A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

开始日期2026-02-03

申办/合作机构

AstraZeneca PLC

NCT07143604

/ Active, not recruiting临床2期

A Phase II, Multicentre, Open-label, Single-arm Study of AZD0901 Monotherapy in Second-or Later-Lines Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

The purpose of this study is to measure the efficacy and safety of AZD0901 monotherapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

开始日期2025-08-29

申办/合作机构

AstraZeneca PLC

NCT07069712

/ Recruiting临床2期

A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)

GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.

开始日期2025-07-17

申办/合作机构

AstraZeneca PLC

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项与 Sonesitatug vedotin 相关的文献（医药）

2026-12-31·mAbs

Antibodies to watch in 2026

Review

作者: Pinto, Kieran ; Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Reichert, Janice M. ; Chenoweth, Alicia ; Hsu, Yu-Shin

The Antibodies to Watch article series provides annual updates on commercial late-stage clinical development, regulatory review, and marketing approvals of antibody therapeutics. Since the first article was published in 2010, the late-stage pipeline has grown from 26 antibody therapeutics to over 200, while during the same time numerous molecules in late-stage studies either transitioned to regulatory review and were approved or were terminated. In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab. As antibody therapeutics development is a global enterprise, we also discuss trends in annual first approvals granted to antibody therapeutics in any country since 2010, stratified by the antibody's country of origin, documenting the notable increases in the total number of first approvals and those approved first in China. Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by their therapeutic area, mechanism of action, format, and country of origin. Our data show that the development and approval period were typically ~6 years, but on average this period was shorter for China-originated products.

2026-12-01·CURRENT TREATMENT OPTIONS IN ONCOLOGY

Antibody-Drug Conjugates in the Treatment of Esophageal Cancer

Review

作者: Zhao, Qi ; Zhu, Wenjing ; Chen, Wei ; Xu, Jian ; Wu, Dapeng

OPINION STATEMENT:

Esophageal cancer remains one of the most lethal malignancies worldwide, with particularly poor outcomes following disease progression after first-line chemoimmunotherapy. Antibody-drug conjugates (ADCs) have emerged as a transformative therapeutic class that combines the targeting precision of monoclonal antibodies with potent cytotoxic payloads, enabling selective tumor cell killing while minimizing off-target toxicity. In the management of advanced esophageal cancer, I advocate for the integration of ADCs as a therapeutic option following progression on first-line chemoimmunotherapy. For patients with human epidermal growth factor receptor 2 (HER2)-positive gastroesophageal junction adenocarcinoma, trastuzumab deruxtecan is my preferred choice based on its superior overall survival benefit and robust bystander killing effect, which also confers activity in HER2-low tumors. For HER2-negative gastroesophageal adenocarcinoma, trophoblast cell-surface antigen 2 represents a promising target given its high prevalence of moderate to strong expression in nearly 80% of cases, and sacituzumab tirumotecan is currently under phase III investigation in this setting. In esophageal squamous cell carcinoma, I recommend biomarker-guided selection among ADCs targeting B7-H3, given its overexpression in over 90% of cases. For Nectin-4-expressing tumors, enfortumab vedotin may be considered as a later-line alternative despite modest activity. Notably, the bispecific ADC targeting both epidermal growth factor receptor and human epidermal growth factor receptor 3, BL-B01D1, has demonstrated compelling efficacy in immunotherapy-refractory esophageal squamous cell carcinoma, and I consider it a breakthrough option in this subtype. For claudin-18.2-positive gastroesophageal junction adenocarcinoma, several ADCs including CMG901, IBI343, and tecotabart vedotin represent promising later-line choices. I emphasize that patient selection should be guided by validated predictive biomarkers, and treatment decisions must account for distinctive toxicity profiles, particularly interstitial lung disease with trastuzumab deruxtecan. Finally, I strongly support advancing ADCs into earlier lines of therapy and perioperative settings through well-designed clinical trials to further improve long-term outcomes in this aggressive malignancy.

2025-02-01·LANCET ONCOLOGY

Claudin 18.2-targeting antibody–drug conjugate CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer (KYM901): a multicentre, open-label, single-arm, phase 1 trial

Article

作者: Wang, Zhen-Ning ; Shi, Xi ; Yang, Jian-Wei ; Luo, Su-Xia ; Liu, Fu-Rong ; Chen, Zhen-Dong ; Wu, Xiao-Jie ; Zhuang, Zhi-Xiang ; Ruan, Dan-Yun ; Chen, Bo ; Liang, Xiao-Hua ; Xu, Rui-Hua ; Liu, Fu-Nan ; Kumar, Rakesh ; Wei, Xiao-Li ; Zheng, Yu-Long ; Liu, Wei ; Zhang, Yan-Qiao ; Wang, Jun-Ye ; Zhang, Dong-Sheng ; Liu, Jian ; Wang, Yong-Sheng

BACKGROUND:

CMG901 is a novel first-in-class antibody-drug conjugate with a humanised anticlaudin 18.2 antibody linked to microtubule-disrupting agent monomethyl auristatin E. We aimed to assess the antitumour activity and safety of CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer and other solid tumours.

METHODS:

KYM901 is a multicentre, open-label, single-arm, phase 1 trial consisting of dose-escalation and dose-expansion stages. Patients with advanced solid tumours, including gastric or gastro-oesophageal junction and pancreatic cancers, were recruited from 31 hospital sites in China. Eligible patients were aged 18 years or older, were refractory to standard therapy or had no available standard-of-care regimen, and had an Eastern Cooperative Oncology Group performance status score of 0-1, a life expectancy of at least 3 months, and at least one measurable lesion. Patients received intravenous CMG901 every 3 weeks (0·3-3·4 mg/kg in dose escalation and 2·2-3·0 mg/kg in dose expansion) until disease progression, unacceptable toxic effects, initiation of new antitumour therapy, study withdrawal, or death. Primary endpoints were adverse events and dose-limiting toxic effects in the dose-escalation phase, and objective response rate and recommended phase 2 dose in the dose-expansion phase. Confirmed objective response was defined as a partial or complete response that was verified by follow-up imaging at least 4 weeks after the initial assessment. Safety was assessed in all patients who received at least one dose of CMG901 with at least one post-dose safety evaluation. Antitumour activity was assessed in all patients who received at least one dose of CMG901 (full analysis set) and in all CMG901-treated patients with at least one post-dose imaging evaluation and no major protocol deviations (efficacy analysis set). Dose-expansion data for patients with pancreatic cancer will be published separately. Due to small sample sizes, results in patients with other solid tumours (n=2) are not planned for publication. This ongoing trial is registered with ClinicalTrials.gov, NCT04805307.

FINDINGS:

Between Dec 24, 2020, and Feb 23, 2023, 27 patients were enrolled in the dose-escalation phase (median age 57·0 years [IQR 48·0-63·0]; 14 [52%] male, 13 [48%] female) and 107 patients with gastric or gastro-oesophageal junction cancer in the dose-expansion phase (median age 56·0 years [44·0-64·0]; 57 [53%] male, 50 [47%] female). As of Feb 24, 2024, one dose-limiting toxic effect (grade 3 pancreatitis) occurred at 2·2 mg/kg, and the maximum tolerated dose was not reached in the dose-escalation phase. All 27 patients reported at least one treatment-emergent adverse event, most frequently vomiting (19 [70%]), decreased appetite (16 [59%]), proteinuria (16 [59%]), and anaemia (15 [56%]), and five (19%) had drug-related grade 3 or worse treatment-emergent adverse events. In 107 patients, grade 3 or worse treatment-emergent adverse events occurred in 73 (68%) patients and serious adverse events occurred in 54 (50%) patients in dose expansion. The most common grade 3-4 adverse events were neutrophil count decreased (22 [21%]), anaemia (15 [14%]), and vomiting (11 [10%]). One treatment-related death was reported. At median follow-up of 9·0 months (IQR 4·4-12·9), among 113 patients with gastric or gastro-oesophageal junction cancer in the 2·2-3·0 mg/kg cohort full analysis set across both the dose-escalation and dose-expansion phases, the confirmed objective response rate was 28% (95% CI 20-38; 32 of 113 patients). In the 109 patients included in the efficacy analysis set, the confirmed objective response rate was 29% (95% CI 21-39; 32 of 109 patients). Based on overall safety, activity, and pharmacokinetics of CMG901, 2·2 mg/kg was the proposed recommended phase 2 dose.

INTERPRETATION:

CMG901 showed a manageable safety profile and had promising antitumour activity in patients with advanced gastric or gastro-oesophageal junction cancer.

FUNDING:

KYM Biosciences.

1,457

项与 Sonesitatug vedotin 相关的新闻（医药）

2026-10-29

·astrazeneca.com

AstraZeneca to present overall survival data from four pivotal Phase III trials in Presidential Symposia at ESMO 2026 featuring Sone-Ve, Imfinzi, Tagrisso and Orpathys

AstraZeneca advances its ambition to revolutionise cancer care with new data across its diverse, industry-leading portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress, 23-27 October 2026. More than 100 abstracts will be presented, including data from five pivotal Phase III trials, four of which will be featured in Presidential Symposia. This breadth of data will demonstrate how AstraZeneca is redefining the way cancer is treated with innovative combinations, precision medicine and antibody drug conjugates (ADCs) across bladder, lung and gastric cancers. Highlights include: CLARITY-Gastric01: Phase III trial of sonesitatug vedotin (Sone-Ve), a wholly owned Claudin-18.2 (CLDN18.2) ADC, in 2nd and later-line CLDN18.2-positive (≥25%) advanced gastric or gastroesophageal junction (GEJ) cancers versus investigator’s choice of therapy. This is the first Phase III trial to show a statistically significant and clinically meaningful overall survival (OS) benefit with an anti-CLDN18.2 ADC in this setting. Approximately 60% of patients have CLDN18.2 expression ≥25% in this setting. (Presidential Symposium 2 Abstract #LBA7). SAFFRON: Phase III trial of Tagrisso (osimertinib) plus Orpathys (savolitinib) in patients with MET-driven, epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who progressed on prior treatment versus platinum-based chemotherapy (Presidential Symposium 2 Abstract #LBA6). DeLLphi-305: Amgen-led Phase III trial of Imfinzi (durvalumab) plus tarlatamab as a 1st-line maintenance treatment for extensive-stage small cell lung cancer versus Imfinzi alone (Presidential Symposium 1 Abstract #LBA3). VOLGA: Phase III trial of perioperative Imfinzi in combination with neoadjuvant enfortumab vedotin in patients with muscle-invasive bladder cancer who are ineligible for or have refused cisplatin-based chemotherapy, versus surgery with or without approved adjuvant treatment (Presidential Symposium 1 Abstract #LBA2). SANOVO: Hutchmed-led Phase IIItrial of Tagrisso plus Orpathys in treatment-naïve patients with MET-overexpressed, EGFRm locally advanced or metastatic NSCLC versus Tagrisso alone in China (Proffered Paper Abstract #LBA69). NeoCOAST-2: Association of ctDNA clearance with clinical outcomes in a global platform Phase II perioperative trial of Imfinzi combinations with Datroway (datopotomab deruxtecan), oleclumab and monalizumab in NSCLC (Rapid Oral Session Abstract #4244RO). FONTANA: Phase I/IIa trial of torvutatug samrotecan (Torvu-Sam), a folate receptor α (FRα)-targeting ADC as monotherapy in patients with platinum-resistant recurrent ovarian cancer (Rapid Oral Session Abstract #1245RO). AZD7003: Updated results from a Phase I trial of C-CAR031, a Glypican 3 (GPC3) CAR-T, in advanced hepatocellular carcinoma (Rapid Oral Session Abstract #1680RO). Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "AstraZeneca’s portfolio of scientific data at ESMO is our strongest to date, showcasing transformative combinations including emerging modalities. Findings from VOLGA, DeLLphi-305 and SAFFRON demonstrate the potential of combination regimens with complementary mechanisms to improve on today’s standards of care, extend treatment benefit and meaningfully improve survival outcomes for more patients. These data, alongside practice-changing results for our first wholly owned ADC Sone-Ve from CLARITY-Gastric01 underscore how AstraZeneca is transforming cancer care." Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “At ESMO, we are presenting pivotal data that demonstrate how we are advancing new standards of care by adding novel medicines to AstraZeneca’s proven backbone therapies. Results from VOLGA, DeLLphi-305 and SAFFRON highlight the potential of innovative Imfinzi- and Tagrisso-based regimens to improve outcomes for patients across bladder and lung cancers, reinforcing our commitment to continually raising the bar for patients with cancer across the treatment landscape." Key AstraZeneca presentations during ESMO 20261 Lead Author Abstract Title Presentation details (CEST) Lead Author Antibody drug conjugates Lead Author Xu, R-H Abstract Title CLARITY-Gastric01 (CG-01): a Phase III trial of Sone-Ve in second or later-line (2L+) advanced or metastatic Claudin 18.2 (CLDN18.2) positive gastroesophageal carcinoma (GEC) Presentation details (CEST) Abstract #LBA7 Presidential Symposium 2 25 October 2026 4:30 PM Lead Author Meric-Bernstam, F Abstract Title Updated results from FONTANA: Torvutatug samrotecan (torvu-sam), a folate receptor α (FRα)-targeted antibody-drug conjugate (ADC), in patients (pts) with platinum-resistant ovarian cancer (PROC) Presentation details (CEST) Abstract #1245RO Rapid Oral Session 24 October 2026 Lead Author Dent, R Abstract Title First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients (pts) with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Exploratory analysis of pts with brain metastases in TROPION-Breast02 (TB-02) Presentation details (CEST) Abstract #LBA96 Proffered Paper Session 24 October 2026 8:30 AM Lead Author Boileau, JF Abstract Title DESTINY-Breast11 (DB-11): MRI-assessed objective responses during neoadjuvant treatment (NAT) with trastuzumab deruxtecan (T-DXd) followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose- dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in HER2+ early breast cancer (eBC) Presentation details (CEST) Abstract #543RO Rapid Oral Session 23 October 2026 4:15 PM Lead Author Novello, S Abstract Title First-line (1L) trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-mutant (HER2m) NSCLC: Patient-reported outcomes (PROs) from DESTINY-Lung04 (DL-04) Presentation details (CEST) Abstract #LBA74 Rapid Oral Session 24 October 2026 9:00 AM Lead Author Manich, S Abstract Title A DESTINY-Breast09 (DB-09) analysis of trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for patients (pts) with HER2+ advanced/metastatic breast cancer (a/mBC) and baseline (BL) brain metastases (BMs) Presentation details (CEST) Abstract #LBA49 Rapid Oral Session 26 October 2026 10:15 AM Lead Author Immuno-oncology Lead Author Powles, T Abstract Title Perioperative durvalumab with or without tremelimumab plus neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer: results from the Phase 3 VOLGA trial Presentation details (CEST) Abstract #LBA2 Presidential Symposium 1 24 October 2026 4:30 PM Lead Author Sands, J Abstract Title Tarlatamab plus durvalumab (durva) vs durva as 1L maintenance (1LM) therapy following durva, platinum, and etoposide (1L durva + EP) in extensive-stage small cell lung cancer (ES-SCLC): Primary analysis of the phase 3 DeLLphi-305 trial Presentation details (CEST) Abstract #LBA3 Presidential Symposium 1 24 October 2026 4:30 PM Lead Author Kudo, M Abstract Title Liver function trajectory and post-progression outcomes in the Phase III EMERALD-3 trial of tremelimumab (T) + durvalumab (D) ± lenvatinib (L) + transarterial chemoembolisation (TACE) in participants (pts) with embolisation-eligible hepatocellular carcinoma (eeHCC) Presentation details (CEST) Abstract #LBA48 Proffered Paper Session 24 October 2026 10:15 AM Lead Author Westin, S Abstract Title Durvalumab (D) plus carboplatin/paclitaxel (CP) followed by D with or without olaparib (O) in advanced/recurrent endometrial cancer (a/rEC): interim overall survival (OS) and safety from the randomised Phase III DUO-E/GOG-3041/ENGOT-EN10 trial Presentation details (CEST) Abstract #LBA37 Proffered Paper Session 24 October 2026 2:45 PM Lead Author De Santis, M Abstract Title Durvalumab (D) in Combination With BCG Induction and Maintenance (I+M) for BCG-Naïve, High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC): Early Recurrence and Cystectomy-Free Survival in Patients (pts) With Papillary Only Tumours From POTOMAC Presentation details (CEST) Abstract #4737RO Rapid Oral Session 24 October 2026 10:15 AM Lead Author Cascone, T Abstract Title NeoCOAST-2: Association of ctDNA clearance with clinical outcomes in a global platform Phase III perioperative trial Presentation details (CEST) Abstract #4244RO Rapid Oral Session 25 October 2026 8:30 AM Lead Author Spicer, J Abstract Title ctDNA clearance (CL) during neoadjuvant treatment (neoadj Tx) and its association with outcomes in patients (pts) with resectable/borderline resectable stage IIB–IIIB NSCLC from MDT-BRIDGE Presentation details (CEST) Abstract #LBA69 Rapid Oral Session 26 October 2026 10:15 AM Lead Author Lorenza, R Abstract Title Seven-year overall survival (OS) and OS by tumour response measures from the Phase III HIMALAYA trial of tremelimumab plus durvalumab in first-line (1L) unresectable hepatocellular carcinoma (uHCC) Presentation details (CEST) Abstract #1683P Poster Session 25 October 2026 12:00 PM Lead Author Tumour drivers and resistance Lead Author Lu, S Abstract Title Osimertinib (osi) + savolitinib (savo) vs platinum–pemetrexed (plat–pem) in EGFRm MET-overexpressed (OE) and/or -amplified (AMP) advanced NSCLC post-osi: SAFFRON Phase III primary results Presentation details (CEST) Abstract #LBA6 Presidential Symposium 2 25 October 2026 4:30 PM Lead Author Wu, YL Abstract Title Savolitinib or Placebo Combined with Osimertinib in Treatment-Naïve Advanced NSCLC with EGFR Mutation and MET Overexpression: Results from the Phase III SANOVO trial Presentation details (CEST) Abstract #LBA69 Proffered Paper Session 26 October 2026 8:30 AM Lead Author Fizazi, K Abstract Title Capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN-deficient metastatic hormone sensitive prostate cancer (mHSPC): updated overall survival (OS) from CAPItello-281 Presentation details (CEST) Abstract #LBA56 Rapid Oral Session 23 October 2026 1:30 PM Lead Author Cell therapy Lead Author Liang, T Abstract Title Phase I trial of C-CAR031, a GPC3-targeted TGFβRIIDN armored autologous CAR-T, in advanced hepatocellular carcinoma (aHCC): Updated Results Presentation details (CEST) Abstract #1680RO Rapid Oral Session 26 October 2026 2:45 PM 1 More than 100 abstracts at ESMO 2026 will feature AstraZeneca medicines and pipeline molecules Notes AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. Oncology Corporate and financial

临床结果临床3期临床1期临床2期免疫疗法

2026-10-29

·QQ浏览器

瞭望ESMO·现场速递丨院士领衔、双星闪耀：两项中国Ⅲ期研究登顶主席研讨会，勾勒消化道肿瘤治疗新格局

2026年欧洲肿瘤内科学会（ESMO 2026）年会于当地时间10月23~27日在西班牙马德里召开。作为全球肿瘤领域极具影响力的综合性学术盛会，ESMO年会汇聚全球顶尖学者、临床研究者与医药创新力量，集中展示肿瘤诊疗领域前沿突破。主席研讨会（Presidential Symposium）是ESMO年会最高规格的数据发布环节，入选研究被视为有望改变临床实践的重磅证据。在消化道肿瘤领域，两项来自中国的重磅Ⅲ期研究登上主席研讨会：CLARITY-Gastric 01研究（摘要号：LBA7）由中山大学肿瘤防治中心徐瑞华院士领衔，旨在评估靶向Claudin 18.2的抗体偶联药物（ADC）Sonesitatug vedotin（Sone-Ve）用于晚期或转移性胃食管癌患者二线及以上治疗的疗效与安全性；HARMONi-GI1研究（摘要号：LBA8）由复旦大学附属中山医院周俭院士领衔，旨在评估PD-1/VEGF双特异性抗体依沃西单抗联合化疗用于晚期胆道癌的疗效和安全性。两项研究分别聚焦晚期胃食管癌与晚期胆道癌，从ADC精准靶向和双抗联合免疫两条技术路径，为消化道肿瘤治疗格局带来新的循证证据。《肿瘤瞭望消化时讯》特作整理，以飨读者，共同见证有望影响临床实践的关键研究。CLARITY-Gastric 01研究：Sone-Ve后线治疗显著改善OS，获益覆盖广泛Claudin 18.2阳性人群摘要号：LBA7标题：Ⅲ期CLARITY-Gastric 01（CG-01）研究：Sonesitatug vedotin（Sone-Ve）二线及以上（2L+）治疗Claudin 18.2阳性晚期或转移性胃食管癌讲者：中山大学肿瘤防治中心徐瑞华院士研究背景Claudin 18.2是晚期胃食管癌中已验证的治疗靶点。Sone-Ve是一种靶向Claudin 18.2、基于单甲基澳瑞他汀E（MMAE）的抗体偶联药物，在晚期胃食管癌的Ⅰ/Ⅱ期研究中已显示出临床活性。研究方法CG-01研究是一项随机、开放标签、多中心、全球Ⅲ期研究，旨在评估Sone-Ve用于晚期或转移性胃食管癌患者二线及以上治疗的疗效与安全性。研究纳入既往接受过≥1线治疗、Claudin18.2 IHC任意染色强度且≥25%肿瘤细胞阳性的不可切除、局部晚期/转移性胃食管癌患者。研究初期采用1∶1∶1比例，将患者随机分配至Sone-Ve 1.8 mg/kg组、Sone-Ve 2.2 mg/kg组或研究者选择的治疗方案组（INV组）。完成剂量选择阶段后，后续患者按1:1比例随机分配至Sone-Ve 2.2 mg/kg组或INV组（2L：雷莫西尤单抗+紫杉醇、紫杉醇或多西他赛；3L+：伊立替康、曲氟尿苷替匹嘧啶或阿帕替尼[仅限中国]）。随机分层因素包括地区、既往胃切除术史和治疗线数。双重主要终点为3L+人群的总生存期（OS），以及意向治疗（ITT）人群中经盲态独立中心评审（BICR）评估的无进展生存期（PFS）；关键次要终点为ITT人群的OS。研究结果截至数据截止日(2026年5月31日)，594例患者中共有532例随机分配至Sone-Ve 2.2 mg/kg组（N=267）或INV组（N=265）。中位随访时间为8.6个月。在疗效方面，Sone-Ve 2.2 mg/kg组在3L+人群中显著改善OS（中位OS：10.0个月 vs. 5.0个月，HR=0.47，95%CI：0.36~0.62，P<0.001），在2L+（ITT）人群中亦显著改善OS（中位OS：10.6个月 vs. 6.4个月，HR=0.58，95%CI：0.47~0.73，P<0.001）。ITT人群经BICR评估的PFS未达到统计学显著性阈值。ITT人群的OS获益在Claudin 18.2≥75%（HR=0.59，95%CI：0.45~0.78）和≥25且<75%（HR=0.63，95%CI：0.42~0.94）表达亚组中一致（表1）。安全性方面，Sone-Ve组和INV组任何级别治疗相关不良事件（TRAE）发生率分别为85.8%和81.3%；≥3级TRAE发生率分别为36.4%和44.8%。其中胃肠道不良事件（AE）在Sone-Ve组更常见，而Sone-Ve组血液学毒性明显更少（表1）。表1. CG-01研究疗效与安全性分析结果研究结论CG-01研究显示，与INV相比，Sone-Ve在3L+和ITT人群中均带来显著OS获益，安全性特征可控。这些发现支持Sone-Ve作为广泛晚期CLDN18.2阳性GEC患者人群的潜在2L+治疗选择。HARMONi-GI1研究：依沃西单抗联合化疗一线治疗晚期胆道癌实现OS、PFS与ORR全面获益，安全性可控摘要号：LBA8标题：Ⅲ期HARMONi-GI1研究：依沃西单抗联合化疗 vs. 度伐利尤单抗联合化疗一线治疗晚期胆道癌讲者：复旦大学附属中山医院周俭院士研究背景度伐利尤单抗联合化疗是晚期胆道癌的标准一线治疗。在本项于中国开展的Ⅲ期研究中，评估了依沃西单抗（一种PD-1/VEGF双特异性抗体）联合化疗对比度伐利尤单抗联合化疗作为晚期胆道癌一线治疗的疗效和安全性。此处报告预设期中分析结果。研究方法符合条件的不可切除局部晚期或转移性胆道癌患者按疾病状态（局部晚期 vs. 转移性）和原发肿瘤部位（肝内胆管癌 vs. 肝外胆管癌 vs. 胆囊癌）分层，并按1:1随机接受依沃西单抗或度伐利尤单抗联合吉西他滨和顺铂（每3周一次，共8个周期），随后接受依沃西单抗或度伐利尤单抗维持治疗。主要终点为OS。关键次要终点包括PFS和客观缓解率（ORR）。研究结果共682例患者被随机分配（依沃西单抗组：340例；度伐利尤单抗组：342例）。两组基线特征均衡。中位随访时间为14.3个月。疗效方面，主要终点达到。与度伐利尤单抗联合化疗相比，依沃西单抗联合化疗显著改善中位OS（14.9个月 vs. 12.1个月，HR=0.75，95%CI：0.61~0.92，P=0.0031）。中位PFS分别为8.4个月和5.8个月（HR=0.61，95%CI：0.51~0.72，P<0.0001）。ORR分别为53.8%和32.5%（P<0.0001）。安全性方面，治疗相关不良事件总体耐受良好，安全性特征可控。最常见的治疗中出现的不良事件（TEAEs）为血液学毒性。依沃西单抗未发现新的安全信号。研究结论与度伐利尤单抗联合化疗相比，依沃西单抗联合化疗显著改善晚期胆道癌患者的OS、PFS和ORR，且安全性特征可控。这些结果支持依沃西单抗联合化疗作为晚期胆道癌潜在的新一线标准治疗。小结本届ESMO主席研讨会上，两项中国原研研究分别围绕晚期胃食管癌和晚期胆道癌交出高质量Ⅲ期证据。CG-01研究证实，CLDN18.2靶向ADC Sone-Ve在2L+ CLDN18.2阳性GEC中较研究者选择治疗显著延长OS，尤其在3L+人群中HR低至0.47，且安全性可控；尽管ITT人群PFS未达统计学显著性阈值，但OS获益在总体人群及不同CLDN18.2表达亚组中保持一致，支持其成为该人群潜在2L+治疗新选择。HARMONi-GI1研究则在一线晚期胆道癌中，以PD-1/VEGF双特异性抗体依沃西单抗联合化疗头对头挑战度伐利尤单抗联合化疗标准方案，显著改善OS、PFS和ORR，且安全性可控，有望推动一线治疗格局更新。两项研究从ADC精准靶向和双抗联合免疫两条技术路径，展现了中国学者在消化道肿瘤全球Ⅲ期研究中的引领作用，也为后续生物标志物精细化选择、治疗序贯和联合策略优化提供了重要方向。参考文献[1] Rui-Hua Xu, et al. 2026 ESMO. Abstract:LBA7.[2] Jian Zhou, et al. 2026 ESMO. Abstract:LBA8.声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。（来源：肿瘤瞭望消化时讯）

2026-10-29

·腾讯自选股

信达生物Q3产品收入超47亿元，同比增长超40%！港股通创新药ETF汇添富指数逆市涨超1%！Q3主动权益基金季报分析：减持科技增持医药

今日，港股主要指数集体下挫，港股通创新药逆市飘红。“创新药含量100%”的港股通创新药ETF汇添富（159570）标的指数逆市涨1.23%，连续第二日回升。从指数表现来看，港股通创新药与港股科技近阶段呈现“跷跷板”关系，日内和阶段性表现常出现对冲特征。这或许说明，当科技主线高位分歧或回撤时，资金往往“高切低”流向创新药，形成相对收益优势。更进一步看，这是因为在市场波动或风险偏好下行阶段，创新药相对更具“防御”属性，但需注意其抗跌是相对的、阶段性的，板块自身波动仍然较高。业绩方面，信达生物第三季度产品收入超47亿元，同比增长超40%。10月29日，信达公布2026年第三季度财报，产品收入超47亿元人民币，同比增长超过40%。信达致力于可持续成长与全球创新两大核心战略,布局了肿瘤与综合产品线（心血管及代谢、自身免疫、眼科）的丰厚管线。截至目前，信达已经取得20款产品获批上市，其中包括15款新药、4款生物类似药和1款改良新产品。根据公告，信达表示其当前正处在战略跃升的关键窗口期，全力推进从本土领先生物制药企业迈向国际一流生物制药企业的转型征程。面向2030年，信达锚定核心战略目标：致力于于实现总收入人民币350亿至400亿元、跻身一流药企利润率水平、推动至少五个候选分子进入全球多中心III期开发，并实现产品在主要欧美市场上市。创新药企接连发布业绩利好！10月27日，恒瑞医药公告称，第三季度营业收入为89.53亿元，同比增长20.55%；归属于上市公司股东的净利润为24.58亿元，同比增长88.92%。前三季度实现营业收入244.09亿元，同比增长5.26%；归属于上市公司股东的净利润69.23亿元，同比增长20.38%。业绩变动主要系本报告期对外许可收入增加所致。消息面上，百济神州在2026年ESMO大会公布多项实体瘤管线关键进展：GPC3/4-1BB双抗治疗晚期肝癌I期ORR达36%，安全性优异；PRMT5抑制剂在EGFR野生型肺癌中ORR达38.5%，颅内缓解率30.8%；CEAADC在高表达肺癌患者中ORR高达56%。公司计划于2026年底前启动后线肝癌全球注册临床，PRMT5抑制剂与CEAADC则预计于2027年推向后阶段。港股通创新药ETF汇添富（159570）标的指数热门股多数飘红：翰森制药涨超2%，百济神州、三生制药涨近2%，石药集团涨超1%，信达生物、科伦博泰生物、中国生物制药微涨。注：成分股仅做展示，不作为个股推介。【ESMO大会闭幕，关注创新药国际化进展】2026年欧洲肿瘤内科学会（ESMO）年会于10月23日至27日在西班牙马德里召开1。本次大会共47项中国学者牵头研究入选常规口头报告，29项研究入选突破性摘要（LBA），其中5项进入主席研讨会，均创近年来新高。国产新药集中披露重磅数据，全球研发取得里程碑。本次ESMO大会国产创新药发布多项III期注册性临床数据，科伦博泰sac-TMT、康诺亚/乐普生物CMG901、和黄医药赛沃替尼等在全球III期MRCT中取得积极结果，有望逐步推进全球商业化；中国临床方面，科伦博泰sac-TMT、百利天恒iza-bren、恒瑞医药SHRA2009和SHR-A1811、翰森制药HS-20093、中国生物制药TQB2102等发布III期研究数据，ADC管线集中在后期临床研究中验证价值。多款FIC/BIC设计管线崭露头角，国产新药逐步实现源头创新。维立志博PD-L1/4-1BB双抗在一线和末线EP-NEC中验证免疫长拖尾优势；信达生物EGFR/B7H3ADC国际多中心I期数据展现积极抗肿瘤疗效和优异安全性；复宏汉霖首次发布PD-L1ADC经治胃癌II期PoC研究数据，及PD-1单抗联合化疗1LES-SCLC美国桥接研究积极结果；百济神州首次披露CEAADC重度经治NSCLC数据初步显示活性信号。本次ESMO大会中国研究入选数量和发布数据质量均实现突破，以ADC、IO2.0为代表的国产创新药资产持续获得全球学术认可。中金认为，中国正逐渐确立全球医药早期创新核心策源地位，国内药企在靶点发现、技术迭代与工程化设计方面实现领跑。基于丰富的管线储备和高效的临床效率，中金预计国产创新药数据将继续密集读出、对外授权不断达成，推动全球研发提速。（中金公司20261028《医疗健康热点速评：ESMO大会闭幕关注创新药国际化进展》）【Q3主动权益基金季报分析：三季度减持科技增持医药】申万宏源证券分析后指出，主动权益基金的重仓股在三季度显著减持科技板块。行业上看，电子是三季度重仓股配置比例最高的行业，当前重仓比例34.18%，但也是减持最明显的行业，减持幅度达3.32%（剔除涨跌幅影响后）；医药生物行业则被较多增持，26Q3占比达到11.26%，较上季度主动增持1.80%。申万宏源证券也统计了剔除行业主题基金、港股基金后最新一期各行业配置占比的变化情况对比。剔除行业主题基金后，科技板块的重仓股占比较上季度有大幅下降，而医药、消费、周期板块的提升幅度较大。行业上来看，剔除涨跌幅后电子、电力设备、机械设备下降幅度较为明显，医药生物、有色金属则上升幅度较大。（申万宏源证券20261028《26Q3主动权益基金季报分析：万亿体量科技基金仅净赎回约620亿三季度减持科技增持医药》）港股通创新药ETF汇添富（159570）标的指数100%布局创新药！截至9月30日，前十大成分股权重超75%，浓缩港股通创新药精华！底层资产是港股，可以T+0交易！场外联接（A类：021030；C类：021031）港股医药主线——港股通医疗ETF汇添富(526010)标的指数CXO含量超50%，多元布局CXO、创新药、生物制品等多领域！底层资产是港股，可以T+0交易！风险提示：基金有风险，投资需谨慎。文中个股仅作为指数成份股客观展示，不代表任何投资建议。本文中的任何观点、分析及预测不构成对阅读者任何形式的投资建议。上述基金均属于中高风险等级（R4）产品，适合经客户风险等级测评后结果为进取型（C4）及以上的投资者。请投资者关注指数化投资的风险以及集中投资于国证生物医药指数成分股的持有风险，请关注部分指数成分股权重较大、集中度较高的风险，请关注指数化投资的风险、ETF运作风险、投资特定品种的特有风险等。文中提及个股仅为指数成份股客观展示列举，本文出现信息只作为参考，投资人须对任何自主决定的投资行为负责。本文中的任何观点、分析及预测不构成对阅读者任何形式的投资建议。本基金投资范围包括港股，会面临因投资环境、投资标的、市场制度以及交易规则等差异带来的特有风险。投资者在申购/赎回ETF基金份额时，申购赎回代理券商可按照不超过0.50%的标准收取佣金，其中包含证券交易所、登记机构等收取的相关费用。其他基金的销售费用请参见相应基金的招募说明书、产品资料概要等法律文件。本基金投资范围包括港股，会面临因投资环境、投资标的、市场制度以及交易规则等差异带来的特有风险。国证港股通创新药指数近5个完整年度（2021-2025）表现：-21.59%、-25.60%、-22.80%、-10.50%、+66.52%。恒生科技指数近5个完整年度（2021-2025）表现：-32.70%、-27.19%、-8.83%、+18.70%、+23.45%。

财报临床3期生物类似药

100 项与 Sonesitatug vedotin 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
食管腺癌	临床3期	美国	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	中国	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	日本	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	澳大利亚	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	奥地利	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	比利时	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	巴西	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	加拿大	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	法国	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	德国	AstraZeneca PLC	2026-02-03

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适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06219941 (CLARITY-PT-01, ESMO_GI2026)	临床1期	胃癌三线 CLDN18.2-positive	31	Sonesitatug vedotin (CLDN18.2-positive)	獵鹹製鏇獵繭遞淵窪鹽(膚築鏇鹹廠顧鏇積選憲) = 願觸齋艱廠鬱範選鏇鏇壓襯齋窪鏇壓繭窪艱膚 (範積衊鑰願繭夢衊鬱齋 )	积极	2026-07-02
NCT04805307 (KYM901, Pubmed) 人工标引	临床1期	晚期胃癌 \| 胃食管交界处癌二线 CLDN18.2 Positive	134	CMG901	鹹範構壓網願淵廠齋蓋(繭觸壓膚齋築顧衊鬱窪) = 襯夢選選鹽鏇憲選顧淵築艱築淵鏇遞憲繭齋遞 (鬱壓廠觸觸鑰繭廠顧壓, 21 ~ 39) 更多	积极	2025-01-06
				CMG901 (dose-escalation phase)	範範糧壓鬱壓鏇糧膚淵(憲窪淵蓋築遞蓋鏇齋衊) = 鏇範願繭衊淵衊繭廠衊艱壓顧窪壓觸憲鹽壓網 (選憲壓簾鏇製積衊衊壓 )
NCT04805307 (KYM901, NEWS) 人工标引	临床1期	晚期胃癌	113	CMG901	願壓鬱獵齋壓鹽窪蓋糧(鹹齋製淵願廠鹽襯蓋壓) = 選糧壓獵窪窪鏇簾遞醖餘網簾網淵鹽鏇積餘鹽 (餘醖觸廠繭遞餘憲觸網 ) 更多	积极	2024-06-03
				CMG901 (2.2 mg/kg)	願壓鬱獵齋壓鹽窪蓋糧(鹹齋製淵願廠鹽襯蓋壓) = 憲製蓋醖鏇鹽顧觸鬱遞餘網簾網淵鹽鏇積餘鹽 (餘醖觸廠繭遞餘憲觸網 )
NCT04805307 (ASCO_GI2023) 人工标引	临床1期	CLDN18.2阳性胃食管交界处腺癌 \| CLDN18.2阳性胰腺癌 \| CLDN18.2阳性胃癌 CLDN18.2-positive	27	CMG901	簾願願壓襯淵鹹願窪鹹(壓積醖壓齋簾餘襯獵遞) = 獵鑰窪艱膚壓壓獵積顧蓋製蓋壓觸鏇鹽夢夢艱 (鑰築糧壓鹹遞艱衊鹹襯 )	积极	2023-01-24
				CMG901 (CLDN18.2-positive Gastric/GEJ Cancer)	夢構淵選築鬱壓觸夢構(窪餘廠窪獵顧廠網齋艱) = 製鬱繭窪鑰繭艱蓋蓋獵餘餘鹹鹽廠範積餘獵獵 (鑰窪鏇窪鹹鑰醖遞襯鏇 ) 更多