An Exploratory Study to Evaluate Safety and Efficacy of the Neoantigen Personalized mRNA Vaccine AK154 Monotherapy or in Combination With AK104 or AK112,and the Sequential mFOLFIRINOX Regimen as Adjuvant Therapy in Surgically Resectable Pancreatic Ductal Adenocarcinoma

To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC

开始日期2025-07-22

申办/合作机构

中山康方生物医药有限公司

[+1]

NCT06984718

/ Not yet recruiting临床2期

A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination With Lenvatinib Versus Lenvatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab

This is a Phase II, randomized, open-label, global, multi-center study to compare the efficacy and safety of AK104 in combination with lenvatinib versus lenvatinib in patients with advanced hepatocellular carcinoma who have progressed on the first line treatment of atezolizumab and bevacizumab.

开始日期2025-06-25

申办/合作机构

中山康方生物医药有限公司

NCT07003022

/ Recruiting临床2期IIT

An Open and Exploratory Phase Ⅱ Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H Colorectal Cancer

This study is a prospective, open-label, dual-arm exploratory Phase II clinical trial designed to assess the efficacy and safety of cadonilimab combined with anti-angiogenic agents in patients with dMMR/MSI-H recurrent or metastatic colorectal cancer. Eligible patients are enrolled into two cohorts based on their prior exposure to PD-1/PD-L1 antibody therapy: Cohort A (immune-naive group - patients with no prior PD-1/PD-L1 treatment) and Cohort B (immune rechallenge group - patients who previously received and failed PD-1/PD-L1 therapy). All participants receive combination therapy with cadonilimab and an anti-angiogenic agent, which is selected by the investigator from bevacizumab, regorafenib, or fruquintinib. Treatment continues until the occurrence of intolerable toxicity, disease progression, withdrawal of informed consent, loss to follow-up, death, other conditions deemed by the investigator to warrant discontinuation, or study termination-whichever occurs first. Cadonilimab treatment will not exceed two years. Tumor response is evaluated every six weeks using RECIST v1.1 criteria. Safety is assessed using CTCAE v5.0, and adverse events are recorded from the first dose to 30 days after the end of treatment.

开始日期2025-06-01

申办/合作机构

复旦大学

100 项与卡度尼利单抗相关的临床结果

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100 项与卡度尼利单抗相关的转化医学

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100 项与卡度尼利单抗相关的专利（医药）

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266

项与卡度尼利单抗相关的文献（医药）

2025-12-31·Journal of Pharmaceutical Policy and Practice

Cost-effectiveness analysis of a first-line treatment with cadonilimab plus platinum-based chemotherapy with or without bevacizumab for persistent, recurrent, or metastatic cervical cancer in China: COMPASSION-16 trial

Article

作者: Wang, Jinglin ; Wang, Chunping ; Zhang, Qilin ; Ding, Yiling ; Shu, Yamin

Background:

The addition of cadonilimab to first-line platinum-based chemotherapy with or without bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) in patients with persistent, recurrent, or metastatic cervical cancer. However, the economic value of using this novel therapy for this indication is currently unknown. The aim of this study is to evaluate the cost-effectiveness of the addition of cadonilimab to first-line standard chemotherapy for patients with persistent, recurrent, or metastatic cervical cancer from the perspective of Chinese healthcare system.

Methods:

A partitioned survival model was constructed to compare the cost-effectiveness of cadonilimab versus placebo in patients enrolled in the COMPASSION-16 trial. Cost, life-year, quality-adjusted life-year (QALY), incremental cost-effectiveness ratio (ICER), incremental net health benefit (INHB), and incremental net monetary benefit (INMB) were calculated for 2 treatment strategies. Sensitivity, scenario, and subgroup analyses, and value of information analysis (EVPI) were performed.

Results:

Cadonilimab provided an additional 1.18 QALYs and $89,528.64 compared with placebo, which resulted in an ICER of $75,944.56/QALY. At the willingness-to-pay threshold of $38,042.49/QALY, INHB was estimated to be -1.17 QALYs, while INMB amounted to -$44,681.55 and EVPI was calculated as $71.40/person. Sensitivity analyses revealed that the model was most sensitive to hazard ratio (HR) for OS and PFS, and the probability of cadonilimab being cost-effective was 0.70%. To achieve cost-effectiveness, the price of cadonilimab must be reduced by approximately 50%. Subgroup analysis found that all subgroups unfavored cadonilimab by varying the HR for OS and PFS. Scenario analyses showed using life-year as effectiveness, altering time horizon and selection of survival analysis did not reverse results.

Conclusions:

Although the use of cadonilimab resulted in clinical benefit, it was not deemed cost-effective as a first-line therapy for persistent, recurrent, or metastatic cervical cancer in China. Lowering the price of cadonilimab may enhance its cost-effectiveness.

2025-05-01·BMJ Open

Efficacy and safety of cadonilimab combined with chemotherapy as the first-line treatment for primary advanced or recurrent endometrial cancer: a prospective single-arm open-label phase II clinical trial

Article

作者: Chen, Xiaoxiang ; Liu, Tongyu ; Lin, Yingtao ; Lin, Jie ; Chen, Jian ; Jiang, Yu ; Sun, Yang ; Zou, Jianping ; Li, Yuzhi ; Tu, Chunhua ; Zhuo, Yanhong ; Liu, Bin ; Yang, Linlin ; Chen, Lijun

Introduction:

Recently, immunotherapy has significantly transformed the treatment landscape of endometrial cancer (EC). Results from KEYNOTE-158, RUBY and AtTEnd showed programmed cell death 1 (PD-1) or programmed cell death-ligand 1 inhibitors with promising efficacy in primary advanced or recurrent EC. However, few studies focused on the role of dual immune checkpoints in primary advanced or recurrent EC. Cadonilimab is an immune checkpoint inhibitor targeting the PD-1 and T-lymphocyte antigen-4, which is expected to show substantial clinical efficacy in EC. Combining cadonilimab with standard chemotherapy may have synergistic effects, making this combination a promising first-line treatment for primary advanced or recurrent EC. Furthermore, incorporating molecular classification for guidance on the use of cadonilimab may hold valuable clinical benefits.

Methods and analysis:

In this multicentre, open-label, phase II study, patients with histologically confirmed EC were eligible. Forty-five patients will be recruited. Seventeen patients will be enrolled in stage I, and at least seven cases of complete response (CR) and partial response (PR) should be observed before entering stage II. All patients will receive cadonilimab at a dosage of 10 mg/kg along with carboplatin (area under the curve (AUC)=4–5) plus paclitaxel (175 mg/m2) every 3 weeks (Q3W) for 6–8 cycles. Subsequently, patients with CR, PR or stable disease will receive maintenance of cadonilimab at 10 mg/kg Q3W for 24 months or until progressive disease or adverse events are reported. The objective response rate is the primary endpoint. The secondary endpoints include the disease control rate, duration of response, progression-free survival, overall survival and safety. Additionally, exploratory endpoints involve biomarkers that may predict the efficacy of cadonilimab and chemotherapy, as well as their relationship with molecular classifications. The interim analysis will be conducted after 17 patients have been enrolled.

Ethics and dissemination:

The study protocol meets the approval of the ethical committee of Fujian Cancer Hospital (K2023-173-04) and all other participating hospitals. Study findings will be disseminated in peer-reviewed publications.

Trial registration number:

NCT06066216.

2025-04-18·ANGLE ORTHODONTIST

Effects of chemotherapeutic vs regular toothpastes on dental plaque and gingival inflammation in orthodontic patients with fixed appliances: a systematic review and meta-analysis

Article

作者: Liu, Yinli ; Jonkman, Ronald Edwin Gaston ; Slot, Dagmar Else ; Valkenburg, Cees

ABSTRACT:

Objectives:

To analyze, appraise, and synthesize papers in which authors have compared the effects of chemotherapeutic toothpaste (CTP) and regular toothpaste (RTP) on plaque scores (PSs), gingival scores (GSs), and bleeding scores (BSs) in orthodontic patients wearing fixed appliances (FAs).

Materials and Methods:

PubMed-MEDLINE, Cochrane-CENTRAL, and Embase databases were searched with predefined search terms until April 2024 for controlled or randomized controlled clinical trials aligning with the aim. In the eligible papers, risk of bias was evaluated, data of interest were extracted, and a descriptive analysis was performed. If possible, meta-analyses and subanalyses on specific factors were conducted. The quality of evidence and strength of the recommendation were rated.

Results:

In our search and selection, we obtained five papers describing eight comparisons. Potential risk of bias was assessed as some concerns to high, and heterogeneity was considered substantial. Descriptive analysis revealed no significant difference in PS and BS, with an improvement in GS favoring CTP. Meta-analyses of the end scores showed CTP significantly reduced PS (standardized mean difference [SMD] = −0.26; 95% confidence interval [CI] = −0.52, −0.01; P = .04). However, no significant effects were observed on GS and BS. These findings were supported by the subanalyses on CTP with chlorhexidine (CHX; PS: mean difference [MD] = −5.12; 95% CI = −10.08, −0.15; P = .04). The quality of evidence was graded as very low, and strength of the recommendation was judged as very weak.

Conclusions:

For orthodontic patients with FAs, very weak certainty exists in recommending CTP (eg, with CHX) over RTP for use with toothbrushing. CTP may have a very small effect on PS and a small effect on GS.

808

项与卡度尼利单抗相关的新闻（医药）

17 小时之前

·ioncology

ASCO热评丨郑伏甫教授：创新NMIBC/MIBC/UTUC治疗方案，中国原研ADC改善多种尿路上皮癌患者获益

编者按：近40年来，含铂化疗是晚期患者的标准疗法，但约50%患者因顺铂不耐受或肾功能损伤而无法获益，且传统化疗有效率仅40%左右，5年生存率亟待提升；随着抗体偶联药物（ADC）及免疫治疗的突破性进展，膀胱癌及UTUC患者的获益得到明显改善。在肿瘤领域盛会ASCO年会上，中国原研RC48-ADC治疗尿路上皮癌的多项研究入选，肿瘤瞭望-泌尿时讯特邀中山大学附属第一医院郑伏甫教授进行精彩分享。01维迪西妥单抗（RC48-ADC）联合卡度尼利单抗（AK104，PD-1/CTLA-4双抗）围术期治疗HER2表达的肌层浸润性膀胱癌的II期研究更新结果[1]背景：目前多项正在进行的临床试验表明，抗体偶联药物（ADC）单药治疗及联合免疫检查点抑制剂（ICI）新辅助治疗肌层浸润性膀胱癌（MIBC）具有良好的疗效和安全性。维迪西妥单抗是一种新型人源化抗HER2 ADC。RC48-ADC联合卡度尼利单抗（AK104），可能由于协同机制而增强抗肿瘤作用，并带来更大的临床获益。这项报告了一项II期研究的最新结果，探讨RC48-ADC联合AK104治疗HER2表达的MIBC的围手术期疗效。方法：这项单组、开放标签、多中心研究评估了RC48-ADC联合AK104作为新型新辅助和辅助疗法对初治HER2表达（IHC 1+、2+、3+）MIBC（T2-T4a、N0-1、M0；ECOG PS评分 0-1）患者的疗效和安全性。符合条件的患者接受新辅助治疗：RC48-ADC（2.0 mg/kg，每日1次，每2周一次，4个周期）+AK104（6.0 mg/kg，每日1次，每2周一次，4个周期），随后行根治性膀胱切除术和盆腔淋巴结清扫术（RC+PLND），以及术后辅助治疗：RC48-ADC（2.0 mg/kg，每日1次，每3周一次，6个周期）+AK104（10.0 mg/kg，每日1次，每3周一次，14个周期）。主要终点为病理完全缓解（pCR，pT0N0M0）。次要终点为病理降期率（pDS，yp≤T1N0）、无病生存期（DFS）、总生存期（OS）、客观缓解率（ORR）和安全性。结果：截至2025年1月，已成功入组43例患者。其中男性占81.4%（35/43），女性占18.6%（8/43），中位年龄65岁（范围：44-78岁）。HER2表达阳性（IHC 2+或3+）占72.1%，PD-L1表达阳性（CPS≥10）占34.9%。所有可评估患者的pCR率为64.71%（22/34，95% CI, 47.85-78.58），其中HER2 1+患者pCR率为81.82%（9/11），HER2 2+/3+患者pCR率为56.57%（13/23）；cT2患者pCR率为77.78%（14/18），cT3患者pCR率为30.00%（3/10），cT4a/N1患者pCR率为83.33%（5/6）。总体pDS率为76.47%（26/34）。90.7%（39/43）的患者发生了任意级别治疗相关不良事件（TRAE），其中18.6%（8/43）的患者发生了≥3级TRAE，包括发热、皮疹、骨髓细胞减少、丙氨酸氨基转移酶升高以及免疫介导的心肌炎或肺炎。未发生4级或5级TRAE。中位随访时间为11.3个月，有2例患者死亡，但中位DFS和OS尚未达到，研究期间数据保持稳定，后续将进行更新。结论：RC48-ADC联合AK104的新辅助和辅助治疗显示出良好的疗效和可控的安全性，支持其作为HER2表达MIBC的有效治疗方案。长期获益和进一步分析这种联合疗法在MIBC围手术期中的作用对于推进治疗策略至关重要。大咖点评：ASCO 2025本项研究探索了维迪西妥单抗联合AK104在HER2表达（IHC 1+/2+/3+）MIBC患者围术期治疗的疗效和安全性。研究中所有可评估患者的pCR率高达64.71%（22/34，95% CI，47.85-78.58），≥3级TRAE的发生率仅为18.6%（8/43）。作为一种全新的尿路上皮癌围术期联合治疗模式，维迪西妥单抗联合AK104展现出了卓越的疗效和良好的安全性，证明其治疗HER2表达的MIBC具有极大潜力，期待未来三期的研究结果与长期随访获益的数据，为患者带来全新的选择。02维迪西妥单抗联合特瑞普利单抗作为HER2过表达上尿路尿路上皮癌（UTUC）患者根治术后辅助治疗的疗效和安全性：一项单臂、前瞻性、II期临床试验[2]背景：UTUC罕见且极具侵袭性。即使根治性手术后，其预后仍不佳，尤其对于高危患者。辅助化疗是标准治疗，但疗效有限，需要更有效的方案。RC48与特瑞普利单抗联合治疗在局部晚期或转移性尿路上皮癌中已显示出良好的疗效。这项研究评估了RC48联合特瑞普利单抗作为HER2 IHC 2+/3+ UTUC患者根治性手术后辅助治疗的疗效和安全性。方法：这是一项单组、前瞻性、II期临床试验。入选标准：根治性手术后经组织学确诊HER2 IHC 2+/3+ UTUC，分期为T2-4NanyM0或TanyN1-2M0，且未接受过新辅助治疗的患者。干预措施为静脉注射RC48（2 mg/kg）联合特瑞普利单抗（3 mg/kg），每三周一次，共6个周期，之后每三周一次特瑞普利单抗（3 mg/kg），疗程最长1年。主要终点为DFS，次要终点为OS、安全性和MRD分析。结果：共入选45例患者（35例男性，中位年龄68岁）。患者分期如下：II期43例（95.6%），III期1例（2.2%），IV期1例（2.2%）。所有患者均为HER2过表达（IHC 2+中80%，IHC 3+中20%）。25名患者（55.6%）不符合顺铂治疗条件。截至2025年1月14日，中位随访时间为12.2个月。发生4例复发：2例发生在淋巴结，1例发生在前列腺，1例发生在淋巴结和膀胱。1年DFS率为90.0%，尚未达到中位DFS。所有患者均经历了治疗相关不良事件（TRAE）。最常见的TRAE是感觉减退（51.1%）、血糖升高（48.9%）、贫血（46.7%）、肌酐升高（46.7%）和高甘油三酯血症（46.7%）。20%的患者发生≥3级TRAE。8.9%的患者出现免疫相关不良事件，包括皮疹和甲状腺功能减退症。其中，16例（35.6%）患者完成治疗，19例（42.2%）仍在接受干预，4例（8.9%）因TRAE停止治疗：1例感觉减退，1例淋巴细胞减少和感觉减退，1例恶心、呕吐和食欲下降，1例瘙痒和腹泻，2例因个人原因在完成4个周期的联合方案后退出治疗。随访期间无患者死亡。结论：这是首个评估新型辅助治疗方案对HER2-IHC 2+/3+ UTUC患者疗效和安全性的前瞻性临床试验。它显示出良好的DFS结果和可控的安全性，凸显了其作为HER2-IHC 2+/3+ UTUC患者的新辅助疗法的潜力。大咖点评：ASCO 2025含铂化疗在UTUC术后辅助治疗中占据重要地位，但患者术后肾功能丢失限制了辅助化疗的应用；Checkmate274研究研究显示，NIVO辅助免疫治疗可以改善高危MIUC的DFS，但目前尚不清楚是否能改善UTUC患者的DFS，亟需寻找新的辅助治疗方案。本项研究探索了维迪西妥单抗联合免疫辅助治疗HER2过表达（IHC 2+/3+）UTUC患者的疗效和安全性，研究入组45例患者，其中25例顺铂不耐受。1年DFS率为90.0%，≥3级TRAE发生率20%。这一联合方案显示出令人鼓舞的DFS结果和可控的安全性，凸显了其作为HER2过表达UTUC患者术后辅助治疗的潜力，有望改变UTUC术后辅助治疗的格局。03PUNCH03：维迪西妥单抗联合替雷利珠单抗和BCG治疗HER2过表达的高危非肌层浸润性膀胱癌(HR NMIBC)的II期研究[3]背景：RC48是一种靶向HER2蛋白的新型抗体偶联药物。KEYNOTE-057研究已证实PD-1抑制剂可为高危非肌层浸润性膀胱癌（HR NMIBC）患者带来获益。本研究旨在评估RC48联合替雷利珠单抗和卡介苗（BCG）作为HER2阳性HR NMIBC患者保留膀胱治疗的疗效和安全性。方法：这项开放标签II期研究纳入了未接受BCG治疗且伴有多发乳头状肿瘤（高级别Ta或T1肿瘤）的HR NMIBC患者，所有患者均为HER2阳性（IHC 2+或3+）。首先，应通过经尿道膀胱肿瘤切除术（TURBT）切除所有可见的乳头状肿瘤病灶。其次，患者每2周给予RC48（2.0 mg/kg，ivgtt），共1个周期，并每3周给予替雷利珠单抗（200 mg，ivgtt），共1个周期。然后，患者接受第二次TURBT，患者接受3个周期的RC48（2.0 mg/kg，Q2W，ivgtt）和替雷利珠单抗（200mg，Q3W，ivgtt）。最后，患者接受18次BCG滴注加上至少1年的替雷利珠单抗（200 mg，Q3W，ivgtt）。具体而言，患者开始BCG诱导疗程，每周滴注6次，随后维持疗程，每2周滴注3次，每4周滴注9次。主要终点是12个月无复发生存率（RFS）。次要终点是膀胱保留率、OS和安全性。本研究估计12个月的RFS率不低于 85%，研究将纳入38名患者。大咖点评：ASCO 2025高危/极高危NMIBC具有易复发、高进展的风险，国内外指南推荐根治性膀胱切除手术作为标准治疗，但全膀胱术后会极大降低患者的生活质量。PUNCH03研究探索了维迪西妥单抗联合替雷利珠单抗和BCG膀胱灌注在HER2过表达（IHC 2+/3+）的HR-NMIBC患者保膀胱治疗中的疗效和安全性。研究创新性地提出了HER2靶向治疗联合BCG膀胱灌注和免疫的保膀胱策略，以期改善高危NMIBC患者的传统治疗困境。我们期待这项研究的结果，使得患者在肿瘤控制与器官保留、生活质量之间获得真正的平衡，满足患者的治疗需求，实现临床获益。▌参考文献1. Updated results from a phase II study of perioperative disitamab vedotin (RC48-ADC) plus cadonilimab (AK104) for HER2-expressing muscle-invasive bladder cancer (MIBC). ASCO 2025. 45882. Efficacy and safety of disitamab vedotin (RC48) combined with toripalimab as adjuvant therapy after radical surgery for patients with HER2-overexpression upper tract urothelial cancer (UTUC): A single-arm, prospective, phase 2 clinical trial. ASCO 2025. 45903. PUNCH03: A phase II study of disitamab vedotin combined with tislelizumab and bacillus Calmette-Guerin (BCG) in Her2-positive high-risk non-muscle-invasive bladder cancer (HR NMIBC). ASCO 2025. TPS4624郑伏甫教授主任医师，博士生导师，博士后合作导师中山大学附属第一医院泌尿外科哈佛大学麻省总医院访问学者美国泌尿外科学会（AUA）国际会员中国医疗保健国际交流促进会泌尿生殖分会委员中国科技产业化促进会精准医学专委会常务委员广东省医学会泌尿外科分会前列腺学组副组长广东省医师协会泌尿外科分会委员广东省抗癌协会泌尿生殖肿瘤专委会委员广东省中西医结合学会泌尿外科分会常务委员广东省泌尿生殖协会肿瘤分会常委委员广东省癌症中心肾癌诊疗质控专委会常务委员泌尿外科杂志（电子版）常务编委JU,WJU,中华实验外科杂志等审稿专家（来源：《肿瘤瞭望-泌尿时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。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。

临床结果ASCO会议抗体药物偶联物

2025-06-05

·PRNewswire

Akeso's PD-1/CTLA-4 Bispecific Antibody Cadonilimab Approved for First-Line Treatment of Cervical Cancer in All-Comer Populations--Third Approved Indication for Cadonilimab

HONG KONG, June 4, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has approved the company's first- in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer, in combination with platinum-based chemotherapy, with or without bevacizumab. The NMPA approval marks the third approved indication for cadonilimab. With the approval for first-line cervical cancer, cadonilimab has achieved comprehensive coverage for the treatment of advanced cervical cancer, offering an innovative treatment option for patients across all stages of advanced cervical cancer. This approval addresses the critical unmet need for immune-based therapies for first-line cervical cancer patients in China and represents a significant step forward in the treatment of this disease. In addition to the treatment for first-line cervical cancer, cadonilimab is also approved for first-line treatment of advanced gastric cancer, and for the treatment of relapsed or metastatic cervical cancer who progressed on or after platinum-based chemotherapy. The approval for cadonilimab's use in combination with chemotherapy (with or without bevacizumab) in first-line cervical cancer is based on the clinical data from the Phase III COMPASSION-16 (AK104-303) study. In COMPASSION-16, the cadonilimab combination regimen showed a notable efficacy benefit in patients with tumors that have a negative PD-L1 expression (CPS <1), comprising 27.9% of the population in the treatment group, compared to 24.2% in the control group. The study met both progression-free survival (PFS) and overall survival (OS) endpoints, demonstrating significant improvements in both endpoints for patients treated with the cadonilimab regimen compared to standard therapies in the first-line setting for cervical cancer. Subgroup analyses from COMPASSION-16 study indicated that both PD-L1-positive and PD-L1-negative populations, regardless of bevacizumab inclusion, benefited from the treatment. The results of the COMPASSION-16 trial were presented as a Late-Breaking Abstract (LBA) at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting, and were subsequently published in The Lancet and later reported again in Nature Reviews Clinical Oncology. Cervical cancer remains one of the most prevalent and deadly cancers among women, with a 5-year survival rate of approximately 17.0% for patients in the advanced stages. In 2022, China reported 150,700 new cervical cancer cases, resulting in the second-largest burden of cervical cancer worldwide. Professor Wu Xiaohua, the principal investigator of COMPASSION-16 and a professor at the Fudan University Shanghai Cancer Center, stated, "COMPASSION-16 is the first Phase III study focused on first-line cervical cancer patients in China, with internationally recognized data. We've seen cadonilimab's breakthrough efficacy in both recurrent and metastatic cervical cancer, showing high effectiveness, low toxicity, and strong anti-tumor activity regardless of PD-L1 expression. This first-line combination therapy sets a new standard in cancer treatment and is expected to accelerate the clinical adoption of cadonilimab, benefiting more patients." Dr. Xia Yu, founder, chairwoman, president, and CEO of Akeso, commented, "Cadonilimab has demonstrated significant survival benefit for cervical cancer patients across all-comer populations in both clinical trials and real-world settings. For patients who respond to PD-1/L1 monotherapy, cadonilimab offers superior therapeutic outcomes over PD-1/PD-L1 therapies. For patients with low PD-L1 expression or those who are resistant to PD-1 monotherapy, cadonilimab provides significant clinical benefits over current treatment options. Cadonilimab takes advantage of the synergistic anti-tumor effect of two immune checkpoint targets, PD-1 and CTLA-4, while producing a meaningfully lower immune side effects than the combination of PD-1 and CTLA-4 antibody therapies. This approval represents another advancement of immunotherapy 2.0 in cervical cancer therapy, offering clinically meaningful improvements in disease treatment and in patient quality of life. This achievement reflects Akeso's robust innovation capabilities and commitment to cancer patient outcomes, and it also aligns with our corporate vision to become a global leader in developing next-generation therapeutic antibodies for patients worldwide. " Currently, cadonilimab is included in 16 authoritative clinical treatment guidelines and consensus documents across multiple oncology indications, including gastric cancer, gynecological cancers, liver cancer, esophageal cancer, and nasopharyngeal cancer. Beyond the three approved indications, cadonilimab is also currently in over 30 Phase II and III clinical trials for other cancer types, which includes different stages of disease progression as well as different cancer sub-types. These include clinical studies on gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. ( 9926.HK, "Akeso") contains "forward-looking statements" . These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准临床结果免疫疗法临床2期

2025-06-05

·药闻康策

医药代表被调查！康方生物回应了

☝ 点击上方一键预约 ☝ 最新最热的医药健康新闻政策单支价值高达 1.3 万余元的抗癌药，一场疑云重重的用药纠纷。近日，康方生物公司一起“临床研究用药”流入市场事件引发广泛关注，大三甲医院医生推荐，医药代表介绍院外用药，出现不良反应后，这起事件才浮出水面。康方生物向媒体解释原因是，重庆一销售人员涉嫌伪造材料，从公司骗取药物并无偿给予患者李某美使用。据媒体报道，重庆市药监局已对涉事医药代表展开调查。据最初报道事件的媒体河南广电集团《大象新闻》，重庆市巫山县肿瘤患者李某美向大象新闻反映，她通过医生推荐，从医药代表处以79320元购买“卡度尼利单抗注射液”，共用了约70支，除6支正规上市药品，5支标有“慈善基金会捐赠”字样的赠品药之外，其余均为“仅供临床研究使用”的药品。和她相同遭遇的还有患者唐某莲。6月2日，大象新闻以《流入市场的“临床试验”抗癌药》报道此事。6月4日，康方生物发布声明。据中新网今晚报道，康方生物提供的《关于重庆某宫颈癌患者使用公司药物相关新闻报道的声明》，确认患者使用了他们公司的临床研究药物，2024年6月至2025年1月期间，李某美从公司一位销售人员处先后 9 次获得并使用标有 ‘仅供临床研究使用的药物’，系“销售人员伪造研究立项文件及医院伦理批件等材料，从公司骗取若干药物，并无偿给予患者李某美使用”。康方生物称，经自查，对于患者李某美使用的临床研究药物，公司从未向患者李某美收取任何费用。同时表示，患者李某美所获得的药物，系按照国家GMP标准生产的药物。声明中提到，“经公司内部自查，并向相关DTP药房以及患者李某美本人核实：2024年4-5月间，患者李某美通过院外DTP药房共购买了6支卡度尼利单抗注射液，价格为13220元人民币/支，共计79320元人民币，并获得了DTP药房开具的发票。2024年6月至2025年1月期间，李某美从公司一位销售人员处先后9次获得并使用标有‘仅供临床研究使用’的药物。经调查核实：对于患者李某美使用的临床研究药物，公司从未向李某美收取任何费用，公司经办销售人员亦未收取患者李某美的任何费用。即，不存在患者‘花钱购买了临床研究用药’的情况。”本应被严格管控的临床试验药物，为何却通过灰色渠道流入市场？据河南广电集团《大象新闻》描述，宫颈癌患者李某美表示，2023年8月，住院期间，重庆某肿瘤医院主任医师李某向其推荐名叫“卡度尼利”的药。主任医师李某称认识医药代表，可以帮其联系在院外使用。2024年4月，又一期放化疗结束后，李某美决心尝试主任医师李某推荐的卡度尼利。从康方生物的声明内容来看，康方生物及其经办销售人员均未收取这部分药物的任何费用。大象新闻跟进的报道里表示，针对声明，李某美告诉大象新闻记者，买药的时候，是提前与医药代表冉某元沟通好，然后在冉某元指定的“刘作芬诊所”内完成交易，并不是通报里说的DTP药房，“冉某元派来的人给我出示一张印着二维码的卡片，我扫码打钱，发票都是医药代表通过手机发给我的。”李某美说，当时医药代表向她推销“卡度尼利”时，称可享受买一赠一、买二赠二、买三增三的优惠。如果一次购买满6支，就可以交足6支的钱之后，享受剩余药物一年内免费的优惠。李某美补充说，“后面我给康方生物打电话的时候，客服人员也说了买的药和送的药是一样的，不是‘仅供临床研究使用’的药，这些我有电话录音。”大象新闻记者此前的采访中，按照李某美使用的药剂包装所标注的临床试验研究申办方的名称，先后随李某美夫妇走访了重庆市中医院和重庆市医科大附属二院，两家医院均表示从未参与“卡度尼利”的临床研究。没有参与临床研究的医院，名称为什么会出现在患者使用的药品包装上？康方生物解释称，经公司内部自查并初步核实，系公司重庆销售人员通过伪造研究立项文件及医院伦理批件等材料，以研究者发起的药品上市后临床研究的名义，从公司骗取了若干药物。如前所述，该司声明里也提到，对于这部分药物，公司及经办销售人员均未向患者收取任何费用。报道中的另一患者唐某莲说，她和李某美加起来用了一百多支“临床研究药”，“我知道的还有其他患者，这么大的量，如果按通报里所说，他们是怎么弄出来的？”总之，事情还是疑点重重。中新网今晚的报道分享了北京市京都律师事务所律师林斐然的看法，根据《药品管理法》，药企需对药品的全生命周期起到管理责任，该事件中，临床试验药明确标注 “仅供临床研究使用”却流入市场，违反了临床试验用药不得流入市场的规定。且患者在不知情的情况下使用了临床试验药，未参与试验登记，也未获得任何补偿，更未签署知情同意书，严重侵犯了患者的知情权和合法权益。康方生物表示，公司将尽快与相互患者进一步沟通，并配合相关监督管理部门就此事件开展必要调查。据媒体报道，6月3日上午，重庆市药品监督管理局已对康方生物医药代表冉某元展开调查，并向康方生物所在地的药品监督管理机构发了协查函。(来源：医药代表）药闻康策新媒体矩阵微信公众号点击下方一键关注【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看

临床1期临床申请申请上市

100 项与卡度尼利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12190	-	-	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期胃癌	中国	康方药业有限公司	2024-09-26
晚期胃食管交界处腺癌	中国	康方药业有限公司	2024-09-26
转移性宫颈癌	中国	康方药业有限公司	2022-06-28
复发性宫颈癌	中国	康方药业有限公司	2022-06-28

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胃食管交界处腺癌	申请上市	中国	中山康方生物医药有限公司	2024-01-05
非小细胞肺癌 III期	临床3期	中国	中山康方生物医药有限公司	2024-11-12
转移性非小细胞肺癌	临床3期	中国	中山康方生物医药有限公司	2023-11-14
鳞状非小细胞肺癌	临床3期	中国	中山康方生物医药有限公司	2023-11-14
鼻咽癌	临床3期	中国	康方药业有限公司	2023-08-01
肝细胞癌	临床3期	中国	中山康方生物医药有限公司	2022-12-14
局部晚期宫颈癌	临床3期	中国	中山康方生物医药有限公司	2022-06-08
局部晚期胃食管交界处腺癌	临床3期	中国	中山康方生物医药有限公司	2021-09-17
局部晚期不可切除的胃腺癌	临床3期	中国	中山康方生物医药有限公司	2021-09-17
子宫颈转移癌	临床3期	中国	中山康方生物医药有限公司	2021-08-27

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临床结果

适应症

分期

评价

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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


ESMO_ELCC2025	N/A	进行性非小细胞肺癌	70	Cadonilimab alone	衊顧窪壓壓構網鑰窪襯(艱觸獵壓範製衊願鬱鏇) = 觸窪鹹網範築築窪廠觸顧築簾網顧糧獵夢壓簾 (廠選廠範襯積醖網鬱簾 ) 更多	积极	2025-03-26
NCT05235516 (AK104-305 \| COMPASSION-18, Company_Website) 人工标引	临床3期	局部晚期宫颈癌	-	AK104 + CCRT	繭壓築廠夢夢壓艱壓鬱(艱築夢選願壓鏇觸築顧) = 淵壓範夢憲憲鏇襯齋餘選衊製鹽觸糧憲窪鏇艱 (網憲鏇夢夢憲鏇鏇艱遞 ) 更多	积极	2025-03-21
				AK104 + CCRT (PD-L1 CPS≥1)	鑰鹽衊顧築遞構鬱鬱憲(膚遞構醖窪鹽遞獵鏇願) = 構夢繭遞襯鬱鹽鏇鏇鬱蓋艱窪鹽廠築觸窪餘鏇 (鹹齋艱製網鏇鏇衊廠願 )
NCT05792735 (NeoCaCRT, ASCO_GI2025) 人工标引	临床2期	局部晚期直肠癌新辅助 Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	27	SCRT + Cadonilimab + mFOLFOX6	鑰衊憲簾築製餘壓夢鹹(積繭夢醖鹹積獵築餘繭) = 製製衊衊鏇襯窪繭憲構網膚鏇壓繭餘齋鬱遞糧 (構壓觸艱鏇廠範選鑰壓, 19.4 ~ 57.6) 更多	积极	2025-01-23
NCT05522894 (AK104-IIT-014, ASCO_GI2025) 人工标引	临床2期	晚期食管鳞状细胞癌维持 \| 一线	43	Cadonilimab + Paclitaxel + Cisplatin	獵獵顧構積繭積艱獵鑰(獵壓鏇夢觸製獵遞淵鏇) = 齋範繭蓋壓醖觸鑰鑰膚憲選餘獵鹽鑰艱範願構 (簾簾獵鏇簾網衊齋繭構, 66.1 ~ 91.1) 更多	积极	2025-01-23
				Cadonilimab + Paclitaxel + Cisplatin (PD-L1 CPS≥10)	獵獵顧構積繭積艱獵鑰(獵壓鏇夢觸製獵遞淵鏇) = 鬱鬱膚鑰膚遞願窪鹽築憲選餘獵鹽鑰艱範願構 (簾簾獵鏇簾網衊齋繭構, 77.1 ~ 100.0) 更多
NCT05008783 (Pubmed) 人工标引	临床3期	HER2阴性胃癌 \| HER2阴性胃食管结合部腺癌一线 HER2 Negative	610	Cadonilimab + Chemotherapy	憲餘餘餘夢膚鬱製餘齋(餘簾鏇糧夢鑰觸齋製範) = 構衊顧壓衊製網製範蓋餘醖膚夢鹹鏇齋膚襯鹽 (鹽廠顧觸觸網淵簾壓醖 ) 达到更多	积极	2025-01-22
				Placebo + Chemotherapy	憲餘餘餘夢膚鬱製餘齋(餘簾鏇糧夢鑰觸齋製範) = 衊鏇廠鹹餘衊齋鹽糧鹹餘醖膚夢鹹鏇齋膚襯鹽 (鹽廠顧觸觸網淵簾壓醖 ) 达到更多
ESMO_IO2024 人工标引	N/A	转移性非小细胞肺癌二线 \| 末线 \| 三线	21	Cadonilimab (AK104) + Single-agent Chemotherapy	鏇構鬱壓醖襯觸艱簾積(獵構遞襯鹹夢構積憲積) = 鑰膚網願夢構願選鏇醖網廠顧鏇窪鹹範餘鹹遞 (鹹網膚獵構願窪鬱鬱鏇 ) 更多	积极	2024-12-12
NCT05430906 (AK104-IIT-003, ESMO_IO2024) 人工标引	临床2期	卵巢癌新辅助	28	Cadonilimab + Platinum-Taxane Chemotherapy	獵夢齋範築選鑰壓襯遞(醖醖選鹹衊網餘觸製廠) = 網鏇網蓋範廠鹹獵鏇窪繭鏇遞觸齋製膚製鑰鹹 (鏇構廠範範網壓願願窪 ) 更多	积极	2024-12-12
NCT05815290 (ESMO_IO2024) 人工标引	临床2期	错配修复缺陷或微卫星高度不稳定性结直肠癌新辅助 MSI-High \| Deficient DNA Mismatch Repair (dMMR)	34	Cadonilimab (AK104) 10mg/kg	蓋蓋壓憲顧艱鹹衊獵簾(齋襯顧鑰鏇餘顧襯製膚) = 繭廠鬱鏇醖衊窪鹹製醖憲醖壓壓膚選鹹繭壓鬱 (蓋糧艱窪鏇夢製獵醖鑰 ) 更多	积极	2024-12-12
ESMO_IO2024 \| NEWS 人工标引	N/A	转移性胃食管结合部腺癌 \| 转移性胃腺癌一线	31	Cadonilimab plus chemotherapy (SOX, XELOX or FOLFOX)	衊糧構壓壓觸獵顧憲繭(鏇廠鏇憲壓範遞憲願窪) = 願淵鑰鹽繭繭積夢鏇網衊憲淵繭築鑰廠範選艱 (糧齋蓋鹽鑰齋觸鑰蓋齋 ) 更多	积极	2024-12-12
				Cadonilimab plus chemotherapy (SOX, XELOX or FOLFOX) (PD-L1 CPS＜1)	衊糧構壓壓觸獵顧憲繭(鏇廠鏇憲壓範遞憲願窪) = 艱繭積顧遞鏇製淵廠遞衊憲淵繭築鑰廠範選艱 (糧齋蓋鹽鑰齋觸鑰蓋齋 ) 更多
ESMO_IO2024 人工标引	临床2期	晚期胃癌 \| 晚期胃食管交界处腺癌一线	19	Cadonilimab+SOX (HER2-negative)	衊憲積蓋膚廠鬱廠廠鹽(糧餘鏇積襯鹽膚網願蓋) = 憲願膚製製鏇襯網獵壓願糧蓋顧醖範衊構築壓 (夢廠積醖憲積醖襯窪觸 ) 更多	积极	2024-12-12
				Cadonilimab+Trastuzumab+SOX (HER2-positive)	衊憲積蓋膚廠鬱廠廠鹽(糧餘鏇積襯鹽膚網願蓋) = 獵糧廠蓋積網淵淵遞壓願糧蓋顧醖範衊構築壓 (夢廠積醖憲積醖襯窪觸 ) 更多