{"success":true,"data":{"pressRelease":{"id":"178196","rtpr_id":"nPn82n9y7a-20261023","ticker":"1801","exchange":"HKEX","all_tickers":["1801"],"title":"2026 ESMO LBA | Innovent Announces International Phase 3 Study of Arcotatug Tavatecan (CLDN18.2-ADC) in Gastric Cancer Met Dual Primary Endpoints of PFS and OS","author":"PR Newswire","published_at":"2026-10-23T10:10:01.229Z","article_body":"2026 ESMO LBA | Innovent Announces International Phase 3 Study of Arcotatug Tavatecan (CLDN18.2-ADC) in Gastric Cancer Met Dual Primary Endpoints of PFS and OS\nPR Newswire\n\nSAN FRANCISCO and SUZHOU, China, Oct. 23, 2026\n\n * Registrational Phase 3 G-HOPE-001 Study Met Both Primary Endpoints,\nDemonstrating Statistically Significant and Clinically Meaningful Overall\nSurvival and Progression-Free Survival Benefits in Previously Treated,\nCLDN18.2-positive Gastric Cancer\n * Arcotatug Tavatecan Demonstrated a Favorable Safety Profile, with a Low\nIncidence of Gastrointestinal Adverse Events\n * Arcotatug tavatecan is the First CLDN18.2-ADC to have a New Drug Application\nAccepted for Regulatory Review Globally\nSAN FRANCISCO and SUZHOU, China, Oct. 23, 2026 /PRNewswire/ -- Innovent\nBiologics, Inc. (HKEX: 01801), a biopharmaceutical company committed to the\ndiscovery, development, manufacturing and commercialization of innovative\nmedicines for the treatment of major diseases including oncology,\ncardiovascular and metabolic diseases, autoimmune diseases, and ophthalmic\ndiseases, announced positive topline results from the Phase 3 (G-HOPE-001)\nstudy (NCT06238843) of arcotatug tavatecan (IBI343; Takeda R&D\nCode:TAK-921) in patients with Claudin (CLDN)18.2-positive, previously\ntreated, advanced gastric or gastroesophageal junction adenocarcinoma\n(G/GEJA). The data were orally presented as a Late-Breaking Abstract at the\n2026 European Society for Medical Oncology (ESMO) Congress.\n\nGastric cancer is a leading cause of cancer-related death worldwide, and\noutcomes are particularly poor once the disease is advanced.([1]) Because\ntreatment options are limited for people whose cancer continues to progress\nafter multiple therapies, there is a significant need for new targeted\ntherapies.([2]) CLDN18.2, a protein found at abnormally high levels on the\nsurface of certain cancer cells, has emerged as a key biomarker for some\ngastrointestinal cancers, including gastric cancer.([3]) Arcotatug tavatecan\nis a novel, potential best-in-class Claudin 18.2-targeted antibody-drug\nconjugate (ADC) with an exatecan payload and an Fc-silenced backbone designed\nto reduce risk of Fc-mediated effects. Innovent entered into a license and\ncollaboration agreement with Takeda in which Takeda will develop, manufacture\nand commercialize arcotatug tavatecan worldwide outside of Greater China.\n\nArcotatug Tavatecan Significantly Prolonged OS and PFS in Later-Line\nCLDN18.2-Positive G/GEJA\n\nG-HOPE-001 is an international, multicenter, randomized, open-label study\nbeing conducted in China and Japan to evaluate arcotatug tavatecan monotherapy\nversus the treatment of physician's choice (TPC, irinotecan, paclitaxel or\ntrifluridine/tipiracil) in patients with previously treated, unresectable\nlocally advanced or metastatic CLDN18.2-positive G/GEJA.\n\nThe data reported at this ESMO were from two protocol-prespecified interim\nanalyses: the first interim analysis (IA1) evaluated PFS, and the second\ninterim analysis (IA2) evaluated OS, with data cutoff dates of February 13,\n2026, and September 3, 2026, respectively. Compared with the TPC group, the\narcotatug tavatecan group achieved statistically significant and clinically\nmeaningful improvements in OS, PFS, and objective response rate (ORR).\n\n * A significant improvement in OS. The median OS was 10.2 months in the\narcotatug tavatecan group versus 6.9 months in the TPC group, representing a\n43% reduction in the risk of death (HR=0.57, 95% CI: 0.45–0.73;\nP<0.0001).\n * A substantial prolonged PFS. The IA1 showed that median PFS met the\nprotocol-prespecified statistical criteria, demonstrating a statistically\nsignificant and clinically meaningful improvement. The IA2 showed that, by\nIndependent Radiology Review Committee (IRRC) assessment, the arcotatug\ntavatecan group continued to demonstrate a substantial benefit in median PFS\nversus the TPC group (7.1 months versus 3.1 months (HR=0.45, 95% CI:\n0.35–0.58).\n * A remarkably higher ORR. The confirmed ORR per IRRC assessment in the\narcotatug tavatecan group was 37.4%, significantly higher than 7.7% in the TPC\ngroup.\nArcotatug Tavatecan Demonstrated a Favorable Safety Profile with Incidences of\nGrade≥3 Nausea and Vomiting of only 0.9% and 2.6%\n\n * Among patients receiving arcotatug tavatecan monotherapy, the overall safety\nprofile was manageable, with a Grade ≥3 treatment-related adverse event\n(TRAE) rate of 47.4% versus 55.9% with TPC.\n * The most common Grade ≥3 treatment-emergent adverse events (TEAEs) with\narcotatug tavatecan versus TPC included anemia (20.4% vs. 13.1%), decreased\nneutrophil count (17.4% vs. 32.0%) and decreased white blood cell count (11.7%\nvs. 22.5%).\n * There was a low incidence of severe gastrointestinal events with Grade ≥3\nnausea, vomiting and diarrhea occurring in 0.9%, 2.6% and 1.3% of patients\nreceiving arcotatug tavatecan, respectively, compared with 1.8%, 3.2% and 4.1%\nwith TPC. This characteristic of the safety profile differentiates arcotatug\ntavatecan and may ease this aspect of treatment burden for patients in the\nfuture.\n * TEAEs leading to dose interruption were reported in 47.4% of patients treated\nwith arcotatug tavatecan versus 51.4% with TPC. Treatment-related drug\ndiscontinuations were uncommon and comparable between treatment arms,\noccurring in 1.7% of patients receiving arcotatug tavatecan.\nAdditional pos-hoc analyses data from the ongoing study will be shared at a\nfuture medical congress or published in a peer-reviewed journal.\n\nProfessor Lin Shen, Director of Department of Gastrointestinal Oncology,\nBeijing Cancer Hospital, said, \"Gastric cancer remains a malignancy with a\nsubstantial disease burden in China and globally. For patients with advanced\ngastric cancer, treatment options become increasingly limited as the disease\nprogresses to later lines of therapy, and overall prognosis remains poor,\nhighlighting a substantial unmet medical need. As a notable therapeutic target\nin gastric cancer, CLDN18.2 has emerged as an important focus of precision\ntreatment in gastrointestinal oncology. As a novel ADC targeting CLDN18.2,\narcotatug tavatecan not only demonstrated promising antitumor activity in\nG-HOPE-001 study, but also showed clear clinical benefits in both PFS and OS.\nWe look forward to arcotatug tavatecan potentially providing a new treatment\noption for more patients with CLDN18.2-positive advanced gastric cancer and\nfurther advancing precision treatment in gastric cancer.\"\n\nProfessor Kohei Shitara, Director of the Department of Gastrointestinal\nOncology, National Cancer Center Hospital East, Japan, said,\" Arcotatug\ntavatecan is a novel ADC targeting CLDN18.2. Given the relatively high\nexpression of CLDN18.2 in G/GEJA, precision treatment targeting CLDN18.2 has\nimportant clinical significance. The data from the G-HOPE-001 study\ndemonstrate encouraging antitumor activity of arcotatug tavatecan in patients\nwith CLDN18.2-positive G/GEJ adenocarcinoma who had received multiple prior\nlines of therapy. Of note, interim results showed that arcotatug tavatecan\ndemonstrated clear clinical benefits in both PFS and OS, further supporting\nits potential as a later-line treatment option. The results of G-HOPE-001\nprovide important Phase 3 clinical evidence for CLDN18.2-targeted ADC therapy\nand establish a foundation for further exploration of precision treatment\nstrategies targeting CLDN18.2.\"\n\nDr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, said, \"Arcotatug\ntavatecan was discovered by Innovent's research team, leveraging a novel\nFc-silencing technology., Owing to its differentiated profile, Phase 3\nclinical development was accelerated, positioning it as the first CLDN18.2 ADC\nto be accepted for regulatory review by a health authority globally. Arcotatug\ntavatecan is also Innovent's first ADC to achieve positive results in both PFS\nand OS, marking the validation of the SyntecanE® ADC platform based on an\nexatecan payload. We continue to deliver more innovative oncology therapies to\nbenefit patients worldwide. \"\n\nAbout Arcotatug Tavatecan\n\nArcotatug tavatecan is a biomarker-directed, CLDN18.2-targeted ADC being\ndeveloped as a precision medicine for the treatment of multiple\nCLDN18.2-expressing tumors. Through a cleavable linker, arcotatug tavatecan\nselectively delivers a highly potent exatecan payload, a topoisomerase I\ninhibitor, to tumor cells. It also incorporates an Fc-silenced structural\ndesign intended to minimize off-tumor, on-target toxicity.\n\nArcotatug tavatecan is the first CLDN18.2-directed ADC to have a new drug\napplication accepted for regulatory review globally. Following positive\nresults from the first interim analysis of the global Phase 3 G-HOPE-001\nstudy, a new drug application (NDA) was submitted to China's National Medical\nProducts Administration (NMPA) for the treatment of patients with\nCLDN18.2-positive, locally advanced unresectable or metastatic gastric or\ngastroesophageal junction (GEJ) adenocarcinoma who have received prior\nsystemic therapy. The application is currently under priority review. AT is\nalso being evaluated in an ongoing Phase 3 study in China for\nCLDN18.2-positive advanced pancreatic cancer, while its potential in\nfirst-line treatment of gastric and pancreatic cancer is being explored in\nPhase 1 clinical studies. Building on the progress of PoC studies, Takeda\nplans to initiate global Phase 3 trials in gastric and pancreatic cancer.\n\nIn addition, AT has received two Breakthrough Therapy Designations from the\nNMPA's Center for Drug Evaluation (CDE) for specified patient populations with\nadvanced gastric and pancreatic cancer, respectively, and Fast Track\nDesignation from the U.S. Food and Drug Administration (FDA) for the treatment\nof patients with CLDN18.2-positive, locally advanced or metastatic pancreatic\ncancer who have received two prior systemic therapies.\n\nAbout the G-HOPE-001 Study\n\nThe Phase 3 G-HOPE-001 study (NCT06238843) is an ongoing, international,\nmulticenter, randomized, open-label study evaluating arcotatug tavatecan\nmonotherapy versus treatment of physician's choice (TPC) (irinotecan,\npaclitaxel or trifluridine/tipiracil) in patients with previously treated,\nunresectable locally advanced or metastatic Claudin (CLDN)18.2-positive\ngastric or gastroesophageal junction adenocarcinoma (G/GEJA). Eligible\npatients had CLDN18.2-positive tumors, defined as IHC ≥2+ in ≥75% of tumor\ncells as measured by the VENTANA CLDN18 (43-14A) Assay, and had progressed on\ntwo to four prior systemic regimens. Patients were randomized 1:1 to receive\narcotatug tavatecan 6 mg/kg once every three weeks or TPC, stratified by\nregion, primary tumor site and prior gastrectomy. The study's dual primary\nendpoints are progression-free survival (PFS) per RECIST v1.1 and overall\nsurvival (OS). Secondary endpoints include objective response rate (ORR),\ndisease control rate, duration of response, time to response and safety. The\nstudy enrolled 464 participants across China and Japan.\n\nAbout Gastric and Gastroesophageal Junction Adenocarcinoma (G/GEJA)\n\nGastric cancer is the fifth most common cancer and fifth leading cause of\ncancer-related deaths worldwide with Japan and China among the\nhighest-incidence regions globally.([1],)([4]) Five-year net survival rates\nvary globally but are approximately 20 to 40%, with markedly poorer rates in\npatients with advanced disease.([5] )Treatment options become increasingly\nlimited as the disease progresses, and median overall survival remains less\nthan 10 months for patients receiving later lines of therapy.([6]) Claudin\n18.2, a tight junction protein typically found in healthy gastric tissue but\nabnormally expressed on the surface of tumor cells in a significant proportion\nof gastric and gastroesophageal junction cancers, has emerged as an important\nbiomarker-driven target for the development of novel precision therapies in\nthis disease.([3])\n\nAbout Innovent\n\nInnovent is a leading biopharmaceutical company founded in 2011 with the\nmission to empower patients worldwide with affordable, high-quality\nbiopharmaceuticals. The company discovers, develops, manufactures and\ncommercializes innovative medicines that target some of the most intractable\ndiseases. Its pioneering therapies treat cancer, cardiovascular and metabolic,\nautoimmune and eye diseases. Innovent has launched 20 products in the market.\nIt has 1 asset under NMPA review, 5 assets in phase 3 or pivotal clinical\ntrials, and 20 more molecules in early clinical stage.\n\nInnovent has entered into more than 30 strategic partnerships with global\nplayers such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD\nAnderson Cancer Center, representing an aggregate value of over RMB 350\nbillion. These efforts have set a benchmark for the high quality outbound\ninternationalization of China's innovative drug industry.\n\nGuided by the motto, \"Start with Integrity, Succeed through Action,\" Innovent\nmaintains the highest standard of industry practices and works collaboratively\nto advance the biopharmaceutical industry so that first-rate pharmaceutical\ndrugs can become widely accessible.\n\nFor more information, visit www.innoventbio.com\n(https://www.innoventbio.com/) , or follow Innovent on Facebook\n(https://www.facebook.com/innovent2011)  and LinkedIn\n(https://www.linkedin.com/company/innovent-biologics/) .\n Statement: (1) Innovent does not recommend the use of any unapproved drug\n (s)/indication (s).\n (2) Ramucirumab Injection (Cyramza®), Selpercatinib Capsules (Retsevmo®),\n Pirtobrutinib Tablets (Jaypirca®) and abemaciclib (Verzenios®) are products\n discovered and developed by Eli Lilly.\n\nForward-Looking Statements\n\nThis news release may contain certain forward-looking statements that are, by\ntheir nature, subject to significant risks and uncertainties. The words\n\"anticipate\", \"believe\", \"estimate\", \"expect\", \"intend\" and similar\nexpressions, as they relate to Innovent, are intended to identify certain of\nsuch forward-looking statements. Innovent does not intend to update these\nforward-looking statements regularly.\n\nThese forward-looking statements are based on the existing beliefs,\nassumptions, expectations, estimates, projections and understandings of the\nmanagement of Innovent with respect to future events at the time these\nstatements are made. These statements are not a guarantee of future\ndevelopments and are subject to risks, uncertainties and other factors, some\nof which are beyond Innovent's control and are difficult to predict.\nConsequently, actual results may differ materially from information contained\nin the forward-looking statements as a result of future changes or\ndevelopments in our business, Innovent's competitive environment and\npolitical, economic, legal and social conditions.\n\nReferences\n ([1]) Yashima K, et al. Gastric Cancer Screening in Japan: A Narrative Review.\n J Clin Med. 2022;11(15):4337. Published 2022 Jul 26. doi:10.3390/jcm11154337\n ([2]) Rowsell A, et al. Systematic review of health-related quality of life\n (HRQoL) issues associated with gastric cancer: capturing cross-cultural\n differences. Gastric Cancer. 2022;25(4):665-677.\n doi:10.1007/s10120-022-01309-6\n ([3]) Sahin U, et al. Claudin-18 splice variant 2 is a pan-cancer target\n suitable for therapeutic antibody development. Clin Cancer Res.\n 2008;14(23):7624–7634. doi:10.1158/1078-0455.CCR-08-1547\n ([4]) Sung H, et al. Global cancer statistics 2024: GLOBOCAN estimates of\n incidence and mortality worldwide for 34 cancers in 186 countries. CA Cancer J\n Clin. 2026;70090. doi:10.3322/caac.70090\n ([5]) Allemani C, et al. Global surveillance of trends in cancer survival\n 2000–14 (CONCORD-3): analysis of individual records for 37 513 025\n patients diagnosed with one of 18 cancers from 322 population-based registries\n in 71 countries. Lancet. 2018;391(10125):1023-1075.\n doi:10.1016/S0140-6736(17)33326-3\n ([6]) Shitara K, et al. Trifluridine/tipiracil versus placebo in patients with\n heavily pretreated metastatic gastric or gastro-oesophageal junction cancer\n (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet\n Oncol. 2018;19(11):1437-1448. doi:10.1016/S1470-2045(18)30739-3\n\n \n\nView original\ncontent:https://www.prnewswire.com/news-releases/2026-esmo-lba--innovent-announces-international-phase-3-study-of-arcotatug-tavatecan-cldn18-2-adc-in-gastric-cancer-met-dual-primary-endpoints-of-pfs-and-os-302917985.html\n(https://www.prnewswire.com/news-releases/2026-esmo-lba--innovent-announces-international-phase-3-study-of-arcotatug-tavatecan-cldn18-2-adc-in-gastric-cancer-met-dual-primary-endpoints-of-pfs-and-os-302917985.html)\n\nSOURCE Innovent Biologics\n\n\n\nInnovent Biologics, Inc., pr@innoventbio.com, +86 512-69566088; Innovent Biologics, Inc., ir@innoventbio.com, +86 512-69566088\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPn82n9y7a-20261023","title":"2026 ESMO LBA | Innovent Announces International Phase 3 Study of Arcotatug Tavatecan (CLDN18.2-ADC) in Gastric Cancer Met Dual Primary Endpoints of PFS and OS","author":"PR Newswire","ticker":"1801","created":"2026-10-23T10:10:01.229Z","tickers":["1801"],"exchange":"HKEX","article_body":"2026 ESMO LBA | Innovent Announces International Phase 3 Study of Arcotatug Tavatecan (CLDN18.2-ADC) in Gastric Cancer Met Dual Primary Endpoints of PFS and OS\nPR Newswire\n\nSAN FRANCISCO and SUZHOU, China, Oct. 23, 2026\n\n * Registrational Phase 3 G-HOPE-001 Study Met Both Primary Endpoints,\nDemonstrating Statistically Significant and Clinically Meaningful Overall\nSurvival and Progression-Free Survival Benefits in Previously Treated,\nCLDN18.2-positive Gastric Cancer\n * Arcotatug Tavatecan Demonstrated a Favorable Safety Profile, with a Low\nIncidence of Gastrointestinal Adverse Events\n * Arcotatug tavatecan is the First CLDN18.2-ADC to have a New Drug Application\nAccepted for Regulatory Review Globally\nSAN FRANCISCO and SUZHOU, China, Oct. 23, 2026 /PRNewswire/ -- Innovent\nBiologics, Inc. (HKEX: 01801), a biopharmaceutical company committed to the\ndiscovery, development, manufacturing and commercialization of innovative\nmedicines for the treatment of major diseases including oncology,\ncardiovascular and metabolic diseases, autoimmune diseases, and ophthalmic\ndiseases, announced positive topline results from the Phase 3 (G-HOPE-001)\nstudy (NCT06238843) of arcotatug tavatecan (IBI343; Takeda R&D\nCode:TAK-921) in patients with Claudin (CLDN)18.2-positive, previously\ntreated, advanced gastric or gastroesophageal junction adenocarcinoma\n(G/GEJA). The data were orally presented as a Late-Breaking Abstract at the\n2026 European Society for Medical Oncology (ESMO) Congress.\n\nGastric cancer is a leading cause of cancer-related death worldwide, and\noutcomes are particularly poor once the disease is advanced.([1]) Because\ntreatment options are limited for people whose cancer continues to progress\nafter multiple therapies, there is a significant need for new targeted\ntherapies.([2]) CLDN18.2, a protein found at abnormally high levels on the\nsurface of certain cancer cells, has emerged as a key biomarker for some\ngastrointestinal cancers, including gastric cancer.([3]) Arcotatug tavatecan\nis a novel, potential best-in-class Claudin 18.2-targeted antibody-drug\nconjugate (ADC) with an exatecan payload and an Fc-silenced backbone designed\nto reduce risk of Fc-mediated effects. Innovent entered into a license and\ncollaboration agreement with Takeda in which Takeda will develop, manufacture\nand commercialize arcotatug tavatecan worldwide outside of Greater China.\n\nArcotatug Tavatecan Significantly Prolonged OS and PFS in Later-Line\nCLDN18.2-Positive G/GEJA\n\nG-HOPE-001 is an international, multicenter, randomized, open-label study\nbeing conducted in China and Japan to evaluate arcotatug tavatecan monotherapy\nversus the treatment of physician's choice (TPC, irinotecan, paclitaxel or\ntrifluridine/tipiracil) in patients with previously treated, unresectable\nlocally advanced or metastatic CLDN18.2-positive G/GEJA.\n\nThe data reported at this ESMO were from two protocol-prespecified interim\nanalyses: the first interim analysis (IA1) evaluated PFS, and the second\ninterim analysis (IA2) evaluated OS, with data cutoff dates of February 13,\n2026, and September 3, 2026, respectively. Compared with the TPC group, the\narcotatug tavatecan group achieved statistically significant and clinically\nmeaningful improvements in OS, PFS, and objective response rate (ORR).\n\n * A significant improvement in OS. The median OS was 10.2 months in the\narcotatug tavatecan group versus 6.9 months in the TPC group, representing a\n43% reduction in the risk of death (HR=0.57, 95% CI: 0.45–0.73;\nP<0.0001).\n * A substantial prolonged PFS. The IA1 showed that median PFS met the\nprotocol-prespecified statistical criteria, demonstrating a statistically\nsignificant and clinically meaningful improvement. The IA2 showed that, by\nIndependent Radiology Review Committee (IRRC) assessment, the arcotatug\ntavatecan group continued to demonstrate a substantial benefit in median PFS\nversus the TPC group (7.1 months versus 3.1 months (HR=0.45, 95% CI:\n0.35–0.58).\n * A remarkably higher ORR. The confirmed ORR per IRRC assessment in the\narcotatug tavatecan group was 37.4%, significantly higher than 7.7% in the TPC\ngroup.\nArcotatug Tavatecan Demonstrated a Favorable Safety Profile with Incidences of\nGrade≥3 Nausea and Vomiting of only 0.9% and 2.6%\n\n * Among patients receiving arcotatug tavatecan monotherapy, the overall safety\nprofile was manageable, with a Grade ≥3 treatment-related adverse event\n(TRAE) rate of 47.4% versus 55.9% with TPC.\n * The most common Grade ≥3 treatment-emergent adverse events (TEAEs) with\narcotatug tavatecan versus TPC included anemia (20.4% vs. 13.1%), decreased\nneutrophil count (17.4% vs. 32.0%) and decreased white blood cell count (11.7%\nvs. 22.5%).\n * There was a low incidence of severe gastrointestinal events with Grade ≥3\nnausea, vomiting and diarrhea occurring in 0.9%, 2.6% and 1.3% of patients\nreceiving arcotatug tavatecan, respectively, compared with 1.8%, 3.2% and 4.1%\nwith TPC. This characteristic of the safety profile differentiates arcotatug\ntavatecan and may ease this aspect of treatment burden for patients in the\nfuture.\n * TEAEs leading to dose interruption were reported in 47.4% of patients treated\nwith arcotatug tavatecan versus 51.4% with TPC. Treatment-related drug\ndiscontinuations were uncommon and comparable between treatment arms,\noccurring in 1.7% of patients receiving arcotatug tavatecan.\nAdditional pos-hoc analyses data from the ongoing study will be shared at a\nfuture medical congress or published in a peer-reviewed journal.\n\nProfessor Lin Shen, Director of Department of Gastrointestinal Oncology,\nBeijing Cancer Hospital, said, \"Gastric cancer remains a malignancy with a\nsubstantial disease burden in China and globally. For patients with advanced\ngastric cancer, treatment options become increasingly limited as the disease\nprogresses to later lines of therapy, and overall prognosis remains poor,\nhighlighting a substantial unmet medical need. As a notable therapeutic target\nin gastric cancer, CLDN18.2 has emerged as an important focus of precision\ntreatment in gastrointestinal oncology. As a novel ADC targeting CLDN18.2,\narcotatug tavatecan not only demonstrated promising antitumor activity in\nG-HOPE-001 study, but also showed clear clinical benefits in both PFS and OS.\nWe look forward to arcotatug tavatecan potentially providing a new treatment\noption for more patients with CLDN18.2-positive advanced gastric cancer and\nfurther advancing precision treatment in gastric cancer.\"\n\nProfessor Kohei Shitara, Director of the Department of Gastrointestinal\nOncology, National Cancer Center Hospital East, Japan, said,\" Arcotatug\ntavatecan is a novel ADC targeting CLDN18.2. Given the relatively high\nexpression of CLDN18.2 in G/GEJA, precision treatment targeting CLDN18.2 has\nimportant clinical significance. The data from the G-HOPE-001 study\ndemonstrate encouraging antitumor activity of arcotatug tavatecan in patients\nwith CLDN18.2-positive G/GEJ adenocarcinoma who had received multiple prior\nlines of therapy. Of note, interim results showed that arcotatug tavatecan\ndemonstrated clear clinical benefits in both PFS and OS, further supporting\nits potential as a later-line treatment option. The results of G-HOPE-001\nprovide important Phase 3 clinical evidence for CLDN18.2-targeted ADC therapy\nand establish a foundation for further exploration of precision treatment\nstrategies targeting CLDN18.2.\"\n\nDr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, said, \"Arcotatug\ntavatecan was discovered by Innovent's research team, leveraging a novel\nFc-silencing technology., Owing to its differentiated profile, Phase 3\nclinical development was accelerated, positioning it as the first CLDN18.2 ADC\nto be accepted for regulatory review by a health authority globally. Arcotatug\ntavatecan is also Innovent's first ADC to achieve positive results in both PFS\nand OS, marking the validation of the SyntecanE® ADC platform based on an\nexatecan payload. We continue to deliver more innovative oncology therapies to\nbenefit patients worldwide. \"\n\nAbout Arcotatug Tavatecan\n\nArcotatug tavatecan is a biomarker-directed, CLDN18.2-targeted ADC being\ndeveloped as a precision medicine for the treatment of multiple\nCLDN18.2-expressing tumors. Through a cleavable linker, arcotatug tavatecan\nselectively delivers a highly potent exatecan payload, a topoisomerase I\ninhibitor, to tumor cells. It also incorporates an Fc-silenced structural\ndesign intended to minimize off-tumor, on-target toxicity.\n\nArcotatug tavatecan is the first CLDN18.2-directed ADC to have a new drug\napplication accepted for regulatory review globally. Following positive\nresults from the first interim analysis of the global Phase 3 G-HOPE-001\nstudy, a new drug application (NDA) was submitted to China's National Medical\nProducts Administration (NMPA) for the treatment of patients with\nCLDN18.2-positive, locally advanced unresectable or metastatic gastric or\ngastroesophageal junction (GEJ) adenocarcinoma who have received prior\nsystemic therapy. The application is currently under priority review. AT is\nalso being evaluated in an ongoing Phase 3 study in China for\nCLDN18.2-positive advanced pancreatic cancer, while its potential in\nfirst-line treatment of gastric and pancreatic cancer is being explored in\nPhase 1 clinical studies. Building on the progress of PoC studies, Takeda\nplans to initiate global Phase 3 trials in gastric and pancreatic cancer.\n\nIn addition, AT has received two Breakthrough Therapy Designations from the\nNMPA's Center for Drug Evaluation (CDE) for specified patient populations with\nadvanced gastric and pancreatic cancer, respectively, and Fast Track\nDesignation from the U.S. Food and Drug Administration (FDA) for the treatment\nof patients with CLDN18.2-positive, locally advanced or metastatic pancreatic\ncancer who have received two prior systemic therapies.\n\nAbout the G-HOPE-001 Study\n\nThe Phase 3 G-HOPE-001 study (NCT06238843) is an ongoing, international,\nmulticenter, randomized, open-label study evaluating arcotatug tavatecan\nmonotherapy versus treatment of physician's choice (TPC) (irinotecan,\npaclitaxel or trifluridine/tipiracil) in patients with previously treated,\nunresectable locally advanced or metastatic Claudin (CLDN)18.2-positive\ngastric or gastroesophageal junction adenocarcinoma (G/GEJA). Eligible\npatients had CLDN18.2-positive tumors, defined as IHC ≥2+ in ≥75% of tumor\ncells as measured by the VENTANA CLDN18 (43-14A) Assay, and had progressed on\ntwo to four prior systemic regimens. Patients were randomized 1:1 to receive\narcotatug tavatecan 6 mg/kg once every three weeks or TPC, stratified by\nregion, primary tumor site and prior gastrectomy. The study's dual primary\nendpoints are progression-free survival (PFS) per RECIST v1.1 and overall\nsurvival (OS). Secondary endpoints include objective response rate (ORR),\ndisease control rate, duration of response, time to response and safety. The\nstudy enrolled 464 participants across China and Japan.\n\nAbout Gastric and Gastroesophageal Junction Adenocarcinoma (G/GEJA)\n\nGastric cancer is the fifth most common cancer and fifth leading cause of\ncancer-related deaths worldwide with Japan and China among the\nhighest-incidence regions globally.([1],)([4]) Five-year net survival rates\nvary globally but are approximately 20 to 40%, with markedly poorer rates in\npatients with advanced disease.([5] )Treatment options become increasingly\nlimited as the disease progresses, and median overall survival remains less\nthan 10 months for patients receiving later lines of therapy.([6]) Claudin\n18.2, a tight junction protein typically found in healthy gastric tissue but\nabnormally expressed on the surface of tumor cells in a significant proportion\nof gastric and gastroesophageal junction cancers, has emerged as an important\nbiomarker-driven target for the development of novel precision therapies in\nthis disease.([3])\n\nAbout Innovent\n\nInnovent is a leading biopharmaceutical company founded in 2011 with the\nmission to empower patients worldwide with affordable, high-quality\nbiopharmaceuticals. The company discovers, develops, manufactures and\ncommercializes innovative medicines that target some of the most intractable\ndiseases. Its pioneering therapies treat cancer, cardiovascular and metabolic,\nautoimmune and eye diseases. Innovent has launched 20 products in the market.\nIt has 1 asset under NMPA review, 5 assets in phase 3 or pivotal clinical\ntrials, and 20 more molecules in early clinical stage.\n\nInnovent has entered into more than 30 strategic partnerships with global\nplayers such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD\nAnderson Cancer Center, representing an aggregate value of over RMB 350\nbillion. These efforts have set a benchmark for the high quality outbound\ninternationalization of China's innovative drug industry.\n\nGuided by the motto, \"Start with Integrity, Succeed through Action,\" Innovent\nmaintains the highest standard of industry practices and works collaboratively\nto advance the biopharmaceutical industry so that first-rate pharmaceutical\ndrugs can become widely accessible.\n\nFor more information, visit www.innoventbio.com\n(https://www.innoventbio.com/) , or follow Innovent on Facebook\n(https://www.facebook.com/innovent2011)  and LinkedIn\n(https://www.linkedin.com/company/innovent-biologics/) .\n Statement: (1) Innovent does not recommend the use of any unapproved drug\n (s)/indication (s).\n (2) Ramucirumab Injection (Cyramza®), Selpercatinib Capsules (Retsevmo®),\n Pirtobrutinib Tablets (Jaypirca®) and abemaciclib (Verzenios®) are products\n discovered and developed by Eli Lilly.\n\nForward-Looking Statements\n\nThis news release may contain certain forward-looking statements that are, by\ntheir nature, subject to significant risks and uncertainties. The words\n\"anticipate\", \"believe\", \"estimate\", \"expect\", \"intend\" and similar\nexpressions, as they relate to Innovent, are intended to identify certain of\nsuch forward-looking statements. Innovent does not intend to update these\nforward-looking statements regularly.\n\nThese forward-looking statements are based on the existing beliefs,\nassumptions, expectations, estimates, projections and understandings of the\nmanagement of Innovent with respect to future events at the time these\nstatements are made. These statements are not a guarantee of future\ndevelopments and are subject to risks, uncertainties and other factors, some\nof which are beyond Innovent's control and are difficult to predict.\nConsequently, actual results may differ materially from information contained\nin the forward-looking statements as a result of future changes or\ndevelopments in our business, Innovent's competitive environment and\npolitical, economic, legal and social conditions.\n\nReferences\n ([1]) Yashima K, et al. Gastric Cancer Screening in Japan: A Narrative Review.\n J Clin Med. 2022;11(15):4337. Published 2022 Jul 26. doi:10.3390/jcm11154337\n ([2]) Rowsell A, et al. Systematic review of health-related quality of life\n (HRQoL) issues associated with gastric cancer: capturing cross-cultural\n differences. Gastric Cancer. 2022;25(4):665-677.\n doi:10.1007/s10120-022-01309-6\n ([3]) Sahin U, et al. Claudin-18 splice variant 2 is a pan-cancer target\n suitable for therapeutic antibody development. Clin Cancer Res.\n 2008;14(23):7624–7634. doi:10.1158/1078-0455.CCR-08-1547\n ([4]) Sung H, et al. Global cancer statistics 2024: GLOBOCAN estimates of\n incidence and mortality worldwide for 34 cancers in 186 countries. CA Cancer J\n Clin. 2026;70090. doi:10.3322/caac.70090\n ([5]) Allemani C, et al. Global surveillance of trends in cancer survival\n 2000–14 (CONCORD-3): analysis of individual records for 37 513 025\n patients diagnosed with one of 18 cancers from 322 population-based registries\n in 71 countries. Lancet. 2018;391(10125):1023-1075.\n doi:10.1016/S0140-6736(17)33326-3\n ([6]) Shitara K, et al. Trifluridine/tipiracil versus placebo in patients with\n heavily pretreated metastatic gastric or gastro-oesophageal junction cancer\n (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet\n Oncol. 2018;19(11):1437-1448. doi:10.1016/S1470-2045(18)30739-3\n\n \n\nView original\ncontent:https://www.prnewswire.com/news-releases/2026-esmo-lba--innovent-announces-international-phase-3-study-of-arcotatug-tavatecan-cldn18-2-adc-in-gastric-cancer-met-dual-primary-endpoints-of-pfs-and-os-302917985.html\n(https://www.prnewswire.com/news-releases/2026-esmo-lba--innovent-announces-international-phase-3-study-of-arcotatug-tavatecan-cldn18-2-adc-in-gastric-cancer-met-dual-primary-endpoints-of-pfs-and-os-302917985.html)\n\nSOURCE Innovent Biologics\n\n\n\nInnovent Biologics, Inc., pr@innoventbio.com, +86 512-69566088; Innovent Biologics, Inc., ir@innoventbio.com, +86 512-69566088\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-10-23T10:10:01.292303421Z","server_sent_at_ms":1792750201292},"received_at":"2026-10-23T10:10:01.464Z","source_url":"https://www.prnewswire.com/news-releases/2026-esmo-lba--innovent-announces-international-phase-3-study-of-arcotatug-tavatecan-cldn18-2-adc-in-gastric-cancer-met-dual-primary-endpoints-of-pfs-and-os-302917985.html"},"analysis":{"id":"166116","press_release_id":"178196","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["open-label study design; OS/PFS results from interim analyses","Grade ≥3 anemia of 20.4% with the ADC vs 13.1% control"],"eventType":"clinical_trial","narrative":"Innovent's registrational Phase 3 G-HOPE-001 study of arcotatug tavatecan (CLDN18.2-ADC) met both primary endpoints in previously treated CLDN18.2-positive gastric/GEJ cancer, presented as a Late-Breaking Abstract at the 2026 ESMO Congress.\n\nMedian overall survival was 10.2 months versus 6.9 months with physician's choice (HR=0.57, P<0.0001), and median PFS was 7.1 versus 3.1 months, with an ORR of 37.4% versus 7.7% and a favorable GI safety profile.\n\nArcotatug tavatecan is the first CLDN18.2 ADC with an NDA accepted for regulatory review globally (NMPA priority review in China); Takeda holds ex-Greater China rights and plans global Phase 3 trials in gastric and pancreatic cancer, validating Innovent's SyntecanE ADC platform.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Dual primary endpoint Phase 3 win validates Innovent's ADC platform and de-risks the NMPA priority review for its first global CLDN18.2 franchise."},"keyFigures":{"drugName":"Arcotatug Tavatecan (IBI343; Takeda code TAK-921)","phaseOfTrial":"Phase 3","customDimensions":{"orr":"37.4% vs 7.7% per IRRC","enrollment":464,"median_os_months":"10.2 vs 6.9 (HR=0.57, P<0.0001)","median_pfs_months":"7.1 vs 3.1 (HR=0.45)","grade3plus_trae_rate":"47.4% vs 55.9% with TPC","risk_of_death_reduction":"43%"}},"quotedText":"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.","namedEntities":{"people":[{"name":"Professor Lin Shen","role":"Director of GI Oncology, Beijing Cancer Hospital"},{"name":"Professor Kohei Shitara","role":"Director of GI Oncology, National Cancer Center Hospital East, Japan"},{"name":"Dr. Hui Zhou","role":"Chief R&D Officer (Oncology), Innovent"}],"products":["Arcotatug Tavatecan","IBI343","TAK-921","SyntecanE ADC platform","VENTANA CLDN18 (43-14A) Assay"],"companies":[{"name":"Innovent Biologics, Inc.","ticker":"01801","relationship":"filer/developer"},{"name":"Takeda","relationship":"partner - ex-Greater China development and commercialization rights"},{"name":"Beijing Cancer Hospital","relationship":"investigator site"},{"name":"National Cancer Center Hospital East","relationship":"investigator site"}],"dollarAmounts":[{"amount":"RMB 350 billion","context":"aggregate value of Innovent's 30+ strategic partnerships (background)"}]},"materialImpact":{"score":4,"reasoning":"Registrational Phase 3 G-HOPE-001 met both primary endpoints (OS and PFS) with strong effect sizes for Innovent's lead CLDN18.2 ADC, which already has an NDA under priority review in China and a global Takeda partnership. Major pipeline validation, though not a U.S. FDA binary event."},"tickerRelevance":{"others":[],"primary":"1801"},"globalImportance":55,"audienceRelevance":40,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"mid-cap foreign issuer (HKEX-listed)","eventGravity":"positive Phase 3 registrational readout with dual primary endpoint success","partnerWeight":"Takeda ex-Greater China collaboration adds global relevance","retailFavoriteBoost":"low in U.S. retail audience"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":4,"narrative":"Innovent's registrational Phase 3 G-HOPE-001 study of arcotatug tavatecan (CLDN18.2-ADC) met both primary endpoints in previously treated CLDN18.2-positive gastric/GEJ cancer, presented as a Late-Breaking Abstract at the 2026 ESMO Congress.\n\nMedian overall survival was 10.2 months versus 6.9 months with physician's choice (HR=0.57, P<0.0001), and median PFS was 7.1 versus 3.1 months, with an ORR of 37.4% versus 7.7% and a favorable GI safety profile.\n\nArcotatug tavatecan is the first CLDN18.2 ADC with an NDA accepted for regulatory review globally (NMPA priority review in China); Takeda holds ex-Greater China rights and plans global Phase 3 trials in gastric and pancreatic cancer, validating Innovent's SyntecanE ADC platform.","key_figures":{"drugName":"Arcotatug Tavatecan (IBI343; Takeda code TAK-921)","phaseOfTrial":"Phase 3","customDimensions":{"orr":"37.4% vs 7.7% per IRRC","enrollment":464,"median_os_months":"10.2 vs 6.9 (HR=0.57, P<0.0001)","median_pfs_months":"7.1 vs 3.1 (HR=0.45)","grade3plus_trae_rate":"47.4% vs 55.9% with TPC","risk_of_death_reduction":"43%"}},"named_entities":{"people":[{"name":"Professor Lin Shen","role":"Director of GI Oncology, Beijing Cancer Hospital"},{"name":"Professor Kohei Shitara","role":"Director of GI Oncology, National Cancer Center Hospital East, Japan"},{"name":"Dr. Hui Zhou","role":"Chief R&D Officer (Oncology), Innovent"}],"products":["Arcotatug Tavatecan","IBI343","TAK-921","SyntecanE ADC platform","VENTANA CLDN18 (43-14A) Assay"],"companies":[{"name":"Innovent Biologics, Inc.","ticker":"01801","relationship":"filer/developer"},{"name":"Takeda","relationship":"partner - ex-Greater China development and commercialization rights"},{"name":"Beijing Cancer Hospital","relationship":"investigator site"},{"name":"National Cancer Center Hospital East","relationship":"investigator site"}],"dollarAmounts":[{"amount":"RMB 350 billion","context":"aggregate value of Innovent's 30+ strategic partnerships (background)"}]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-23T10:10:09.475Z","global_importance":55,"audience_relevance":40,"importance_components":{"tickerTier":"mid-cap foreign issuer (HKEX-listed)","eventGravity":"positive Phase 3 registrational readout with dual primary endpoint success","partnerWeight":"Takeda ex-Greater China collaboration adds global relevance","retailFavoriteBoost":"low in U.S. retail audience"}},"durationMs":7982,"modelName":"glm-5.3-flashx"}}