Rilvegostomig

The first patient has been dosed in the TROPION-Urothelial04 phase 3 trial evaluating Datroway® (datopotamab deruxtecan) plus rilvegostomig or Datroway monotherapy versus current standard of care (durvalumab monotherapy or nivolumab monotherapy or enfortumab vedotin plus pembrolizumab) as an adjuvant treatment (after surgery) in patients with muscle invasive urothelial cancer (MIUC) at high risk of recurrence following radical surgical resection with or without prior neoadjuvant therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). Rilvegostomig is AstraZeneca’s anti-PD-1/TIGIT dual checkpoint inhibitor bispecific antibody. MIUC is a highly progressive disease, representing approximately 30% of all urothelial cancer cases.1,2 While adjuvant immunotherapy remains standard of care in the muscle invasive setting, many patients still face a high risk for disease recurrence after surgery, underscoring the need for new treatments that can further improve long-term outcomes.3 There are currently no TROP2 directed medicines approved for the treatment of urothelial cancer. “Following the encouraging results in the urothelial cancer cohorts of the TROPION-PanTumor03 and TROPION-PanTumor01 trials, we are now evaluating the combination of Datroway and rilvegostomig in earlier lines of treatment for this disease,” said Abderrahmane Laadem, MD, Head, Therapeutic Area Oncology Development, Daiichi Sankyo. “TROPION-Urothelial04 marks our second pivotal trial in urothelial cancer as we continue to identify different types of cancer where Datroway may contribute to improving outcomes for patients.” “Patients with muscle invasive urothelial cancer continue to face a significant risk of disease recurrence despite recent new advances,” said Leora Horn, MD, FRCPC, Senior Vice President, Late Development Oncology, AstraZeneca. “TROPION-Urothelial04 will allow us to further evaluate the potential of Datroway in combination with rilvegostomig to help advance treatment approaches and move closer to a cure for these patients with significant unmet need.” Daiichi Sankyo and AstraZeneca also are evaluating Datroway plus platinum-based chemotherapy compared to gemcitabine and platinum-based chemotherapy in patients with metastatic urothelial carcinoma following progression during or after treatment with enfortumab vedotin in combination with pembrolizumab in the TROPION-Urothelial03 phase 2/3 trial. TROPION-Urothelial04 is a global, multicenter, three-arm open-label phase 3 trial where patients will be randomized in a 2:1:2 ratio to evaluate the efficacy and safety of Datroway in combination with rilvegostomig or Datroway monotherapy versus current standard of care (durvalumab monotherapy or nivolumab monotherapy or enfortumab vedotin plus pembrolizumab) in patients with high-risk MIUC, including those with residual disease at surgical resection following neoadjuvant therapy and those with high-risk disease after surgery without neoadjuvant therapy. The primary endpoint of TROPION-Urothelial04 is disease free survival (DFS) as assessed by investigator for the combination of Datroway and rilvegostomig versus standard of care. Key secondary endpoints include DFS as assessed by blinded independent central review, disease specific survival, non-urothelial tract recurrence-free survival, distant metastasis-free survival, patient reported outcomes, overall survival and safety. TROPION-Urothelial04 will enroll approximately 915 patients across multiple sites in Asia, Europe, North America, Oceania and South America.. The TIGIT component of rilvegostomig is derived from the clinical-stage anti-TIGIT antibody, COM902, developed by Compugen Ltd. (Nasdaq/TASE: CGEN). The most common type of bladder cancer is urothelial cancer, accounting for approximately 90% of cases.4 Urothelial cancer can originate in the upper urinary tract (renal pelvis, ureter) or the lower urinary tract (bladder, urethra).5 Muscle invasive urothelial cancer is a highly progressive disease, which occurs when the cancer has spread to the muscle walls of the bladder and represents approximately 30% of all urothelial cancer cases.1,2,6 More than 635,000 bladder cancer cases were diagnosed globally in 2024, and while the five-year survival rate for localized urothelial and bladder cancer is more than 70%, survival decreases to approximately 9% in the metastatic setting.6,7,8 While adjuvant immunotherapy remains standard of care in the muscle invasive setting, many patients still face a high risk for disease recurrence after surgery, underscoring the need for new treatments that can further improve long-term outcomes.3 TROP2 is a protein broadly expressed in several solid tumors including urothelial cancer.9 TROP2 expression is positively correlated with disease severity in patients with urothelial cancer.10 Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, Datroway is one of seven 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-TROP2 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 more than 30 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy based on the results from the TROPION-Breast02 trial. Datroway (6 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial. Datroway (6 mg/kg) is approved in Brazil, Russia, Singapore and the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on the results from TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in a confirmatory trial. A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The program includes eight phase 3 trials in lung cancer, five phase 3 trials in breast cancer, one phase 3 trial and one phase 2/3 trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings. 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. The content above comes from the network. if any infringement, please contact us to modify.

📝 研报客AI助手-AI报告总结 创新药边际催化：2026 WCLC和ESMO重点管线和时间点总结核心内容概览 2026年WCLC和ESMO年会将聚焦于创新药临床试验数据的读出，重点关注双抗和ADC（抗体药物偶联物）领域的最新进展。这些数据将有助于验证药物的临床疗效、安全性以及潜在的市场价值，为药物研发和商业化提供重要依据。双抗竞争格局靶点分布 主要靶点包括：VEGF类、TGF-β、CTLA-4、4-1BB、TIGIT、IL-15、IL-2等。 PD-(L)1/VEGF类双抗是最为拥挤的赛道，已有多个药物进入临床III期或获批上市。 重点药物及进展 依沃西单抗（Ivonescimab）：康方生物研发，已在中国获批上市，在美国申请上市，处于临床III期阶段。 特泊利单抗（Tebotelimab）：Macrogenics研发，处于临床III期。 沃苏米单抗（Volrustomig）：Medimmune研发，处于临床III期。 卡度尼利单抗（Cadonilimab）：康方生物研发，已在中国获批上市。 雷格苏米单抗（Rilvegostomig）：阿斯利康研发，处于临床III期。 SHS-006：圣和药业研发，处于临床III期。 关键信息 PD-(L)1/VEGF类双抗已有多款药物实现出海，竞争激烈。 IO耐药市场在非小细胞肺癌领域有140亿美金的潜在市场空间。 LBA（Late-Breaking Abstract）是大会中最具含金量的数据展示形式，其次是常规口头报告（ORAL）和壁报展示（Poster）。 ADC竞争格局靶点分布 广谱靶点：TROP2、HER3、B7H3等。 消化道靶点：CLDN18.2和CDH17竞争尤为激烈。 重点药物及进展 Trodelvy：吉利德研发，已获批上市。 DB-1311：映恩生物研发，处于临床III期，安全性较好。 JMT108：石药创新研发，PD-1×IL-15双功能融合，具有拖尾效应。 ZG005：泽璟制药研发，PD-1×TIGIT双抗，联合HLX43 ADC。 HS-20122：翰森制药研发，EGFR×c-MET双抗ADC，处于临床I期。 CM518D1：康诺亚研发，CDH17 ADC，处于临床I期。 HDM2017：华东医药研发，CDH17 ADC，处于临床I期。 JK06：信立泰研发，5T4 ADC，处于临床I期。 关键信息 DB-1311联合BNT327为进度最快的双抗+ADC管线，有望推动IO2.0+ADC的发展。 EGFR ADC在一线治疗中表现突出，需关注其安全性和疗效。 WCLC和ESMO数据读出时间表 WCLC：关注一线治疗非小细胞肺癌（NSCLC）的双抗和ADC数据，如RC148、SSGJ-707、JS207、LBL-024、Iza-bren、SYS6010等。 ESMO：关注多瘤种I/II期数据、非小细胞肺癌二线+数据、其他适应症数据（如胃癌、MSS CRC、神经内分泌肿瘤等）。 重点关注药物和数据多瘤种I/II期数据 DB-1311/BNT324：映恩/BioNTech，B7-H3 ADC + PD-L1/VEGF双抗，II期试验。 JMT108：津曼特生物/石药创新，PD-1×IL-15双功能融合，I/II期试验。 ZG005：泽璟制药，PD-1×TIGIT双抗，联合HLX43 ADC，II期试验。 IBI3001：信达生物，EGFR×B7H3双抗ADC，I期试验。 HS-20122：翰森制药，EGFR×c-MET双抗ADC，I期试验。 CM518D1：康诺亚，CDH17 ADC，I期试验。 HDM2017：华东医药，CDH17 ADC，I期试验。 JK06：信立泰，5T4 ADC，I期试验。 非小细胞肺癌一线数据 RC148：荣昌生物，PD-1×VEGF，联合化疗一线晚期NSCLC，Ph1试验。 SSGJ-707 / PF-08634404：辉瑞/三生，PD-1×VEGF，联合化疗晚期NSCLC，II期试验。 LBL-024：维立志博，PD-L1×4-1BB，联合化疗一线晚期NSCLC，II期试验。 IBI363：信达生物，PD-1×IL-2α，联合化疗一线晚期NSCLC，Ib/II期试验。 Iza-bren (BL-B01D1)：百利天恒，EGFR×HER3双抗ADC，II期试验。 SYS6010：石药，EGFR ADC，联合化疗一线晚期NSCLC，II期试验。 非小细胞肺癌二线+数据 IBI363：信达生物，PD-1×IL-2α，联合贝伐 vs 多西他赛 2L IO耐药肺腺癌，Ib期试验。 依沃西单抗（AK112）：康方生物，PD-1×VEGF，联合贝伐 + 化疗 2L 晚期胃/GEJ腺癌，II期试验。 SKB264 + K 药：科伦博泰，TROP2 ADC + PD-1，NSCLC 2L，II期试验。 其他适应症数据 LBL-025：维立志博，PD-L1×4-1BB，MSS CRC，II期试验。 Sac-TMT：科伦博泰，TROP2 ADC，mTNBC III期试验。 RC118 + RC148：荣昌生物，CLDN18.2 ADC + PD-1×VEGF，联合治疗晚期胃/GEJ腺癌，Ph2试验。 Pumitamig：普米斯/BioNTech，PD-L1×VEGF-A，联合化疗二线晚期神经内分泌肿瘤，II期试验。 LBL-024：维立志博，PD-L1×4-1BB，联合化疗一线晚期肺外神经内分泌癌，Ib/II期试验。 ZG005：泽璟制药，PD-1×TIGIT，±化疗一线晚期宫颈癌，II期试验。 关键信息总结 双抗：PD-(L)1/VEGF类药物竞争最为激烈，已有部分药物获批上市或进入III期临床。 ADC：TROP2、HER3、B7H3等靶点管线较多，CLDN18.2和CDH17在消化道肿瘤中竞争激烈。 数据读出：WCLC和ESMO年会是获取关键临床数据的重要窗口，重点关注LBA、ORAL和Poster展示。 市场潜力：IO耐药市场在非小细胞肺癌领域有巨大潜力，需关注不同双抗和ADC在一线和二线治疗中的表现。 投资评级说明 行业投资评级：推荐、中性、回避。 上市公司投资评级：买入、增持、中性、回避。 分析师声明与免责声明 本报告基于合规数据来源，分析逻辑基于作者职业理解，结论独立、客观、公正。 本报告仅供参考，不构成投资建议，投资者需自行评估风险。 报告正文 免费获取报告源文件，请点下方图片 📚 文章推荐 📌 20260817-南京证券-创新药边际催化_2026_WCLC和ESMO重点管线和时间点整理_10页... 📌 20260825-招银国际-药明合联-02268.HK-Capacity_expansion_sup... 📌 20260823-湘财证券-药品行业周报_AI重塑药物研发早期范式_溢出效应正向上游传导_9页_73... 📌 20260822-西南证券-医药行业周报_mRNA肿瘤疫苗突破_相关板块情绪有所波动_30页_4mb... 📌 深度报告-2026-08-22-西南证券-医药行业周报_mRNA肿瘤疫苗突破_相关板块情绪有所波动_... 📌 20260823-华源证券-医药行业周报_中报陆续披露_重视传统BigPharma机会_14页_2m... 📌 海外CXO-生命科学上游2Q26业绩剖析_早研需求已达实质性向上拐点_普遍上调2026年业绩指引_5... 📌 海外AI制药系列1_五大技术路径_市场测算与监管演进全景_AI重构制药工业核心变量_31页_2mb.... 📌 20260820-国金证券-和黄医药-00013.HK-拐点已至_公司有望迎业绩与创新双击_25页_... 📌 20260821-群益证券-恒瑞医药-01276.HK-非肿瘤创新药增长强劲_3页_388kb.pd... 📌 20260821-招银国际-石药集团-01093.HK-Domestic_sales_stabili... 📌 20260821-交银国际证券-医药行业_全球首款mRNA肿瘤疫苗III期研究成功_多家中国内地企业... 📌 20260820-中国银河-恒瑞医药-600276.SH-恒瑞医药2026年半年报业绩点评_业绩阶段... 📌 2016-04-21-深交所-京新药业_2016年第一季度报告正文_13页_238kb.pdf 📌 2016-04-25-深交所-金陵药业_2016年第一季度报告正文_10页_239kb.pdf 📌 2016-04-28-上交所-上海医药2016年第一季度报告_20页_499kb.pdf 📌 2016-04-28-深交所-北大医药_2016年第一季度报告全文_31页_306kb.pdf 📌 2016-04-28-深交所-北大医药_2015年年度报告_177页_988kb.pdf 📌 2025年7-8月处方药销售全景洞察_主动迎变开拓新机_32页_5mb.pdf 📌 20260816-华源证券-医药行业周报_代谢中间体持续布局_多项创新资产稳步推进_建议关注海特生物... 研报客 - 全球行业报告 图表数据聚合AI平台 5000多家机构，五百万+报告 覆盖全行业深度研究 一站式行业研究报告平台，汇聚全球百强智库，百万中英文报告 ✨ 核心功能 📊 海量报告：覆盖全行业，AI搜索+全文检索 🤖 AI翻译：多语言互译，保留原排版 💬 AI对话：智能研报助手，深度解读文档 🔔 实时推送：订阅关键词，更新主动通知 📱 全平台：网页、APP、小程序数据同步 🤖 AI能力 🔍 智能检索：快速理解问题意图，提供精准信息 🌐 多源整合：综合多个可靠来源，给出全面答案 💡 语境理解：不只是字面翻译，更能理解上下文和文化差异 🎯 专业领域：适应技术、文学、商务等不同领域的翻译需求 🧠 自然交流：理解复杂对话上下文，保持连贯性 📚 研报专家：深度理解文档，进行专业回复 ⚡ 实时性：能够获取最新信息，主动推送更新 🎯 适用场景 💼 投资分析：券商研报、市场分析、投资策略 📈 市场调研：行业分析、市场趋势、竞争格局 🏭 行业研究：深度行业报告、产业链分析 🚀 趋势预测：未来趋势、技术发展、政策解读 🌐 访问方式 💻 网页版：pc.yanbaoke.cn 📱 APP下载：各大手机商店搜索「研报客」 🖥️ 软件版：pc.yanbaoke.cn/pc2.html 📲 小程序：微信搜索「研报客」 💡 PDF/DOC/PPT互转 | 文字版一键复制 | 支持下载分享 网页、APP、小程序多端同步，随时随地阅读研报 内容由ai生成，仅供参考