Raludotatug deruxtecan

New data from six landmark trials reinforce practice-changing results of Enhertu and Datroway across a broad spectrum of patients in breast and lung cancer Additional analyses from two trials of raludotatug deruxtecan in ovarian cancer demonstrate emerging potential in gynecological cancers TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 30 abstracts, including four late breaking presentations, in multiple cancers at the 2026 European Society for Medical Oncology (#ESMO26) Congress. New data from six landmark trials demonstrate the company’s progress toward advancing new standards of care for patients in breast and lung cancer, including the DESTINY-Breast05 ( 539RO ), DESTINY-Breast06 ( 4279P ), DESTINY-Breast09 ( LBA49 ), DESTINY-Breast11 ( 543RO ) and DESTINY-Lung04 ( LBA74 ) phase 3 trials of Enhertu ® (trastuzumab deruxtecan) and the TROPION-Breast02 ( LBA96 ) phase 3 trial of Datroway ® (datopotamab deruxtecan). Additional data at ESMO also will spotlight the company’s commitment to advancing research for patients with advanced ovarian cancer across lines of therapy. An updated analysis, including progression-free survival and duration of response, will be presented from the REJOICE-Ovarian01 ( 1331P ) phase 2/3 trial evaluating raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. A mini oral presentation will highlight preliminary findings from the REJOICE-Ovarian02 ( 1247RO ) phase 1b/2 trial evaluating raludotatug deruxtecan in combination with bevacizumab in patients with platinum-resistant ovarian cancer. “The promising data for raludotatug deruxtecan in ovarian cancer and the robust scientific innovation demonstrated across our pipeline reflects our progress in advancing research for patients across multiple types of cancer,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “Daiichi Sankyo continues to draw from its scientific and technological expertise to turn science into new medicines that can change the standard of care.” Data Demonstrate Benefit of DXd ADCs in Patients with Brain Metastases Research updates highlighting the impact of DXd ADCs in patients with brain metastases include late-breaking rapid oral and proffered paper presentations from the DESTINY-Breast09 ( LBA49 ) phase 3 trial evaluating Enhertu in combination with pertuzumab as a first-line treatment for patients with HER2 positive metastatic breast cancer and the TROPION-Breast02 ( LBA96 ) phase 3 trial evaluating Datroway as a first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option. Final overall survival results of the TUXEDO-3 ( 690O ) phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with active brain metastases from metastatic breast cancer, advanced non-small cell lung cancer (NSCLC) or leptomeningeal disease from any solid tumor will be presented as a proffered paper. New Data and Trials-in-Progress Presentations Across DXd ADC Portfolio Additional data highlighting new research across the DXd ADC portfolio include oral and poster presentations, including final results of the TALENT ( LBA23 ) phase 2 trial of Enhertu alone or in combination with anastrozole, or in sequence with chemotherapy, as neoadjuvant treatment for patients with HR positive, HER2 low early stage breast cancer. New data in NSCLC include the NeoCOAST-2 ( 4244RO ) phase 2 trial reporting event-free survival results, as well as findings on the association of ctDNA clearance with clinical outcomes in patients with resectable, early stage NSCLC treated with a combination of Datroway plus durvalumab and chemotherapy, and a retrospective analysis evaluating mechanisms of insensitivity to the Datroway payload in subgroups of patients with advanced NSCLC in the TROPION-Lung01 ( 4451P ) phase 3 trial. Updated findings from the EPOC2003 ( 2888P ) phase 2 trial evaluating neoadjuvant chemotherapy in combination with Enhertu in patients with HER2 positive gastric cancer: results from ESPERANZA ( 1014P ), an external comparator study evaluating Enhertu versus real-world standard of care as a second line or later treatment for patients with HER2 IHC 3+ solid tumors; and, the primary analysis evaluating patritumab deruxtecan monotherapy in patients with melanoma in the HERTHENA-PanTumor01 ( 2073RO ) phase 2 trial also will be presented. Trials-in-progress poster presentations include the DESTINY-Breast Guide ( 1795TiP ) prospective and interventional trial evaluating first-line treatment with Enhertu plus pertuzumab followed by palbociclib, endocrine therapy and dual HER2 blockade (trastuzumab plus pertuzumab), as well as retreatment with Enhertu following progression on maintenance therapy (palbociclib, endocrine therapy and trastuzumab plus pertuzumab) in previously untreated patients with HER2 positive advanced or metastatic breast cancer and the TROY ( 1335TiP ) phase 2 trial evaluating Enhertu in patients with recurrent ovarian cancer with disease progression on prior PARP inhibitor therapy. An overview of late-breaking, clinical data and trials-in-progress presentations from the ADC portfolio of Daiichi Sankyo includes: Presentation Title Author Abstract Presentation (CEST) LBAs Final results of TALENT: a neoadjuvant trial of T-DXd with or without anastrozole, or in sequence with chemotherapy for HER2-low, HR+ early-stage breast cancer S. Hurvitz LBA23 Proffered Paper Presentation Friday, October 23 1:30 pm – 3:00 pm First-line datopotamab deruxtecan (Dato-DXd) vs. chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: exploratory analysis of patients with brain metastases in TROPION-Breast02 R. Dent LBA96 Proffered Paper Presentation Saturday, October 24 8:30 am – 10:00 am First-line trastuzumab deruxtecan (T-DXd) in patients with HER2-mutant NSCLC: patient-reported outcomes from DESTINY-Lung04 S. Novello LBA74 Rapid Oral Presentation Saturday, October 24 8:30 am – 10:00 am DESTINY-Breast09 analysis of trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab for patients with HER2+ advanced/metastatic breast cancer and baseline brain metastases C. Saura LBA49 Rapid Oral Presentation Monday, October 26 10:15 am – 11:45 am Breast DESTINY-Breast11: MRI-assessed objective responses during neoadjuvant treatment with trastuzumab deruxtecan (T-DXd) followed by paclitaxel + trastuzumab + pertuzumab vs. dose-dense doxorubicin + cyclophosphamide followed by THP in HER2+ early breast cancer J.F. Boileau 543RO Rapid Oral Presentation Friday, October 23 4:15 pm – 5:45 pm Patient-reported outcomes from DESTINY-Breast05: health-related quality of life with trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with high-risk HER2 positive early breast cancer C. Barrios 539RO Rapid Oral Presentation Friday, October 23 4:15 pm – 5:45 pm Paired-biopsy multi-omic analysis reveals target-independent mechanisms of antibody-drug conjugate resistance in metastatic breast cancer P. Tarantino 4449RO Rapid Oral Presentation Monday, October 26 10:15 am – 11:45 am Trastuzumab deruxtecan (T-DXd) vs. physician’s choice of chemotherapy in HR+, HER2 low metastatic breast cancer: a DESTINY-Breast06 ctDNA molecular response analysis G. Curigliano 4279P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm Trastuzumab deruxtecan (T-DXd) + pembrolizumab in previously treated human epidermal growth factor receptor 2-expressing advanced or metastatic breast cancer: primary analyses of the breast cohorts from the open-label, multicenter, phase 1b study DS8201-A-U106 H. Rugo 1771P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm DESTINY-Breast Respond HER2 low Europe non-interventional study of trastuzumab deruxtecan (T-DXd) in HER2 low metastatic breast cancer: update on baseline characteristics and anti-emetic treatment J.Y. Pierga 12P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Improving accuracy in HER2 ultralow identification: multi-site validation of an AI-decision support tool B. Van der Vegt 1784P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Comparative evaluation of 7 artificial intelligence tools for HER2-low and ultralow scoring in breast cancer J.S. Frenel 287P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm A global, interventional, open-label trial of trastuzumab deruxtecan (T-DXd)-based therapy followed by palbociclib, endocrine therapy, and dual HER2 blockade in first-line human epidermal growth factor receptor positive, hormone receptor-positive advanced or metastatic breast cancer and retreatment with T-DXd (DESTINY-Breast Guide) S. Sammons 1795TiP Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Lung NeoCOAST-2: association of ctDNA clearance with clinical outcomes in a global platform phase 2 perioperative trial T. Cascone 4244RO Rapid Oral Presentation Sunday, October 25 8:30 am – 10:00 am Mechanisms of insensitivity to the datopotamab deruxtecan (Dato-DXd) payload in subgroups of patients with advanced non-small cell lung cancer in TROPION Lung01 N. Girard 4451P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer: IDeate-Lung01 updated results M. Ahn 3842P Poster Presentation Monday, October 26 12:00 pm – 12:45 pm Ovarian Raludotatug deruxtecan (R-DXd) + bevacizumab in participants with platinum-resistant recurrent ovarian cancer: results for cohort B-1 of the phase 1b/2 REJOICE-Ovarian02 study A. Oaknin 1247RO Rapid Oral Presentation Saturday, October 24 08:30 am – 10:00 am Raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer: an updated analysis of efficacy and tolerability from the phase 2 part of REJOICE-Ovarian01 K. Hasegawa 1331P Poster Presentation Monday, October 26 12:00 pm – 12:45 pm A randomized phase 2, open-label, multicenter, study of trastuzumab deruxtecan versus investigator’s choice chemotherapy in recurrent ovarian cancer that progressed on prior PARP inhibitor therapy: TROY (APGOT-OV14) J.Y. Lee 1335TiP Poster Presentation Monday, October 26 12:00 pm – 12:45 pm Gastric Quality-adjusted time without symptoms or toxicity (Q-TWiST) of trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with HER2+ unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma from DESTINY-Gastric04 M. Gumus 2925P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm Perioperative trastuzumab deruxtecan plus capecitabine and durvalumab in HER2 positive gastric or gastroesophageal junction cancer: a phase II study (EPOC2003) D. Takahari 2888P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm PanTumor Final results of the TUXEDO-3 phase II trial of patritumab deruxtecan (HER3-DXd) in active brain metastases and leptomeningeal disease M. Preusser 690O Proffered Paper Presentation Sunday, October 25 10:15 am – 11:45 am Patritumab deruxtecan (HER3-DXd) in melanoma after anti-PD-(L)1 therapy: primary analysis from HERTHENA-PanTumor01 M. McKean 2073RO Rapid Oral Presentation Sunday, October 25 10:15 am – 11:45 am ESPERANZA: Results from an external comparator study of trastuzumab deruxtecan in HER2 IHC3+ solid tumors F. Meric-Bernstam 1014P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of nine ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. Additional ADCs being developed by Daiichi Sankyo include DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING, and DS1025, which consists of a CD25 directed antibody attached to an immuno-oncology optimized cytotoxic payload. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610, DS3790 and DS1025 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 (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit . Contacts MEDIA CONTACTS: Global: Jennifer Brennan Jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com

2026年10月23日至27日，欧洲肿瘤内科学会（ESMO）年会在西班牙马德里举行。作为全球三大肿瘤学会议之一，今年大会的看点高度集中在两个词上：ADC与双抗。 ADC（抗体偶联药物）：把单克隆抗体与细胞毒小分子通过连接子拼成一个分子，靠抗体将毒性药物精准递送到肿瘤细胞，兼顾靶向性与杀伤力。双抗（双特异性抗体）：一个抗体分子携带两个不同的抗原结合位点，可同时抓住两个靶点、或把T细胞桥接到肿瘤细胞旁，实现单抗做不到的协同。 中国原研的存在感同样明显。多家券商统计显示，本届大会官网披露的90余项最新突破性摘要（LBA）中，中国研究入选约29项，约占全部LBA的三分之一、创历史新高；12项主席研讨会（Presidential Symposium）LBA中，5项来自中国药企，占比超40%，覆盖肺癌、胆道癌、胃癌、骨肉瘤等，均为注册性III期确证性研究。 比数量更关键的是终点。过去中国创新药在顶级会议上多是“早期疗效展示”，今年多项注册性III期研究首次把OS、PFS这类硬终点摆上台面。下面把产品干货与配套诊断一并聚合，全文按“会议全程+收官日”组织，最后一天的新读数集中在第八至第十节。 一、总盘子：29项LBA、5项主席论坛 先说口径。国金证券统计中国入选LBA为28项，世纪证券29项；若纳入海外合作方主导的中国分子全球研究，爱建证券宽口径可达32项。无论哪种口径，“约占总数三分之一、创历史新高”一致，涉及约20家中国药企。 从治疗类型看，ADC是最拥挤的赛道：29项中国LBA中ADC占15项、超过一半，其中3项为双抗ADC——百利天恒的iza-bren两项、正大天晴的TQB2102一项。 二、5项主席论坛中国研究，逐项看数据 1）赛沃替尼+奥希替尼：SAFFRON（LBA6）。和黄医药与阿斯利康合作，口服MET抑制剂赛沃替尼（沃瑞沙®）联合三代EGFR-TKI奥希替尼（泰瑞沙®），对照铂类双药化疗，用于奥希替尼治疗后进展、伴MET过表达或扩增的EGFR突变非小细胞肺癌。BICR评估的中位PFS为7.6个月 vs 5.4个月（HR 0.55，进展或死亡风险降45%），中位OS 17.8个月 vs 12.9个月（HR 0.68，死亡风险降32%），1年OS率70% vs 53%。这是MET靶点在三代EGFR-TKI耐药人群的首个全球III期阳性结果，也是全口服、免化疗方案；数据同步发表于《新英格兰医学杂志》，阿斯利康已据此向FDA提交上市申请。同一组合的SANOVO研究（LBA69）在中国做一线MET过表达人群。该方案要求入组前明确MET状态，检测结果直接决定患者能否用上这一组合。 2）CLDN18.2 ADC：CLARITY-Gastric01（LBA7）。康诺亚、乐普生物与阿斯利康合作的CMG901（AZD0901，Sone-Ve），用于二线及以上CLDN18.2阳性（≥25%）的晚期胃或胃食管结合部腺癌，全球III期约594例、19国175家中心，主要研究者为中山大学肿瘤防治中心徐瑞华教授。这是全球首个OS阳性的抗CLDN18.2 ADC III期研究；但另一双主要终点BICR评估的PFS仅呈改善趋势、未达统计学显著，“适用人群是约38%还是约60%”因此成为现场讨论焦点。而这一切的前提，是一次CLDN18.2免疫组化检测。 3）依沃西单抗：HARMONi-GI1（LBA8）。康方生物的PD-1/VEGF双抗依沃西单抗联合化疗，头对头对比度伐利尤单抗联合化疗，一线治疗晚期胆道癌，入组682例，主要研究者为复旦大学附属中山医院周俭院士。mOS 14.9个月 vs 12.1个月（HR 0.75），mPFS 8.4个月 vs 5.8个月（HR 0.61），ORR 53.8% vs 32.5%。这是依沃西在肺癌之外的首个III期阳性结果，PD-1/VEGF双抗的价值正从肺癌向消化道肿瘤延伸。国内已拟授予优先审评，海外由合作伙伴Summit Therapeutics推进。 4）B7-H3 ADC：ARTEMIS-011（LBA9）。翰森制药与GSK合作的B7-H3靶向ADC（Ris-Rez），关键性III期用于骨肉瘤，复发难治人群中PFS阳性、间质性肺炎可控，入选主席论坛。GSK同场还带来双方合作的B7-H3、B7-H4 ADC全球进展。 5）TROP2 ADC：TroFuse-005。科伦博泰与默沙东合作的芦康沙妥珠单抗（sac-TMT，佳泰莱®），用于既往接受过治疗的晚期或复发性子宫内膜癌，776例随机入组。PFS 7.2个月 vs 3.9个月（HR 0.59），OS 19个月 vs 12.1个月（HR 0.68），ORR 35.1% vs 17.3%。这是sac-TMT首个公开读出的全球III期研究，也是首个在子宫内膜癌同时观察到PFS与OS获益的ADC。 三、ADC主线：靶点竞赛从“验证”走向“排序” ADC的竞争重心，已从“技术能不能成”转向“哪款分子、在哪个瘤种、用哪个靶点排序更优”： 恒瑞医药本届共64项抗肿瘤及相关研究成果入选，涉及21款创新药，其中3项为优选论文口头报告。焦点之一是HER2 ADC瑞康曲妥珠单抗（SHR-A1811）的HORIZON-Breast06研究，用于HER2低表达晚期乳腺癌：全人群mPFS 16.4个月 vs 6.8个月（HR 0.27），ORR 75.5% vs 41.2%。另一款HER3 ADC瑞康芦泽妥塔单抗（SHR-A2009）的HERON-Lung01研究，用于EGFR-TKI进展后的EGFR突变NSCLC，在会上公布III期期中分析。这类ADC的入组依赖HER2低表达判定（IHC 1+，或IHC 2+且ISH阴性），检测结果本身就是用药“入场券”。 科伦博泰的sac-TMT另有两条硬数据：OptiTROP-Lung06（LBA66）评估其联合帕博利珠单抗一线治疗PD-L1阴性晚期非鳞状NSCLC，中位PFS 15.0个月 vs 5.7个月（HR 0.49），是全球首个ADC联合免疫检查点抑制剂在PD-L1阴性一线非鳞状NSCLC达到主要终点的III期研究，成果同步发表于《新英格兰医学杂志》；OptiTROP-Lung04（LBA67）读出经EGFR-TKI治疗后进展人群的最终OS，中位OS 25.9个月 vs 17.4个月（HR 0.69）。此外，B7-H3 ADC SKB500首次公布治疗广泛期小细胞肺癌的I期数据。 信达生物的坦康阿妥塔单抗（IBI343）是CLDN18.2 ADC，其治疗CLDN18.2阳性晚期经治胃或胃食管结合部腺癌的中日国际多中心III期G-HOPE-001以LBA形式口头报告，是全球首个提交上市申请的CLDN18.2 ADC。同场还可见其PD-1×IL-2双抗IBI363、EGFR×B7H3双抗ADC IBI3001。 中国生物制药（正大天晴）的TQB2102是HER2双表位ADC，同时靶向HER2的ECD2与ECD4结构域，采用可裂解连接子与拓扑异构酶I抑制剂载荷，两项临床数据分别入选优选口头报告与快速口头报告，涵盖HER2低表达乳腺癌等方向。映恩生物的B7-H3 ADC DB-1311联合PD-L1/VEGF-A双抗治疗晚期实体瘤的II期数据也在会上披露。 四、双抗与IO 2.0：PD-1/VEGF是主战场 ADC拼“载荷与连接子”，双抗拼的则是“把两个信号通路装进一个分子”。本届这一赛道的国产分子格外密集： 康方生物依沃西单抗（PD-1/VEGF）以胆道癌III期站上主席论坛；三生制药的707、荣昌生物的RC148押注PD-1×VEGF；泽璟制药的ZG005走PD-1×TIGIT路线；百济神州的BGB-B2033为GPC3×4-1BB双抗；基石药业的CS2009是PD-1/VEGF/CTLA-4三抗，已在肺癌与结直肠癌读出数据；信达生物的IBI363则是PD-1×IL-2。真正用头对头III期证明“单分子双靶点优于现有免疫联合方案”的，目前主要是依沃西的胆道癌数据。 五、还有几项值得单独记一笔 百利天恒的伦康依隆妥单抗（宜泽康®，iza-bren，EGFR×HER3双抗ADC）本届共有4项研究入选。其联合帕博利珠单抗一线治疗复发或转移性头颈部鳞癌的II期数据显示：2.5mg/kg组ORR 57.9%、cORR 47.4%、DCR 81.6%，中位缓解持续时间13.6个月，中位PFS 8.5个月，中位随访16.6个月时mOS尚未达到，且未报告间质性肺炎事件。同日公布的二线EGFR突变NSCLC III期PANKU-Lung01结果以LBA形式发布，并同步登上《柳叶刀》主刊。 微芯生物的西达本胺联合纳武利尤单抗一线治疗晚期黑色素瘤III期（LBA54）：mPFS 11.7个月 vs 7.4个月（HR 0.73），ORR 41.4% vs 32.3%。迈威生物的Nectin-4 ADC 9MW2821用于三阴性乳腺癌，口头报告ORR 30%、DCR 80%。再鼎医药公布zoci联合阿替利珠单抗一线治疗广泛期小细胞肺癌的全球Ib期首个数据；荣昌生物共21项研究入选，亚盛医药、君实生物等也有多项报告。 六、诊断产品与伴随诊断：检测端成了“准入项” 药物越精准，对检测的依赖就越硬。本届ESMO多个III期研究的入组门槛本身就是一次分子检测：SAFFRON要看MET过表达或扩增，CLARITY-Gastric01要看CLDN18.2阳性（≥25%），子宫内膜癌的HER2状态也需检测明确。ADC与双抗的“精准”，有一半写在诊断端。 伴随诊断（CDx）：与特定药物绑定、用于筛选用药人群的体外诊断产品，药物获批往往要求有配套的检测方法。ctDNA：肿瘤释放到血液中的游离DNA，可无创反映肿瘤的基因状态与负荷。MRD（微小残留病灶）：治疗后残存的极微量癌细胞，靠ctDNA等高灵敏检测发现，用于评估复发风险与随访策略。IHC／FISH：免疫组化与荧光原位杂交，分别检测蛋白表达与基因扩增，是肿瘤组织标志物检测的两大常规手段。 先看组织标志物检测。CLDN18.2阳性胃／胃食管结合部腺癌的筛选以免疫组化（IHC）为主，但不同研究的抗体克隆、检测平台与判读标准并不统一，原发灶与转移灶、膜性与胞质染色的差异都可能影响结果可靠性——这也是CLARITY-Gastric01现场讨论“适用人群到底多大”的技术根源。靶向CLDN18.2的治疗已覆盖单抗（佐妥昔单抗）、ADC、双抗与CAR-T（如科济药业舒瑞基奥仑赛）。另一个方向是把门槛做低：SEZ6靶向ADC ABBV-706按1%（1+）阈值IHC阳性率达93%，且跨治疗线数稳定。 再看液体活检与MRD。本届大会把微小残留病灶（MRD）检测列为官方核心议题之一，ESMO转化研究奖得主Dan Landau教授的报告即围绕“可规模化、普适的残留病灶检测”。具体研究里，FLAURA2用微滴数字PCR（ddPCR，Biodesix）追踪血浆EGFR突变清除，ABBV-706把ctDNA清除与PFS、OS改善关联，一项DLBCL研究中8例达完全缓解的患者在缓解时ctDNA MRD阴性率100%。国内华大基因已推出“华见微”肿瘤MRD定制化检测产品；胃癌领域，《胃癌分子残留病灶检测与临床应用中国专家共识（2023版）》推荐进展期胃癌根治术后可考虑做MRD检测。 更现实的变化发生在产业侧。伴随诊断正从配角变成药物开发的同步项：艾德生物、燃石医学、世和基因等国内企业均在布局，而监管侧临床证据门槛抬升（要求配对样本、与原研药头对头比对）后，“药诊联合开发”比“先做CDx再找药物桥接”更稳妥。合规能力也被拉到台前——2026年9月，艾德生物自研的AmoyDx HRD Complete Panel获欧盟IVDR认证，成为中国诊断企业开发并上市的首个IVDR伴随诊断产品（Class C）。与此同时，各省病理类医疗服务价格目录陆续落地，肿瘤基因检测的院内收费路径明确，对质控完备的头部企业是实质利好。 七、国际看点：mRNA疫苗与小细胞肺癌的一线维持 中国管线之外，本届最受关注的国际研究有几项，收官日读数尤其值得记： DeLLphi-305（LBA3，SCLC一线维持）：安进的DLL3×CD3双抗塔拉妥单抗联合度伐利尤单抗，对照度伐利尤单药。mOS 21.1个月 vs 12.7个月（HR 0.42，死亡风险降58%），mPFS 7.4个月 vs 1.9个月（HR 0.34），ORR 26.4% vs 4.1%，数据同步发表于《新英格兰医学杂志》——破局点不在“单药更强”，而在维持期方案的重构。 VOLGA（LBA2，MIBC围手术期）：度伐利尤单抗联合Nectin-4 ADC维恩妥尤单抗的新辅助方案，对照标准治疗。EFS HR 0.51（复发、进展或未手术风险降49%），OS HR 0.58（死亡风险降42%），2年EFS 64% vs 45%。 INTerpath-001（LBA1，黑色素瘤辅助）：默沙东与Moderna的个体化肿瘤疫苗intismeran autogene联合帕博利珠单抗，对照帕博利珠单抗加安慰剂。RFS HR 0.58、DMFS HR 0.62；OS HR 0.77，未达预设显著性边界但方向一致，提示“疫苗+免疫”仍需优化给药节奏。 此外，第一三共的CDH6 ADC raludotatug deruxtecan在铂耐药卵巢癌II期中ORR达50.5%；礼来的FR靶向ADC、阿斯利康Enhertu的辅助治疗数据也在会上公布。 八、收官日中国新读数：从“跟随终点”到“定义新标准” 会议最后一天的优选口头报告又补上几项中国主导的III期读数——对照臂直接指向当前国际标准方案，等于用中国人群数据重设基准。 G-HOPE-001：信达生物IBI343。坦康阿妥塔单抗（CLDN18.2 ADC）用于后线CLDN18.2阳性胃癌：mPFS 7.1个月 vs 3.1个月（进展风险降约55%），mOS 10.2个月 vs 6.9个月（死亡风险降约43%）；消化道毒性少见，≥3级恶心0.9%、呕吐2.6%。疗效与安全性标签一起，构成它的核心竞争位。 HEALER：石药集团与康宁杰瑞的HER2一线组合。安尼妥单抗联合白蛋白多西他赛，对照THP方案（曲妥珠单抗+帕妥珠单抗+紫杉类），一线治疗HER2阳性乳腺癌，PFS显著优于当前标准；研究同步发表于《新英格兰医学杂志》，成为内地乳腺癌领域首篇登上该刊的研究。 TQB2102：正大天晴的HER2双表位ADC。HER2低表达乳腺癌中PFS风险降低71%，间质性肺炎（ILD）发生率仅2.2%；胃癌方向联合贝莫苏拜单抗，ORR达84.2%（6mg组95.8%）。双表位设计叠加可裂解连接子，指向“更大覆盖人群、更低毒性”的排序逻辑。 与此同时，主导权也在挪动。徐兵河院士（HEALER、HORIZON系列）、沈琳教授（G-HOPE）、周俭院士（HARMONi-GI1）、陆舜与谢璐等在主席会场直接发声；复旦大学附属肿瘤医院戴波团队的AI术前沟通随机对照研究入选快速口头报告，说明“临床工程化”类研究也开始进入国际会议主线。 九、临床路径重构：这些瘤种的决策变量变了 把这些读数放回日常诊疗，变化落在几个决策点上： 广泛期小细胞肺癌：一线“化疗+免疫”后未进展的患者，维持期从“免疫单药”转向“免疫+DLL3 T细胞衔接器”，中位OS 21.1个月成为新的参照系。 膀胱癌（肌层浸润性）：非顺铂人群的围手术期，从单纯膀胱切除转向“免疫+ADC新辅助”，EFS与OS双终点均见获益。 EGFR突变NSCLC耐药后：必须做MET的IHC／FISH检测；MET过表达或扩增人群，赛沃替尼+奥希替尼成为新标准，而不再是直接上含铂化疗。 胃癌后线：CLDN18.2检测从“可选项”变成“必检项”；信达IBI343、阿斯利康Sone-Ve、康诺亚CMG901同台竞速，选择时需要区分表达阈值与安全性标签。 胆道癌：PD-(L)1联合化疗的基准被依沃西改写，但仍需等待全球多中心验证与国内审评口径确认。乳腺癌：HER2低表达与HR+后线格局重排——TROP2 ADC、HER2双表位ADC、双抗ADC三线同台，化疗锚点继续后移。 贯穿这些变化的，是同一条主张——沈琳、徐兵河、周俭等专家多次强调“以中国人群数据反哺国际指南”，它正从口号落到具体的对照臂设计上。 十、产业与资本：BD、板块共振与政策变量 数据之外，会议期间最直接的反应在交易和盘面。翰森制药与罗氏达成ADC平台授权：4亿美元首付款、1.1亿美元周年款项，外加最高150亿美元以上的里程碑，覆盖两款临床前ADC及多靶点合作；招银国际与中金公司随即把目标价上调至50–52港元——市场验证的不是单个分子，而是“平台级”的估值逻辑。康方生物生态侧，阿斯利康向Summit Therapeutics战略投资20亿美元，推进依沃西与Sone-Ve等联合开发，HARMONi-GI1的阳性数据进一步强化“双抗出海”叙事。 板块层面，ESMO周的创新药Beta行情启动，10月26日医药生物板块活跃，港股通创新药ETF连续走强；机构的判断逻辑从“研发叙事”切换到“收入与里程碑兑现”。交易结构也在变：MNC抢购中国ADC／双抗早期资产时，条款正从“首付款+销售分成”升级为“平台合作+美国商业化选择权”。政策变量上，限制出口技术目录的修订预期，使源头创新的护城河权重上升。 国产阵容也完成一次“结构升级”。信达、百利天恒、翰森、科伦博泰、恒瑞、康方、正大天晴等构成本届主矩阵；科创板群体（百济、君实、荣昌、迈威、百奥泰）从单品展示转向“平台化管线输出”。可及性信号同样明确：IBI343成为全球首个报产的CLDN18.2 ADC，TQB2102已报产；CLDN18.2、MET、HER2低表达等伴随诊断的国内需求即将放量；若OS与PFS双达标，后续医保准入谈判的锚点也可能从“单药ORR”转向“总生存质量调整年”。 十一、这届ESMO该怎么读 第一，叙事换挡。过去三年中国创新药靠license out集中“亮相”，本届则是多项注册性III期在全球舞台完成数据兑现——衡量标准从“登上多少讲台”变成“对照更严、随访更长后，硬终点是否仍站得住”。 第二，注意终点之间的一致性。同一个研究里PFS与OS同为阳性最理想；出现“OS阳性而PFS未达统计学显著”（如CLARITY-Gastric01）或“OS尚不成熟”的情况，需结合亚组、表达阈值和随访时长再判断，不能只看单一数字。 第三，ADC的下一阶段竞争围绕耐药与排序。首批ADC已验证“靶向递送细胞毒载荷”的可行性，接下来的问题是：双表位、双抗ADC能否覆盖更大的人群、能否与免疫治疗形成协同、以及在不同治疗线数里怎么排兵布阵。 第四，看清数据来源与口径。本文数据来自公司公告、大会公开摘要与券商研报的公开报道，各家统计口径存在差异（如LBA数量28/29/32项之分），请以大会官网摘要与公司披露原文为准。 第五，看组合主权。ESMO 2026的意义，不在于“中国药企第一次亮相”，而在于中国研究者开始定义适应症标准、中国平台被MNC按平台定价。接下来的议题，会从“数据是否阳性”转向“谁拥有联合疗法的组合主权”。写在最后：肿瘤治疗格局的变化，往往先从一场会议上的几个HR值开始。对从业者而言，本届ESMO最值得带的，不是“中国占三分之一”这句话，而是那些已进入全球III期兑现期的分子——它们的下一次读数，才真正决定谁能被写进指南与处方。免责声明：本文内容基于公开信息整理，仅用于信息交流与知识分享，不构成任何投资建议或诊疗依据；具体临床决策请以药品说明书、监管机构批准信息及临床医生意见为准。