Top KOLs Discussing CLARITY-Gastric01
CLARITY-Gastric01 Key Slides & Visuals
ESMO 2026 slides
| Sone-Ve 2.2 mg/kg (n=178) | Investigator’s choice (n=177) | HR (95% CI) | |
|---|---|---|---|
| Deaths, n | 85 | 122 | 0.47 (0.36–0.62), P < 0.000001 |
| Median OS, months (95% CI) | 10.0 (7.2–11.4) | 5.0 (4.2–6.4) | — |
| 12-month OS rate | 38.1% | 18.1% | — |
| Population | Sone-Ve 2.2 mg/kg: median PFS, months (95% CI) | Investigator’s choice: median PFS, months (95% CI) | HR (95% CI) |
|---|---|---|---|
| ITT, all 2L+ (dual primary endpoint; n=267 vs 265) | 4.2 (3.5–5.3) | 3.8 (3.0–4.2) | 0.77 (0.62–0.96), P = 0.053193 — not statistically significant |
| 3L+ (secondary endpoint; n=178 vs 177) | 4.1 (3.0–5.3) | 2.7 (2.4–3.0) | 0.56 (0.43–0.74), not formally tested |
Same slides also posted by @OncBrothers, @HHorinouchi, @ArndtVogel, @CathyEngMD, @OncologyMarwarD, @DrVilmaPBarcia, @RussellPetty19.
| CLDN18.2 expression (any intensity) | Sone-Ve 2.2 mg/kg: n, median OS (95% CI) | Investigator’s choice: n, median OS (95% CI) | HR (95% CI) |
|---|---|---|---|
| ≥75% of tumour cells | 183, 10.6 mo (8.1–13.5) | 194, 6.4 mo (5.6–8.0) | 0.59 (0.45–0.78) |
| ≥25% to <75% | 83, 10.5 mo (7.1–12.4) | 71, 6.2 mo (4.3–8.8) | 0.63 (0.42–0.94) |
Same slides also posted by @DrVilmaPBarcia.
| Sone-Ve 2.2 mg/kg (n=267) | Investigator’s choice (n=265) | HR (95% CI) | |
|---|---|---|---|
| Deaths, n (press release) | 139 | 174 | 0.58 (0.47–0.73), P = 0.000004 |
| Median OS, months (95% CI) | 10.6 (9.1–12.0) | 6.4 (5.8–7.6) | — |
| 12-month OS rate | 42.6% | 27.8% | — |
Same slides also posted by @RussellPetty19, @DaniCastilloMD.
| Assessment | Sone-Ve 2.2 mg/kg (n=267) | Investigator’s choice (n=265) | HR (95% CI) |
|---|---|---|---|
| Blinded central review (dual primary endpoint) | 4.2 mo (3.5–5.3) | 3.8 mo (3.0–4.2) | 0.77 (0.62–0.96), P = 0.053193 |
| Investigator (exploratory endpoint) | 4.4 mo (3.8–5.7) | 3.0 mo (2.7–4.1) | 0.59 (0.48–0.73) |
Same slides also posted by @ArndtVogel, @OncologyMarwarD.
Same slides also posted by @DraMartinezLago, @SunnieSKim.
KOL-Made Infographics
Summary graphics designed by physicians (not conference slides). Values are as the authors drew them. Click to enlarge.
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@ozdogan_mdCLARITY-Gastric01 conversations on X
Replying to a reader’s question about patients previously treated with zolbetuximab (Vyloy); the question is not shown because its author is not a physician.
Physician reactions to CLARITY-Gastric01
CLARITY-Gastric 01: sonesitatug vedotin vs investigator’s choice in CLDN18.2+ gastric/GEJ cancer. Open: ORR, ocular/neuropathy events? #ESMO26 https://t.co/UgWWsM287l
3. CLARITY-Gastric01: PhIII Sonesitatug vedotin (CLDN18.2 ADC) vs Chemo in 2L+ CLDN18.2+ Gastric/GEJ - 3L+ mOS 10.0 vs 5.0mos (HR 0.47) - 2L+ mOS 10.6 vs 6.4 mos (HR 0.58) - PFS not significant 🤔 - ADC activity even at lower CLDN18.2 expression 4/5 https://t.co/hNFhJsi6M6 https://t.co/dRhWgUE9cA
🚨 #ESMO26 | CLARITY-Gastric01 Phase III Sonesitatug vedotin in CLDN18.2+ gastric/GEJ cancer: ✅ 3L+ OS: 10 vs 5 mo (HR 0.47) ✅ ITT OS: 10.6 vs 6.4 mo ✅ ORR: 23.3% vs 13.8% ⚠️ ITT PFS not significant (p=0.053) 🎯 Promising new ADC in gastric cancer! #GastricCancer #ADC https://t.co/MUINCaFIkK
ツチノコ的ESMOレビュー⑪ 胃がんのもう一つのCLDN18.2を狙うADCです。 今回はこちら、 「CLARITY-Gastric01」 CLDN18.2を狙うADC 「sonesitatug vedotin」 （ソネシタツグ ベドチン） の第Ⅲ相試験です。 （これCLDN系は抗体はtug系っぽいですね。） ツチノコ的ESMOレビュー④のArcotatug tavatecanのライバルになります。 https://t.co/0JWvQ5K8Vo がん細胞の表面にあるCLDN18.2という目印を見つけて、抗がん剤を届ける治療は一緒です。 搭載している爆弾は「MMAE」。 細胞分裂に必要な微小管の働きを邪魔する薬ですね。 ADCといえばトポイソメラーゼⅠ阻害薬を搭載したものが目立ちますが、こちらは違うタイプです。 今回の対象は、すでに治療を受けた進行胃がんなどの患者さん。 二次治療以降で、Sone-Ve単剤と医師が選択した治療を比較しました。 結果は、、 主要評価項目である三次治療以降の全生存期間が、 Sone-Ve：10.0か月 対照群：5.0か月 HR 0.47、p＜0.000001。 生存期間の中央値が約2倍となっています。 さらに、二次治療以降の全体532人でも、 Sone-Ve：10.6か月 対照群：6.4か月 HR 0.58、p＜0.000004。 これは注目したい結果ですね。 そして、もう一つ面白いのが、、 CLDN18.2の条件が、 「染色の強さを問わず、腫瘍細胞の25%以上に発現」 だったこと。 発現が25%以上75%未満の群でも、OSのHRは0.63でした。 強く発現している患者さんだけでなく、対象を広げられる可能性があります。 ただし、ここで一つ大事な点があります。 もう一つの主要評価項目である、中央判定の無増悪生存期間は、 4.2か月 vs 3.8か月 HR 0.77、p＝0.053。 こちらは統計学的有意差に届いていません。 つまり、、 「がんが進行するまでの期間では有意差がつかなかったが、全生存期間は延長した」 という結果です。 ここは気になります？？ ライバルのArcotatug tavatecanはPFSでも効果を示したのでこれは難しい。 後治療の影響や画像評価の違いなど、なぜこの乖離が生じたのかは詳細を確認したいところです。 ただし、Arcotatug tavatecanはCLDN75%以上陽性なので対象選択の問題もあるかもしれません。 Grade 3以上の治療関連有害事象は、 36.4% vs 44.8%。 少なくとも、重い副作用が増えて得られた生存期間の延長という結果ではありません。 副作用パラメータは追えてませんが、同じ薬剤の他の発表で悪心が6%ほどなのでArcotatug tavatecanの方がやや使いやすいかも？？ 使い分けとしてはCLDN陽性75%以上はArcotatug tavatecan それ以外はsonesitatug vedotinみたいな感じ？？ 少なくともADCが標準治療にはなりそうですが、これも1次治療にどうせ上がってきそうなので 今後の使い分けも非常に大事かなと思います。 Sonesitatug vedotin reduced the risk of death by 42% in 2nd- and later-line CLDN18.2-positive advanced gastric/GEJ cancers in CLARITY-Gastric01 - AstraZeneca https://t.co/CouYIPpwrz
Clarity Gastric 01 . New player in Claudine 18.2 sector . Sone-Ve. Face off with zolbetuximab ? @OncBrothers @OncoAlert @myESMO #ESMO26 https://t.co/NOGn87EK8f
#ESMO26 🧬 23 years from CLDN18.2 discovery to approval! 🔬 2001 → Discovery 💊 2024 → First approval 🚀 2026 → Phase III ADC breakthroughs 💬 “We owe it to our patients to move faster. Cancer is a race against time.” 👏 Powerful message from Salah-Eddin Al-Batran! @OncoAlert
📣 Second Presidential Symposium #ESMO26 👉🏽 CLARITY-Gastric 01 (CG-01): phase 3 study of sonesitatug vedotin (Sone-Ve) in second or later-line (2L+) advanced or metastatic Claudin 18.2 (CLDN18.2)-positive gastroesophageal carcinoma (GEC) 🗣️ Discussed by @salahAlBatran 📌 PFS 4.1 vs 2.7m HR 0.56 (3+L) 📌 OS 10 vs 5m HR 0.47 (3+L) ☣️ Most frequent GI, decreased appetite and hematologic ☣️ Grade 3 or higher 36.4% @OncoAlert @myESMO @ASCO @_SEOM @UTMDAnderson @NEJM @brunolarvol 👇🏽👇🏽
Very nice summary by Prof Al-Batran about the rapid progress in treating CLDN18.2+ gastroesoph cancer with zolbe and now sone-ve... Many more advancements to come. #CLDN18 #GEcancers #ESMO26 https://t.co/3zSERkTHsf
🔬 23 years from discovery to approval! 2001: CLDN18.2 identified 2024: First targeted therapy approved 2026: Phase III ADC breakthroughs at #ESMO26! 🚀 A remarkable scientific journey transforming #GastricCancer care. @OncoAlert @myESMO https://t.co/gX6qII7ahw
Impressive results:👏👏👏👏👏👏 We have a new medicine and new treatment option for gastroesophageal cancer patients! Nice positive and clinically meaningful benefits for Sone-Ve in CLARITY—Gastric 02 presented today at #ESMO26 https://t.co/DZCcUGt48H
Context: the trial presented was CLARITY-Gastric01; CLARITY-Gastric02 is the separate first-line trial of Sone-Ve with capecitabine, with or without rilvegostomig (AstraZeneca).
CLARITY- Gastric 01 (CG-01) Phase III AZD-0901 (Sone-Ve) in 2L+ met #Claudin 18.2 (+) in #Gastroesophageal #cancer vs. investigators choice (N=594) Primary endpoints: PFS + OS 🔹OS: 10M vs. 5M (HR = 0.47) 👏 🔹12M OS: 38.1% vs. 18.1%, HR = 0.47 (3rd line) 🔹 12M 42.6% in 2nd line 🔹 ORR: 23.3% vs. 13.8% 🔹PFS: HR = 0.77 was NS in 2L+ 🔹PFS: HR = 4.1 vs. 2.7M; HR = 0.56 in 3L+ 🔹Need more data in the 2L setting; largest benefit seen in 3L+ setting #ESMO2026 @OncoAlert #cancerresearch @AstraZeneca
Context: 594 is total enrolment, including 62 patients randomised to the 1.8 mg/kg arm that was closed after dose selection; efficacy compares 267 vs 265 patients. The 42.6% 12-month OS rate is for the whole 2L+ (ITT) population, not 2nd line alone.
🚨🎗️ ESMO26 | CLARITY-Gastric01 – Fase III Sonesitatug vedotina (ADC anti-CLDN18.2) vs. tratamento padrão no câncer gastroesofágico avançado CLDN18.2 positivo. ✅ Sobrevida global em 3ª linha ou mais: 10,0 vs. 5,0 meses (HR 0,47) ✅ 53% de redução no risco de morte ✅ Sobrevida global na população total: 10,6 vs. 6,4 meses (HR 0,58) ✅ Resposta objetiva: 23,3% vs. 13,8% ⚠️ PFS na população total não atingiu significância estatística. 🎯 Potencial novo padrão terapêutico, especialmente a partir da terceira linha, com ganho expressivo de sobrevida. #ESMO26 #CLARITYGastric01 #SonesitatugVedotin #GastricCancer #CLDN182
🎯 #ESMO26 CLARITY-Gastric01 (ph III): sone-ve (CLDN18.2 ADC) vs TPC in 2L+ gastric/GEJ with CLDN18.2 ≥25% (any intensity) 📈 3L+ OS 10.0 vs 5.0 mo (HR 0.47) 📈 ITT OS 10.6 vs 6.4 mo (HR 0.58); 2L HR 0.88 🧬 Benefit at ≥75% and 25–74% expression ⚠️ Less heme tox, more GI tox https://t.co/0n6cZfKqh5
🔥Presidential session at ESMO 2026 🔥 CLARITY-Gastric 01: Ph 3 of sonesitatug vedotin in 2L+ CLDN18.2-positive GEC #ESMO26 #ESMOAmbassadors 👉ORR: 23 vs 13% 👉mPFS: 4.2 vs 3.8 mo 👉mOS: 10 vs 5 mo 👉No new safety signals 🧐 exciting results, new option for 2L+ CLDN18.2+ pts @myESMO @ASCO
🚨 #ESMO26 Plenary | #CLARITYGastric01 Sonesitatug vedotin significantly improves OS in CLDN18.2+ advanced gastric/GEJ cancer! Median OS: - 3L+: 10 vs 5 months (HR 0.47) - 2L+: 10.6 vs 6.4 months (HR 0.58) 💥 Potential new standard of care! @OncoAlert #GastricCancer @myESMO https://t.co/84HELwsuNf
As co-author, excited to share CLARITY-Gastric01 data. Sone-Ve showed a meaningful survival benefit for pts with previously treated CLDN18.2-positive GC/GEJ cancers, reinforcing CLDN18.2 as a key therapeutic target beyond the frontline setting. #ESMO2026 #GIOncology https://t.co/P1Y1RqW4i2
🆙#ESMO26 Presidential Symposium II 🔥CLARITY-Gastric 01 (CG-01): A Phase 3 Study of Sonesitatug Vedotin (Sone-Ve) in Second or Later-Line (2L+) Advanced or Metastatic Claudin 18.2 (CLDN18.2)-Positive Gastroesophageal Carcinoma (GEC) 🎙️Dr. Rui-Hua Xu 🔢LBA7 🎯Significantly Improved OS: 3L+ 10.0 vs 5.0mo (HR 0.47, p<0.001); ITT 10.6 vs 6.4mo (HR 0.58, p<0.001; n=532) 🎯PFS Not Significant (HR 0.77, p=0.05) 🎯Grade≥3 TRAEs 36.4% vs 44.8% ☑️NCT06346392 🔗 https://t.co/bIUj6lFjno @OncoAlert @Larvol @myESMO
🧬 CLARITY-Gastric01 | #ESMO2026 LBA7 A GIANT OS LEAP. A TINY PFS STEP! 4 visuals: Cartoon • Design • Efficacy • Verdict 🎯 CLDN18.2 ≥25% | Sone-Ve (MMAE ADC) 📈 3L+ OS: 10 vs 5 mo (HR 0.47) 2L+ OS: 10.6 vs 6.4 mo (HR 0.58) ⚠️ PFS: HR 0.77 — prespecified significance threshold missed! 🛡️ Grade ≥3 TRAEs: 36.4% vs 44.8% Remarkable survival benefit. But why the OS–PFS disconnect? 📚 Xu R-H et al. ESMO 2026; LBA7. @myESMO @OncoAlert @larvol #MVOnco
Posted on October 25 from the LBA7 abstract, before the presentation.
🚨 ESMO26: A major breakthrough in CLDN18.2+ gastric cancer! CLARITY-Gastric 01 (Phase III) Sonesitatug vedotin vs physician’s choice: 🔹 3L+ OS: 10.0 vs 5.0 months (HR 0.47) 🔹 2L+ OS: 10.6 vs 6.4 months (HR 0.58) 🔹 Grade ≥3 TRAEs: 36.4% vs 44.8% ⚠️ PFS did not meet the prespecified significance threshold. Verdict: A promising new ADC with substantial survival benefit, even in heavily pretreated patients. #ESMO26 @myESMO @ESMO_open @ASCO @OncoAlert
Posted on the morning of October 25 from the LBA7 abstract, before the presentation.
ESMO 2026 Presidential2 | CLARITY-Gastric 01: Phase III: Sonesitatug vedotin vs investigator's choice in previously treated CLDN18.2+ advanced gastroesophageal cancer (n=532). 📊 Key results: ✅ 3L+ median OS: 10.0 vs 5.0 months (HR 0.47; p<0.001) ✅ 2L+ median OS: 10.6 vs 6.4 months (HR 0.58; p<0.001) ⚠️ Median PFS: 4.2 vs 3.8 months (HR 0.77; p=0.05) — did not meet statistical significance threshold. ✅ Grade ≥3 TRAEs: 36.4% vs 44.8% 🔥 53% reduction in risk of death in 3L+! Notably, OS benefit was observed even with lower CLDN18.2 expression (≥25% to <75%). A striking OS benefit despite a modest, statistically nonsignificant PFS improvement. Could this ADC redefine later-line treatment of gastric cancer? @myESMO @OncoAlert #ESMO26 #GastricCancer #ADC
Posted on October 24 from the LBA7 abstract, before the presentation.
Five Clinical Questions Behind the ESMO 2026 Headlines CLARITY reports an OS benefit, but its broader PFS endpoint was not significant. KEYNOTE-C93 has a positive PFS readout with immature OS. MOIO asks whether responders need less frequent immunotherapy. The details will matter more than the headlines. #ESMO26
Posted on October 19, before the LBA7 abstract and presentation.
CLARITY-Gastric01 Trial Design
CLARITY-Gastric01 asked whether an antibody-drug conjugate aimed at CLDN18.2 could improve survival after first-line therapy for advanced gastroesophageal adenocarcinoma, using a broader CLDN18.2 definition than earlier trials. AstraZeneca is the sponsor; the trial runs at 175 centres in 19 countries (press release). Results were presented by Rui-Hua Xu, MD, at ESMO 2026 (LBA7, Presidential Symposium II, October 25, 2026), with Salah-Eddin Al-Batran, MD, as invited discussant.
Study Design
Randomized, open-label, sponsor-blinded, global phase 3 (NCT06346392). Initially 1:1:1 to Sone-Ve 2.2 mg/kg, Sone-Ve 1.8 mg/kg or investigator’s choice; the 1.8 mg/kg arm closed after dose selection (January 2025) and randomization continued 1:1. 594 enrolled; efficacy compares 267 vs 265. Stratified by region, prior gastrectomy and line of therapy.
Population
Unresectable locally advanced or metastatic gastric, GEJ or oesophageal adenocarcinoma after ≥1 prior therapy, CLDN18.2 in ≥25% of tumour cells with membranous staining at any intensity. Median age 57; about one third 2L, two thirds 3L+; CLDN18.2 ≥75% in about 71%; prior zolbetuximab in 17 patients.
Interventions
Sone-Ve 2.2 mg/kg IV every 3 weeks. Control at 2L: ramucirumab + paclitaxel, or paclitaxel or docetaxel if ramucirumab contraindicated; at 3L+: irinotecan, trifluridine/tipiracil (except China) or apatinib (China only).
Endpoints
Dual primary: OS in 3L+; PFS by BICR in ITT (all 2L+). Key secondary: OS in ITT. Other: PFS by BICR in 3L+, ORR and DoR, safety, OS by CLDN18.2 expression, investigator-assessed PFS/ORR/DoR, OS in prespecified subgroups.
Presenter & Discussant
Presenter and principal investigator: Rui-Hua Xu, MD, PhD (Sun Yat-sen University Cancer Center, Guangzhou). Invited discussant: Salah-Eddin Al-Batran, MD (Frankfurt am Main). Session chairs: Giuseppe Curigliano and Yelena Y. Janjigian.
Data Cut
Planned interim analysis; data cutoff May 31, 2026; median follow-up 8.6 months.
CLARITY-Gastric01 in the News
CLARITY-Gastric01 Questions
What is the CLARITY-Gastric01 trial?
CLARITY-Gastric01 (CG-01, NCT06346392) is a global, randomized, open-label, sponsor-blinded phase 3 trial sponsored by AstraZeneca. It compared sonesitatug vedotin (Sone-Ve, AZD0901), an investigational CLDN18.2-directed antibody-drug conjugate with an MMAE payload, with investigator’s choice of therapy in previously treated advanced gastric, gastroesophageal junction or oesophageal adenocarcinoma expressing CLDN18.2 in at least 25% of tumour cells at any intensity. Design: Trial Design.
Did CLARITY-Gastric01 meet its primary endpoints?
One of its two dual primary endpoints was met. Median overall survival in the 3L+ population was 10.0 vs 5.0 months (HR 0.47; 95% CI 0.36–0.62). Median PFS by blinded central review in all randomized 2L+ patients was 4.2 vs 3.8 months (HR 0.77; 95% CI 0.62–0.96; P=0.053) and did not reach statistical significance. Median OS in all 2L+ patients, the key secondary endpoint, was 10.6 vs 6.4 months (HR 0.58; 95% CI 0.47–0.73). Figures: At a Glance.
Did Sone-Ve help in the second-line setting?
That is not settled. Second-line patients were about a third of the trial. In the prespecified but descriptive 2L subgroup, the OS hazard ratio was 0.88 (95% CI 0.60–1.30), with confidence intervals not adjusted for multiplicity. The discussant, Salah-Eddin Al-Batran, MD, concluded that the 2L benefit is potential but needs more data, particularly versus ramucirumab plus paclitaxel, and that combining 2L and 3L+ complicates interpretation. See Discussion Threads.
Does Sone-Ve work after zolbetuximab?
The trial cannot answer that yet. Only 17 randomized patients had received prior zolbetuximab (10 in the Sone-Ve arm, 7 in the control arm), and no separate result was presented for them. Physicians raised whether CLDN18.2 status should be re-tested by biopsy after earlier treatment.
Is sonesitatug vedotin approved?
No. Sone-Ve is investigational and not approved by the FDA or any other regulator; it has FDA and European Commission Orphan Drug Designation for gastric and GEJ cancers. The only approved CLDN18.2-directed agent is zolbetuximab (VYLOY, Astellas), approved by the FDA on October 18, 2024 for first-line use with fluoropyrimidine- and platinum-containing chemotherapy in HER2-negative, CLDN18.2-positive gastric or GEJ adenocarcinoma, with the VENTANA CLDN18 (43-14A) RxDx Assay as companion diagnostic.
How did safety compare?
Grade ≥3 treatment-related adverse events occurred in 36.4% with Sone-Ve vs 44.8% with investigator’s choice. Gastrointestinal adverse events (any grade, all causes: nausea 54.4% vs 26.6%, vomiting 41.0% vs 24.6%) were more common with Sone-Ve and haematologic toxicity less common. Treatment-related deaths were 1.1% vs 0.8%. Details: At a Glance.