Exatecan mesilate

注册性临床III期G-HOPE-001研究达到双主要终点：在既往接受过治疗的CLDN18.2阳性胃癌患者中，坦康阿妥塔单抗显著且具有临床意义地改善总生存期（OS）和无进展生存期（PFS）。 坦康阿妥塔单抗展现出优异的安全性特征，胃肠道不良事件发生率低。 坦康阿妥塔单抗是全球首个申报NDA的CLDN18.2 ADC。 2026年10月23日，美国旧金山和中国苏州——信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、心血管及代谢、自身免疫、眼科等重大疾病领域创新药物的生物制药公司宣布，坦康阿妥塔单抗(IBI343;武田研发代号:TAK-921)治疗 Claudin(CLDN)18.2 阳性、既往接受过治疗的晚期胃或胃食管结合部腺癌(G/GEJA)患者的中日国际多中心III期注册临床研究(G-HOPE-001,NCT06238843)取得积极的顶线结果。相关数据在 2026 年欧洲肿瘤内科学会(ESMO)年会上以最新突破性摘要(LBA)形式进行口头报告。 胃癌是全球癌症相关死亡的主要原因之一，晚期患者的预后尤其不佳1。对于经多线治疗后疾病进展的患者，后续治疗选择有限，因此对新型靶向治疗存在巨大需求2。CLDN18.2 是一种在某些癌细胞表面异常高表达的蛋白,已成为包括胃癌在内的部分消化道肿瘤的重要生物标志物3。坦康阿妥塔单抗是一种潜在同类最佳(best-in-class)的 Claudin 18.2 靶向抗体偶联药物(ADC),采用依喜替康(exatecan)作为载荷,并采用 Fc 沉默骨架设计, 以降低 Fc 介导效应的风险。信达生物与武田制药于2025年11月达成许可与合作协议,武田将负责坦康阿妥塔单抗在大中华区以外全球范围内的开发、生产和商业化。 坦康阿妥塔单抗显著改善CLDN18.2阳性后线胃癌患者的OS和PFS G-HOPE-001 是一项在中国和日本开展的国际多中心、随机对照开放标签III期临床研究,旨在评估坦康阿妥塔单抗对比研究者选择的治疗方案（TPC，伊立替康、紫杉醇或曲氟尿苷/替匹嘧啶）在至少接受过两种系统性治疗的局部晚期不可切除或转移性CLDN18.2阳性胃或胃食管结合部腺癌受试者中的疗效与安全性。 本次ESMO大会报告的数据来自方案预设的两次期中分析，第一次期中分析（IA1）为PFS的主要分析，第二次期中分析（IA2）为OS的主要分析，两次分析的数据截止时间分别为2026 年2月13日和 9 月 3 日。与研究者选择的治疗组（对照组）相比，坦康阿妥塔单抗组在OS、PFS和客观缓解率(ORR) 均取得具有统计学显著性和临床意义的改善。 OS显著延长。 坦康阿妥塔单抗组的中位 OS 为 10.2 个月，对照组为6.9 个月 ，死亡风险降低43% (HR=0.57, 95% CI: 0.45-0.73; P<0.0001)。 PFS显著延长。第一次期中分析结果显示，中位PFS达到方案预设的统计标准，呈现显著统计学差异及临床意义的改善。第二次期中分析结果，经 IRRC 评估 ，相较对照组的 3.1 个月，坦康阿妥塔单抗组的中位 PFS为 7.1 个月，中位PFS获益进一步延长， 疾病进展风险降低55% (HR=0.45, 95% CI: 0.35-0.58)。 ORR显著提高。坦康阿妥塔单抗组经 IRRC 评估后确认的 ORR 为 37.4%，显著高于对照组的7.7%。  坦康阿妥塔单抗胃肠道不良事件发生率较低，≥3级恶心和呕吐的发生率仅0.9%和2.6% 在接受坦康阿妥塔单抗单药治疗的患者中，整体安全性特征可控，≥3级治疗相关不良事件（TRAE）发生率为47.4%，而对照组为55.9%。 坦康阿妥塔单抗组与对照组最常见的≥3级治疗期间不良事件（TEAE）包括：贫血（20.4% vs. 13.1%）、中性粒细胞计数降低（17.4% vs. 32.0%）和白细胞计数降低（11.7% vs. 22.5%）。 严重胃肠道事件发生率较低，接受坦康阿妥塔单抗治疗的患者中，≥3级恶心、呕吐和腹泻的发生率分别为0.9%、2.6%和1.3%，对照组分别为1.8%、3.2%和4.1%。这一安全性特征使坦康阿妥塔单抗具有差异化优势，有望减轻患者治疗负担。 TEAE导致剂量中断的发生率在坦康阿妥塔单抗组为47.4%，对照组为51.4%。TRAE导致停药的事件不常见且两组相当，坦康阿妥塔单抗组发生率为1.7%。 研究详细数据将在未来的医学会议或学术期刊上进一步发表。 北京大学肿瘤医院消化肿瘤内科主任沈琳教授表示：“胃癌是中国乃至全球范围内疾病负担较重的恶性肿瘤之一。对于晚期胃癌患者而言，随着疾病进入后线治疗阶段，可选择的治疗方案逐渐减少，患者整体预后仍然较差，临床上仍存在巨大的未满足治疗需求。CLDN18.2作为胃癌领域重要的治疗靶点之一，其精准靶向治疗正在成为消化肿瘤领域的重要发展方向。坦康阿妥塔单抗在关键三期临床研究中观察到了PFS和OS的双重获益，为后线胃癌治疗提供了强有力的循证医学证据，也将进一步推动胃癌精准治疗的发展。” 日本国立癌症中心东医院Kohei Shitara教授表示：“坦康阿妥塔单抗是一款靶向CLDN18.2的新一代ADC药物。从G-HOPE-001研究公布的数据来看，坦康阿妥塔单抗在既往接受多线治疗的CLDN18.2阳性胃癌/胃食管结合部腺癌患者中展现出了令人鼓舞的抗肿瘤活性和良好的安全性，为未来进一步在更前线的人群中探索抗CLDN18.2治疗奠定了坚实的基础，期待坦康阿妥塔单抗在未来给更多的胃癌患者带来获益。” 信达生物制药集团首席研发官（肿瘤管线）周辉博士表示：“坦康阿妥塔单抗是信达生物自主研发的CLDN18.2靶向ADC，采用Fc沉默差异化设计。得益于差异化特征和临床高效推进，坦康阿妥塔单抗成为全球首个进入监管审评的CLDN18.2 ADC。坦康阿妥塔单抗也是信达生物第一个获得PFS和OS双阳性结果的ADC，也标志着以依喜替康载荷为基础的SyntecanE® ADC平台的验证和建立。我们将继续致力于开发出更多创新肿瘤疗法，惠及全球患者。” 关于坦康阿妥塔单抗 (IBI343/TAK-921) 坦康阿妥塔单抗是一款靶向CLDN18.2的抗体药物偶联物（ADC），作为精准治疗药物研发，用于治疗CLDN18.2表达阳性的各类肿瘤。该药通过可裂解连接子，可将高活性的依喜替康有效载荷（拓扑异构酶Ⅰ抑制剂）选择性递送至肿瘤细胞；同时采用Fc沉默结构设计，以最大程度减少肿瘤外脱靶毒性。 坦康阿妥塔单抗为全球首个递交监管审评申请的CLDN18.2靶向ADC药物。基于国际多中心 III 期临床研究 G-HOPE-001 期中分析的阳性结果，已向中国 NMPA 递交用于既往接受过系统治疗的局部晚期不可切除或转移性 CLDN18.2 阳性胃癌或胃食管结合部腺癌患者的上市申请，目前处于优先审评中；坦康阿妥塔单抗也正在中国开展一项针对 CLDN18.2 阳性晚期胰腺癌患者的 III 期临床研究，同时正在 I 期临床研究中探索用于胃癌和胰腺癌患者的一线治疗。根据进行中的PoC临床研究结果,武田将计划启动胃癌和胰腺癌的全球 III期临床研究。 坦康阿妥塔单抗获国家药品监督管理局（NMPA）药品审评中心（CDE）授予两项突破性治疗药物（BTD）认定，分别用于治疗经一线及以上治疗失败或不能耐受的CLDN18.2阳性晚期胃癌、用于已接受两种系统性治疗的 CLDN18.2 阳性、局部晚期或转移性胰腺癌，并就已接受两种系统性治疗的 CLDN18.2 阳性、局部晚期或转移性胰腺癌获美国食品药品监督管理局（FDA）授予快速审批通道（FTD）认定。 关于G-HOPE-001 研究  G-HOPE-001 研究(NCT06238843)是一项国际多中心、随机、开放标签 III期临床研究,旨在评估坦康阿妥塔单抗单药对比研究者选择的治疗方案(TPC，[伊立替康、紫杉醇或曲氟尿苷/替匹嘧啶]),用于既往接受过治疗的、不可切除的局部晚期或转移性 Claudin(CLDN)18.2 阳性胃或胃食管结合部腺癌(G/GEJA)患者。 符合入组条件的患者为 CLDN18.2 阳性肿瘤(定义为采用 VENTANA CLDN18(43-14A)检测试剂检测,≥75% 的肿瘤细胞免疫组化(IHC)染色强度≥2+),且在既往二至四种系统治疗方案后出现进展。患者按 1:1 随机分配接受坦康阿妥塔单抗 6 mg/kg 每三周一次(Q3W)或 TPC,分层因素为地区、原发肿瘤部位和既往是否接受胃切除术。 研究的双重主要终点为根据 RECIST v1.1 评估的无进展生存期(PFS)和总生存期(OS)。次要终点包括客观缓解率(ORR)、疾病控制率、缓解持续时间、至缓解时间和安全性。该研究在中国和日本共入组 464 例受试者。  关于胃及胃食管结合部腺癌(G/GEJA)  胃癌是全球第五大常见癌症和第五大癌症相关死亡原因,日本和中国是全球发病率最高的地区之一1,4 。全球五年净生存率存在差异,约为 20%–40%,晚期患者的生存率明显更低5。随着疾病进展,治疗选择日益有限,接受后线治疗的患者中位总生存期仍不足10个月6。Claudin 18.2 是一种紧密连接蛋白,通常存在于健康的胃组织中,但在相当比例的胃癌和胃食管结合部癌中异常表达于肿瘤细胞表面,已成为该疾病新型精准治疗开发中重要的生物标志物3。 关于信达生物 “始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有20个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®）， 雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®），氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®），替妥尤单抗N01注射液（信必敏®），玛仕度肽注射液（信尔美®），匹康奇拜单抗注射液（信美悦®），伊匹木单抗N01注射液（达伯欣®），阿贝西利片（唯择®）和盐酸奎扎替尼片（维复泰®）。目前，还有1个品种在NDA审评中，5条管线进入注册或关键性临床阶段，另有20条管线处于临床研究阶段。 公司已与礼来、罗氏、武田、辉瑞、赛诺菲、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及20余万普通患者，药物捐赠总价值40亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。 详情请访问公司网站：www.innoventbio.com或公司领英账号：Innovent Biologics。 声明： 1.本文仅为医学科学信息分享，不构成任何诊疗建议或用药指导，亦不涉及任何药品推荐，信达生物不推荐未获批的药品/适应症的使用。个体用药情况可能存在差异，请及时就医，处方药购买及使用需谨遵医嘱。 2.雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），匹妥布替尼片 （捷帕力®）和阿贝西利片（唯择®）由礼来公司研发。 参考文献： 1.Yashima K, et al. Gastric Cancer Screening in Japan: A Narrative Review. J Clin Med. 2022;11(15):4337. Published 2022 Jul 26. doi:10.3390/jcm11154337 2.Rowsell A, et al. Systematic review of health-related quality of life (HRQoL) issues associated with gastric cancer: capturing cross-cultural differences. Gastric Cancer. 2022;25(4):665-677. doi:10.1007/s10120-022-01309-6 3.Sahin U, et al. Claudin-18 splice variant 2 is a pan-cancer target suitable for therapeutic antibody development. Clin Cancer Res. 2008;14(23):7624–7634. doi:10.1158/1078-0455.CCR-08-1547 4.Sung H, et al. Global cancer statistics 2024: GLOBOCAN estimates of incidence and mortality worldwide for 34 cancers in 186 countries. CA Cancer J Clin. 2026;70090. doi:10.3322/caac.70090 5.Allemani C, et al. Global surveillance of trends in cancer survival 2000–14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018;391(10125):1023-1075. doi:10.1016/S0140-6736(17)33326-3 6.Shitara K, et al. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric or gastro-oesophageal junction cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018;19(11):1437-1448. doi:10.1016/S1470-2045(18)30739-3 前瞻性声明 本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。 本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。 本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

Registrational Phase 3 G-HOPE-001 Study Met Both Primary Endpoints, Demonstrating Statistically Significant and Clinically Meaningful Overall Survival and Progression-Free Survival Benefits in Previously Treated, CLDN18.2-positive Gastric Cancer Arcotatug Tavatecan Demonstrated a Favorable Safety Profile, with a Low Incidence of Gastrointestinal Adverse Events Arcotatug tavatecan is the First CLDN18.2-ADC to have a New Drug Application Accepted for Regulatory Review Globally SAN FRANCISCO and SUZHOU, China, Oct. 23, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (HKEX: 01801), a biopharmaceutical company committed to the discovery, development, manufacturing and commercialization of innovative medicines for the treatment of major diseases including oncology, cardiovascular and metabolic diseases, autoimmune diseases, and ophthalmic diseases, announced positive topline results from the Phase 3 (G-HOPE-001) study (NCT06238843) of arcotatug tavatecan (IBI343; Takeda R&D Code:TAK-921) in patients with Claudin (CLDN)18.2-positive, previously treated, advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA). The data were orally presented as a Late-Breaking Abstract at the 2026 European Society for Medical Oncology (ESMO) Congress. Gastric cancer is a leading cause of cancer-related death worldwide, and outcomes are particularly poor once the disease is advanced.[1] Because treatment options are limited for people whose cancer continues to progress after multiple therapies, there is a significant need for new targeted therapies.[2] CLDN18.2, a protein found at abnormally high levels on the surface of certain cancer cells, has emerged as a key biomarker for some gastrointestinal cancers, including gastric cancer.[3] Arcotatug tavatecan is a novel, potential best-in-class Claudin 18.2-targeted antibody-drug conjugate (ADC) with an exatecan payload and an Fc-silenced backbone designed to reduce risk of Fc-mediated effects. Innovent entered into a license and collaboration agreement with Takeda in which Takeda will develop, manufacture and commercialize arcotatug tavatecan worldwide outside of Greater China. Arcotatug Tavatecan Significantly Prolonged OS and PFS in Later-Line CLDN18.2-Positive G/GEJA G-HOPE-001 is an international, multicenter, randomized, open-label study being conducted in China and Japan to evaluate arcotatug tavatecan monotherapy versus the treatment of physician's choice (TPC, irinotecan, paclitaxel or trifluridine/tipiracil) in patients with previously treated, unresectable locally advanced or metastatic CLDN18.2-positive G/GEJA. The data reported at this ESMO were from two protocol-prespecified interim analyses: the first interim analysis (IA1) evaluated PFS, and the second interim analysis (IA2) evaluated OS, with data cutoff dates of February 13, 2026, and September 3, 2026, respectively. Compared with the TPC group, the arcotatug tavatecan group achieved statistically significant and clinically meaningful improvements in OS, PFS, and objective response rate (ORR). A significant improvement in OS. The median OS was 10.2 months in the arcotatug tavatecan group versus 6.9 months in the TPC group, representing a 43% reduction in the risk of death (HR=0.57, 95% CI: 0.45–0.73; P<0.0001). A substantial prolonged PFS. The IA1 showed that median PFS met the protocol-prespecified statistical criteria, demonstrating a statistically significant and clinically meaningful improvement. The IA2 showed that, by Independent Radiology Review Committee (IRRC) assessment, the arcotatug tavatecan group continued to demonstrate a substantial benefit in median PFS versus the TPC group (7.1 months versus 3.1 months (HR=0.45, 95% CI: 0.35–0.58). A remarkably higher ORR. The confirmed ORR per IRRC assessment in the arcotatug tavatecan group was 37.4%, significantly higher than 7.7% in the TPC group. Arcotatug Tavatecan Demonstrated a Favorable Safety Profile with Incidences of Grade≥3 Nausea and Vomiting of only 0.9% and 2.6% Among patients receiving arcotatug tavatecan monotherapy, the overall safety profile was manageable, with a Grade ≥3 treatment-related adverse event (TRAE) rate of 47.4% versus 55.9% with TPC. The most common Grade ≥3 treatment-emergent adverse events (TEAEs) with arcotatug tavatecan versus TPC included anemia (20.4% vs. 13.1%), decreased neutrophil count (17.4% vs. 32.0%) and decreased white blood cell count (11.7% vs. 22.5%). There was a low incidence of severe gastrointestinal events with Grade ≥3 nausea, vomiting and diarrhea occurring in 0.9%, 2.6% and 1.3% of patients receiving arcotatug tavatecan, respectively, compared with 1.8%, 3.2% and 4.1% with TPC. This characteristic of the safety profile differentiates arcotatug tavatecan and may ease this aspect of treatment burden for patients in the future. TEAEs leading to dose interruption were reported in 47.4% of patients treated with arcotatug tavatecan versus 51.4% with TPC. Treatment-related drug discontinuations were uncommon and comparable between treatment arms, occurring in 1.7% of patients receiving arcotatug tavatecan. Additional post-hoc analyses data from the ongoing study will be shared at a future medical congress or published in a peer-reviewed journal. Professor Lin Shen, Director of Department of Gastrointestinal Oncology, Beijing Cancer Hospital, said, "Gastric cancer remains a malignancy with a substantial disease burden in China and globally. For patients with advanced gastric cancer, treatment options become increasingly limited as the disease progresses to later lines of therapy, and overall prognosis remains poor, highlighting a substantial unmet medical need. As a notable therapeutic target in gastric cancer, CLDN18.2 has emerged as an important focus of precision treatment in gastrointestinal oncology. As a novel ADC targeting CLDN18.2, arcotatug tavatecan not only demonstrated promising antitumor activity in G-HOPE-001 study, but also showed clear clinical benefits in both PFS and OS. We look forward to arcotatug tavatecan potentially providing a new treatment option for more patients with CLDN18.2-positive advanced gastric cancer and further advancing precision treatment in gastric cancer." Professor Kohei Shitara, Director of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Japan, said," Arcotatug tavatecan is a novel ADC targeting CLDN18.2. Given the relatively high expression of CLDN18.2 in G/GEJA, precision treatment targeting CLDN18.2 has important clinical significance. The data from the G-HOPE-001 study demonstrate encouraging antitumor activity of arcotatug tavatecan in patients with CLDN18.2-positive G/GEJ adenocarcinoma who had received multiple prior lines of therapy. Of note, interim results showed that arcotatug tavatecan demonstrated clear clinical benefits in both PFS and OS, further supporting its potential as a later-line treatment option. The results of G-HOPE-001 provide important Phase 3 clinical evidence for CLDN18.2-targeted ADC therapy and establish a foundation for further exploration of precision treatment strategies targeting CLDN18.2." Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, said, "Arcotatug tavatecan was discovered by Innovent's research team, leveraging a novel Fc-silencing technology. Owing to its differentiated profile, Phase 3 clinical development was accelerated, positioning it as the first CLDN18.2 ADC to be accepted for regulatory review by a health authority globally. Arcotatug tavatecan is also Innovent's first ADC to achieve positive results in both PFS and OS, marking the validation of the SyntecanE® ADC platform based on an exatecan payload. We continue to deliver more innovative oncology therapies to benefit patients worldwide. " About Arcotatug Tavatecan Arcotatug tavatecan is a biomarker-directed, CLDN18.2-targeted ADC being developed as a precision medicine for the treatment of multiple CLDN18.2-expressing tumors. Through a cleavable linker, arcotatug tavatecan selectively delivers a highly potent exatecan payload, a topoisomerase I inhibitor, to tumor cells. It also incorporates an Fc-silenced structural design intended to minimize off-tumor, on-target toxicity. Arcotatug tavatecan is the first CLDN18.2-directed ADC to have a new drug application accepted for regulatory review globally. Following positive results from the first interim analysis of the global Phase 3 G-HOPE-001 study, a new drug application (NDA) was submitted to China's National Medical Products Administration (NMPA) for the treatment of patients with CLDN18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received prior systemic therapy. The application is currently under priority review. AT is also being evaluated in an ongoing Phase 3 study in China for CLDN18.2-positive advanced pancreatic cancer, while its potential in first-line treatment of gastric and pancreatic cancer is being explored in Phase 1 clinical studies. Building on the progress of PoC studies, Takeda plans to initiate global Phase 3 trials in gastric and pancreatic cancer. In addition, AT has received two Breakthrough Therapy Designations from the NMPA's Center for Drug Evaluation (CDE) for specified patient populations with advanced gastric and pancreatic cancer, respectively, and Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with CLDN18.2-positive, locally advanced or metastatic pancreatic cancer who have received two prior systemic therapies. About the G-HOPE-001 Study The Phase 3 G-HOPE-001 study (NCT06238843) is an ongoing, international, multicenter, randomized, open-label study evaluating arcotatug tavatecan monotherapy versus treatment of physician's choice (TPC) (irinotecan, paclitaxel or trifluridine/tipiracil) in patients with previously treated, unresectable locally advanced or metastatic Claudin (CLDN)18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA). Eligible patients had CLDN18.2-positive tumors, defined as IHC ≥2+ in ≥75% of tumor cells as measured by the VENTANA CLDN18 (43-14A) Assay, and had progressed on two to four prior systemic regimens. Patients were randomized 1:1 to receive arcotatug tavatecan 6 mg/kg once every three weeks or TPC, stratified by region, primary tumor site and prior gastrectomy. The study's dual primary endpoints are progression-free survival (PFS) per RECIST v1.1 and overall survival (OS). Secondary endpoints include objective response rate (ORR), disease control rate, duration of response, time to response and safety. The study enrolled 464 participants across China and Japan. About Gastric and Gastroesophageal Junction Adenocarcinoma (G/GEJA) Gastric cancer is the fifth most common cancer and fifth leading cause of cancer-related deaths worldwide with Japan and China among the highest-incidence regions globally.[1],[4] Five-year net survival rates vary globally but are approximately 20 to 40%, with markedly poorer rates in patients with advanced disease.[5]Treatment options become increasingly limited as the disease progresses, and median overall survival remains less than 10 months for patients receiving later lines of therapy.[6] Claudin 18.2, a tight junction protein typically found in healthy gastric tissue but abnormally expressed on the surface of tumor cells in a significant proportion of gastric and gastroesophageal junction cancers, has emerged as an important biomarker-driven target for the development of novel precision therapies in this disease.[3] About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 20 products in the market. It has 1 asset under NMPA review, 5 assets in phase 3 or pivotal clinical trials, and 20 more molecules in early clinical stage. Innovent has entered into more than 30 strategic partnerships with global players such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center, representing an aggregate value of over RMB 350 billion. These efforts have set a benchmark for the high quality outbound internationalization of China's innovative drug industry. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. REFERENCES SOURCE Innovent Biologics, Inc. 21% more press release views with Request a Demo