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马德里时间今天上午，ESMO 2026开幕 10月23日，西班牙马德里IFEMA，2026年欧洲肿瘤内科学会（ESMO）年会正式开幕。会期五天，到10月27日结束。 今年大会一共收录96项突破性摘要（LBA），其中12项进入最高规格的主席研讨会（Presidential Symposium）。中国药企相关的LBA有29项，占比刚过三成。 主席研讨会上，中国原研药占了5个席位。这个数字放在五年前，很难想象。 这29项里，15项是ADC，20项是III期临床。换句话说，中国创新药在ESMO舞台上拿出来的，不是早期探索数据，而是III期注册研究的顶线结果。 01 主席研讨会5席，都是什么药 12项主席研讨会LBA，中国占5席。逐一看： LBA6｜和黄医药 赛沃替尼+奥希替尼（SAFFRON研究） 适应症是奥希替尼耐药后、MET过表达/扩增的EGFR突变非小细胞肺癌。8月17日公布的顶线数据显示，联合疗法对比含铂双药化疗，PFS和OS均达统计学显著。阿斯利康已基于这项研究向FDA提交NDA。这是MET靶点在三代EGFR-TKI耐药后人群中，首个全球III期阳性结果，也是全口服无化疗方案。 LBA7｜康诺亚/乐普生物 CMG901（CLDN18.2 ADC） 二线及以上CLDN18.2阳性胃/胃食管腺癌。7月底公布顶线，OS显著改善且临床意义重大。这是全球首个OS阳性的抗CLDN18.2 ADC III期。这款药由阿斯利康负责全球开发，康诺亚与乐普生物共同研发。 LBA8｜康方生物 依沃西+化疗（HARMONi-GI1研究） 一线晚期胆道癌，对照组是度伐利尤单抗+化疗。8月25日公布顶线，OS统计学显著阳性。依沃西是PD-1×VEGF双抗，这是它在胆道癌领域首次拿下III期OS阳性。Summit Therapeutics负责海外权益。 LBA9｜翰森制药 HS-20093（B7-H3 ADC，Ris-Rez） 二线后复发难治骨肉瘤，对照组是吉西他滨+多西他赛。7月28日公布顶线，IRC评估PFS达到主要终点。这是近十年这个瘤种的首个阳性III期。GSK负责大中华区外权益，NDA已获CDE受理。 LBA11｜科伦博泰 sac-TMT（TROP2 ADC） 经治晚期/复发子宫内膜癌。5月18日公布，OS和PFS双主要终点均达成。默沙东牵头全球开发，中国权益在科伦博泰。这是首个在该适应症中同时证明OS和PFS获益的ADC。 5项主席研讨会，全部是III期，全部在会前已经公布了顶线阳性结果。ESMO大会本身要读出具体的HR和中位数数据。 02 ADC占了半壁江山 29项LBA里，ADC有15项，超过一半。其中3项是双抗ADC：百利天恒的BL-B01D1（EGFR×HER3双抗ADC）占了两项——一项乳腺癌（LBA50），一项三代EGFR-TKI耐药后NSCLC（LBA71）；正大天晴的TQB2102（HER2双表位ADC）是第三项。 TROP2 ADC是出现频次最高的靶点：科伦博泰的sac-TMT有3项LBA——子宫内膜癌（LBA11）、PD-L1阴性非鳞NSCLC（LBA66）、EGFR-TKI耐药后NSCLC（LBA67）。 B7-H3 ADC也有3项：翰森HS-20093（骨肉瘤LBA9）、宜联生物YL201（鼻咽癌LBA43）、映恩生物DB-1311（铂耐药卵巢癌，壁报）。 HER2 ADC至少4项：恒瑞SHR-A1811（HER2低表达乳腺癌LBA13）、正大天晴TQB2102（HER2低表达乳腺癌LBA27）、荣昌生物RC48（乳房外Paget病LBA61）。另外，石药/康宁杰瑞的HER2双抗KN026在乳腺癌（LBA15）和胃癌（LBA80）各有一项。 CLDN18.2 ADC有两项：康诺亚CMG901（主席研讨会LBA7）和信达生物IBI343（胃/胃食管腺癌LBA77，武田合作）。 一个明显的趋势：中国ADC的靶点覆盖面已经从HER2/TROP2扩展到B7-H3、B7-H4、CLDN18.2、Nectin-4、c-Met等新兴靶点，而且多个资产已经走到全球III期。 图｜29项LBA靶点分布或ADC占比示意图03 几家重点企业的数字 恒瑞医药这次拿了64项研究入选：3项Proffered Paper、3项Rapid Oral、32项壁报、26项电子壁报，创公司纪录。9月底前瞻口径还是"70余项"，最终以10月20日的64项为准。LBA层面，恒瑞有HER2 ADC SHR-A1811（乳腺癌LBA13）和HER3 ADC SHR-A2009（NSCLC LBA72）两项。 石药集团8项入选，其中2项LBA——都是与康宁杰瑞共研的HER2双抗KN026（乳腺癌LBA15、胃癌LBA80）。1项优选口头、3项快速口头、3项壁报、1项电子壁报。 百济神州（已更名BeOne Medicines）11项报告，核心亮点是泽尼达妥单抗+替雷利珠联合化疗一线HER2阳性胃食管腺癌的HERIZON-GEA-01第二次期中分析（LBA79），今天上午已报告。另有替雷利珠单抗系列的多项探索性分析。 复宏汉霖斯鲁利单抗10项研究入选。美国桥接研究ASTRIDE将在10月26日首次口头报告。根据公司公开摘要，201例美国ES-SCLC患者中，斯鲁利单抗组中位OS为12.4个月，对照组阿替利珠单抗组为10.2个月；24个月OS率分别为32.2%和17.6%。作为头对头桥接研究，这个数据为斯鲁利单抗在美国的注册提供了支持。 百利天恒的BL-B01D1（EGFR×HER3双抗ADC）有两项III期LBA：HR+/HER2-乳腺癌（LBA50）和三代EGFR-TKI耐药后NSCLC（LBA71），均与BMS合作开发。 信达生物的CLDN18.2 ADC（IBI343/TAK-921）有一项III期LBA（LBA77，武田合作），国内NDA已获优先审评。04 接下来四天，看什么 大会从10月23日持续到27日，LBA详细数据会在会期内陆续读出。几个关键时间点： 10月24日（周五）：翰森HS-20089（B7-H4 ADC，铂耐药卵巢癌）更长随访更新；康宁杰瑞JSKN033宫颈癌数据快速口头报告。 10月25日（周六）：和黄SAFFRON主席研讨会（LBA6）；康方HARMONi-GI1主席研讨会（LBA8）；宜联YL201鼻咽癌（LBA43）；科伦sac-TMT肺癌两项（LBA66/67）。 10月26日（周日）：和黄SANOVO中国研究（LBA69）；百利天恒iza-bren肺癌（LBA71）；恒瑞SHR-A2009 HER3 ADC（LBA72）；复宏汉霖ASTRIDE美国桥接；科伦TroFuse-005主席研讨会（LBA11）；君实NEOTORCH围术期NSCLC（LBA64）。 这些报告读出的HR、中位PFS/OS、安全性数据，才是最终判断药物价值的硬指标。05 为什么这件事值得关注 29项LBA、5个主席研讨会席位、15个ADC——三个数字放在一起，说明中国创新药在ESMO上的角色已经从"参与者"变成了"主要报告者"。 更值得注意的是合作模式。5项主席研讨会里，4项有跨国药企深度参与：阿斯利康（和黄SAFFRON、康诺亚CMG901）、GSK（翰森HS-20093）、默沙东（科伦sac-TMT）、Summit（康方依沃西）。中国原研药的全球权益，通过BD交易进入MNC的全球开发管线，然后以全球III期的形式回到ESMO舞台。 这不是简单的"中国药企在ESMO发文章"。中国资产已经成为全球肿瘤临床开发链条的一部分——靶点来自中国发现，全球多中心入组，MNC牵头国际注册，最后在国际顶会读出数据。 当然，顶线阳性只是第一步。HR值能不能到0.7以下，OS获益能不能转化为监管批准和临床标准治疗的更替，还要看后续的详细数据和监管反馈。 接下来四天，马德里还会读出更多数字。我们会持续跟踪。 识别微信二维码，添加生物制品圈小编，符合条件者即可加入 生物制品微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

17.4-month median OS in 2L SCLC (n=51) and 14.7-month median OS in 2L + ≥3L SCLC (n=101) 72.5% (37/51) ORR and 60.8% (31/51) cORR in 2L SCLC with 6.9-month median PFS; 68.3% (69/101) ORR and 54.5% (55/101) cORR in 2L + ≥3L SCLC with 6.8-month median PFS 76.9% (20/26) ORR and 65.4% (17/26) cORR in SCLC patients with brain metastases Efficacy observed in NECs, with 52.6% (10/19) ORR, 36.8% (7/19) cORR, 7.0-month median PFS and an 82.4% nine-month OS rate Grade ≥3 TRAE of 33.3% at the 2.4 mg/kg expansion dose. 2.5% treatment-related discontinuation rate and 0.8% Grade ≥3 ILD rate observed across the study (n=122) In IDEAYA's separate IDE849 global clinical study at the 2.4 mg/kg and 3.5 mg/kg expansion doses a Grade ≥3 TRAE rate of 5% (1/20) and 22.2% (4/18) have been observed, respectively Following successful Type C meetings with the U.S. FDA, IDEAYA is targeting to initiate two Phase 3 registrational trials with IDE849 in ES-SCLC and NEC. Evaluation of a potential 1L ES-SCLC Phase 3 study design is ongoing with continued data generation from several clinical combinations SOUTH SAN FRANCISCO, Calif., Oct. 23, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA) today announced updated clinical results that show promising anti-tumor activity and preliminary overall survival results for IDE849 (SHR-4849), its investigational antibody-drug conjugate (ADC) directed against delta-like ligand 3 (DLL3) and carrying a topoisomerase I (TOP1) inhibitor payload. IDEAYA's partner, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui), is presenting the results from its Phase 1 study in China in relapsed small cell lung cancer (SCLC) and other neuroendocrine carcinomas (NECs) at the European Society for Medical Oncology (ESMO) Congress 2026. The update builds on the initial findings Hengrui presented at the World Conference on Lung Cancer (WCLC) in 2025, adding longer follow-up, a larger patient population and the first OS results from the study. The findings show substantial anti-tumor activity together with more mature PFS results and encouraging preliminary overall survival, including median overall survival (OS) of 17.4 months in the second-line SCLC setting. "We are highly encouraged by the first-reported preliminary median overall survival and 9-month landmark OS results observed for IDE849 monotherapy in both relapsed SCLC and NEC, respectively. We look forward to advancing IDE849 globally with our partner Hengrui, as we target to advance registrational studies in the high unmet medical need indications of SCLC and NEC. IDEAYA also looks forward to providing the first efficacy and safety update from our global clinical study of IDE849 monotherapy, including in the post-Imdelltra SCLC and relapsed NEC settings," said Yujiro S. Hata, Chief Executive Officer and Chairman, IDEAYA Biosciences, Inc. Key data highlights from the ESMO 2026 presentation At the August 21, 2026 data cutoff, 122 patients had enrolled, including 103 with SCLC and 19 with other NECs at IDE849 doses ≥1.8 mg/kg IV dosed once every 3-weeks (Q3W). Median follow-up was 12.1 months (interquartile range: 8.2–16.0 months). Among patients with SCLC, 78.6% (81/103) had received prior immunotherapy, 49.5% (51/103) had one prior line of therapy (2L), and 50.5% (52/103) were heavily pre-treated having received two or more prior lines (≥3L) of treatment. Efficacy in previously treated SCLC Overall response rate (ORR) and confirmed overall response rate (cORR) results for SCLC patients receiving IDE849 at doses ≥1.8 mg/kg IV Q3W are summarized below. ORR includes confirmed and unconfirmed responses. Response rates in the brain metastases subgroup represent overall tumor response; the poster does not report an intracranial response rate. In IDEAYA's separate ongoing global clinical study, intracranial tumor shrinkage has been observed in the SCLC setting. In second-line (2L) SCLC (n=51), median OS was 17.4 months (95% CI: 9.9–not reached), and median PFS was 6.9 months (95% CI: 5.5–8.3). Across previously treated (2L + ≥3L) SCLC patients (n=101) receiving doses ≥1.8 mg/kg, median OS was 14.7 months (95% CI: 11.9–18.3), and median PFS was 6.8 months (95% CI: 5.5–8.1). The survival analyses included 55 OS events (53.9%) and 86 PFS events (84.3%). In patients with brain metastases, confirmed ORR was 65.4% (17/26; 95% CI: 44.3–82.8), with disease control observed in all 26 patients. The longer follow-up provides a more mature assessment of progression free survival (PFS) and the first assessment of preliminary OS reported from the study. The WCLC 2025 analysis had a median follow-up of 3.5 months and reported median PFS of 6.7 months in previously treated SCLC, with median PFS not yet reached in the second-line setting. The ESMO update includes a larger population and patients treated at doses ≥1.8 mg/kg Q3W. Efficacy in other neuroendocrine carcinomas Among 19 patients with other NECs, ORR was 52.6% (10/19; 95% CI: 28.9–75.6), confirmed ORR was 36.8% (7/19; 95% CI: 16.3–61.6), and disease control rate was 84.2% (16/19). Median PFS was 7.0 months and the nine-month OS rate was 82.4%, supporting further evaluation beyond SCLC. High DLL3 expression (reference: Front. Endocrinol., 11 August 2026) has been reported across multiple solid tumor subtypes of NECs that remain areas of high unmet medical need with few treatment options, including gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) and large cell neuroendocrine carcinoma (LC-NEC). The projected annual incidence of GEP-NEC and LC-NEC globally (excluding China) in the metastatic setting, is projected to be approximately 40,000 patients and 30,000 patients, respectively. In the major market countries of the US, EU5, and Japan, the GEP-NEC and LC-NEC metastatic annual incidence is projected to be approximately, 7,000 patients and 8,000 patients, respectively. There are multiple additional subtypes of NECs that have high DLL3 expression, including bladder and cervical, among others. Safety in SCLC and other neuroendocrine carcinomas At the expansion dose of 2.4 mg/kg, the most common treatment-related adverse events were neutrophil count decrease, white blood cell count decrease, and anemia. At the 2.4 mg/kg expansion dose, the Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 33.3% of patients and the serious TRAEs occurred in 15.2% of patients. The investigators reported a safety profile comparable to that observed previously and reported at the WCLC in 2025. Across all 122 patients and all dose levels, the most common Grade 3 or higher TRAEs were hematologic. Across the dose escalation, Grade 3 or higher TRAEs occurred in 59.8% (73/122) of patients, and serious TRAEs occurred in 21.3% (26/122). TRAEs led to dose reductions in 18.9% (23/122) and treatment discontinuation in 2.5% (3/122) of patients. One treatment-related death due to pneumonia was reported (0.8%), which is the same patient that was reported at WCLC 2025. Across the study (n=122), Grade 1 to 2 interstitial lung disease (ILD) was observed in 6.6% (n=8) of patients and Grade ≥3 ILD in 0.8% (n=1). IDEAYA's separate ongoing Phase 1/2 global study of IDE849 in extensive-stage SCLC (ES-SCLC) and NEC is enrolling patients in the Americas, Europe, and Asia. The company is evaluating several expansion doses to determine the recommended Phase 3 dose (RP3D), including 2.4 mg/kg and 3.5 mg/kg IV Q3W. As of an October 1, 2026 data cut-off, a Grade ≥3 TRAE rate of 5% (1/20) at 2.4 mg/kg and 22.2% (4/18) at 3.5 mg/kg have been observed. The most common adverse events were hematologic, including neutropenia, white blood cell count decrease, and anemia, and the maximum tolerated dose (MTD) was determined to be 4.2 mg/kg. IDEAYA is targeting to provide a clinical efficacy and safety update from the global Phase 1/2 trial of IDE849 monotherapy by the end of 2026 or early in 2027, with a focus on post-Imdelltra ES-SCLC and relapsed NEC. Based on successful Type C meetings with the U.S. Food and Drug Administration (FDA), IDEAYA is targeting to initiate two randomized global Phase 3 registrational trials with IDE849 in ES-SCLC (post-Imdelltra) and NEC. The company is also evaluating a potential trial design for a Phase 3 registrational trial in 1L SCLC, pending data from its Phase 1 combination cohorts with IDE161 (PARG inhibitor) and Astra Zeneca's PD-L1 antibody, durvalumab. ESMO 2026 presentation details Poster number: 3815P Title: SHR-4849 (IDE849), an ADC targeting delta-like ligand 3 (DLL3), in relapsed small cell lung carcinoma (SCLC) and other neuroendocrine carcinomas (NECs): long-term results from the phase 1 study Lead author: Haifeng Liu, Clinical Research Ward, Jilin Cancer Hospital, Changchun, China Presentation date and time: Monday, October 26, 12:00-12:45pm CET About IDE849 IDE849 (SHR-4849) is an investigational ADC that combines a humanized anti-DLL3 IgG1 antibody with a TOP1 inhibitor payload through a cleavable linker. The program is designed to target DLL3-expressing cancers, including SCLC and other NECs. In December 2024, IDEAYA licensed the global development and commercialization rights to IDE849 outside of Greater China from Hengrui. About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies to address unmet medical needs in cancer. The company integrates small-molecule drug discovery, structural biology and bioinformatics with extensive capabilities in identifying and validating translational biomarkers to develop potentially first-in-class targeted therapies for selected patient populations. IDEAYA has built a robust pipeline of targeted therapies focused on synthetic lethality and antibody-drug conjugates, or ADCs, including bispecifics, with the goal of improving clinical outcomes for patients with cancer. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding the implications of the Phase 1 IDE849 data presented at ESMO 2026 for future clinical development and outcomes; the potential significance of the observed response, progression-free survival, overall survival and safety results in relapsed SCLC and other NECs; the potential therapeutic benefit, clinical activity, safety and tolerability of IDE849 as monotherapy and in combination with other therapies; the selection of a recommended Phase 3 dose; the timing, availability and content of an efficacy and safety update from IDEAYA's global clinical study, including the planned update by the end of 2026 or early 2027 in post-Imdelltra ES-SCLC and relapsed NEC; IDEAYA's plans to initiate two randomized global Phase 3 registrational trials of IDE849 in post-Imdelltra ES-SCLC and NEC, including their timing and design; the evaluation of a potential Phase 3 registrational trial in first-line SCLC and the potential for data from Phase 1 combination cohorts with IDE161 and durvalumab to support such a trial; the projected incidence of metastatic NEC subtypes and the associated potential market opportunity; and the anticipated benefits of IDEAYA's collaboration with Hengrui. These statements reflect IDEAYA's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. The data reported from Hengrui's Phase 1 study and IDEAYA's ongoing global Phase 1 study may change with additional follow-up and may not be reproduced in subsequent trials. Results across studies, dose levels, patient populations and treatment settings may differ. Early clinical results from small patient populations may not predict results in larger or later-stage trials, and single-arm studies do not establish comparative efficacy or safety. IDE849 may not demonstrate the anticipated efficacy, survival benefit, safety or tolerability, and adverse events may emerge with further treatment and follow-up. IDEAYA may experience delays in dose selection, clinical data updates, trial initiation or enrollment. Regulatory authorities may require changes to proposed trial designs or additional data, and clinical results may not support further development or regulatory approval. FDA feedback from Type C meetings does not guarantee acceptance of final trial designs or regulatory approval. Estimates of disease incidence and potential market opportunity are subject to uncertainty and may differ from actual patient populations or commercial opportunities. IDEAYA also depends on Hengrui and other third parties for aspects of the IDE849 program. Additional risks and uncertainties are described in IDEAYA's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K filed February 17, 2026, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These forward-looking statements speak only as of the date of this press release. IDEAYA undertakes no obligation to update or revise them, except as required by law. Investor and Media Contact IDEAYA Biosciences Joshua Bleharski, Ph.D. Chief Financial Officer [email protected] SOURCE IDEAYA Biosciences, Inc. 21% more press release views with Request a Demo