A Master Protocol of a Phase II, Open-label, Multicenter, Global Platform Study to Evaluate the Safety and Efficacy of Immunotherapy With or Without Other Anticancer Drugs in Participants with Unresectable Stage III Non-small Cell Lung Cancer Planning to Undergo Concurrent Chemoradiotherapy (AQUARIUS)

开始日期2027-01-29

申办/合作机构

AstraZeneca AB

NCT07788664

/ Not yet recruiting临床2期IIT

Local and Systemic Immune Modulation by Rilvegostomig (AZD2936) in the Treatment of Advanced Gastric Cancer (RILVE Project)

This is a multicenter, randomized Phase II window-of-opportunity study evaluating rilvegostomig (AZD2936) in patients with treatment-naïve, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥1.
Rilvegostomig is a humanized bispecific monoclonal antibody that concurrently targets PD-1 and TIGIT, two immune checkpoint pathways involved in tumor immune suppression. The study is designed to characterize and quantify the local and systemic immunological effects induced by rilvegostomig and to define the biological consequences of dual PD-1/TIGIT blockade during an initial window-of-opportunity phase and subsequent combination treatment.
Approximately 50 participants will be randomized to receive either rilvegostomig or pembrolizumab. During the window-of-opportunity phase, participants will receive one cycle of immunotherapy monotherapy. Participants in the experimental arm will receive rilvegostomig 750 mg intravenously on Day 1 of a 21-day cycle. Participants in the control arm will receive pembrolizumab 200 mg intravenously on Day 1 of a 21-day cycle.
After the window-of-opportunity phase, participants will continue the assigned immunotherapy in combination with standard-of-care first-line chemotherapy, consisting of either FOLFOX administered every 2 weeks or CAPOX administered every 3 weeks, according to investigator choice and institutional practice. Combination treatment will be administered for up to approximately 8 cycles based on the every-3-week immunotherapy schedule, or until disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met. After completion of combination treatment, participants may continue maintenance therapy with a fluoropyrimidine, either capecitabine or 5-fluorouracil with leucovorin, plus the assigned immunotherapy for up to 24 months from the first immunotherapy dose.
The primary objective is to assess changes from baseline to the post-window-of-opportunity biopsy in predefined tumor and peripheral immune biomarkers reflecting immune cell infiltration, activation, and functional modulation induced by rilvegostomig. Tumor tissue and peripheral blood samples will be collected at predefined time points to evaluate local and systemic immune changes, immune cell composition, immune activation markers, immune function, and exploratory biomarkers associated with treatment response.
Secondary objectives include assessment of antitumor activity, evaluation of whether immunological changes may serve as biomarkers of treatment response, and characterization of the safety and tolerability of rilvegostomig or pembrolizumab as monotherapy and in combination with FOLFOX or CAPOX. Antitumor activity will be evaluated by radiologic tumor assessments using CT or MRI according to RECIST version 1.1, including objective response rate and progression-free survival. Safety will be monitored throughout the study by assessment of adverse events, serious adverse events, immune-mediated adverse events, dose-limiting toxicities, physical examinations, vital signs, ECOG performance status, clinical laboratory evaluations, and other clinically indicated assessments.
The study aims to determine whether rilvegostomig induces a distinct immune modulation profile compared with PD-1 inhibition alone and to support the identification of immune and molecular biomarkers that may inform future therapeutic strategies in advanced gastric cancer.

开始日期2026-10-01

申办/合作机构

Vall d'Hebron Institut d'Oncologia

NCT07720284

/ Recruiting临床3期

A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma

Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection.
Study details:
Duration:
78 months (6.5 years) from FSI to last subject visit Treatment length: up to
12 months, depending on randomized arm Visit frequency: every 3 weeks in Arms 1 and 2; every 2-4 weeks per SoC in Arm 3

开始日期2026-07-16

申办/合作机构

AstraZeneca PLC

[+1]

100 项与 Rilvegostomig 相关的临床结果

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100 项与 Rilvegostomig 相关的转化医学

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100 项与 Rilvegostomig 相关的专利（医药）

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项与 Rilvegostomig 相关的文献（医药）

2026-09-23·POSTGRADUATE MEDICAL JOURNAL

Retraction of: Volrustomig/Rilvegostomig related “triple M”—myasthenia gravis and overlap syndrome

Article

2026-01-01·JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY

TROPION-Lung12: A phase 3 study of adjuvant datopotamab deruxtecan and rilvegostomig in ctDNA-positive or high-risk pathology stage I non–small cell lung cancer

Article

作者: Lim, Eric ; Forcina, Alessandra ; Opitz, Isabelle ; Yanagawa, Jane ; Batig, Anastasiya ; Harpole, David ; Felip, Enriqueta ; Tsutani, Yasuhiro ; Jones, David R ; Lyfar, Pavlo ; Bodla, Shankar ; Dacic, Sanja ; Ganti, Apar Kishor ; Tan, Daniel S W

BACKGROUND:

Five-year disease recurrence rates for patients with stage I non-small cell lung cancer (NSCLC) postsurgery are variable (15%-40%). There is an urgent need for novel biomarker strategies to identify high-risk patients who may benefit from adjuvant treatment. High-risk pathologic features, including high-grade histology and lymphovascular or visceral pleural invasion, serve as independent risk factors for worse outcomes. Preoperative circulating tumor DNA (ctDNA) detection is also correlated with poorer outcomes in stage I NSCLC. Datopotamab deruxtecan (Dato-DXd), an antibody-drug conjugate composed of a humanized anti-TROP2 antibody conjugated to a potent topoisomerase I inhibitor via a plasma-stable linker, and rilvegostomig, an Fc-reduced monovalent bispecific humanized IgG1 antibody targeting both PD-1 and TIGIT receptors, have shown promise in NSCLC studies. Combining Dato-DXd with rilvegostomig may improve treatment outcomes in selected patients with stage I NSCLC.

METHODS:

TROPION-Lung12 (NCT06564844) is a phase 3 randomized study enrolling approximately 660 patients with stage I adenocarcinoma without actionable genomic alterations who have undergone complete surgical resection. Eligible patients must have preoperative ctDNA-positive status or 1 or more high-risk pathologic features. Patients will be randomized 2:1:2 to receive Dato-DXd (6 mg/kg intravenously [IV] every 3 weeks) plus rilvegostomig (750 mg IV every 3 weeks) for 4 cycles, followed by rilvegostomig (up to 12 months/18 cycles total), rilvegostomig alone (up to 12 months/18 cycles total), or standard of care (SoC) for up to 12 months. The primary endpoint is disease-free survival, assessed using blinded independent central review according to RECIST v1.1, with key secondary endpoints including overall survival, for the Dato-DXd plus rilvegostomig arm versus the SoC arm.

Frontiers in Oncology

Correction: TROPION-Lung10: a phase 3 study of datopotamab deruxtecan and rilvegostomig in patients with treatment-naïve locally advanced or metastatic nonsquamous non-small cell lung cancer with high PD-L1 expression and without actionable genomic alterations

[This corrects the article DOI: 10.3389/fonc.2025.1721624.].

380

项与 Rilvegostomig 相关的新闻（医药）

2026-10-06

·PRNewswire

Compugen to Participate in a Fireside Chat at the H.C. Wainwright 3rd Annual AI Based Drug Discovery & Development Conference

HOLON, ISRAEL, Oct. 6, 2026 /PRNewswire/ -- Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery powered by AI, today announced that management will participate in a fireside chat at the H.C. Wainwright 3rd Annual AI Based Drug Discovery & Development Conference, being held virtually on October 8-9, 2026. The fireside chat will be held on Thursday, October 8, 2026, at 9:30 AM ET. A live webcast of the presentation will be available on the events page of the Investor Relations section of Compugen's website at . A replay will be available following the live event. About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing Unigen™, its AI-powered computational discovery platform, to identify novel drug targets and to develop therapeutics in the field of cancer immunotherapies. Compugen's innovative immuno-oncology pipeline consists of COM701, rilvegostomig and GS-0321 (previously COM503). COM701, a potential first-in-class anti-PVRIG antibody, is currently being evaluated in a blinded randomized ovarian cancer adaptive platform trial as a single agent in maintenance therapy in relapsed platinum sensitive ovarian cancer (named MAIA-ovarian trial). Rilvegostomig, a PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from COM902, Compugen's anti-TIGIT antibody, is being developed by AstraZeneca pursuant to an exclusive license agreement between Compugen and AstraZeneca and is being evaluated in multiple Phase 3, Phase 2 and Phase 1 clinical trials. GS-0321 (previously COM503), Compugen's potential first-in-class high affinity antibody, which blocks the interaction between IL-18 binding protein and IL-18, is licensed to Gilead and is being evaluated in a Phase 1 clinical trial that Compugen is conducting. In addition, Compugen has an early-stage immuno-oncology pipeline that consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. Company Contact: Lindsey Trickett Head of Investor Relations and Corporate Communications Email: [email protected] Tel: +1 (628) 241-0071 SOURCE Compugen Ltd. 21% more press release views with Request a Demo

临床1期免疫疗法引进/卖出临床2期临床3期

2026-10-06

·动脉网

Compugen将参加H.C. Wainwright第三届年度人工智能药物发现与开发会议的炉边谈话Compugen to Participate in a Fireside Chat at the H.C. Wainwright 3rd Annual AI Based Drug Discovery & Development Conference

HOLON, ISRAEL 以色列，霍隆, ，Oct. 6, 2026 2026年10月6日/PRNewswire/ -- /美通社/ --Compugen Ltd. Compugen有限公司(NASDAQ: （纳斯达克：CGEN CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery powered by AI, todayannounced that management will participate in a fireside chat at the H.C. Wainwright 3 )（特拉维夫证券交易所股票代码：CGEN）是一家处于临床阶段的癌症免疫治疗公司，也是由人工智能驱动的计算靶点发现领域的先驱，今日宣布，公司管理层将参加 H.C. Wainwright 3rd rdAnnual AI Based Drug Discovery & Development Conference, being held virtually on October 8-9, 2026. 年度人工智能药物研发大会，将于2026年10月8日至9日以虚拟形式举行。The fireside chat will be held on Thursday, October 8, 2026, at 9:30 AM ET. A live webcast of the presentation will be available on the events page of the Investor Relations section of Compugen's 炉边谈话将于2026年10月8日（星期四）美国东部时间上午9:30举行。演讲的网络直播将在Compugen投资者关系部分的活动页面上提供。website 网站at 在www.cgen.com www.cgen.com. A replay will be available following the live event 直播结束后将提供回放。. 。AboutCompugen 关于CompugenCompugenis a clinical-stage therapeutic discovery and development company utilizing Unigen™, its AI-powered computational discovery platform, to identify novel drug targets and to develop therapeutics in the field of cancer immunotherapies. Compugen's innovative immuno-oncology pipeline consists of COM701, rilvegostomigand GS-0321 (previously COM503). Compugen 是一家处于临床阶段的治疗性药物发现与开发公司，利用其人工智能驱动的计算发现平台 Unigen™ 来识别新型药物靶点，并开发癌症免疫治疗领域的疗法。Compugen 创新的肿瘤免疫产品线包括 COM701、rilvegostomig 和 GS-0321（前身为 COM503）。COM701, a potential first-in-class anti-PVRIG antibody, is currently being evaluated in a blinded randomized ovarian cancer adaptive platform trial as a single agent in maintenance therapy in relapsed platinum sensitive ovarian cancer (named MAIA-ovarian trial). Rilvegostomig,a PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from COM902, Compugen's anti-TIGIT antibody, is being developedby AstraZeneca pursuant to an exclusivelicense agreement between Compugenand AstraZeneca and is being evaluated in multiple Phase 3, Phase 2 andPhase 1 clinical trials. COM701是一种具有潜在首创性的抗PVRIG抗体，目前在一项盲法随机卵巢癌适应性平台试验中作为单药用于复发性铂敏感卵巢癌的维持治疗进行评估（该试验名为MAIA-卵巢试验）。Rilvegostomig是一种PD-1/TIGIT双特异性抗体，其TIGIT组分源自Compugen公司的抗TIGIT抗体COM902，由阿斯利康根据与Compugen签订的独家许可协议进行开发，并正在多项III期、II期和I期临床试验中接受评估。GS-0321 (previously COM503), Compugen's potential first-in-class high affinity antibody, which blocks the interaction between IL-18 binding protein and IL-18, is licensed to Gileadand is being evaluated in a Phase 1 clinical trial that Compugen is conducting.In addition, Compugen has an early-stageimmuno-oncology pipeline that consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity. GS-0321（此前称为COM503）是Compugen公司潜在的首创高亲和力抗体，能够阻断IL-18结合蛋白与IL-18之间的相互作用。该药物已授权给吉利德科学公司，并正在由Compugen开展的一项I期临床试验中进行评估。此外，Compugen还拥有一条早期阶段的免疫肿瘤学研发管线，包含多个旨在通过不同机制增强抗癌免疫力的研究项目。Compugen's shares are listed on Nasdaq and the Tel AvivStock Exchange under the ticker symbol CGEN.. Compugen 的股票在纳斯达克和特拉维夫证券交易所上市，股票代码为 CGEN。Company Contact: 公司联系人：Lindsey Trickett 林赛·特里凯特Head of Investor Relations and Corporate Communications 投资者关系与企业传播主管Email: 电子邮件：[emailprotected] [email protected]Tel: +1 (628) 241-0071 电话：+1 (628) 241-0071SOURCE Compugen Ltd. 来源：Compugen有限公司21 二十一% %more press release views with 更多新闻稿浏览量，借助Request a Demo 申请演示

2026-09-30

·微信

阿斯利康20亿美元入股Summit：依沃西从"单药突围"走向"组合作战"

事件速览要素内容时间 2026年9月28日（美东）宣布，预计一周内完成交割金额与形式 20亿美元，认购Summit新发行的可转换优先股价格折算普通股等值18.36美元/股，较周一收盘价15.48美元溢价约18.6% 持股约10.9万优先股（1:1000转换），交割后对应Summit已发行普通股约12.0%权益（全稀释约10.6%）临床合作（已签）依沃西+Sonesitatug Vedotin（Sone-Ve，CLDN18.2 ADC），用于多种胃肠道肿瘤，由阿斯利康主导申办合作备忘录依沃西+阿斯利康多款肿瘤药（含核心ADC管线），全球临床开发，非排他财务安排各自提供药物、共同承担研究费用、各自保留分子的开发与商业化权益市场反应 Summit股价盘后涨超18%01 拆交易：20亿美元换来的三样东西这笔交易的结构比金额更有意思。阿斯利康付的是股权对价，换回来三样东西：第一，一张"组合疗法的通行证"。依沃西的中国以外权益早在2022 年12月就被康方以"5亿美元首付款+最高50亿美元总额+两位数销售提成+Summit股权"的方案授给了 Summit —— 那笔交易至今仍是中国创新药出海的标杆。分子已被锁定，阿斯利康要的是在不改变权益格局的前提下，拿到联合开发的优先席位。股权投资是成本最低、也最体面的入场方式。第二，一款补齐自身版图的IO骨架。阿斯利康下一代免疫布局以rilvegostomig（PD-1/TIGIT双抗）等自有资产为主，而在PD-1/VEGF这条已被头对头III期数据验证的赛道上，它需要一位外部搭档。依沃西是目前唯一在III期头对头研究中同时取得PFS与OS双阳性的PD-1/VEGF双抗。。第三，让自家ADC资产搭上全球最热的IO平台。ADC的商业化天花板，很大程度取决于"联合谁"。阿斯利康手上握着全球最厚的ADC组合之一，这次找到了一个机制互补、且已有注册级数据支撑的联合对象。值得一提的是结构上的克制：MOU明确非排他，双方各自提供药物、各自承担费用、各自保留权益。这种"轻绑定、重协同"的设计，让合作可以快速铺开——依沃西有机会同时与阿斯利康旗下多款ADC及其他肿瘤药展开探索，而不必逐项重谈商务条款。对一款要覆盖全瘤种的基石药来说，这种开放式的联合架构，本身就是效率。02 时机：为什么是2026年9月钱不会无缘无故在这个时点进场。往前推两周：9月中旬，WCLC 2026 ，HARMONi-2研究的OS数据公布。截至2026年8月20日数据截点、中位随访36个月，依沃西单药中位OS 30.8个月 vs 帕博利珠单抗22.6个月，HR 0.73（95% CI 0.57–0.95，P=0.009），死亡风险降低27%；2年、3年生存率分别达57.9%和45.0%。这是全球首个在III期头对头中，同时在PFS（11.14 vs 5.82 个月，HR 0.51）和OS两项硬终点上击败"K药"的方案。ESMO 2026 年会主席论坛，两项结果将同台发布：阿斯利康CLARITY-Gastric01（Sone-Ve二线及以后 CLDN18.2 阳性晚期胃癌，OS显著改善）与康方HARMONi-GI1（依沃西+化疗 vs 度伐利尤单抗+化疗一线晚期胆道癌，OS显著改善）。一个刚拿到OS阳性、一个刚拿到OS阳性，两个"阳性"在同一场主席论坛相遇——这是联合开发叙事最顺理成章的发布窗口。阿斯利康选择在数据公布前入股 Summit，而不是等ESMO之后，本身也说明它对这组数据的预期。03 为什么是依沃西：下一代IO需要什么样的"骨架药" 从药渡数据视角看，阿斯利康的选择有清晰的产业逻辑。 ADC正在成为肿瘤治疗的通用底座，但它需要一个搭档。2026年上半年，Enhertu 全球终端销售额达29.61亿美元（阿斯利康确认收入17.19亿美元，同比+32%），Dato-DXd相关收入约0.98亿美元、同比增长超6倍。ADC已从研发热点进入商业化兑现阶段。而学界公认的下一步，正是"ADC+下一代免疫疗法"——ADC负责直接杀伤与抗原释放，IO负责激活与维持免疫应答，两者在机制上天然互补。 PD‑1/VEGF双抗是目前极具潜力、已获得数据验证的下一代IO骨架。它同时解决两个问题：PD-1 通路介导的免疫逃逸，以及VEGF通路主导的血管生成与免疫抑制微环境。2026年ASCO上，科伦博泰TROP2 ADC芦康沙妥珠单抗联合帕博利珠单抗的OptiTROP-Lung05研究登顶《柳叶刀》，成为全球首个证实"ADC 联合免疫"优于"免疫单药"的III期研究——这条路径已经被临床数据点亮。阿斯利康的官方表述也很直白。其肿瘤学与血液学研发执行副总裁Susan Galbraith 表示：拓展ADC管线的跨瘤种应用、打造"ADC + 下一代免疫疗法"的治疗基石，是公司肿瘤战略的核心方向；PD-1/VEGF双抗有望在肺癌、乳腺癌及胃肠道肿瘤领域实现疗效提升。对中国创新药而言，这是角色变化的信号。过去MNC的做法是"买走资产"，现在是"围绕资产搭组合"——钱没有流向中国药企，却流向了持有中国药企资产的海外平台，而方案的核心仍是中国分子。中国创新药正在从被授权方，变成全球联合开发网络的一个节点。04 数据视角：把交易放回赛道坐标系单看一笔交易容易被叙事带着走。把它放进三个坐标系，价值会更清楚。坐标系一：PD-(L)1/VEGF 双抗 —— 已从"概念"变成"赛道" 据药渡数据统计，全球PD-(L）1/VEGF双抗已有20余款在研分子进入临床，覆盖肺癌、乳腺癌、结直肠癌、胃癌、小细胞肺癌及妇科肿瘤，其中绝大多数分子源自中国biotech。这个赛道近三年的BD交易，几乎就是一部中国创新药出海史：资产授权方 → 受让方时间首付款总额 AK112（依沃西）康方生物 → Summit 2022.12 5.0 亿美元 50 亿美元 LM-299 礼新医药 → 默沙东 2024.11 5.88 亿美元 32.88 亿美元 PM8002 普米斯 → BioNTech（收购） 2024.11 8.0 亿美元 9.5 亿美元 SSGJ-707 三生制药 → 辉瑞（海外） 2025.05 12.5 亿美元 60.5 亿美元 BNT327（原PM8002） BioNTech → BMS 2025.06 15.0 亿美元（+20亿周年款） 35 亿美元以上 RC148 荣昌生物 → 艾伯维 2026.01 6.5 亿美元 56 亿美元第一梯队（依沃西、BNT327/PM8002、SSGJ-707）已全部进入注册临床并与MNC深度绑定；第二梯队正在快速跟进——荣昌生物RC148在2026年1月授权艾伯维后，已由艾伯维于同年8月启动一线NSCLC全球III期（AMUR-Lung-01），国内鳞状与非鳞状NSCLC的III期也先后启动；君实生物JS207、神州细胞SCTB14也均进入到III期阶段，其余华奥泰 HB0025、宜明昂科 IMM2510 等仍处于早中期临床阶段。在这个格局下，谁能率先完成"IO+ADC"的组合验证，谁就能把单药优势放大成平台优势——这正是依沃西当前最抢手的资产属性。坐标系二：CLDN18.2 —— 中国药企把靶点做成了立体战场 Sone-Ve（AZD0901）的出身值得一提：来自康诺亚/乐普体系的CMG901，阿斯利康于2023年2月以6300万美元首付款+约11亿美元里程碑引进，2026年2月一线胃癌全球III期完成首例给药并触发4500万美元里程碑。它面对的竞争格局是：药物类型企业进展（截至 2026.09）佐妥昔单抗（Vyloy）单抗安斯泰来全球首个获批 CLDN18.2 靶向药，中国正推进医保准入 IBI343 ADC（Topo-I）信达生物 2026.06 上市申请受理，全球首款申报上市的 CLDN18.2 ADC LM-302 ADC（MMAE）礼新/正大天晴 2026.06 上市申请受理，第二款 Sone-Ve / CMG901 ADC（MMAE）康诺亚 → 阿斯利康 III 期，二线胃癌关键数据 2026 下半年读出 BL-M05D1 ADC 百利天恒 2026.06 完成 III 期首例入组舒瑞基奥仑赛（CT041） CAR-T 科济药业 2026.06.22 获批，全球首款实体瘤 CAR-T 截止到2026年9月，目前国内共有9款CLDN18.2 ADC处于临床III及以上阶段。赛道足够拥挤，也足够成熟——这恰恰是"CLDN18.2 ADC+PD-1/VEGF双抗"这类组合能够成立的土壤：单药疗效已被验证，下一步比拼的是如何把疗效推到更高的天花板。坐标系三：中国创新药出海 —— 从"卖青苗"到"全球联合开发" 据国家药监局披露，2026年上半年，中国创新药对外授权约81笔，潜在交易总额约1100亿美元，已达2025年全年约八成；已披露首付款合计约50亿美元。上半年全球BD交易金额前十中，中国企业占8席。变化不只在金额。Co-Co（共同开发/共同商业化）、NewCo，以及本次这种"股权投资+联合开发"的组合开始出现，中国药企从被动的"卖家"转向"全球研发合伙人"。而依沃西这条路径更具代表性：2022年授权出海 → 2024—2026年连续读出头对头阳性数据 → 2026 年获得 MNC 的股权级背书。中国创新药资产的全球价值，正在被一层层兑现出来。05 康方得到什么：间接收益的三层含义 20亿美元进入的是Summit的资产负债表，但康方的收获是实在的：其一，海外开发的资金确定性。 Summit 的现金储备直接决定依沃西全球III期（含6项国际多中心注册性研究）的推进节奏与广度。20亿美元的注入，等于给这张全球临床网络加装了引擎。其二，组合数据的跨区域复用。依沃西+Sone-Ve在胃肠道肿瘤的联合研究由阿斯利康主导发起，中国区权益仍完整保留在康方手中。海外读出的数据与方案经验，可以在康方自身的 IO2.0+ADC2.0布局中复用——公司已与GSK、辉瑞、百利天恒、宜联生物等的ADC开展多项中后期联合研究。其三，基石药地位的再确认。一家全球头部MNC用20亿美元股权为一款中国分子背书，这比任何一项里程碑付款都更能说明产业界的判断。对康方正在推进的"依沃西 +"全瘤种矩阵而言，这是最有力的一次外部验证。06 仍需时间回答的开放问题任何一笔早期联合开发合作，最终都要由数据来定价。行业普遍关注的几个节点包括：全球人群的一致性验证。 HARMONi（全球多中心）研究的主要OS分析此前未达统计学显著性，后续随访显示风险比有所改善。西方人群的疗效一致性，仍需更长随访与HARMONi-7（针对 PD-L1 高表达人群设计）等研究继续积累。美国监管路径。依沃西的BLA（EGFR-TKI 经治 NSCLC）已于2026年1月获FDA受理，PDUFA 日期为2026年11月14日。获益人群的精细刻画。 WCLC现场评议专家（比利时 Jules Bordet 研究所 Mariana Brandão）提到，获益主要由PD-L1高表达人群驱动，鳞癌人群也有令人意外的获益趋势；如何找到预测性生物标志物、进一步优化人群选择，是学界正在推进的方向。联合方案的安全性设计。 PD-1/VEGF双抗与MMAE载荷ADC联用时，出血等VEGF相关不良事件的管理方案，将是GI肿瘤研究的关键设计点。这些都不是否定项，而是一款基石药从"数据惊艳"走向"标准治疗"必经的验证过程。一句话总结：依沃西用了四年时间，从一款出海授权的中国双抗，走到被全球头部 MNC 以股权方式纳入其肿瘤组合战略。这笔交易真正的看点不是20亿美元，而是"ADC+下一代 IO"这条路径第一次有了明确的产业组织者——而站在这条路径中心的，是一个源自中国的分子。注：本文由药渡基于公开披露信息整理分析，仅代表第三方研究观点，不构成投资建议。文中数据均来自企业公告、监管披露及公开学术会议报道；不同数据库统计口径存在差异，已在文中标注。推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。 ©2021 医药速览保留所有权利往期链接 “小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记 PROTAC技术| 抗体药物| 抗体药物偶联-ADC 核酸疫苗 | CAR技术| 化学生物学

抗体药物偶联物引进/卖出临床结果临床3期

100 项与 Rilvegostomig 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肌层浸润性膀胱尿路上皮癌	临床3期	美国	AstraZeneca PLC	2026-07-16
肌层浸润性膀胱尿路上皮癌	临床3期	中国	AstraZeneca PLC	2026-07-16
肌层浸润性膀胱尿路上皮癌	临床3期	日本	AstraZeneca PLC	2026-07-16
肌层浸润性膀胱尿路上皮癌	临床3期	澳大利亚	AstraZeneca PLC	2026-07-16
肌层浸润性膀胱尿路上皮癌	临床3期	巴西	AstraZeneca PLC	2026-07-16
肌层浸润性膀胱尿路上皮癌	临床3期	加拿大	AstraZeneca PLC	2026-07-16
肌层浸润性膀胱尿路上皮癌	临床3期	法国	AstraZeneca PLC	2026-07-16
肌层浸润性膀胱尿路上皮癌	临床3期	德国	AstraZeneca PLC	2026-07-16
肌层浸润性膀胱尿路上皮癌	临床3期	印度	AstraZeneca PLC	2026-07-16
肌层浸润性膀胱尿路上皮癌	临床3期	意大利	AstraZeneca PLC	2026-07-16

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临床结果

适应症

分期

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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


NCT07098338 (LIBRA, WCLC2026)	临床2期	非小细胞肺癌一线	168	Ramucirumab plus Rilvegostomig	蓋選壓淵艱選淵鹽鬱範(顧積淵製憲壓選顧築獵) = 繭膚獵衊鹽鹹夢淵壓遞構鏇醖選憲鏇簾衊繭鏇 (憲餘醖鑰蓋蓋願淵構廠 ) 更多	积极	2026-09-12
				Datopotamab deruxtecan	蓋選壓淵艱選淵鹽鬱範(顧積淵製憲壓選顧築獵) = 淵夢齋遞夢遞顧積憲鹽構鏇醖選憲鏇簾衊繭鏇 (憲餘醖鑰蓋蓋願淵構廠 ) 更多
NCT05775159 (GEMINI-Hepatobiliary, ASCO2026)	临床2期	晚期胆道癌一线	30	Rilvegostomig + gemcitabine + cisplatin	廠繭淵餘餘構願膚襯糧(淵窪觸齋廠鏇願築顧餘) = The most common were anemia (53.3%), neutrophil count decreased (50.0%), and platelet count decreased (43.3%). 簾選鑰憲簾鹽築醖構壓 (淵鏇蓋餘襯艱餘醖衊憲 )	积极	2026-05-29
NCT07221253 (ARTEMIDE-Biliary02, ASCO2026)	临床3期	晚期胆道癌一线	1,100	Rilvegostomig + Gemcitabine + Cisplatin	鹽餘鏇憲餘獵遞襯憲淵(構糧觸醖築廠鏇糧願糧) = 鏇鹹蓋糧憲遞觸獵窪憲顧簾鹹築網築顧鹽鏇範 (襯糧製遞齋鹽餘範鏇顧 ) 更多	积极	2026-05-29
				Durvalumab + Gemcitabine + Cisplatin	鹽餘鏇憲餘獵遞襯憲淵(構糧觸醖築廠鏇糧願糧) = 鬱窪獵糧鹽構膚鏇膚蓋顧簾鹹築網築顧鹽鏇範 (襯糧製遞齋鹽餘範鏇顧 ) 更多
NCT05414032 (MERIDIAN, AACR2026)	临床2期	晚期头颈部鳞状细胞癌 human papillomavirus (HPV)	46	Rilvegostomig 750mg IV q3w x 6	顧蓋構蓋壓衊選願衊膚(夢鏇選膚築鏇鹹夢繭積) = The pt on Rv achieved ctDNA clearance at Part D weeks 2 and 10 and remains recurrence-free with undetectable ctDNA 12 months post-Rv. 鹹齋鏇鏇醖鏇鹹構齋艱 (淵鹽選鏇鹽繭鑰顧窪顧 ) 更多	积极	2026-04-20
NCT06989112 (DESTINY-Endometrial01, ESGO2026)	临床3期	复发性子宫内膜癌一线 HER2-expressing \| mismatch repair-proficient (pMMR)	600	trastuzumab deruxtecan + rilvegostomig	鹽遞齋願鑰繭衊顧夢襯(製選範淵鹽製衊觸齋蓋) = 齋築鹽壓顧醖衊觸觸鑰餘艱製鑰願鬱憲膚齋獵 (繭觸淵觸範構願鹹夢襯, 24.9 ~ NR) 更多	积极	2026-02-28
				trastuzumab deruxtecan + pembrolizumab	鑰餘觸壓鹹網窪製憲艱(襯願壓積鹽夢積鹽顧糧) = 憲膚獵範齋壓鏇衊壓齋壓範蓋餘繭膚鏇糧製餘 (窪獵積鑰膚顧衊選糧壓, 8.3 ~ 16.5) 更多
NCT06764875 (ARTEMIDE-Gastric01, ASCO_GI2026)	临床3期	转移性 HER2 阳性胃食管结合部癌一线 HER2-positive \| PD-L1 CPS ≥1	840	rilvegostomig + T-DXd + investigator’s choice of capecitabine or 5-fluorouracil (5-FU)	廠鹽網構淵夢網鑰鬱壓(餘膚廠憲憲鑰鹹積夢製) = 鏇餘壓簾觸獵齋衊廠構鬱醖鑰糧網鹹選獵蓋築 (蓋獵簾襯壓觸窪網簾夢, 24.9 ~ NR)	积极	2026-01-08
				rilvegostomig + trastuzumab + investigator’s choice of FP or CAPOX	築顧艱選蓋鬱餘獵窪壓(衊獵餘築網構餘築選齋) = 繭構範憲窪觸觸憲範築醖蓋繭餘襯艱選範醖壓 (襯夢製構襯築鹽糧衊醖, 17.0 ~ NR) 更多
NCT06921785 (ARTEMIDE-HCC01, ESMO_ASIA2025)	临床3期	不可切除的肝细胞癌一线	1,220	Rilvegostomig + Bevacizumab + Tremelimumab	獵衊糧製選膚淵積襯構(壓觸製襯糧觸餘淵願製) = 積艱窪壓膚淵窪齋蓋顧鬱築積鹹醖餘願顧構醖 (選構鏇憲襯網製膚鬱願, 17 ~ 32) 更多	积极	2025-12-05
				Tremelimumab + Rilvegostomig + Bevacizumab	獵衊糧製選膚淵積襯構(壓觸製襯糧觸餘淵願製) = 遞鹹顧鏇壓獵夢選遞願鬱築積鹹醖餘願顧構醖 (選構鏇憲襯網製膚鬱願, 17 ~ 32) 更多
NCT06868277 (ARTEMIDE-Lung04, ESMO2025)	临床3期	转移性非小细胞肺癌一线 PD-L1 expression ≥50%	830	Rilvegostomig	壓餘衊鏇鹽壓鹽選選鏇(齋憲蓋觸繭鏇壓簾窪網) = 願獵憲積遞蓋壓觸憲夢窪積淵鹹選選遞繭淵艱 (膚糧糧遞繭餘艱鬱簾繭 ) 更多	积极	2025-10-17
				Pembrolizumab	壓餘衊鏇鹽壓鹽選選鏇(齋憲蓋觸繭鏇壓簾窪網) = 憲鹽獵願選製鏇夢餘鏇窪積淵鹹選選遞繭淵艱 (膚糧糧遞繭餘艱鬱簾繭 ) 更多
NCT05775159 (GEMINI-Hepatobiliary substudy 2 Cohort A, ASCO2025)	临床2期	晚期胆道癌一线	-	Rilve plus Gemcitabine and Cisplatin	齋繭艱構簾齋夢願簾願(醖製艱襯鹹簾壓鹽膚鏇) = 夢簾蓋餘齋繭窪淵繭襯醖網夢遞窪繭餘艱鑰憲 (簾餘繭選齋願製鏇鬱願 ) 更多	积极	2025-05-30
NCT05702229 (GEMINI-Gastric, ESMO2024) 人工标引	临床2期	HER2阴性胃癌一线 HER2-negative	40	Rilvegostomig 750 mg Q3W IV + XELOX (oxaliplatin + capecitabine)	構憲遞壓範壓壓餘範構(觸獵餘簾願簾艱網範鬱) = 願構製襯窪鑰鏇齋憲範壓衊簾餘鹹衊製鹹憲憲 (膚淵構網繭繭積觸膚遞, 50.9 ~ 81.4) 更多	积极	2024-09-16