Rilvegostomig

胃癌是全球范围内最常见的消化道恶性肿瘤之一，其发病率和死亡率均位居前列。在中国，胃癌的疾病负担尤为沉重，新发病例和死亡病例分别占全球的44.0%和48.6%。由于早期症状隐匿，多数患者确诊时已为中晚期，导致整体预后不佳，IV期患者的5年生存率甚至低于10%。长期以来，化疗是晚期胃癌的主要治疗手段，但疗效有限且毒副作用显著。 近年来，随着分子生物学和基因组学研究的深入，胃癌的治疗模式正经历一场深刻的变革，即从传统的经验性化疗向基于分子特征的精准治疗转变。这一转变的核心驱动力在于对胃癌分子分型的不断细化以及对新型治疗靶点的持续探索。精准治疗旨在通过检测特定的生物标志物，为患者匹配最可能获益的靶向药物或免疫疗法，从而实现“个体化”治疗，提高疗效并减少不必要的毒副作用。 在这一背景下，胃癌的临床研究项目也呈现出靶点驱动、百花齐放的态势。根据2025年CSCO胃癌诊疗指南的推荐，所有新诊断胃癌患者均需进行关键分子标志物的检测，这直接关联着后续治疗方案的选择。目前，临床研究的焦点主要集中在几个已验证或极具潜力的靶点上，它们构成了当前胃癌精准治疗临床试验的骨架： HER2靶点人表皮生长因子受体2（HER2）是胃癌领域最早确立的靶点之一。在中国胃癌患者中，HER2阳性率约为12%-13%。自ToGA研究确立曲妥珠单抗联合化疗的一线标准地位以来，抗HER2治疗不断演进。当前的研究热点已从单纯的“化疗+靶向”模式，拓展至“化疗+靶向+免疫”的三联强化模式，例如KEYNOTE-811研究证实了帕博利珠单抗联合曲妥珠单抗和化疗在PD-L1 CPS≥1患者中的显著生存获益。此外，新型抗体偶联药物（ADC）如德曲妥珠单抗（T-DXd）和双特异性抗体（如泽尼达妥单抗）的临床研究正在重新定义后线乃至一线的治疗标准，旨在为HER2阳性（包括传统定义下的中低表达）患者提供更优选择。 Claudin 18.2靶点Claudin 18.2（CLDN18.2）是近年来胃癌治疗领域最具突破性的新兴靶点。它是一种紧密连接蛋白，在恶性转化过程中暴露于肿瘤细胞表面，在中国胃癌人群中的高表达率可达35%。基于SPOTLIGHT和GLOW两项III期研究的阳性结果，靶向CLDN18.2的单抗佐妥昔单抗联合化疗方案已于2025年在国内获批，用于CLDN18.2阳性、HER2阴性晚期胃癌的一线治疗。当前，围绕该靶点的临床研究正朝着多元化、联合化的方向飞速发展，包括探索CLDN18.2靶向药与PD-1抑制剂及化疗的“三联方案”、开发CLDN18.2 ADC药物（如SHR-A1904、IBI343）、以及推进CAR-T细胞疗法（如satri-cel）的临床验证，旨在为不同线数的患者提供更丰富的治疗选择。 FGFR2b靶点成纤维细胞生长因子受体2b（FGFR2b）是另一个备受关注的特异性靶点，在非HER2阳性的晚期胃癌患者中，其过表达发生率约为30%。FIGHT II期研究显示，FGFR2b单抗贝玛妥珠单抗联合化疗对比单纯化疗，能显著改善FGFR2b过表达患者的无进展生存期（PFS）和总生存期（OS）。该靶点药物已获得中美监管机构的突破性疗法认定，其III期研究（FORTITUDE-101）的中期分析也达到了OS主要终点，标志着针对这一特定人群的精准治疗路径已经开启。 无明确驱动基因/泛靶点项目对于大量不携带上述特异性驱动基因变异的患者，临床研究的重点则集中在以PD-1/PD-L1为核心的免疫检查点抑制剂上。免疫联合化疗已成为HER2阴性晚期胃癌一线治疗的基石，RATIONALE-305、KEYNOTE-859等研究使其总生存期（OS）突破了一年大关。然而，胃癌的高度异质性导致仅部分患者能从免疫治疗中持久获益。因此，当前的研究致力于通过探索新型免疫联合策略来扩大获益人群、提升疗效天花板，例如： 免疫联合抗血管生成药物：探索协同调节肿瘤微环境的可能性。 双免疫检查点抑制剂：如PD-L1/CTLA-4双抗、PD-L1/TGF-β双抗等，旨在同时阻断多个免疫抑制通路。 免疫联合其他模式：如与ADC药物、CAR-T疗法或新型免疫调节剂（如CD47抑制剂）的联合，这些研究代表了攻克免疫耐药和扩大适用人群的最前沿探索。 综上所述，胃癌的临床研究已进入一个以靶点为核心、多模式协同发展的“精准时代”。从HER2、CLDN18.2、FGFR2b等特异性靶点的深度挖掘，到面向更广泛人群的免疫联合策略创新。 这里需要注意下，下述项目统计是截止2026年4月，如果想获取后续实时更新的内容，可关注公众号并在本文末扫码入群，获得最实时的非小细胞肺癌不同靶点项目讯息。 注：文章内入排可能与链接介绍有所不同，以本文章内所写为准。 术前新辅助治疗可以参加的项目 项目：SHR-1316 队列1：HER2阳性的临床分期为T3-4aN±或T2N+的胃癌或胃食管结合部癌 队列2：Claudin18.2阳性的临床分期为T3-4aN±或T2N+的胃癌或胃食管结合部癌 队列3：dMMR/MSI-H的临床分期为T3-4aN±或T2N+的胃癌或胃食管结合部癌 术后辅助可以参加的项目 项目：CT041 CT041：收IIIa\IIIb期术后辅助化疗≥4周期后无进展胃癌claudin18.2阳性胃癌 初治HER2阳性可以参加的项目 项目1：TQB2102TQB2102：收初治HER2阳性(可盲测）胃癌 项目2：AZD2936 AZD2936：初治HER2阳性胃癌 项目3：KN026KN026：初治的HER2阳性的胃癌 项目4：JSKN003 试验用药：JSKN003+化疗 ✅纳入人群：初治HER2阳（IHC 2+/FISH 扩增或 IHC 3+）的胃癌 SKN003是一种由石药集团附属公司上海津曼特生物与江苏康宁杰瑞合作开发的靶向HER2双表位的抗体偶联药物（ADC），通过糖定点偶联平台制备，采用KN026抗体分子重链糖基经酶催化与点击化学反应形成DAR值约为4的定点修饰结构。JSKN003已获得美国FDA授予的孤儿药资格认定，用于治疗胃癌及胃食管结合部癌。 项目5：HLX22 试验用药：HLX22 ✅纳入人群：初治、HER2（2+ fish阳、3+）的胃或胃食管交界部腺癌 HLX22是一款靶向HER2的创新型单克隆抗体，可结合在HER2的胞外亚结构域IV，但其结合表位与曲妥珠单抗（另一种HER2靶向药物）有所不同。这种差异化的结合方式使得HLX22能够与曲妥珠单抗同时结合至HER2，促进HER2二聚体（包括HER2同源二聚体及HER2/EGFR异源二聚体）的内吞和降解，能够产生更强的HER2受体阻断效果，从而抑制肿瘤细胞的增殖和诱导细胞凋亡。HLX22已获得美国食品药品监督管理局（FDA）和欧盟委员会（EC）授予的孤儿药资格认定，用于胃癌的治疗。这标志着HLX22成为全球首款同时获得欧盟和美国孤儿药资格认定的胃癌抗HER2靶向疗法。 项目6：SHR-A1811 SHR-A1811：初治PD-L1（CPS＞1）的HER2阳性（3+、2+fish阳）胃癌 项目7：HCB101 试验用药：HCB101 ✅纳入人群：初治HER2阳性（已知）的胃癌 HCB101是一种SIRPα-Fc融合蛋白，由人信号调节蛋白α（SIRPα）的工程化IgV结构域与IgG4 Fc融合而成，通过高亲和力与CD47结合，抑制野生型SIRPα的结合，从而阻断CD47-SIRPα免疫检查点通路，增强巨噬细胞对肿瘤细胞的吞噬作用，提高抗原可及性并活化树突细胞。 项目8：SSGJ-705 SSGJ-705：初治HER2低表达、阳性胃癌 claudin 18.2阳性初治可以参加的项目 项目：佐妥昔 佐妥昔：初治PD-L1阳性且CLDN18.2 2+≥75%（可盲测）的胃或胃食管交界处腺癌 没有/其他特异性表达初治可以参加的项目 项目1：SSGJ-706 SSGJ-706：初治消化道系统肿瘤（如胃癌、结直肠癌、胰导管腺癌、食管癌） 项目2：LBL-024 LBL-024：收初治胃癌/胃食管交界处腺癌 项目3：ABSK061 试验用药：ABSK061+ABSK043 ✅纳入人群：初治HER2阴的FGFR2/3 基因突变或过表达（可盲筛）的胃癌 ABSK061与ABSK043是由和誉医药自主研发的两款创新药物，其中ABSK061为全球首款进入临床试验的高选择性口服小分子FGFR2/3抑制剂，通过特异性抑制FGFR2/3信号通路，阻断肿瘤细胞的增殖与存活信号；ABSK043则是新一代口服小分子PD-L1抑制剂，可高效阻断PD-1/PD-L1免疫检查点通路，解除肿瘤微环境对T细胞的抑制作用，恢复机体抗肿瘤免疫应答。二者联合应用通过同时靶向肿瘤细胞内在增殖信号与免疫微环境调控机制，形成协同抗肿瘤效应：ABSK061直接抑制肿瘤生长，ABSK043增强免疫系统对肿瘤的识别与杀伤，这种"靶向+免疫"的联合策略在临床前研究中已显示出优于单药治疗的疗效，且初步安全性数据支持其进一步开发。 项目4：SHR-1826 试验用药：SHR-1826 ✅纳入人群：初治胃癌 SHR-1826是一种靶向c-MET蛋白的抗体偶联药物（ADC），可像“智能导弹”一样识别肿瘤表面高表达的MET，并将强效化疗载荷直接送入癌细胞内部，实现精准杀伤，同时减少对正常组织的损伤。 claudin 18.2经治可以参加的项目 项目1：IMC002 IMC002：≥2线治疗失败或者不耐受的胃/食管胃结合部腺癌患者 项目2：SHR-A1904 SHR-A1904：仅一线耐药的胃癌患者（18.2 2+ 3+ ≥50%） 项目3：XNW27011  XNW27011 ：2-4线治疗的胃癌患者 项目4：SUV2208A SUV2208A：≥2线治疗失败的CLDN18.2 阳性的胃/胃食管结合部腺癌GAC/AEG（胃癌）、胃肠胰神经内分泌肿瘤GEP-NEN、来自上消化道的转移性胃肠道粘液癌 MGMC-UGI 项目5：核元Ga68-碘131（注，这个项目没有治疗，主要是拍PET影像，离得近有需要的患者可以顺便去拍） Ga68-碘131：收经治claudin 18.2胃癌 FGFR2b表达/突变可以参加的项目 项目1：SIM0686 SIM0686：经治FGFR2b（可盲测）的胃癌 项目2：BG-C137 BG-C137： 经治FGFR2b胃癌 CCR8阳性经治可参加项目 项目：LM-108 LM-108：队列1：仅一线治疗（氟尿嘧啶类与铂类药物不少于2个周期）失败发CCR8阳性（可盲筛）的胃癌、贲门癌 队列2：≤2线治疗的MSI-H、dMMR（可盲筛）的胃癌、子宫内膜癌 ROR1表达可以参加的项目 项目：SYS6005 试验用药：注射液SYS6005抗体偶联物 ✅纳入人群：≥1线治疗失败的三阴、子宫内膜癌、 胃癌 、肺腺癌、 卵巢癌 SYS6005是一款重组抗人类受体酪氨酸激酶样孤儿受体1（ROR1）抗体偶联药物（ADC），通过其特异性的单克隆抗体部分，精准识别肿瘤细胞表面的ROR1受体，并通过内吞作用进入细胞内部，释放携带的有丝分裂抑制剂MMAE，从而杀伤肿瘤细胞。 没有特异性表达经治胃癌可以参加的项目 项目1：IMM2510 IMM2510：收经治胃癌 项目2：HC010 试验用药：注射用HC010 ✅纳入人群：≤2线治疗失败的胃癌 HC010是由上海宏成药业自主研发的一款靶向人PD-1、CTLA-4和VEGF的三特异性抗体，属于全球首创的1类生物制品创新药。该药物的设计旨在同时阻断PD-1与其配体PD-L1/L2、CTLA-4与其配体CD80/CD86以及VEGF与其受体VEGFR2之间的相互作用，从而实现同时抑制两个免疫检查点和血管新生的协同效应，促进抗肿瘤免疫和血管正常化。 项目3：SCTB39-1 试验用药：注射用SCTB39G ✅纳入人群：2线治疗的胃癌SCTB39G是神州细胞工程有限公司自主研发的一款靶向PD-L1/TIGIT/CTLA4的三特异性抗体注射液，属于治疗用生物制品1类创新药。该药物通过同时阻断PD-L1介导的肿瘤免疫逃逸通路、TIGIT介导的抑制性信号通路以及CTLA4介导的T细胞活化负调控通路，旨在实现对肿瘤微环境的协同深度激活，增强抗肿瘤免疫应答。 项目4：MAX-10181 试验用药：MAX-10181+卡培他滨片 ✅纳入人群：≤2线治疗耐药或者不耐受的胃癌 MAX-10181由再极医药科技有限公司自主研发。再极医药是一家专注创新药物研发的生物医药公司，拥有全球知识产权，主要在靶向疗法和免疫疗法领域研发全球首创（First-in-Class）的小分子药物。MAX-10181通过抑制PD-L1与其受体的结合，阻断肿瘤细胞对免疫系统的抑制，从而激活T细胞对肿瘤细胞的杀伤作用。 项目5：HDM2012 🔹试验用药：注射用HDM2012抗体偶联物 ✅纳入人群：≥2线治疗失败或者不耐受的胃癌患者 HDM2012是一款靶向人粘蛋白-17（Mucin17，MUC-17）的新型抗体药物偶联物（Antibody-drug conjugate，ADC）。由抗MUC-17的单克隆抗体与拓扑异构酶I抑制剂通过可裂解连接子偶联而成，药物抗体偶联比（DAR）为8。2025年12月，HDM2012的胃癌和胃食管交界癌、胰腺癌两项适应症获得美国FDA授予的孤儿药资格认定。 项目6：ABSK131 试验用药：口服ABSK131胶囊 ✅纳入人群：≥2线治疗的实体瘤 ABSK131通过抑制PRMT5与甲硫代腺苷（MTA）的相互作用，发挥“合成致死”效应，选择性杀伤MTAP缺失的肿瘤细胞。MTAP是一种抑癌基因，其缺失会导致MTA积累，进而抑制PRMT5的活性。在MTAP缺失的肿瘤细胞中，PRMT5的活性对癌细胞的生存至关重要，因此抑制PRMT5与MTA的相互作用可以特异性地杀死这些癌细胞。 项目7：QLM2011 QLM2011：经治（至少接受一线系统性治疗含铂/氟尿嘧啶类双药化疗）的胃癌或者胃食管结合部腺癌 项目8：GK01 GK01：经治胃癌 项目9：BC001 试验组：BC001+紫杉醇 对照组：安慰剂+紫杉醇 ✅纳入人群：仅一线含铂或者氟尿嘧啶类治疗失败的胃或胃食管结合部腺癌患者 BC001能够与VEGFR2结合，阻断VEGF的信号通路，抑制肿瘤血管新生，从而抑制肿瘤的生长。血管内皮细胞生长因子受体2（VEGFR2）是VEGF促进血管新生的关键受体，实体瘤血管生成最为关键的是VEGF信号通路的激活，即VEGF与其受体VEGFR2结合，并引发下游血管内皮细胞增殖和迁移的发生。 怎么知道自己的治疗线数？ 之前我们写过一篇文章，详细介绍在参加临床项目阶段，如何判断自己的治疗史，以及如何获取自己的既往史病历档案： 你知道自己是几线治疗吗？如何获取患者的治疗病史？ 既往史就是我们俗称的几线治疗，对于某一个患者来说，更换一种治疗放哪，就是增加一线治疗。治疗线数在参加临床的入选标准上很关键，从上面项目设计可以看出，越是治疗线更多的患者，可选的临床项目就越少。 长按扫码报名参加临床招募 咨询电话：13282319030   关于诺康国际 诺康国际是一个专注肿瘤患者社群运营管理的患者互助公益社群，从2016年成立至今已有10年，已覆盖数万名肿瘤患者和家属。我们拥有自己的专业临床招募团队，目前已全量纳入全国正在开展的临床项目库。如果想了解某个项目，不用再四处询问，可直接在我们群里了解。 诺康社群有我们自己训练AI模型“小糯米”，已完成CSCO，NCCN等各大指南和不同癌种的专家共识的深度学习，不仅可以24小时在线解答肿瘤相关的任何问题，还可以辅助进行临床项目的查询和筛选，无限次，不收费！入群后直接「@小糯米」即可提问。 参加临床不是目的，而是优化治疗方案的重要手段 声明：本文内容基于公开资料整理，仅作信息分享，如有错误请联系我们及时修改。

Positive high-level results from the EMERALD-3 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab), lenvatinib and transarterial chemoembolisation (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) versus TACE alone for patients with unresectable hepatocellular carcinoma (HCC) eligible for embolisation. At this interim analysis for overall survival (OS), a key secondary endpoint, this combination also demonstrated a trend toward OS improvement versus TACE alone. Patients in the investigational arms were treated with the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), with or without lenvatinib, before TACE, and then alongside TACE. Although not formally tested at this time, data for the treatment arm evaluating the STRIDE regimen plus TACE versus TACE alone showed strong trends toward improved PFS and OS. The trial will continue to follow OS and other key secondary endpoints in both investigational arms. HCC is the most common type of liver cancer.1 In 2026, more than 200,000 patients with HCC will be eligible for embolisation, a standard-of-care procedure that blocks the blood supply to the tumour and can also deliver chemotherapy directly to the liver.2-4 However, most patients who receive embolisation experience disease progression or recurrence within six to ten months.5 Ghassan Abou-Alfa, MD, JD, MBA, PhD(hc), Attending Physician, Professor of Medicine at Memorial Sloan Kettering Cancer Center, and principal investigator in the trial said, “Dual immunotherapy with durvalumab and tremelimumab in the STRIDE regimen represents a meaningful advance for patients with embolisation-eligible liver cancer, who currently lack systemic treatment options to keep their cancer from progressing or recurring, with a trend of improving survival. EMERALD‑3 shows we can now significantly reduce the risk of disease progression with STRIDE as the immunotherapy backbone alongside lenvatinib and TACE.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “EMERALD‑3 now shows that bringing the dual immunotherapy STRIDE regimen earlier, alongside TACE and lenvatinib, can further improve outcomes in earlier‑stage liver cancer. This builds on the HIMALAYA Phase III trial data in patients with advanced, unresectable disease, where the STRIDE regimen has already demonstrated durable overall survival benefit. We are discussing these positive data with global regulatory authorities while awaiting the final results from the key secondary endpoints.” The safety profile for each combination was consistent with the known profiles of each medicine, and there were no new safety findings. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. +++ Notes Liver cancer Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death.1,6 In 2026, more than 200,000 patients will be diagnosed with embolisation-eligible HCC.2 Embolisation is a standard-of-care procedure that blocks the blood supply to the tumour and can also deliver chemotherapy directly to the liver.3-4 Immunotherapy is a proven treatment modality in HCC with approved options available for patients in later-line settings.7 EMERALD-3 EMERALD-3 is a randomised, open-label, sponsor-blinded, multicentre, global Phase III trial of a single priming dose of Imjudo 300mg added to Imfinzi 1500mg followed by Imfinzi every four weeks (STRIDE regimen) plus TACE with or without lenvatinib versus TACE alone in a total of 760 patients with unresectable HCC eligible for embolisation. Participants were randomised in a 1:1:1 ratio to Arm A (TACE, Imfinzi, Imjudo, lenvatinib), Arm B (TACE, Imfinzi, Imjudo) and Arm C (TACE) until each arm reached 175 participants. Randomisation was then continued in a 1:1 ratio to treatment Arms A and C until each reached approximately 275 participants. Patients received Imfinzi with Imjudo, plus TACE as needed, with or without lenvatinib concurrently, followed by Imfinzi with or without lenvatinib until progression. The trial was conducted in 171 centres across 22 countries, including in North America, Europe, South America and Asia. The primary endpoint is PFS for Imfinzi plus Imjudo, lenvatinib and TACE versus TACE alone. Secondary endpoints include OS for Imfinzi plus Imjudo, lenvatinib and TACE, and PFS and OS for Imfinzi plus Imjudo and TACE versus TACE alone. Imfinzi Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. In gastrointestinal (GI) cancer, Imfinzi is approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer (BTC) and in combination with Imjudo in unresectable HCC. Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU. In addition to its indications in GI cancers, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC. Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved in the US, EU, Japan and other countries for patients with muscle-invasive bladder cancer based on results from the NIAGARA Phase III trial. Additionally, in May 2025, Imfinzi added to Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial. Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan. Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several GI cancers. Imjudo Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. In addition to its approved indications in liver and lung cancers, Imjudo is being tested in combination with Imfinzi across multiple tumour types including in SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE). AstraZeneca in GI cancers AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines and a variety of tumour types and stages of disease. In 2022, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.8 Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic and colorectal cancers. In addition to its indications in BTC and HCC, Imfinzi is being assessed in combinations, including with Imjudo, in oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings. Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), is approved in the US and several other countries for HER2-positive advanced gastric cancer. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Lynparza, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada). The Company is also assessing rilvegostomig, a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, in combination with bevacizumab with or without Imjudo as a 1st-line treatment in patients with advanced HCC, and as a 1st-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric and gastroesophageal junction cancers. Rilvegostomig is also being evaluated in combination with Enhertu in previously untreated, HER2-expressing, locally advanced or metastatic BTC. AstraZeneca is advancing multiple modalities that provide complementary mechanisms for targeting Claudin 18.2, a promising therapeutic target in gastric cancer. These include sonesitatug vedotin, a potential first-in-class ADC licensed from KYM Biosciences Inc., currently in Phase III development; AZD5863, a novel Claudin 18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development; and AZD4360, an ADC, currently being evaluated in a Phase I/II trial in patients with advanced solid tumours. In early development, AstraZeneca is developing AZD7003, a Glypican 3 (GPC3) armoured CAR T, in HCC. AstraZeneca in immuno-oncology (IO) AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours. AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers. AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Dr. Abou-Alfa provides consulting and advisory services to AstraZeneca. Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial