cell is a type of white blood cell, which are cells that help the body fight infection.
* An antibody drug conjugate (ADC) is a treatment that attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The goals of this study are to learn:
* About the safety of combining gocatamig and I-DXd and if people tolerate them together
* If people who receive gocatamig and I-DXd have ES-SCLC respond, which means the cancer gets smaller or goes away

开始日期2026-01-14

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

CTR20252497

/ Recruiting临床3期

一项在转移性去势抵抗性前列腺癌（mCRPC）受试者中比较Ifinatamab Deruxtecan与多西他赛的III期、开放标签研究（IDeate-Prostate01）

在前线转移性去势抵抗性前列腺癌（mCRPC）受试者中比较Ifinatamab Deruxtecan与多西他赛的有效性和安全性

开始日期2025-08-21

申办/合作机构

默沙东研发（中国）有限公司

[+2]

CTR20252435

/ Recruiting临床1/2期

一项在一线局部晚期不可切除/转移性食管癌受试者中评价试验用药物联合帕博利珠单抗（MK-3475）联合或不联合化疗的I/II期、开放性、伞式平台设计研究：KEYMAKER-U06子研究06E

主要目的：评价试验用联合治疗的安全性和耐受性，并确定试验用药物的RP2D；针对选定的剂量，基于BICR根据RECIST 1.1的评估，评价ORR 次要目的：针对选定的剂量，基于BICR根据RECIST 1.1的评估，评价DOR；针对选定的剂量，基于BICR根据RECIST 1.1的评估，评价PFS；针对选定的剂量，评价OS；针对选定的剂量，基于BICR根据RECIST 1.1的评估，评价DCR；描述I-DXd与其他药物联合给药的PK特征；描述I-DXd的免疫原性特征

开始日期2025-08-11

申办/合作机构

默沙东研发（中国）有限公司

[+2]

100 项与 Ifinatamab deruxtecan 相关的临床结果

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100 项与 Ifinatamab deruxtecan 相关的转化医学

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100 项与 Ifinatamab deruxtecan 相关的专利（医药）

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项与 Ifinatamab deruxtecan 相关的文献（医药）

2026-12-31·mAbs

Antibodies to watch in 2026

Review

作者: Pinto, Kieran ; Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Reichert, Janice M. ; Chenoweth, Alicia ; Hsu, Yu-Shin

The Antibodies to Watch article series provides annual updates on commercial late-stage clinical development, regulatory review, and marketing approvals of antibody therapeutics. Since the first article was published in 2010, the late-stage pipeline has grown from 26 antibody therapeutics to over 200, while during the same time numerous molecules in late-stage studies either transitioned to regulatory review and were approved or were terminated. In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab. As antibody therapeutics development is a global enterprise, we also discuss trends in annual first approvals granted to antibody therapeutics in any country since 2010, stratified by the antibody's country of origin, documenting the notable increases in the total number of first approvals and those approved first in China. Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by their therapeutic area, mechanism of action, format, and country of origin. Our data show that the development and approval period were typically ~6 years, but on average this period was shorter for China-originated products.

2026-02-01·JOURNAL OF CLINICAL ONCOLOGY

Ifinatamab Deruxtecan in Patients With Extensive-Stage Small Cell Lung Cancer: Primary Analysis of the Phase II IDeate-Lung01 Trial

Article

作者: Tang, Mei ; Singh, Jasmeet ; Johnson, Melissa L. ; Hann, Christine L. ; Qian, Meng ; Paz-Ares, Luis ; Rocha, Pedro ; Nishio, Makoto ; Ahn, Myung-Ju ; Sakai, Tetsuya ; Girard, Nicolas ; Hayashi, Hidetoshi ; Kim, Yu Jung ; Rudin, Charles M. ; Godard, Juliette ; Hu, Haichuan

PURPOSE:

Treatment options for patients with recurrent or progressive extensive-stage small cell lung cancer (ES-SCLC) are limited. This phase II trial evaluated the efficacy and safety of ifinatamab deruxtecan (I-DXd), a B7 homolog 3–directed antibody-drug conjugate, in patients with previously treated ES-SCLC.

METHODS:

Patients were randomly assigned to receive I-DXd 8 or 12 mg/kg intravenously once every 3 weeks in part 1 (dose optimization) and received I-DXd 12 mg/kg in part 2 (extension). The primary end point was objective response rate (ORR) by blinded independent central review per RECIST, version 1.1.

RESULTS:

Overall, 183 patients received I-DXd: 88 in part 1 (8 mg/kg, n = 46; 12 mg/kg, n = 42) and 95 in part 2. The median number of previous lines of treatment was two. In the total 12-mg/kg group from parts 1 and 2 (n = 137), the confirmed ORR was 48.2% (95% CI, 39.6 to 56.9), median duration of response was 5.3 (95% CI, 4.0 to 6.5) months, median time to response was 1.4 (range, 1.0-8.1) months, median progression-free survival was 4.9 (95% CI, 4.2 to 5.5) months, and the 9-month overall survival estimate was 59.1%. Any-grade treatment-related adverse events (TRAEs) occurred in 89.8% of patients (grade ≥3, 36.5%). The most common TRAEs were nausea (43.1%), anemia (34.3%), and neutropenia (34.3%). TRAEs associated with treatment discontinuation and death were reported in 9.5% and 4.4% of patients, respectively. Treatment-related interstitial lung disease (ILD) as determined by the ILD adjudication committee was reported in 12.4% of patients (grade ≥3, 4.4%).

CONCLUSION:

I-DXd 12 mg/kg once every 3 weeks showed promising efficacy in patients with previously treated ES-SCLC. The observed safety profile was consistent with previous reports, with no new safety signals identified.

2025-11-01·BIOCHIMICA ET BIOPHYSICA ACTA-REVIEWS ON CANCER

The evolving landscape of antibody-drug conjugates in small cell lung cancer: From research progress to clinical application

Review

作者: Wang, Haoyu ; Zhang, Chenyue ; Wang, Haiyong

Antibody-drug conjugates (ADCs), one of the emerging developing classes of antitumor drugs, have transformed the therapeutic paradigm in oncology. It stands out due to its properties of boasting the strength of both chemotherapy and targeted therapy. In small cell lung cancer (SCLC), ADC has also demonstrated its potential and appealing effect. Clinical trials of ADCs in SCLC are currently in full swing. While ADC has brought some encouraging results so far, several obstacles have been encountered, such as drug resistance, drug toxicities and the difficulty in the selection of patients benefiting from ADCs. Thus, a deepened and comprehensive understanding of the fundamental researches, as well as summarization of ADC development in SCLC might offer us some enlightenment and solutions to these tricky issues. Therefore, in the present review, we elaborate on the structure and mechanism of ADC, clinical trials conducted in SCLC. Additionally, we also outline the obstacles and propose future directions of ADC in SCLC, highlighting its in-depth research and prospective application in SCLC.

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项与 Ifinatamab deruxtecan 相关的新闻（医药）

2026-02-03

·今日头条

年度盘点｜任胜祥教授：小细胞肺癌临床与转化研究进展——迈向

年度盘点｜任胜祥教授：小细胞肺癌临床与转化研究进展——迈向精准分型治疗的新纪元小细胞肺癌（SCLC）是一种与烟草暴露密切相关、侵袭性强的神经内分泌肿瘤，约占肺癌总数的13%～15%。其临床特点为生长快、早期易转移，约70%的患者确诊时已属广泛期（ES-SCLC），既往治疗长期依赖于铂类为基础的化疗和胸部放疗，预后较差，总体5年生存率仅12%–30%，是肺癌中治疗难度较高的亚型[1,2]。近年来，随着免疫治疗、抗体偶联药物（ADC）、双特异性抗体等新型疗法的涌现，以及分子分型研究的不断深入，SCLC的治疗格局正经历从“一刀切”化疗到“精准分型、多机制协同”的范式转变。时值岁末之际，《肿瘤瞭望》特邀同济大学附属上海市肺科医院任胜祥教授，立足最新临床研究数据与转化研究成果，对近年SCLC领域基础研究与临床转化重要进展进行系统盘点与展望，以期为临床实践与科研探索提供参考。任胜祥教授教授主任医师博士生导师上海市肺科医院肿瘤科主任上海市肺科医院I期临床研究病房主任上海市肺科医院肺癌与免疫实验室主任国家优秀青年医师，上海市先进工作者 IASLC教育委员会委员 CSCO非小细胞肺癌专家委员会副主任委员上海市医师协会肿瘤医师分会副主委上海市抗癌协会转化研究委员会副主委上海市抗癌协会肺癌分子靶向免疫治疗委员会副主委 SCLC临床治疗格局的演进局限期SCLC：步入“免疫巩固”时代同步放化疗（cCRT）一直是局限期SCLC（LS-SCLC）的治疗基石。其演进历程见证了技术的进步：从1992年确立cCRT优于单纯化疗，到1999年研究证实每日两次放疗方案（BID）较每日一次（QD）进一步将5年生存率从16%提升至26%，再到2017年CONVERT研究证实现代放疗技术下患者5年生存率可提升至34%。然而，高复发率始终是临床瓶颈。 2024年，ADRIATIC III期研究结果的公布成为重要里程碑。该研究证实，在cCRT后使用PD-L1抑制剂度伐利尤单抗进行巩固治疗，能显著延长患者总生存期（OS）和无进展生存期（PFS），并大幅降低胸外及脑转移风险[3]。基于此，度伐利尤单抗于2025年相继获得FDA和NMPA批准，用于LS-SCLC cCRT后的巩固治疗，并被CSCO指南列为I级推荐，标志着LS-SCLC正式进入“免疫巩固”时代。广泛期SCLC：从免疫联合化疗到多元化强化治疗在广泛期SCLC（ES-SCLC）一线治疗中，化疗联合免疫检查点抑制剂（ICIs）已成为标准治疗（SOC），多项III期研究（如IMpower133、CASPIAN、CAPSTONE-01等）将中位OS提升至12-15个月左右[4-10]。然而，疗效似乎进入平台期。为寻求突破，当前研究正致力于从“免疫+化疗”的两药模式，向包含抗血管生成药物或新型双抗的“三药乃至四药”协同模式跨越。同时，新型作用机制的药物开始前移至一线。例如，DLL3/CD3双特异性T细胞衔接器塔拉妥单抗在一线联合化疗和免疫的Ib/II期研究（DeLLphi-303）中，展示了高达71%的客观缓解率（ORR）和令人鼓舞的生存数据[11]。另一款DLL3/CD3双抗Obrixtamig在一线联合SOC的早期数据中也显示出高应答率和可控安全性[12]。此外，靶向PD-L1/VEGF的双特异性抗体Pumitamig联合化疗的一线II期研究也取得了积极结果[13]。这些进展预示着ES-SCLC的一线治疗正向更强化、更多元的联合模式演进。后线治疗药物的丰富与探索对于一线治疗后的维持阶段，IMforte研究是全球首个在ES-SCLC一线治疗中证实维持治疗能同时显著改善PFS和OS的III期研究。该研究显示，在阿替利珠单抗联合化疗诱导治疗后，使用芦比替定联合阿替利珠单抗进行维持治疗，相较于阿替利珠单抗单药维持，可显著延长患者生存。联合组将中位PFS从2.1个月提升至5.4个月（疾病进展风险降低46%，HR=0.54），中位OS从10.6个月提升至13.2个月（死亡风险降低27%，HR=0.73）。亚洲亚组数据与此趋势一致，且总体安全性可控。基于此关键结果，美国FDA已于2025年10月批准该联合维持治疗方案，确立了其在ES-SCLC一线治疗中的重要地位[14、15]。在后线治疗领域，长期以来拓扑替康是唯一标准，预后极差。2025年，这一局面被彻底改变。基于DeLLphi-304 III期研究，塔拉妥单抗在二线治疗中，将中位OS从化疗的8.3个月显著延长至13.6个月[16]。同时，抗体偶联药物（ADC）在后线治疗中展现出巨大潜力。针对不同靶点的ADC药物相继报告优异数据：靶向DLL3的SHR-4849在I期研究中ORR达73.2%[17]；靶向B7-H3的I-DXd在经治患者中ORR为48.2%，且对脑转移有效[18, 19]；靶向SEZ6的ABBV-706在二线患者中ORR达77%[20]。这些药物共同构成了SCLC后线治疗的“新武器库”，为化疗及免疫耐药的患者带来了新的希望。分子分型引领精准治疗新方向基础分子亚型的提出与意义近年来，小细胞肺癌的分子分型逐渐成为指导精准治疗的重要依据。自1985年Camey等人根据细胞形态将SCLC分为经典型（Classic)和变异型（Variant）开始，其分型研究不断发展。2019年Rudin教授[20]根据关键转录调控因子的表达水平，将SCLC分为四种分子亚型：SCLC-A型（ASCL1高表达,占比70%），SCLC-N型（NeuroD1高表达，占比11%），SCLC-Y型（YAP1高表达，占比2%）和SCLC-P型（POU2F3高表达，占比16%），为后续研究奠定了基础论[21]。炎症亚型（SCLC-I）与免疫治疗疗效预测 2021年Gay教授将SCLC根据三种关键转录因子将SCLC分为四种亚型：SCLC-A(ASCL1高表达)、SCLC-N(NEUROD1高表达)、SCLC-P(POU2F3高表达)、SCLC-I，其中SCLC-I亚型无上述经典转录因子高表达，但特异性表达免疫检查点及HLA相关基因，肿瘤免疫细胞浸润更多、干扰素-γ信号更强。这一发现深化了对SCLC异质性的理解，并为免疫治疗疗效预测提供了线索[22]。后续研究进一步揭示，抗原提呈能力是影响SCLC免疫治疗反应的关键机制，其核心在于肿瘤细胞表面MHC-I分子的表达水平，这直接决定了免疫系统识别和杀伤肿瘤细胞的效率。这一机制的阐明，为理解SCLC的“免疫沙漠”特性及寻找疗效预测标志物提供了方向。临床证据显示，MHC-I相关特征与免疫治疗获益显著相关。CheckMate 032研究的探索性分析发现，高表达抗原提呈机制（APM）基因谱、肿瘤内CD8+T细胞浸润较多或直接检测到MHC-I高表达的SCLC患者，接受免疫治疗后显示出更长的总生存期（OS）获益趋势[23]。在机制层面，MHC-I的表达受到多层次的精密调控：表观遗传调控：研究发现SCLC中赖氨酸特异性脱甲基酶1（LSD1）常呈高表达，其通过表观遗传学修饰抑制MHC-I表达，导致免疫逃逸。靶向抑制LSD1可激活干扰素信号通路，恢复MHC-I表达，从而增强SCLC的免疫原性和对抗PD-1/PD-L1疗法的反应性。转录调控：近期研究揭示了干扰素诱导跨膜蛋白3（IFITM3）的关键作用。IFITM3能够上调NLRC5（MHC-I基因的关键转录激活因子）的表达并促进其核转位，进而直接提升MHC-I的水平。因此，IFITM3的表达与MHC-I水平及抗PD-1/PD-L1疗法疗效相关，其本身或可作为预测免疫治疗反应的潜在生物标志物。临床前研究还证实，IFITM3诱导剂能够增强抗PD-1单药治疗的疗效[24]。由此可见，MHC-I的表达是连接SCLC肿瘤细胞与免疫系统的枢纽，其受到APM基因、表观遗传修饰因子（如LSD1）和特定信号蛋白（如IFITM3）的共同调控。深入理解这一调控网络，不仅解释了SCLC免疫治疗反应的异质性，也为开发联合治疗策略（如免疫检查点抑制剂联合LSD1抑制剂）和寻找精准的生物标志物（如IFITM3）开辟了新途径。值得注意的是，肿瘤发生部位也与治疗反应相关。相关研究指出，中央型与周围型广泛期SCLC（ES-SCLC）在预后和治疗反应上存在显著差异，其背后机制可能与MYC-Notch信号轴的差异性活化有关。这一发现提示在临床实践中，肿瘤位置或许可作为预后评估和治疗策略选择的参考因素之一[25]。中国人群蛋白基因组学特征及精准治疗方向 2024年，同济大学医学院/附属上海市肺科医院张鹏教授团队在《Cell》上发表了针对中国SCLC患者的大规模蛋白质组与磷酸化蛋白质组学分析，首次系统绘制了中国人群SCLC的蛋白基因组学全景图谱[26]。该研究揭示了区别于西方人群的分子特征，如ZFHX3突变频率更高。基于多组学数据，研究首次对中国SCLC进行了系统免疫分型，发现大部分属于免疫细胞浸润低的“冷肿瘤”，而少数“热肿瘤”则表现出干扰素-γ通路激活、抗原提呈能力增强等特征。重要的是，研究将ZFHX3突变与“热肿瘤”特征及更好的免疫治疗应答相关联，提示其或可作为预测免疫获益的潜在生物标志物。基于非负矩阵分解算法，该研究创新性地将SCLC划分为四个具有独特分子特征的蛋白基因组学亚型（Nmf1-Nmf4），并提出了对应的精准治疗策略： Nmf1（经典亚型）：表现出高增殖、高复制压力特征，可能对以顺铂+依托泊苷为基础的一线化疗方案更为敏感。 Nmf2（神经内分泌亚型）：特异性高表达DLL3，是靶向DLL3的双特异性抗体或抗体偶联药物等新型疗法的潜在优势人群。 Nmf3（RTK激活亚型）：在磷酸化蛋白质组层面呈现受体酪氨酸激酶通路显著激活，提示其对RTK抑制剂可能敏感。 Nmf4（MYC驱动亚型）：特征为MYC通路高激活及细胞周期相关蛋白富集，极光激酶抑制剂可能为该亚型提供有效的治疗选择。此项研究建立了连接中国人群SCLC分子特征与治疗策略的新框架，推动了诊疗进入“分子指导、亚型定向”的精准时代。此外，针对POU2F3亚型的SCLC，最新研究发现SWI/SNF染色质重塑复合物在其转录调控中发挥关键作用。靶向SWI/SNF的小分子抑制剂在临床前模型中显示出对该亚型的显著抑制效果，为这一难治亚型提供了新的治疗思路[27、28]。新型治疗药物与联合策略的突破抗体药物偶联物（ADC）崭露头角多种靶向不同抗原的ADC药物在SCLC中显示出巨大潜力： B7-H3 ADC：B7-H3在SCLC中高表达且与不良预后相关。I-DXd（DS-7300）在IDeate-Lung01研究中，对经治ES-SCLC患者的ORR达48.2%，且对脑转移有效[29, 30]。另一款B7-H3 ADC HS-20093在I期研究中也显示出鼓舞人心的活性（ORR 50%-61.3%）[32]。 B7-H3在SCLC组织中有不同程度表达，B7-H3高表达与淋巴结转移、不良预后相关，逐渐成为当前最受关注的靶点之一。 SEZ6 ADC：人源癫痫相关同源物6（SEZ6）作为神经树突形成和信号传递的关键调控因子，在NET（神经内分泌肿瘤）尤其是SCLC中发挥重要作用。ABBV-706是一种靶向SEZ6的ADC，在I期研究中表现出有希望的抗肿瘤活性和可控安全性，尤其在1.8 mg/kg剂量组[20]。 DLL3 ADC：Delta样配体3（DLL3）在SCLC和神经内分泌癌（NEC）中高表达。SHR-4849在I期研究中，≥2.4 mg/kg剂量组ORR高达73.2%，二线人群ORR达77.1%，合并脑转移患者ORR达83.3%，显示出极具潜力的抗肿瘤活性[17]。双特异性抗体及细胞衔接器 DLL3/CD3双抗：塔拉妥单抗在一线维持治疗的Ib期研究中ORR达71%，中位PFS为10.3个月[11]。Obrixtamig在一线联合SOC或后线联合拓扑替康的研究中，也显示出高ORR（68%-70%）和可控安全性[33, 34]。三重特异性抗体：如靶向DLL3/DLL3/CD3的Alveltamig（ZG006）在治疗晚期SCLC患者早期研究中亦显示出良好的抗肿瘤活性。结果显示，其ORR达到78.6%，DCR高达92.9%，并显示出良好的颅内疗效[35]。抗血管生成联合治疗的探索目前，免疫联合化疗是ES-SCLC的一线标准治疗，为继续提升患者获益，相关研究探索了在化免联合的基础上进一步加用抗血管生成药物的临床疗效。如ETER701研究结果显示，贝莫苏拜单抗+安罗替尼+卡铂+依托泊苷四药联合方案，较单纯化疗将中位OS从11.9个月显著延长至19.3个月（HR=0.61），中位PFS也从4.2个月延长至6.9个月（HR=0.32），破了既往研究的生存瓶颈[36]。转化型小细胞肺癌的研究进展转化型小细胞肺癌（T-SCLC）主要指EGFR突变型非小细胞肺癌经长期酪氨酸激酶抑制剂治疗后，通过组织学转化为SCLC的耐药现象。该转化过程侵袭性强、预后差，是当前肺癌治疗中的重大临床挑战。生物学起源与分子机制 T-SCLC的发生机制主要存在两种假说：一是“共同祖细胞假说”，认为NSCLC与SCLC源于同一多能干细胞，在不同微环境中分化；二是“治疗诱导转化假说”，强调靶向或免疫治疗压力驱动NSCLC细胞发生基因与表观遗传改变，进而获得神经内分泌特征。相关研究证实，PI3K/AKT与Wnt/β-catenin信号通路的异常激活是转化的关键驱动因素，而抑制核输出蛋白XPO1或细胞周期激酶CDC7可有效阻断这一过程[37]。分子异质性与分型 T-SCLC内部具有显著异质性，转录组研究显示，T-SCLC可根据分子特征进一步分为两个亚型：LUAD样亚型（保留NKX2-1等高表达肺腺癌特征）和非LUAD样亚型（呈现典型SCLC分子表型）。这两类亚型在预后上存在显著差异，且基于分型的治疗匹配（如靶向治疗或化疗方案选择）可显著延长患者的无进展生存期，凸显了分子分型在指导精准治疗中的重要性[48]。转化后的分子特征与治疗新靶点绝大多数T-SCLC在转化后仍保留原发EGFR突变，同时高表达DLL3，这为使用DLL3靶向药物（如ADC或双特异性抗体）提供了理论依据。此外，T-SCLC常表现出Wnt通路激活、干细胞特性增强及免疫微环境抑制等特点，与原发性SCLC在通路富集和免疫特征上有所区别。治疗策略探索与展望目前T-SCLC尚无标准治疗方案，临床常用含铂化疗（如依托泊苷+铂类），但疗效有限。研究表明，基于分子亚型的治疗匹配可改善预后。此外，临床前研究表明，Lurbinectedin联合奥希替尼，在转化型SCLC模型中显示出协同抗肿瘤效果，为未来临床转化提供了新思路[39]。未来，针对DLL3等靶点的药物、化疗联合靶向或免疫抑制剂的策略，以及依据分子分型的个体化治疗，是突破T-SCLC治疗瓶颈的重要方向。总结与展望 SCLC的治疗领域正在经历一场深刻变革。治疗模式已从传统的放化疗，发展为免疫治疗巩固、免疫联合化疗一线标准，以及后线多种新型机制药物（如DLL3/CD3双抗、ADC）的应用。分子分型研究正逐步将SCLC从一种疾病解构为多种具有不同驱动特征的亚型，为精准治疗奠定基础。未来的发展方向可聚焦于：深化精准分型：基于多组学特征进一步细化亚型，并开发对应的靶向治疗。优化联合策略：探索ADC、双特异性抗体、免疫检查点抑制剂与化疗/抗血管生成药物之间的最佳组合序列。攻克转化型SCLC：明确其耐药与转化机制，开发如Lurbinectedin联合靶向药等有效疗法。探索新型靶点：随着对SCLC生物学理解的深入，如B7-H3、SEZ6、AURKA等新靶点相关的药物研发将持续推进。尽管挑战犹存，尤其是对于转化型SCLC患者，但不断涌现的临床与转化研究成果，正为改善SCLC这一难治性疾病的预后带来前所未有的希望。参考文献： 1. 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Simoes da Rocha, et al. Intracranial activity of ifinatamab deruxtecan (I-DXd) in patients (pts) with extensive-stage (ES) small cell lung cancer (SCLC) and baseline (BL) brain metastases (BM): Primary analysis of IDeate-Lung01.2025ESMO.2760MO.31. Hidetoshi Hayashi, et al. Ifinatamab deruxtecan (I-DXd) in extensive-stage (ES) small cell lung cancer (SCLC): Asian subgroup analysis from the phase II IDeate-Lung01 study. 2025 ESMO Asia Abstract 930MO.32. Wang J, Duan J, Wu L, et al. OA04. 06 efficacy and safety of HS-20093 in extensive stage small cell lung cancer in a multicenter, phase 1 study (ARTEMIS-001)[J]. Journal of Thoracic Oncology, 2024, 19(10): S17.33. MartinWermke, et al. DAREON-9, a phase Ib study of obrixtamig plus topotecan in patients (pts) with advanced small cell lung cancer (SCLC): Interim analysis results. 2025 ASCO abstract 8094.34. Solange Peters, et al. DAREON®-8: A phase I trial of first-line obrixtamig plus chemotherapy and atezolizumab in extensive-stage small cell lung carcinoma (ES-SCLC). 2025 ESMO. 2759MO .35. X Ai, YY Zhang, T Zhang, T Yi, M Li, W Yao, L Han, L Sun, A Liu, Q Mei, G Han, Z Zhang, Y Li, L Li, L Zheng, Y Fang, Y Luo, JJ Wu, S Lu, A phase 2 dose expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced small cell lung cancer, Journal of Clinical Oncology, 43 (2025) 8007-8007.36. Ying Cheng, et al. Benmelstobart with Anlotinib plus Chemotherapy as First-line Therapy for ES-SCLC: A Randomized, Double-blind, Phase III Trial. 2023 WCLC Abstract OA01.03.11.Dawei Chen, et al. Overall survival of adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line treatment for extensive-stage small cell lung cancer. 2024 ASCO Abstract 8014.37. Quintanal-Villalonga A, Durani V, et al. Exportin 1 inhibition prevents neuroendocrine transformation through SOX2 down-regulation in lung and prostate cancers. Sci Transl Med. 2023 Aug 2;15(707):eadf7006. doi: 10.1126/scitranslmed.adf7006. Epub 2023 Aug 2. PMID: 37531417; PMCID: PMC10777207.38. Sun H, Zhang CY, Zhang XH, et al. Transcriptomic analysis of transformed small-cell lung cancer from EGFR-mutated lung adenocarcinoma reveals distinct subgroups and precision therapy opportunities. Biomark Res. 2025;13(1):79. Published 2025 May 28. doi:10.1186/s40364-025-00789-939. Chakraborty S, Sen U, Vet al. Lurbinectedin sensitizes PD-L1 blockade therapy by activating STING-IFN signaling in small-cell lung cancer. Cell Rep Med. 2024 Dec 17;5(12):101852. doi: 10.1016/j.xcrm.2024.101852. Epub 2024 Dec 9. Erratum in: Cell Rep Med. 2025 Feb 18;6(2):101944. doi: 10.1016/j.xcrm.2025.101944. PMID: 39657664; PMCID: PMC11722101.

2026-02-02

·FierceBiotech

Daiichi stops internal development of next-wave ADC as key Datroway readout delayed again

Friday, Daiichi Sankyo further pushed back a closely watched readout from the phase 3 Avanzar trial for a combination of Datroway and AstraZeneca’s Imfinzi in first-line non-small cell lung cancer. \n Daiichi Sankyo’s development of antibody-drug conjugates continues to hit turbulence. Despite the success of Enhertu, the company has experienced two latest hiccups: the discontinuation of internal development of a next-wave candidate featuring its second ADC platform, and yet another delay for a highly anticipated phase 3 readout for AstraZeneca-partnered Datroway.Daiichi has ended internal development of DS-9606, a CLDN6-directed ADC “following a strategic portfolio review,” Daiichi’s R&D head Yuki Abe said during the company’s quarterly investor call Jan. 30. Abe suggested that “there is room for development” of DS-9606 with potential partners, given it has generated good results in germ cell tumor.DS-9606 is the first candidate using Daiichi’s modified pyrrolobenzodiazepine (mPBD) payload. Daiichi management argued that the decision was not about the mPBD platform but instead stems from “a business and portfolio perspective.”The data Daiichi gathered so far “confirmed the utility of this mPBD technology,” Abe said. Therefore, Daiichi plans to explore different targets and antibodies based on mPBD, he added.CLDN6 is expressed in several tumor types including endometrial, ovarian and gastric cancers, germ cell tumors and non-small cell lung cancer (NSCLC), according to Daiichi. Roche recently axed an anti-CLDN6 trispecific antibody developed by its Japanese subsidiary Chugai. Daiichi made a name in the ADC world with its DXd platform, which is used in both Enhertu and Datroway. But following the success of Enhertu, development of other DXd ADCs has been far from smooth sailing. Disappointing overall survival (OS) results forced AZ and Daiichi to withdraw their initial FDA application for Datroway in 2024 in a broad second-line nonsquamous NSCLC population.Friday, Daiichi further pushed back a closely watched readout from the phase 3 Avanzar trial for a combination of Datroway and AZ’s Imfinzi in first-line NSCLC. The partners now expect to report top-line data in the second half of 2026 rather than the first half, a delay from the original projection of 2025. The postponed timeline is the result of slower than expected event occurrence, according to Daiichi.The Avanzar study became complicated after AZ, based on second-line data, devised a new TROP2-based biomarker to select patients for Datroway. Progression-free survival (PFS) and OS for both the biomarker-defined population and all nonsquamous patients are the study’s primary endpoints.The trial is important because it’s the first for a TROP2 ADC in the first-line NSCLC setting, and it’ll help validate AZ’s biomarker strategy.In its quarterly update, Daiichi said it has added PFS and OS in TROP2-positive population as primary endpoints for the Tropion-Lung07 trial. The trial is combining Datroway with Merck & Co.’s Keytruda—rather than Imfinzi—in first-line nonsquamous NSCLC with PD-L1 expression below 50%. And the company plans to adopt “a similar strategy” for Tropion-Lung08, which is testing the Datroway-Keytruda combo in PD-L1-high patients and has a readout slated for the second half of 2026.Because the biomarker was developed to increase the probability of success for Datroway regimens, one analyst on the call questioned whether using it would be necessary for a Keytruda combination.“This was actually a topic of considerable internal discussion,” Abe said. “At one point, I personally thought that perhaps it was not necessary to add the biomarker.”However, Daiichi learned from experience that patients are “highly heterogeneous” in lung cancer, and it believes “the presence of this biomarker can offer significant benefits to patients,” Abe said.RelatedDaiichi Sankyo navigates complexity of success as Enhertu, Datroway push for market dominanceIn another update, Daiichi said patient recruitment has been stopped for Tropion-Lung12 “due to complexity of study operation.” The study was an adjuvant therapy trial for stage 1 NSCLC with ctDNA-positive or high-risk features evaluating Datroway in combination with AZ’s PD-1/TIGIT bispecific rilvegostomig. In another setback, Daiichi and partner Merck were recently hit with a clinical hold for their B7-H3-directed ADC ifinatamab deruxtecan (I-DXd) after logging an unexpected number of deaths of interstitial lung disease (ILD). The FDA has since lifted the hold, and the two companies have implemented a stricter risk management protocol, including exclusion of patients with high ILD risks and additional training of investigators and clinical trial staff.

临床3期抗体药物偶联物临床终止

2026-02-01

·医学界肿瘤频道

共悦 | 多靶点齐发，精准破局——肺癌ADC治疗领域全景洞察与未来展望

*仅供医学专业人士阅读参考纵观肺癌诊疗发展，从NSCLC到SCLC，从后线治疗的探索到前线治疗的推进，ADC药物正以多靶点布局优化肺癌精准治疗格局，为临床带来全新突破。肺癌治疗领域正迎来抗体偶联药物（ADC）引领的治疗模式转变。凭借“精准靶向”与高效载荷结合的独特优势，ADC已从后线探索迅速迈向治疗前沿，成为解决靶向耐药、应对治疗缺乏有效手段等临床困境的核心力量。当前，ADC在肺癌中的研发与应用已构建起一个“多靶点并行”的局面，在非小细胞肺癌（NSCLC）领域，针对HER2、TROP2、EGFR、c-MET等靶点的药物持续取得进展，从后线治疗积极向一线及围手术期拓展；在治疗手段相对有限的小细胞肺癌（SCLC）领域，以B7-H3、DLL3为靶点的ADC更是带来了新的疗效信号，开启了精准治疗的新篇章。与此同时，药物结构的持续优化、双靶点ADC等前沿技术的探索，以及与免疫、靶向药物的联合应用，正不断拓宽其治疗边界与潜力。在此背景下，医学界肿瘤频道特邀中国人民解放军总医院胡毅教授、张帆教授、王李杰教授及陶海涛教授就肺癌领域ADC进展与展望这一核心议题进行深入探讨，以助力肺癌诊疗水平的提升。宏观图景，多靶点构建肺癌ADC治疗新生态胡毅教授：回顾肺癌药物研发的历程，经历了从化疗到小分子靶向治疗，再到免疫检查点抑制剂的迭代。如今，ADC药物已成为肿瘤治疗领域的焦点。此前，肺癌治疗领域中ADC的探索还主要局限于HER2这一个靶点，目前该领域已进入多元化发展的新阶段。在NSCLC领域，针对HER2、TROP2、c-MET、EGFR、HER3等靶点的药物已相继获批或取得突破；甚至在长期缺乏有效后线治疗的SCLC领域，也成功解锁了B7-H3、DLL3等全新靶标。这种广泛的布局表明ADC已经具备了解决复杂临床问题的能力。在人群覆盖上，它不仅为HER2等基因突变患者提供了强有力的治疗选择，更凭借TROP2等泛表达靶点，覆盖了更广泛的肺癌人群。同时，得益于新一代ADC在载荷、连接子及偶联技术上的优化，药物的疗效和安全性得到平衡与提升。目前，ADC治疗正从后线积极向一线及围术期拓展，可以说，ADC已确立为肺癌精准治疗中的核心支柱。 NSCLC领域ADC药物的全景展现：从标杆确立到多元发展医学界：NSCLC约占总体肺癌的85%，患者群体庞大且异质性强[1]，当前ADC靶点已呈现“百花齐放”的态势。对于HER2这一成熟的靶点，T-DXd已确立为HER2突变NSCLC患者的治疗标杆。同时我们注意到，还有多款ADC药物也在该领域的研究取得显著进展。能否请您结合最新研究谈谈，当前HER2 ADC在NSCLC治疗中有哪些差异化的表现？这对于临床个体化选择有何启示？张帆教授： HER2突变是NSCLC的重要驱动基因亚型之一，约占总体NSCLC的2%-4%[2]。从临床角度看，HER2突变具有重要的预后预测价值。HER2突变NSCLC好发于非鳞状组织学类型、女性、无吸烟史及亚洲人群，且表现出明显的脑转移倾向，脑转移发生率可达47%[3]。然而，既往针对HER2突变晚期NSCLC的治疗选择匮乏，患者生存期普遍较短。在此背景下，T-DXd基于DESTINY-Lung02及中国桥接研究DESTINY-Lung05的数据，在后线治疗中确立了核心地位。全球II期DESTINY-Lung02研究显示，T-DXd（5.4mg/kg）在经治HER2突变患者中，经盲法独立中心审查确认的客观缓解率（ORR）达到50.0%，中位总生存期（OS）为19.0个月[4]。而更值得关注的是DESTINY-Lung05中国桥接研究的最终分析数据，T-DXd展现了优异的疗效，研究纳入34-76岁患者，独立中心评估确认的ORR提升至56.9%，疾病控制率（DCR）高达91.7%。其中位OS长达21.0个月[5]，刷新了HER2突变NSCLC后线治疗的生存纪录。此外，对于入组的30例（41.7%）伴有脑转移的患者，其中位中枢神经系统无进展生存期（PFS）达到了15.5个月，显示出良好的颅内活性。基于上述研究成果，T-DXd被纳入《2025版CSCO非小细胞肺癌诊疗指南》作为HER2突变NSCLC晚期二线治疗的I级推荐方案[6]。与此同时，国内自主研发的ADC药物在HER2领域展现出竞争潜力，且形成了差异化的研发路径。例如，SHR-A1811采用人源化抗HER2单克隆抗体，结合可裂解连接子与新型载荷，在HORIZON-Lung研究中显示出良好的临床疗效*。该研究纳入了50-64岁的患者，26%的患者基线存在脑转移。在此基线特征下，SHR-A1811在4.8 mg/kg剂量治疗经治HER2突变晚期NSCLC患者的ORR达74.5%，且安全性良好[7]。此外，采用双表位设计的TQB2102，旨在通过提升药物对HER2突变及过表达肿瘤细胞的结合亲和力与特异性进一步提高疗效，在早期临床研究中亦显示出对HER2突变及过表达人群的治疗潜力[8]。这些药物的涌现，不仅证明了国产ADC研发实力的提升，更为临床医生提供了更多元的治疗选择。医学界：相比HER2，TROP2靶点因其泛表达特性，承载了覆盖更广泛人群的期望。能否请您谈谈当前TROP2 ADC领域的研究进展如何？王李杰教授： TROP2作为一种在NSCLC中广泛表达的跨膜糖蛋白，受到广泛关注[9,10]。研究显示，TROP2过表达与肿瘤增殖、侵袭及不良预后相关[11]，使其成为ADC治疗的理想靶点。目前，TROP2 ADC已成为EGFR突变NSCLC后线治疗的重要选择。 Dato-DXd作为TROP2 ADC类药物的重要代表，在肺癌治疗领域已取得显著进展，尤其在经治的EGFR突变NSCLC患者中确立了治疗地位。TROPION-Lung01/05研究的汇总分析结果显示[12]，在总人群中（30%脑转移患者）经独立盲态中心评估确认的ORR为42.7%，完全缓解（CR）率为4.3%，中位PFS为5.8个月，中位OS为15.6个月；在奥希替尼经治人群中，ORR为44.8%，中位OS为14.7个月。Dato-DXd已获得FDA加速批准用于治疗既往接受过EGFR靶向治疗和含铂化疗的EGFR突变局部晚期或转移性NSCLC成人患者。在TROP2 ADC领域百花齐放的背景下，其他药物也各具特色，采用新型可裂解连接子与高活性毒素载荷的芦康沙妥珠单抗（SKB264）凭借III期OptiTROP-Lung04研究中延长的PFS结果[13]，已在中国获批用于EGFR-TKI耐药患者。相比之下，早期研发的戈沙妥珠单抗虽在肺癌后线单药治疗中未显示出显著的总生存获益[14]，但针对特定亚组及联合策略的探索仍在继续。基于在后线治疗中确立的疗效优势，Dato-DXd正积极向EGFR突变NSCLC的一线治疗前移，试图通过与第三代EGFR-TKI的联合应用实现突破。II期ORCHARD研究的数据为这一前线布局提供了初步支持，结果显示Dato-DXd联合奥希替尼二线治疗EGFR突变晚期NSCLC患者的中位PFS达到11.7个月（6mg/kg组），且起效迅速，中位至缓解时间仅为1.4个月[15]。基于此积极成果，III期TROPION-Lung14及TROPION-Lung15研究已启动，正分别针对未经治疗及奥希替尼治疗失败后的EGFR突变人群展开验证，以期覆盖更广泛的病程阶段。除了在驱动基因阳性人群中的纵向深耕，为进一步提升在驱动基因阴性人群中治疗的精准度，研究者们引入了TROP2定量连续评分-标准化膜比率（QCS-NMR）这一新型生物标志物，致力于实现从“泛靶点”向“精准分层”的跨越。QCS-NMR通过计算生物算法，精准界定TROP2在肿瘤细胞膜上的表达量与细胞质及膜总表达量的比值，从而量化评估抗原在细胞表面的呈现状态，以更敏锐地筛选优势人群。回顾性分析显示，在TROPION-Lung01研究的非鳞癌/non-AGA患者中[16]，TROP2 NMR阳性人群接受Dato-DXd治疗的ORR为36.8%，优于阴性人群的22.5%，中位PFS也从4.0个月延长至7.2个月，且在多西他赛组未见此预后价值。同样，在TROPION-Lung02一线联合治疗研究中[17]，NMR阳性患者的中位PFS达到12.0个月，长于阴性患者的8.1个月，并观察到了OS获益趋势。目前，全球首个将TROP2 NMR纳入主要终点的前瞻性III期临床试验AVANZAR正在进行中，旨在评估Dato-DXd联合免疫及化疗一线治疗晚期non-AGA NSCLC的疗效，有望为这一新型生物标志物提供最高级别的循证医学证据。与此同时，SKB264在一线治疗领域的探索也取得了进展。III期临床研究OptiTROP-Lung05旨在评估SKB264联合帕博利珠单抗对比帕博利珠单抗一线治疗PD-L1阳性局部晚期或转移性NSCLC的有效性和安全性。在预设的PFS期中分析中，经独立数据监查委员会（IDMC）确认该研究已达到主要终点，显示出统计学意义和临床意义的显著改善，但具体数据尚未公布，这标志着TROP2 ADC联合免疫疗法在肺癌一线治疗格局中正逐步占据重要地位。医学界：针对临床上棘手的EGFR-TKI耐药问题，除了上述靶点外，ADC药物在其他新兴靶点上还有哪些新的研究进展？张帆教授：在EGFR-TKI耐药机制的复杂版图中，c-MET扩增作为关键的旁路激活途径，已成为当前ADC研发的核心突破口。针对这一耐药难题，目前的研发策略主要聚焦于旁路靶点的精准打击与围绕EGFR主靶点的协同与优化两个维度。在旁路靶点探索方面，全球首款c-MET ADC药物Teliso-V已获FDA加速批准[18]，该药精准锁定c-MET高表达人群，填补了该类患者有效治疗手段的空白。与此同时，以ABBV-400为代表的新一代c-MET ADC也在迅速跟进，其在早期临床研究中显示出对不同c-MET表达水平人群均具有治疗潜力，有望进一步拓宽获益人群。除旁路阻断外，通过双特异性ADC或新型EGFR ADC对驱动基因本身的深度挖掘，同样是克服耐药的重要路径。双抗ADC药物BL-B01D1创新性地同时靶向并结合EGFR与HER3，实现对两个肿瘤相关靶点的同时阻断以此获得增强的抗肿瘤活性；Ⅰ/Ⅱ期研究数据显示，BL-B01D1单药在EGFR突变晚期NSCLC患者中整体的ORR为57.9%，中位PFS为6.9个月[19]。此外，直接靶向EGFR的ADC药物如SYS6010，则通过优化抗体亲和力与载荷设计，Ⅰ期研究数据显示，在19例EGFR-TKI耐药的敏感突变人群中取得了高达63.2%的ORR[20]。目前相关Ⅲ期研究正在开展中，期待它们将来能为不适合其他靶向治疗的患者开辟一条重要的治疗路径。打破SCLC后线治疗僵局，开启B7-H3与DLL3精准新篇章医学界：NSCLC治疗领域的进展令人鼓舞，而SCLC治疗领域长期以来后线治疗手段匮乏，患者预后极差。那么ADC药物也是当前SCLC领域的研究热点。那能否请您谈谈，ADC药物的出现是否为SCLC这一难治性肿瘤带来了治疗突破？陶海涛教授： SCLC作为一种高度侵袭性的神经内分泌肿瘤，长期面临“治疗手段少、复发转移快、预后差”的困境。免疫联合化疗是晚期SCLC的主要治疗方式，但疗效已达瓶颈，ORR有限[21]，且耐药后缺乏有效后续治疗。ADC药物的出现为SCLC治疗带来了转机。相较于传统化疗，ADC的精准靶向特性使其能精准定位肿瘤细胞并释放细胞毒药物，在提升疗效的同时，降低了对正常组织的损伤，让患者耐受性更好。 B7-H3在SCLC中呈高表达[22]，且在正常组织中表达受限，是理想的ADC治疗靶点。I-DXd作为首个探索SCLC治疗的B7-H3 ADC，其在II期IDeate-Lung01研究中展现了优异的疗效。在12mg/kg剂量组的总人群中，经BICR确认的ORR达到48.2%，DCR为87.6%，中位PFS和中位OS分别为4.9个月和10.3个月。二线疗效数值上更优，ORR高达56.3%，DCR达到96.9%，中位OS达到了12.0个月[23]。2025年ESMO Asia上公布的亚洲亚组分析数据与全球总体人群高度一致。此外，I-DXd对脑转移的控制效果出色。在65例基线伴有脑转移的患者中，颅内ORR为46.2%，其中30.8%的患者实现了颅内CR；对于有可测量颅内病灶的患者，CNS ORR更是高达65.5%；基线无脑转移患者接受I-DXd治疗后，出现脑部病灶进展事件较为少见，仅9例（12.5%）患者出现新发脑转移[24]，提示I-DXd可能具备预防脑转移的潜力。考虑到SCLC患者极易发生脑转移，这一特性对于改善患者生存质量和延长生存期具有重要意义。基于IDeate-Lung01研究成果，I-DXd已相继获得美国FDA和中国国家药品监督管理局药品审评中心（CDE）授予的突破性疗法认定。此外，其他靶向B7-H3的ADC药物在SCLC领域亦取得显著进展，HS-20093、YL201、QLC5508等均公布了早期研究数据，并已进入III期临床研究阶段。总之，靶向B7-H3的ADC药物的研发推进，不仅使SCLC患者在二线及后线治疗中获得了超越传统化疗的治疗选择，更有望填补SCLC精准治疗的空白，改变当前以化疗为主的后线治疗格局。另一方面，DLL3是Notch信号通路的抑制性配体，在85%的SCLC中表达，与肿瘤增殖、化疗耐药相关，而在正常肺组织中几乎不表达，成为理想的靶向位点[25]。虽早期药物Rova-T的研究未达预期，但新一代ADC药物如ZL-1310、DB-1314、FZ-AD005、SC-002、SHR-4849，重新挖掘了该靶点的治疗潜力。除DLL3、B7-H3靶点外，SEZ6等靶点ADC也有一定的研究进展。这些进展共同表明，ADC正在将SCLC从后线治疗匮乏的局面，转变为有多个精准靶向选择可能的“新战场”。展望肺癌全病程管理未来，描绘生物标志物与联合治疗蓝图胡毅教授：综合来看，肺癌ADC治疗已迈入多靶点、多场景、多机制协同发展的新阶段，HER2、TROP2靶点在NSCLC的持续深耕与B7-H3、DLL3靶点在SCLC的突破性进展，共同构建起完善的精准治疗体系。展望未来，肺癌ADC的发展将以多维协同为核心方向，精准分层的深化是重要基石，借助QCS-NMR等AI辅助数字化病理工具，可实现从“定性”到“定量”的患者筛选，为获益人群的精准匹配提供依据。此外，联合治疗的升级正持续拓展治疗边界，ADC与免疫、靶向药物的跨机制联合已展现强劲潜力，为临床治疗提供更多元的思路。与此同时，技术迭代与场景前移同步推进，双载荷ADC、免疫调节剂ADC等新型结构不断优化，ADC向围手术期新辅助/辅助治疗的拓展更是大势所趋，Dato-DXd的NeoCOAST-2和TROPION-Lung12研究正在积极推进，国产创新药SKB264联合奥希替尼或单药新辅助治疗EGFR突变NSCLC的II期临床试验（SKB264-II-18）也已获NMPA默示许可并即将进入临床阶段。这些前沿探索不仅进一步拓展了TROP2 ADC的应用场景，更有望为早期患者提供新的治疗策略，推动早期肺癌向“临床治愈”迈进。无论是国际药企的全球化布局，还是国产创新药的快速突破，最终都将落脚于改善患者生存，期待更多ADC成果转化为临床获益，为肺癌患者带来更长生存期。 *注：由于各研究在入组基线及用药剂量上存在差异，且非头对头研究，仅供数据参考，谨慎对比。专家简介胡毅教授中国人民解放军总医院上下滑动查看解放军总医院肿瘤医学部主任解放军总医院第一医学中心肿瘤中心主任国家教育部重点实验室、北京市重点实验室、全军肿瘤学重点实验室主任解放军总医院临床试验药理基地肿瘤专业组负责人主任医师、教授、博士生导师中央保健委员会会诊专家, 中央保健先进个人中央军委保健委员会专家组成员国家“百千万人才工程”有突出贡献中青年专家解放军医学杂志副主编中华肿瘤杂志编委 JCO中文版肺癌专刊主编中国临床肿瘤学会（CSCO）老年肿瘤防治专业委员会前任主任委员中国研究型医院学会分子肿瘤与免疫治疗专业委员会主任委员中国抗癌协会（CACA）小细胞肺癌专业委员会主任委员北京医学会肿瘤学分会候任主任委员中国临床肿瘤学会（CSCO）常务理事中国临床肿瘤学会（CSCO）非小细胞肺癌专委会常务委员中国临床肿瘤学会（CSCO）小细胞肺癌专委会常务委员中国临床肿瘤学会（CSCO）肉瘤和黑色素瘤专委会常务委员世界内镜协会呼吸内镜协会常务委员中国医师协会肿瘤多学科诊疗专业委员会常务委员中华医学会肿瘤学分会委员国家自然科学基金委员会评审专家专家简介张帆教授解放军总医院肿瘤医学部肿瘤内科副主任医师副教授军队高层次科技创新人才北京市科技新星中国临床肿瘤学会CSCO青委会常委北京癌症防治学会早诊早筛早治专委会副主任委员中国研究型医院协会分子肿瘤与免疫治疗专委会委员专家简介王李杰教授上下滑动查看肿瘤学博士解放军总医院肿瘤内科副主任医师中国老年保健协会胸部肿瘤精准治疗分会副主任委员北京慢性病防治与健康教育研究会肺癌专委会副主任委员中国研究型医院学会分子肿瘤免疫专业委员会委员中国研究型医院学会肿瘤专业委员会委员北京肿瘤学会肺癌专业委员会常务委员北京癌症防治学会肺癌免疫治疗专业委员会常务委员北京肿瘤防治研究会免疫分委会委员北京医学奖励基金会肺癌医学青年委员会委员承担参与国家、全军及省部级科研项目多项，发表论文40余篇，参编专著8部。专家简介陶海涛教授解放军总医院肿瘤学部副主任医师医学博士北京癌症防治学会肺癌免疫治疗专委会常委世界内镜医师协会呼吸内镜协会理事中国研究型医院学会肿瘤专业委员会委员中国肿瘤临床学会（CSCO）青年委员会委员参考文献： [1]中国临床肿瘤学会非小细胞肺癌专家委员会, PACC专家共识编写小组. EGFR PACC突变晚期非小细胞肺癌诊疗专家共识（2025版）[J]. 中华肿瘤杂志, 2025, 47(9): 811-829. [2]Reinhorn D, et al. Targeting HER2 in lung cancers: Evolving treatment landscape and drug development strategies. Cancer. 2025;131 Suppl 1:e35780. [3]Offin M, et al. Frequency and outcomes of brain metastases in patients with HER2-mutant lung cancers. Cancer. 2019;125(24):4380-4387. [4]Jänne PA, et al. Final Analysis Results and Patient-Reported Outcomes From DESTINY-Lung02-A Dose-Blinded, Randomized, Phase 2 Study of Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic NSCLC. J Thorac Oncol. Published online July 30, 2025. [5]Cheng Y, et al. Trastuzumab Deruxtecan in Patients From China With Pretreated HER2-Mutant NSCLC: Final Results From the DESTINY-Lung05 Study. 2025 WCLC. Abstract P2.10.12. [6]2025版《CSCO NSCLC诊疗指南》 [7]Lu S, et al. SHR-A1811, a HER2-directed antibody-drug conjugate (ADC), in advanced HER2-mutant non-small cell lung cancer (NSCLC): Updated phase 2 results from HORIZON-Lung. 2025 AACR. Abstract CT009. [8]Zhang L, et al. Efficacy and Safety of TQB2102, a Biparatopic HER2-Targeting ADC, in HER-2 Aberrant NSCLC: A Phase II Study. 2025 WCLC. WS04.12. [9]Guo X, et al. Tumor-associated calcium signal transducer 2 regulates neovascularization of non-small-cell lung cancer via activating ERK1/2 signaling pathway. Tumour Biol. 2017;39(3):1010428317694324. [10]Jiang A, et al. Expression and clinical significance of the Trop-2 gene in advanced non-small cell lung carcinoma. Oncol Lett. 2013;6(2):375-380. [11]Inamura K, et al. Association of tumor TROP2 expression with prognosis varies among lung cancer subtypes. Oncotarget. 2017;8(17):28725-28735. [12]Myung-Ju Ahn, et al. Efficacy and safety of datopotamab deruxtecan (Dato-DXd) in patients (pts) with previously-treated EGFR-mutated advanced non-small cell lung cancer (NSCLC): A pooled analysis of TROPION-Lung01 and TROPION-Lung05. 2024 ESMO Asia. LBA7. [13]Zhang L, et al. LBA5 Sacituzumab tirumotecan (sac-TMT) vs platinum-based chemotherapy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) following progression on EGFR-TKIs: results from the randomized, multi-center phase III OptiTROP-Lung04 study[J]. Annals of Oncology, 2025, 36: S1728-S1729. [14]Zhang L, et al. Efficacy and Safety of TQB2102, a Biparatopic HER2-Targeting ADC, in HER-2 Aberrant NSCLC: A Phase II Study. 2025 WCLC. WS04.12. [15]Le X, et al. Osimertinib (osi) + datopotamab deruxtecan (Dato-DXd) in patients (pts) with EGFR-mutated (EGFRm) advanced NSCLC (aNSCLC) whose disease progressed on first-line (1L) osi: ORCHARD. 2025 ELCC. Abstract 1O. [16]Garassino MC, et al. Normalized Membrane Ratio of TROP2 by Quantitative Continuous Scoring is predictive of Clinical Outcomes in TROPION-Lung 01. 2024 WCLC. PL02.11. [17]Benjamin Levy, et al. TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC). 2025 ASCO. Abstr#8501. [18]Jonathan W, et al. LUMINOSITY, a phase 2 study of telisotuzumab vedotin in patients with c-Met protein–overexpressing non-squamous EGFR -wildtype advanced NSCLC: Efficacy outcomes by prior therapy. Journal of Clinical Oncology (2025): n. pag. [19]Fang W, et al. Phase I/II Study of Iza-Bren (BL-B01D1) as Monotherapy in Patients With Locally Advanced or Metastatic EGFR Mutated NSCLC. 2025 WCLC. OA10.03. [20]Lu S, et al. First-in-human study of SYS6010, a novel EGFR targeting antibody drug conjugate (ADC) for patients with advanced solid tumors. 2025 AACR. CT008. [21]Horita N, et al. Topotecan for Relapsed Small-cell Lung Cancer: Systematic Review and Meta-Analysis of 1347 Patients. Sci Rep. 2015. [22]Carvajal-Hausdorf D, et al. Expression and clinical significance of PD-L1, B7-H3, B7-H4 and TILs in human small cell lung Cancer (SCLC)[J]. Journal for immunotherapy of cancer, 2019, 7(1): 65. [23]Ahn MJ, et al. Ifinatamab Deruxtecan (I-DXd) in Extensive-Stage Small Cell Lung Cancer: Primary Analysis of the Phase 2 IDeate-Lung01 Study. 2025 WCLC. OA06.03. [24]Rocha P, et al. Intracranial activity of ifinatamab deruxtecan (I-DXd) in patients with extensive-stage small cell lung cancer and baseline brain metastases: Primary analysis of IDeate-Lung01.2025 ESMO. 2760MO. [25]Bylsma LC, Pundole X, Ju CH, et al. Systematic Literature Review of the Prevalence and Prognostic Value of Delta-Like Ligand 3 Protein Expression in Small Cell Lung Cancer. Target Oncol. 2023;18(6):821-835. 本内容来自于中国医药教育协会的晚期肺癌多学科精准诊疗规范化项目，感谢第一三共(中国)投资有限公司支持。 *此文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场。更多医疗资讯，点击“阅读原文”查看

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适应症	最高研发状态	国家/地区	公司	日期
转移性去势抵抗性前列腺癌	临床3期	美国	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	中国	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	日本	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	阿根廷	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	奥地利	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	巴西	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	智利	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	哥伦比亚	Merck Sharp & Dohme LLC	2025-05-13
转移性去势抵抗性前列腺癌	临床3期	捷克	Merck Sharp & Dohme LLC	2025-05-13

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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


NCT06644781 (IDeate-Esophageal01, ESMO_ASIA2025)	临床3期	转移性食管鳞状细胞癌二线 B7 homolog 3 (B7-H3)	474	Ifinatamab deruxtecan (I-DXd) 12 mg/kg	網繭廠網網繭齋鑰積衊(齋艱艱網衊鹹鏇淵艱憲) = 糧糧網鏇觸顧願顧積襯醖衊選積製觸鹹蓋鬱糧 (壓鬱繭範壓選繭醖壓蓋 ) 更多	积极	2025-12-05
				Investigator’s choice of chemotherapy (paclitaxel, docetaxel, or irinotecan)	網繭廠網網繭齋鑰積衊(齋艱艱網衊鹹鏇淵艱憲) = 願遞積鏇鬱艱鬱築獵鏇醖衊選積製觸鹹蓋鬱糧 (壓鬱繭範壓選繭醖壓蓋 )
NCT05280470 (IDeate-Lung01, ESMO2025) 人工标引	临床2期	广泛期小细胞肺癌	137	I-DXd 12 mg/kg (with BL BM)	壓夢憲簾簾襯顧醖艱窪(蓋築範範鬱淵製構廠醖) = 窪獵鏇壓襯網憲願網廠壓壓夢鏇膚鬱窪鑰鑰淵 (淵觸構觸願遞鏇鏇簾蓋, 33.7 ~ 59.0) 更多	积极	2025-10-18
				I-DXd 12 mg/kg (No prior brain RT for BL BM)	壓夢憲簾簾襯顧醖艱窪(蓋築範範鬱淵製構廠醖) = 鬱鬱淵鬱膚廠夢構構蓋壓壓夢鏇膚鬱窪鑰鑰淵 (淵觸構觸願遞鏇鏇簾蓋, 37 ~ 77) 更多
NCT06780085 (KEYMAKER-U01, ESMO2025)	临床2期	转移性非小细胞肺癌	240	R-DXd 5.6 mg/kg Q3W	窪鬱窪襯鏇鹹顧願淵築(簾廠願顧鏇簾衊製鑰遞) = 醖齋鹽獵簾窪鏇積壓壓窪襯築鬱鑰築構醖觸憲 (憲鬱願醖鑰積繭夢淵築 )	积极	2025-10-17
				I-DXd 12 mg/kg Q3W	窪鬱窪襯鏇鹹顧願淵築(衊築觸衊廠製獵積製構) = 顧醖獵簾鏇蓋襯艱範遞簾願選觸觸夢夢鹹齋選 (鏇壓壓淵獵壓夢廠廠醖 ) 更多
NCT05280470 (IDeate-Lung01, WCLC2025)	临床2期	广泛期小细胞肺癌二线 \| 三线 \| 末线 B7-H3	137	Ifinatamab Deruxtecan (I-DXd) 12 mg/kg (second-line (23.4%) + third-line (54.7%) + fourth-line (21.9%))	簾願蓋範選淵顧鬱鏇觸(製選構顧積網蓋蓋憲衊) = 積構遞憲衊鏇顧壓蓋襯選鹹遞積齋衊鑰築積簾 (憲鑰齋鑰鹹積齋艱膚網, 39.6 ~ 56.9) 更多	积极	2025-09-09
NCT05280470 (IDeate-Lung01, WCLC2025 \| NEWS) 人工标引	临床2期	广泛期小细胞肺癌二线 \| 末线 \| 三线	137	Ifinatamab deruxtecan (I-DXd) 12 mg/kg every 3 weeks	選醖範夢糧築觸積繭廠(築選鹽製獵淵構蓋選鏇) = 築壓鬱鏇鏇齋壓醖壓積鹽膚網齋選窪淵憲蓋鬱 (齋遞醖簾簾齋艱膚廠積, 39.6 ~ 56.9) 更多	积极	2025-09-07
				Ifinatamab deruxtecan (I-DXd) 12 mg/kg every 3 weeks (2nd-line)	選醖範夢糧築觸積繭廠(築選鹽製獵淵構蓋選鏇) = 鬱獵鏇淵築夢築鏇齋窪鹽膚網齋選窪淵憲蓋鬱 (齋遞醖簾簾齋艱膚廠積, 37.7 ~ 73.6) 更多
NCT06362252 (IDeate-Lung03, ESMO2024)	临床1/2期	广泛期小细胞肺癌一线 \| 维持 B7 homolog 3 (B7-H3)	149	I-DXd 12 mg/kg + atezo maintenance	顧鏇遞壓夢築構繭製淵(積網淵網齋壓顧顧遞淵) = 齋鏇夢衊憲廠範窪鏇製顧糧齋糧淵遞淵鏇憲淵 (鑰夢餘壓襯築夢廠糧選 ) 更多	积极	2024-09-14
NCT05280470 (ESMO2024)	临床2期	广泛期小细胞肺癌	-	Ifinatamab deruxtecan 8 mg/kg	鹽範窪醖餘獵醖鑰餘餘(顧築鬱鑰窪廠艱夢艱壓) = 35% had Grade ≥3 TEAEs (47% in pts without BL BM) 膚網鏇築鹹衊襯鏇齋獵 (鏇淵願窪鑰糧膚簾憲願 ) 更多	-	2024-09-14
				Ifinatamab deruxtecan 12 mg/kg
NCT05280470 \| NCT04145622 (IDeate-L01, WCLC2024) 人工标引	临床1/2期	广泛期小细胞肺癌	256	I-DXd 8 mg/kg	簾網醖艱簾餘糧膚淵築(鏇選鹽範壓衊積廠簾顧) = 選選鬱醖憲積壓憲窪鹹膚鑰膚鹹餘齋繭網鹹壓 (壓餘願夢糧醖夢鏇觸廠 ) 更多	积极	2024-09-08
NCT05280470 (IDeate-Lung01, BusinessWire) 人工标引	临床2期	广泛期小细胞肺癌	88	Ifinatamab deruxtecan 12 mg/kg	壓夢襯獵鬱製鑰願鏇鑰(獵蓋範衊壓網餘觸襯餘) = 鹹選膚艱淵夢餘醖艱願壓艱憲網醖願網淵鹽顧 (範窪醖觸蓋選觸窪築繭, 38.7 ~ 70.2) 更多	积极	2024-09-07
				Ifinatamab deruxtecan 8 mg/kg	壓夢襯獵鬱製鑰願鏇鑰(獵蓋範衊壓網餘觸襯餘) = 壓淵獵築願鹹蓋範顧鹹壓艱憲網醖願網淵鹽顧 (範窪醖觸蓋選觸窪築繭, 14.3 ~ 41.1) 更多
NCT04145622 (ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	实体瘤	-	Ifinatamab deruxtecan (CRPC)	範蓋顧鑰膚鬱願衊範選(窪蓋鬱顧願顧淵淵憲範) = 願餘鬱襯夢鑰壓膚鹹觸壓鏇襯鬱齋積鹽顧獵醖 (製鑰網齋網齋廠鏇齋艱 ) 更多	积极	2023-10-23
				Ifinatamab deruxtecan (ESCC)	範蓋顧鑰膚鬱願衊範選(窪蓋鬱顧願顧淵淵憲範) = 鑰築構鹽簾獵襯範獵簾壓鏇襯鬱齋積鹽顧獵醖 (製鑰網齋網齋廠鏇齋艱 ) 更多