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Claudin 18.2-directed therapies are on track to become foundational in the treatment of gastrointestinal and select solid tumors. Fueled by innovation in antibody engineering, combination strategies, and biomarker testing, this therapeutic class is set to play a transformative role in the next generation of precision oncology. LAS VEGAS, July 23, 2025 /PRNewswire/ -- DelveInsight's Claudin 18.2 Directed Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging Claudin 18.2-directed therapies, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the Claudin 18.2 Directed Therapies Market Report As per DelveInsight's analysis, the total market size of Claudin 18.2-directed therapies in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as Gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors Leading Claudin 18.2-directed therapies companies, such as AskGene, Innovent, AstraZeneca, Antegene, Antennova, Kelun, Phanes, and others, are developing novel Claudin 18.2-directed therapies that can be available in the Claudin 18.2-directed therapies market in the coming years. Some of the key Claudin 18.2-directed therapies in the pipeline include ASKB589, IBI-343, AZD0901, ATG022/ATN022, SKB315, Spevatamig (PT886), and others. In May 2025, Astellas entered an exclusive license agreement with Evopoint Biosciences for XNW27011, a novel clinical-stage antibody-drug conjugate targeting CLDN18.2. Discover which indication is expected to grab the major Claudin 18.2-directed therapies market share @ Claudin 18.2 Directed Therapies Market Report Claudin 18.2 Directed Therapies Market Dynamics The Claudin 18.2-directed therapies market has been witnessing significant momentum driven by advancements in targeted oncology therapies. Claudin 18.2 is a tight junction protein selectively expressed in certain cancers, such as gastric cancer, gastroesophageal junction adenocarcinoma, and pancreatic cancer, making it an attractive therapeutic target. The approval of zolbetuximab (VYLOY) by Astellas has validated the clinical potential of Claudin 18.2-targeting monoclonal antibodies, positioning the pathway as a critical frontier in precision oncology. Other players, including domestic and international pharmaceutical companies, are actively developing monoclonal antibodies, antibody-drug conjugates (ADCs), and bispecific antibodies directed against Claudin 18.2, further intensifying the competitive dynamics. The market is characterized by a robust pipeline across various modalities. Monoclonal antibodies such as zolbetuximab lead the segment, but the pipeline also features novel ADCs and bispecifics, aiming to improve efficacy and overcome resistance mechanisms. Several companies are exploring combination regimens with checkpoint inhibitors and chemotherapy to enhance treatment outcomes. Additionally, there is a growing interest in expanding the therapeutic scope beyond gastric and gastroesophageal junction cancers to include pancreatic, lung, and other solid tumors where Claudin 18.2 expression is evident, potentially broadening the patient pool. Despite the growth prospects, the Claudin 18.2-directed therapies market faces several challenges. These include the need for reliable diagnostic tools to identify Claudin 18.2 expression, patient heterogeneity in expression levels, and potential off-target effects leading to safety concerns. Moreover, market penetration may be impacted by the high cost of biologics and the evolving reimbursement landscape, particularly in emerging markets. Nonetheless, the strong clinical efficacy signals, favorable regulatory momentum, and increasing physician awareness position Claudin 18.2 therapies for substantial growth over the next decade. Looking ahead, the Claudin 18.2-directed therapy landscape is expected to diversify with the introduction of next-generation modalities such as CAR-T therapies and vaccines targeting the protein. The competitive intensity is likely to increase as additional players enter late-stage development and as combination regimens redefine the treatment paradigm. Continued biomarker-driven patient selection and companion diagnostic development will be critical to optimizing outcomes and driving adoption. Overall, the Claudin 18.2 market represents a dynamic and evolving segment of the oncology therapeutics space, poised for continued innovation and expansion. Claudin 18.2 Directed Therapies Treatment Market Therapies targeting Claudin 18.2 have shown activity across several cancers, such as gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors. Astellas' VYLOY (zolbetuximab) is currently the first and only approved therapy directed against Claudin 18.2 for advanced gastric and gastroesophageal junction adenocarcinoma. It was first approved in Japan in March 2024, followed by regulatory clearance in the UK in August 2024, and later by the US FDA in October 2024. VYLOY is a cytolytic monoclonal antibody that targets claudin 18.2 and is approved for use alongside fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. This treatment is specifically intended for patients whose tumors express claudin 18.2, as confirmed by an FDA-approved diagnostic test. As a claudin 18.2-targeting cytolytic antibody, VYLOY destroys CLDN18.2-positive cells through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Preclinical models have shown that combining VYLOY with chemotherapy enhances antitumor activity in CLDN18.2-positive tumors compared to the use of either treatment alone. Learn more about the Claudin 18.2-directed therapies @ Claudin 18.2 Directed Therapies Analysis Key Emerging Claudin 18.2 Directed Therapies and Companies Several companies, including AskGene (ASKB589), Innovent (IBI-343), Antegene (ATG022/ATN022), Kelun (SKB315), AstraZeneca (AZD0901), Phanes (Spevatamig), and others, are currently engaged in the development and production of CLDN 18.2 therapies, which have the potential to significantly impact and enhance the MCR therapies market. ASKB589 is a humanized IgG1 monoclonal antibody targeting CLDN1, specifically designed to enhance antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). In combination with CAPOX chemotherapy and a PD-1 inhibitor as a first-line therapy for patients with gastric/gastroesophageal junction (G/GEJ) cancer, ASKB589 showed a favorable safety and tolerability profile. The addition of a PD-1 inhibitor to the ASKB589 plus CAPOX regimen in patients expressing moderate to high levels of CLDN18.2 led to promising anti-tumor effects, characterized by strong and lasting responses. IBI-343 is a recombinant human monoclonal antibody targeting Claudin 18.2, linked to a topoisomerase I inhibitor payload (Exatecan). Engineered with an Fc-silenced backbone to reduce unwanted immune activation, it features a cleavable linker for targeted drug release within tumor cells, enabling a bystander killing effect that affects neighboring tumor cells with low antigen expression. IBI-343 has been granted Fast Track Designation by the U.S. FDA and is currently being investigated in the Phase III G-HOPE trial (NCT06238843). The anticipated launch of these emerging therapies are poised to transform the Claudin 18.2-directed therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Claudin 18.2-directed therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about Claudin 18.2-directed therapies clinical trials, visit @ Claudin 18.2 Directed Therapies Treatment Claudin 18.2 Directed Therapies Overview Claudin 18.2 is a tight junction protein essential for preserving the integrity of the stomach lining. It is one of the two isoforms produced by the CLDN18 gene and is normally found only in differentiated epithelial cells of the gastric mucosa. In healthy tissues, Claudin 18.2 is hidden within tight junctions, making it inaccessible to drugs. However, during the development of cancers like gastric, gastroesophageal junction (GEJ), and pancreatic cancer, Claudin 18.2 becomes abnormally exposed on the surface of tumor cells, while its expression in normal tissues remains limited. This distinct expression profile makes Claudin 18.2 a promising and highly specific therapeutic target. The most advanced treatment targeting this protein is VYLOY, a monoclonal antibody that binds to Claudin 18.2 and induces immune-mediated killing of tumor cells. VYLOY has demonstrated encouraging results in late-stage clinical trials and is now approved for treating CLDN18.2-positive gastric and GEJ cancers. Additional therapies under investigation include CAR-T cell therapies, bispecific antibodies, and antibody-drug conjugates. Testing for CLDN18.2 expression using immunohistochemistry (IHC) helps identify patients who may benefit from these targeted treatments, highlighting the dual role of CLDN18.2 as both a biomarker and a therapeutic target in precision cancer therapy. Claudin 18.2 Directed Therapies Epidemiology Segmentation The Claudin 18.2-directed therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases of Selected Indications for Claudin 18.2-directed Therapies Total Eligible Patients of the Selected Indications of Claudin 18.2-directed Therapies Total Treated Cases in Selected Indications for Claudin 18.2-directed Therapies Scope of the Claudin 18.2 Directed Therapies Market Report Claudin 18.2 Directed Therapies Therapeutic Assessment: Claudin 18.2 Directed Therapies current marketed and emerging therapies Claudin 18.2 Directed Therapies Market Dynamics: Conjoint Analysis of Emerging Claudin 18.2 Directed Therapies Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Claudin 18.2 Directed Therapies Market Access and Reimbursement Discover more about Claudin 18.2-directed therapies in development @ Claudin 18.2 Directed Therapies Clinical Trials Table of Contents Related Reports Gastric Cancer Market Gastric Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key gastric cancer companies, including BeiGene, Linton Pharm Co. Ltd., RAPT Therapeutics, Leap Therapeutics, Idience, Bolt Biotherapeutics, Hubro Therapeutics, Immunocore, Ambrx, Hangzhou DAC Biotech, Beijing Immunoah Pharma Tech, Nanjing KAEDI Biotech, HiberCell, Transcenta Holding, Suzhou Zelgen Biopharmaceuticals, Daiichi Sankyo, Ipsen, Alligator Bioscience, Bristol Myers Squibb, Jiangsu Hengrui Medicine, Shanghai Junshi Biosciences, ImmunoACT, among others. Pancreatic Cancer Market Pancreatic Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pancreatic cancer companies, including AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, Celgene, Bristol Myers Squibb, BioLineRx, Alligator Bioscience, Bellicum Pharmaceuticals, OSE Immunotherapeutics, Actuate Therapeutics, FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, Merus, Mirati Therapeutics, Rexahn Pharmaceuticals, Ocuphire Pharma, Processa Pharmaceuticals, ImmunityBio, Berg, Panbela Therapeutics, GlaxoSmithKline, Eleison Pharmaceuticals, Molecular Templates, Lokon Pharma AB, Cantargia AB, Bristol-Myers Squibb, among others. Gastroesophageal Junction Adenocarcinoma Market Gastroesophageal Junction Adenocarcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key gastroesophageal junction adenocarcinoma companies, including Astellas Pharmaceuticals, AstraZeneca, Bayer, Beigene, Bristol-Myers Squibb, Daichii Sankyo, Elevar Therapeutics, Eli Lilly, FivePrime Therapeutics, Incyte Corporation, Macrogenics, Merck Co., Ono Pharmaceuticals, Roche, Taiho Pharmaceuticals, Zai Labs, ZymeWorks, among others. Pancreatic Ductal Adenocarcinoma Market Pancreatic Ductal Adenocarcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PDAC companies, including Cardiff Oncology, Cantargia, RenovoRx, Jeil Pharmaceutical, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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在生命与病魔的漫长拔河中，抗癌之路仿若暗夜行舟，每一次新突破都似远方亮起的航标。踏入6 月，抗癌领域再次迎来诸多令人瞩目的进展，宛如熠熠星辰照亮前行方向。新药的上市为患者开启全新希望之门，CAR - T 技术持续革新，在精准打击癌细胞的征程中迈出坚实步伐，癌症疫苗的研发也不断传来佳音，为人类抵御癌症构筑更坚固防线。 抗癌新药月报（2025.6） MET扩增有救了！国研肺癌新药赛沃替尼震撼上市！ 6月30日，和黄医药宣布沃瑞沙（ORPATHYS，赛沃替尼/ savolitinib）和泰瑞沙（TAGRISSO，奥希替尼/ osimertinib）的联合疗法的新药上市申请获中国国家药品监督管理局（NMPA）批准，用于治疗表皮生长因子受体（EGFR）基因突变阳性经EGFR酪氨酸激酶抑制剂（TKI）治疗后进展的伴MET扩增的局部晚期或转移性非鳞状非小细胞肺癌患者。沃瑞沙是一款选择性MET抑制剂，用于治疗伴有MET外显子14 跳变的局部晚期或转移性非小细胞肺癌成人患者。临床研究结果显示：沃瑞沙和泰瑞沙的联合疗法降低患者的疾病进展风险达66%，中位PFS为8.2个月，而化疗组则为4.5个月。 小细胞肺癌新药度伐利尤单抗获批上市 6月4日，阿斯利康宣布抗PD-L1单抗度伐利尤单抗已获中国国家药品监督管理局(NMPA)批准新适应症，作为单药用于在接受铂类药物为基础的放化疗后未出现疾病进展的局限期小细胞肺癌（LS-SCLC）成人患者的治疗。此次获批是基于ADRIATIC 3期临床试验的积极结果，数据显示：接受度伐利尤单抗治疗的患者显示出了显著的总生存获益，三年总生存率高达57%，度伐利尤单抗有望成为中国乃至全球的治疗新标准。 宫颈癌一线治疗迎来重磅新方案 6月4日，中国国家药监局（NMPA）官网最新公示，康方生物研发的PD-1/CTLA-4双特异性抗体卡度尼利单抗注射液的一项新适应症上市申请已获得批准。根据康方生物早先新闻稿，该药本次获批的适应症为：卡度尼利单抗加含铂化疗联合/不联合贝伐珠单抗用于一线治疗持续、复发或转移性宫颈癌。 ROS1肺癌新药获FDA批准上市！ Taletrectinib 是一种强效的新一代ROS1靶向药，在未接受 TKI 治疗和接受克唑替尼治疗的ROS1+ NSCLC 患者中均表现出显著的疗效。在未接受 TKI 治疗和接受克唑替尼治疗的患者中均观察到高且持久的 ORR，无论采用哪种治疗方案，颅内 ORR 均较高，未接受 TKI 治疗和接受克唑替尼治疗的患者的 PFS 延长，并且对 G2032R 的活性也具有很高的临床意义，为ROS1 TKI 治疗领域增添了新的选择！2025 年 6 月 11 日，美国食品药品监督管理局批准激酶抑制剂塔雷替尼 (Ibtrozi，Nuvation Bio Inc.) 用于治疗局部晚期或转移性 ROS1 阳性非小细胞肺癌 (NSCLC) 的成年人。 奥希耐药迎来新方案！Dato-DXd获批上市 2025 年 6 月 23 日，美国食品药品监督管理局加速批准 datopotamab deruxtecan-dlnk（Datroway，第一三共株式会社），用于治疗已接受过 EGFR 靶向治疗和铂类化疗的局部晚期或转移性表皮生长因子受体 (EGFR) 突变非小细胞肺癌 (NSCLC) 成人患者。研究结果显示：既往接受奥希替尼（Tagrisso；n = 96）治疗的患者客观缓解率（ORR）高达 44.8% ，其中 4.2% 的患者肿瘤靶病灶全部消失，达到完全缓解（ CR），疾病控制率（DCR ）为 85.4% 。中位无进展生存期（ PFS） 和总生存期（ OS） 分别为 5.7 个月和 14.7 个月。 抗癌新药招募（2025.6） 肺癌 药品名称： SYS6010 作用靶点： EGFR 研发公司：石药 药物介绍： SYS6010抗肿瘤1类新药SYS6010是一种EGFR抗体-偶联药物，其与肿瘤细胞表面的EGFR受体结合后，通过内吞作用进入到细胞内，在溶酶体内被蛋白酶降解，释放毒素小分子JS-1(新型拓扑异构酶I抑制剂)，JS-1和DNA形成稳定复合物，诱导DNA损伤，进而导致细胞凋亡，且发挥旁观效应非特异性杀伤周围肿瘤组织细胞。 临床前研究发现SYS6010对EGFR高表达的人结直肠癌(DiFi)、人乳腺癌(MDA-MB-468)移植瘤模型具有抗肿瘤作用，对一代TKI吉非替尼耐药的非小细胞肺腺癌PC9-GR、L858R/T790M双突变的非小细胞肺癌NCI-H1975、三代TKI奥希替尼耐药且Ex19del/T790M/C797S三突变的非小细胞肺癌PC9-DTC等移植瘤模型也有显著的抗肿瘤作用，药效均显著优于基于MMAE或Dxd等成熟毒素的对照ADC药物。 目前开展的I期临床试验中，该产品在非小细胞肺癌以及诸多瘤种患者中均显示出积极的抗肿瘤疗效。SYS6010已于2024年12月24日被CDE授予经EGFR-TKI和含铂化疗治疗失败的EGFR突变阳性晚期NSCLC突破性治疗。 招募信息（部分）： 1.组织学确诊的局部晚期或转移性NSCLC患者，包括：基于AJCC分期第8版，ⅢB或ⅢC期且不适合进行手术切除或接受根治性放化疗患者，或IV期NSCLC患者。既往接受过针对局部晚期或转移性疾病的EGFR TKI治疗且治疗失败（必须包括三代已上市EGFR TKI）的EGFR突变型局部晚期或转移性NSCLC； 2.至少携带一种EGFR敏感突变（ex19del、L858R、G719X、S768I或L861Q，可合并其他EGFR突变）。 药品名称： SYS6040 作用靶点：小细胞肺癌 研发公司：石药 药物介绍： SYS6040是一种靶向人DLL3的ADC。 SYS6040可与表达DLL3的肿瘤细胞特异性结合，通过受体介导的内吞作用进入细胞并释放毒性载荷，从而起到杀伤肿瘤细胞作用。 适应症： 经组织学或细胞学证实的晚期小细胞肺癌 队列1:既往至少接受一线含铂化疗失败或不耐受的 SCLC参与者 队列 2:既往经标准治疗失败或标准治疗方案不耐受或无标准治疗的其他神经内分泌肿瘤参与者 队列3:既往经标准治疗失败或标准治疗方案不耐受或无标准治疗方案的 DLL3表达阳性的其他恶性实体瘤参与者。 药品名称：谷美替尼 作用靶点： MET 研发公司： 海和药物 适应症：MET过表达的局部晚期或转移性非小细胞肺癌 药物介绍：谷美替尼（商品名：海益坦；英文通用名：Glumetinib；代号：SCC244）是一款口服强效、高选择性小分子MET抑制剂。临床前研究显示谷美替尼可强效和特异性靶向抑制MET激酶活性，并可以选择性抑制MET异常的非小细胞肺癌（NSCLC）肿瘤模型的生长。此外，临床研究结果显示，谷美替尼具有优良的药代动力学特性以及良好的安全性和耐受性，并且在具有MET改变的晚期NSCLC人群中显示了明确疗效。2023年3月8日，国家药监局（NMPA）官网最新公示，谷美替尼的上市申请已获得附条件批准，用于治疗MET外显子14跳变的局部晚期或转移性NSCLC患者。 招募信息（部分）： 　经由申办方指定的中心实验室确认肿瘤组织标本中MET过表达： ①3+，≥90%； ②3+，50%~89%； ③≥ 2+，≥50%且3+，<50%。 胃癌 试验药组LM302注射液药物介绍CLDN18.2ADCC单克隆抗体适合患者无法手术切除初治胃癌，需要CLDN18.2 表达阳性。HER-2 阴性的胃和胃食管结合部腺。 试验药组TQB2103药物介绍Claudin 18.2ADC适合患者标准治疗后不耐受或进展，需要CLDN18.2 表达检测。HER-2 阴性的胃和胃食管结合部腺癌 试验药组SYSA1801药物介绍Claudin 18.2ADC适合患者无法手术切除初治胃癌，需要CLDN18.2 表达检测。 尿路上皮癌 【项目名称】： SYS6002 联合 SG001 在晚期尿路上皮癌及其他晚期实体瘤患者中的安全性、耐受性、药代动力学特征和初步疗效的开放、多中心Ⅱ期临床试验。 【入排信息（部分）】： 对于一线尿路上皮癌需要满足：病理学确诊的、未接受过系统性抗肿瘤治疗的局部晚期或转移性尿路上皮癌患者，如果既往接受过新辅助或辅助治疗，则新辅助或辅助治疗结束至疾病进展（影像学证实）的时间间隔超过 12 个月可入组； 对于后线尿路上皮癌需要满足：病理学确诊的、既往接受过含铂化疗治疗或不耐受或不适合接受含铂治疗的尿路上皮癌患者。 其他热招新药 【项目名称】 评价Vx-001在晚期实体瘤/非小细胞肺癌患者中的安全性、免疫原性和临床抗肿瘤效果的剂量递增和扩展临床研究。 【入排信息（部分）】： 1.经组织学和/或细胞学明确诊断为局部晚期或复发、转移性非小细胞肺癌患者，既往PD-1/PD-L1 治疗失败或不适合 PD-1/PD.L1治疗，且接受过完整含铂类化疗治疗(4~6 个疗程)后，无疾病进展； 2.18 周岁≤年龄≤75 周岁，性别不限； 3.患者 HLA 抗原检测必须含有 HLAA*0201型(多肽呈递的基序仅与该 HLA 分子匹配)TERT 表达阳性且肿瘤浸润淋巴细胞(CD3/CD8 TILS)表达为阴性4)根据实体瘤疗效评价标准(RECISTv1.1)，具有至少一个可测量病灶。 【项目名称】 实体瘤疫苗-ABO2011 【入排信息（部分）】 1、受试者必须为18岁及以上。 2、经病理组织学或细胞学证实的进展或转移的晚期实体瘤。 3、既往接受过系统性标准治疗后疾病进展或不可耐受毒性(不可耐受毒性定义:>IV级的血液学毒性;或>亚级的非血液学毒性:或>工级的心、肝、肾等主要脏器的损害)，且缺乏有效治疗方案的晚期实体瘤。 抗癌新技术进展（2025.6） 实现近10年无癌超长生存！“钻石”靶点GPC3为晚期肝癌创下生命奇迹！ CT011是肝细胞癌中同类首创的针对GPC3靶点的CAR T细胞疗法。2015年5月，国内知名的癌症中心启动了全球首个针对GPC3(Glypican-3)蛋白的CAR T细胞疗法治疗晚期肝细胞癌的临床研究，这项研究数据曾在2020年发表在国际重磅肿瘤学期刊《Clin Cancer Res》上。 值得振奋的是，其中两位患者接受CAR-T治疗后，仅接受口服抗乙型肝炎病毒药物治疗，未接受其他癌症治疗。近日，两位幸运的患者接受了随访，截至目前已实现无癌超过9年，接近10年，完全回归正常生活！实现近10年无癌超长生存！“钻石”靶点GPC3为晚期肝癌创下生命奇迹！ 2名患者在最近一次随访（2025年4 月11日）时，仍处于无癌状态 肠癌患者实现完全缓解！新型TIL疗法为胃肠道癌症患者带来生存新希望 近日，一项刊登于国际顶级期刊《柳叶刀》的 Ⅰ 期临床研究（NCT04426669）带来震撼突破 —— 经 CRISPR-Cas9 基因编辑的肿瘤浸润淋巴细胞（TIL）疗法，通过敲除胞内免疫检查点基因 CISH，在转移性胃肠道癌患者中展现出显著抗肿瘤活性 ，尤其对传统免疫治疗耐药的患者实现完全缓解，为消化道肿瘤治疗开辟了全新路径。免疫治疗新边疆：新型TIL 疗法为胃肠道癌患者带来生存新希望 第一个人体Ⅰ期研究入组的是18-70岁、一线治疗失败的转移性胃肠道组织上皮癌患者（包括疤痕、结直肠癌等），要求可手术肿瘤获得以制备TIL，且存在可测量病灶。2020年5月12日至2022年9月16日期间，共有22名参与者入组接受TIL治疗。 结果显示：疾病控制率（DCR） 第28天：50%（6/12） 局势稳定（SD） 第56天：33%（4/12）持续SD 值得警惕的是，1名幸运的微卫星不稳定性高（MSI-H）结直肠癌患者，在既往接受PD-1/CTLA-4联合治疗后，接受新型CISH敲除TIL治疗后，肿瘤靶病灶全部消失，实现完全缓解（CR），需持续超21个月 ，且未接受其他抗肿瘤治疗。 全球首例！NK细胞疗法助胃癌患者无病生存近4年，点亮免疫治疗新希望 自然杀伤（NK）细胞无需预先致敏即可诱导细胞毒性的独特特性，使其成为免疫治疗的理想选择。《Medicine》杂志曾报道一则经典案例：一位晚期胃印戒细胞癌（SRC）患者经NK细胞辅助治疗联合手术及化疗后，实现了长达46个月的无病生存。这一突破首次以临床实例证实了NK细胞辅助治疗在晚期胃印戒细胞癌中的显著价值！相信随着免疫治疗研究的不断深入，像NK细胞这样的创新疗法将为更多晚期癌症患者点燃生命的希望！ 41岁女性患者，确诊为胃窦小弯侧溃疡性低分化腺癌（以印戒细胞癌为主，伴少部分黏液腺癌），肿瘤大小7×6×1.8cm，侵犯胃壁全层，脉管内见癌栓，胃大弯侧部分淋巴结转移，术后病理分期为ⅢC期（T4a，N3a，M0），行根治性（R0）胃切除术后，接受6个周期奥沙利铂为基础的化疗方案。 NK细胞治疗后，患者肿瘤标志物检测及腹部CT扫描均恢复正常，CA72-4水平逐步降至正常范围。截至最后一次随访， 患者已实现46个月（≈3.8年）无病生存，且状态良好，未见疾病进展迹象 全身转移肿瘤消退！新型抗癌药ASKB589为晚期胃癌患者带来新选择 ASKB589 是 AskGene研发的一种创新生物药物，它是一种针对 CLDN 18.2 的重组人源化单克隆抗体。该药物通过与表达 CLDN18.2 的癌细胞高亲和力结合，介导抗体依赖性细胞介导的细胞毒作用 (ADCC) 和补体依赖性细胞毒作用 (CDC)。ASKB589 旨在治疗 G/GEJ 癌、胰腺癌以及表达 CLDN18.2 的其他癌症类型。 2024年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）上公布了这款国研药物的鼓舞人心的最新数据。 ASKB589 联合化疗 (CAPOX) 和 PD-1 抑制剂作为局部晚期、复发和转移性胃 (G) 或胃食管连接部 (GEJ) 腺癌患者的一线治疗，疾病控制率高达 100% ！ 中位生存暴增5倍！《Science》揭示“粪菌移植+免疫”组合拳，打破PD-1耐药魔咒 近期，国际顶刊《Science》发布的一项单臂临床试验（NCT03341143）带来颠覆性突破！研究团队大胆创新，将粪便微生物群移植（FMT）与抗PD-1疗法强强联合，直击转移性黑色素瘤患者的耐药困局。这场“菌群+免疫”的协同作战，不仅成功重塑肠道菌群生态，更强势改写肿瘤微环境的“免疫剧本”！15例患者中，6人重获临床获益，从而逆转了部分患者对抗PD-1药物的耐药性，为无数陷入治疗僵局的患者带来了新的希望与选择！ 想寻求癌症疫苗，TCR-T疗法及其他国内外新抗癌治疗帮助，且经济条件允许的情况下，可以先将病历提交至全球肿瘤医生网医学部进行初步评估，一旦审核通过，有机会获得”天价“疗法免费治疗的机会。 过去十年，肿瘤的治疗已经取得了长足的进展，逆转了晚期患者的生存期，除了上面整理的内容，还有更多的新药正在研发中，更多的病友可以通过新药获得更长的生存期。让我们拭目以待，期待更多新药早日上市，造福大众！也期待2025，病友们能够打败癌症，活过一个又一个10年！ 本文为全球肿瘤医生网原创，未经授权严禁转载