{"schema_version":"1.0","type":"article","title":"Gastric ADC Race: Takeda Wins Data, AZ Wins US","url":"https://drugnews.com.tw/articles/2026-10-28-gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race-en.html","markdown_url":"https://drugnews.com.tw/articles/2026-10-28-gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race-en.md","lang":"en","date":"2026-10-28","publish_at":"2026-10-28T08:00:00+08:00","updated_at":"2026-10-28","category":"醫學大會","topic":"醫學大會","tags":["gastric cancer","CLDN18.2","ADC","Takeda","AstraZeneca"],"summary":"Takeda's CLDN18.2 ADC added 3.3 months of median survival in late-line gastric cancer at ESMO 2026. But its trial ran only in China and Japan with a 75% cutoff, so AstraZeneca's Sone-Ve will reach US patients first.","key_points":["AstraZeneca's sonesitatug vedotin will win US FDA approval before Takeda and Innovent's arcotatug tavatecan, because the G-HOPE-001 phase 3 Takeda presented at ESMO on October 23, 2026 enrolled only in China and Japan and Takeda needs a new global phase 3 for US filing.","In G-HOPE-001, 464 previously treated CLDN18.2-positive gastric cancer patients on arcotatug tavatecan lived a median 10.2 months versus 6.9 months on chemotherapy (HR 0.57), with a confirmed response rate of 37.4% versus 7.7%.","AstraZeneca's CLARITY-Gastric01 enrolled in 19 countries with a CLDN18.2 cutoff of 25% of tumor cells, which about 60% of gastric cancers meet, while Takeda and Astellas's Vyloy use a 75% cutoff; Taiwan's NHI has reimbursed only first-line Vyloy since April 1, 2026."],"facts":[{"claim":"G-HOPE-001 phase 3 enrollment (China and Japan)","value":464,"unit":"patients","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"Median overall survival on arcotatug tavatecan (G-HOPE-001 IA2)","value":10.2,"unit":"months","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"Median overall survival on chemotherapy in G-HOPE-001","value":6.9,"unit":"months","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"G-HOPE-001 overall survival hazard ratio","value":0.57,"unit":"HR","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"G-HOPE-001 median progression-free survival, ADC vs chemotherapy","value":"7.1 vs 3.1","unit":"months","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"G-HOPE-001 confirmed response rate, ADC vs chemotherapy","value":"37.4% vs 7.7%","unit":"%","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"G-HOPE-001 grade 3+ treatment-related adverse events, ADC vs chemotherapy","value":"47.4% vs 55.9%","unit":"%","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"G-HOPE-001 grade 3+ anemia, ADC vs chemotherapy","value":"20.4% vs 13.1%","unit":"%","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"Takeda's October 2025 upfront payment to Innovent (incl. $100M equity)","value":1.2,"unit":"billion USD","as_of":"2025-10-22","source":"https://www.biospace.com/press-releases/innovent-biologics-announces-global-strategic-partnership-with-takeda-to-bring-innovents-next-gen-io-backbone-therapy-and-adc-molecules-to-the-global-market"},{"claim":"Potential total value of the Takeda-Innovent deal","value":11.4,"unit":"billion USD","as_of":"2025-10-22","source":"https://www.biospace.com/press-releases/innovent-biologics-announces-global-strategic-partnership-with-takeda-to-bring-innovents-next-gen-io-backbone-therapy-and-adc-molecules-to-the-global-market"},{"claim":"CLARITY-Gastric01 countries and centers","value":"19 countries, 175 centers","unit":"","as_of":"2026-07-27","source":"https://www.astrazeneca.com/media-centre/press-releases/2026/sone-ve-improved-survival-in-gastric-cancers.html"},{"claim":"Sone-Ve CLDN18.2 cutoff (share of tumor cells, any intensity)","value":25,"unit":"%","as_of":"2026-07-27","source":"https://www.astrazeneca.com/media-centre/press-releases/2026/sone-ve-improved-survival-in-gastric-cancers.html"},{"claim":"Share of gastric/GEJ cancers meeting the 25% cutoff (AstraZeneca estimate)","value":60,"unit":"%","as_of":"2026-07-27","source":"https://www.astrazeneca.com/media-centre/press-releases/2026/sone-ve-improved-survival-in-gastric-cancers.html"},{"claim":"Share of CLDN18.2-positive (≥75% moderate-to-strong) patients in GLOW and SPOTLIGHT","value":38,"unit":"%","as_of":"2023-03-22","source":"https://newsroom.astellas.com/2023-03-22-Astellas-Announces-Positive-Findings-from-Phase-3-GLOW-Trial-of-Zolbetuximab-during-March-ASCO-Plenary-Series"},{"claim":"GLOW median overall survival, Vyloy + chemo vs placebo + chemo","value":"14.39 vs 12.16","unit":"months","as_of":"2023-03-22","source":"https://newsroom.astellas.com/2023-03-22-Astellas-Announces-Positive-Findings-from-Phase-3-GLOW-Trial-of-Zolbetuximab-during-March-ASCO-Plenary-Series"},{"claim":"Vyloy global revenue, fiscal 2025 (to March 2026)","value":63.1,"unit":"billion JPY","as_of":"2026-04-27","source":"https://www.astellas.com/content/dam/astellas-com/global/en/confidential-documents/financial-results/4q2025_sup_en.pdf"},{"claim":"Vyloy global revenue, fiscal 2024","value":12.2,"unit":"billion JPY","as_of":"2026-04-27","source":"https://www.astellas.com/content/dam/astellas-com/global/en/confidential-documents/financial-results/4q2025_sup_en.pdf"},{"claim":"AstraZeneca's 2023 upfront for CMG901 (Sone-Ve)","value":63,"unit":"million USD","as_of":"2023-02-23","source":"https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-enters-license-agreement-with-kym-biosciences-for-cmg901-a-claudin-182-antibody-drug-conjugate.html"},{"claim":"Taiwan NHI reimbursement start date for Vyloy","value":"2026-04-01","unit":"date","as_of":"2026-04-01","source":"https://www.nhi.gov.tw/ch/dl-97151-a6aec2bac5b0488a87cc56995538c5ca-1.pdf"},{"claim":"Gastric cancer rank among cancer deaths in Taiwan, 2024","value":8,"unit":"rank","as_of":"2025-06-16","source":"https://www.mohw.gov.tw/cp-16-82775-1.html"},{"claim":"New gastric cancer diagnoses per year in Taiwan (2022 registry)","value":"more than 4,000","unit":"patients","as_of":"2025-02-19","source":"https://health.tvbs.com.tw/cancer/353026"}],"sections":["01 | A nameplate on the surface of gastric cancer cells","02 | Takeda's scorecard: nearly five times as many tumors shrank","03 | One yardstick: who qualifies, where the trial ran, and how close to market","04 | The price of arriving early, and the price of arriving late","05 | What Taiwan's patients can get today: first-line Vyloy only","06 | Two finish lines","References"],"references":[{"title":"Takeda Announces Arcotatug Tavatecan (TAK-921) Demonstrated Statistically Significant and Clinically Meaningful Improvements in Overall Survival and Progression-Free Survival in Phase 3 Advanced Gastric Cancer Study","source":"Takeda","date":"2026-10-23","url":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"title":"ESMO: Takeda's $1.2B bet on Innovent 'absolutely' pays off with details of ADC's phase 3 win","source":"Fierce Biotech","date":"2026-10-23","url":"https://www.fiercebiotech.com/biotech/esmo-takedas-12b-bet-innovent-absolutely-pays-adcs-phase-3-win"},{"title":"Innovent Biologics Announces Global Strategic Partnership with Takeda","source":"BioSpace (Innovent press release","date":"2025-10-22","url":"https://www.biospace.com/press-releases/innovent-biologics-announces-global-strategic-partnership-with-takeda-to-bring-innovents-next-gen-io-backbone-therapy-and-adc-molecules-to-the-global-market"},{"title":"Innovent, fresh from $1.2B deal, posts phase 3 win for Takeda-partnered ADC","source":"Fierce Biotech","date":"2026-06-04","url":"https://fiercebiotech.com/biotech/innovent-fresh-12b-deal-posts-phase-3-win-cldn182-adc"},{"title":"Sonesitatug vedotin demonstrated a statistically significant and highly clinically meaningful improvement in overall survival in 2nd and later-line CLDN18.2-positive advanced gastric/GEJ cancers","source":"AstraZeneca","date":"2026-07-27","url":"https://www.astrazeneca.com/media-centre/press-releases/2026/sone-ve-improved-survival-in-gastric-cancers.html"},{"title":"AstraZeneca to present overall survival data from four pivotal Phase III trials in Presidential Symposia at ESMO 2026","source":"AstraZeneca","date":"2026-10-19","url":"https://www.astrazeneca.com/media-centre/press-releases/2026/astrazeneca-present-survival-data-from-four-pivotal-phase-iii-trials-at-esmo-2026-featuring-sone-ve-imfinzi-tagrisso-orpathys.html"},{"title":"AstraZeneca enters license agreement with KYM Biosciences for CMG901, a Claudin 18.2 antibody drug conjugate","source":"AstraZeneca","date":"2023-02-23","url":"https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-enters-license-agreement-with-kym-biosciences-for-cmg901-a-claudin-182-antibody-drug-conjugate.html"},{"title":"Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab","source":"Astellas","date":"2023-03-22","url":"https://newsroom.astellas.com/2023-03-22-Astellas-Announces-Positive-Findings-from-Phase-3-GLOW-Trial-of-Zolbetuximab-during-March-ASCO-Plenary-Series"},{"title":"FY2025 Financial Results Supplementary Information (Sales of major products","source":"Astellas","date":"2026-04-27","url":"https://www.astellas.com/content/dam/astellas-com/global/en/confidential-documents/financial-results/4q2025_sup_en.pdf"},{"title":"Drug reimbursement rule revision, item 9.133 zolbetuximab (effective April 1, 2026","source":"Taiwan National Health Insurance Administration","date":"2026-04-01","url":"https://www.nhi.gov.tw/ch/dl-97151-a6aec2bac5b0488a87cc56995538c5ca-1.pdf"},{"title":"2024 cause of death statistics","source":"Taiwan Ministry of Health and Welfare","date":"2025-06-16","url":"https://www.mohw.gov.tw/cp-16-82775-1.html"},{"title":"More than 4,000 gastric cancer cases a year in Taiwan","source":"TVBS Health","date":"2025-02-19","url":"https://health.tvbs.com.tw/cancer/353026"},{"title":"Sonesitatug Vedotin Improves Overall Survival in Second- and Later-Line CLDN18.2-Positive Gastric/GEJ Cancer","source":"OncLive","date":"2026-07-27","url":"https://www.onclive.com/view/sonesitatug-vedotin-improves-overall-survival-in-second--and-later-line-cldn18-2-positive-gastric-gej-cancer"}],"images":[{"alt":"Fig. 1 | One nameplate, three ways to attack it","url":"https://drugnews.com.tw/assets/articles/gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race-en/figure-01.png"},{"alt":"Fig. 2 | Late-line gastric cancer: 3.3 more months","url":"https://drugnews.com.tw/assets/articles/gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race-en/figure-02.png"},{"alt":"Fig. 3 | Three CLDN18.2 drugs on one yardstick","url":"https://drugnews.com.tw/assets/articles/gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race-en/figure-03.png"},{"alt":"Fig. 4 | The CLDN18.2 race to market","url":"https://drugnews.com.tw/assets/articles/gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race-en/figure-04.png"}],"cover_image":"https://drugnews.com.tw/assets/articles/gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race-en/cover.png","publisher":{"name":"Drugnews｜藥時事","url":"https://drugnews.com.tw/","profile":"https://drugnews.com.tw/brand-profile.json"},"citation":"Drugnews｜藥時事（2026-10-28）。Gastric ADC Race: Takeda Wins Data, AZ Wins US。https://drugnews.com.tw/articles/2026-10-28-gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race-en.html","disclaimer":"This article is intended for industry research and knowledge sharing only. It does not constitute investment, medical, fundraising, or individual stock advice.","translations":{},"relationship":"independent_editorial","disclosure_url":"https://drugnews.com.tw/policy/"}