恒星集团(中国)

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适应症

胃癌

宫颈癌

肝癌
其他肿瘤

·卡度尼利联合化疗1L治疗晚期胃癌或胃食管结合部腺癌(G/GEJC)(已获批上市)                                                                      ·卡度尼利治疗G/GEJC的Ib/II期研究显示:

全人群长期获益显著

无论PD-L1表达

17.41
个月

mOS

9.20
个月

mPFS

61.4%

12个月OS率

68.2%

ORR

92%

DCR

PD-L1高表达人群疗效优异

CPS≥5

20.24
个月

mOS

未达到

mPFS

PD-L1低表达人群疗效同样显著

CPS<5

17.28
个月

mOS

7.23
个月

mPFS

PD-L1表达阴性人群疗效突出

CPS<1

17.64
个月

mOS

8.18
个月

mPFS

数据来源: ASCO 2023,abs#4031

胃癌是全球最常见的恶性肿瘤之一,全球癌症死亡的第3大原因,每年约有77万患者死于胃癌,晚期或转移性胃癌的5年生存率约为5%-20%

·卡度尼利2/3L治疗R/M 宫颈癌(已获批上市)

全人群获益

  1. 无论PD-L1表达

  2. 33.0%

    ORR

  3. 3.75
    个月

    mPFS

  4. 17.51
    个月

    mOS

  1. CPS≥1人群

  2. 43.8%

    ORR

  3. 6.34
    个月

    mPFS

  4. 未达到

    mOS

·卡度尼利1L 治疗R/M宫颈癌

全人群获益

  1. 无论PD-L1表达

  2. 79.3%

    ORR

  1. CPS≥1人群

  2. 82.4%

    ORR

  1. CPS<1人群

  2. 75.0%

    ORR

·卡度尼利联合含铂化疗+/-贝伐珠单抗用于一线治疗持续R/M宫颈癌的sNDA已取得CDE受理

宫颈癌是最常见的妇科恶性肿瘤之一,中国发病人数高居全球第二,2020年新发病例逾十一万。在卡度尼利上市之前,国内无标准治疗方案,化疗是临床常用治疗方案,疗效有限,毒性明显。

·高复发风险肝细胞癌根治术后辅助治疗的Ⅲ期临床研究正在进行中

· 联合仑伐替尼一线治疗不可切除肝癌的Ⅱ期临床研究:

  1. 44.4%

    ORR

  1. 77.8%

    DCR

· 卡度尼利联合仑伐替尼和经动脉化疗栓塞(TACE)用于治疗不可切除、非转移性肝细胞癌的Ib/Ⅱ期临床研究正在进行中

肝癌是全球死亡率第三位的恶性肿瘤,2020年中国肝癌发生数为41万例,死亡人数为39万例,中国肝癌患者约占全球50%,肝细胞癌(HCC)是最主要的病理类型。

·卡度尼利也已在肾细胞癌、非小细胞肺癌及各类实体瘤召开了各项研究

学术发表

《Nature Medicine》2025

First-line cadonilimab plus chemotherapy in HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma: a randomized, double-blind, phase 3 trial

《Nature Reviews Clinical Oncology》2024

Cadonilimab is effective and safe in recurrent cervical cancer

ESMO 2024

Neoadjuvant and Adjuvant AK104 in patients with recurrent, resectable squamous cell carcinoma of the head and neck: A phase II study

ESMO 2024

A phase II study of cadonilimab plus chemotherapy in persistent recurrent/ metastatic cervical cancer patients who failed previous immuno/chemotherapy

ESMO 2024

Real-world efficacy and safety of cadonilimab in recurrent or metastatic cervical cancer: A multicenter retrospective analysis in China

ESMO 2024

Cadonilimab with neoadjuvant chemotherapy in advanced ovarian cancer patients (AK104-IIT-003): An open, prospective, single arm, phase II trial

ESMO 2024

Combination of cadonilimab (anti-PD-1 and CTLA-4 bispecific antibody) with chemotherapy in anti-PD-1-resistant recurrent or metastatic nasopharyngeal carcinoma: An open-label, single-arm, phase II clinical trial

ESMO 2024

Cadonilimab in combined with gemcitabine and cisplatin in advanced biliary tract cancer (BicureX): A phase II, single-arm clinical trial

ESMO 2024

Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastroesophageal junction cancer: A prospective, single-arm, phase II clinical trial

ESMO 2024

Neoadjuvant SOX combined with cadonilimab (AK104) for PD-L1 negative upper GC/GEJC patients

ESMO 2024

Efficacy and safety of cadonilimab combined albumin-paclitaxel, cisplatin and fluorouracil (APF) in neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC): Results from the CAPITAL trial

《Nature Medicine》2024

Cadonilimab with chemotherapy in HER2-negative gastric or gastroesophageal junction adenocarcinoma: the phase 1b/2 COMPASSION-04 trial

ASCO 2024

Efficacy and safety of cadonilimab in combination with pulocimab and paclitaxel as second-line therapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) cancer who failed immunochemotherapy: A multicenter, double-blind, randomized trial.

ASCO 2024

Neoadjuvant cadonilimab (PD-1/CTLA-4 bispecific antibody) plus FLOT chemotherapy in locally advanced gastric/gastroesophageal junction cancer (GC/GEJC): A prospective, multi-center, phase II study

ASCO 2024

Efficacy, safety and DNA methylation analysis of cadonilimab combined with taxane and cisplatin as the first-line treatment in patients with advanced esophageal squamous cell carcinoma (ESCC): An open-label, multicenter phase II trial– Updated results from AK104-IIT-014

ASCO 2024

Neoadjuvant Immune-Checkpoint Blockade Therapy Combining with TACE For Resectable Hepatocellular Carcinoma with High Recurrence Risk: A Phase II, Single-arm Clinical Trial (MORNING)

ASCO 2024

Two stage, multi-center trial of cadonilimab and LM-302 for patients with CLDN18.2+ biliary tract cancer (BTC) that failed chemotherapy and PD-(L)1 antibody (ZSAB-Calm)

ASCO 2024

Cadonilimab in combined with gemcitabine and cisplatin in advanced biliary tract cancer (BicureX): A Phase II, Single-arm Clinical Trial

ASCO 2024

A phase II study of cadonilimab plus mFOLFIRINOX as induction therapy for locally advanced pancreatic adenocarcinoma (LAPC)

ASCO 2024

Efficacy and safety of cadonilimab plus anti-EGFR monoclonal antibody as de-chemotherapy regimen in persistent, recurrent, or metastatic gynecologic cancer

ASCO 2024

Cadonilimab plus lenvatinib in patients with advanced endometrial cancer: A multicenter, single-arm, phase II trial

ASCO 2024

Cadonilimab safety and efficacy in recurrent or metastatic cervical cancer: First real-world experience from a Chinese multicenter study

2024 ASCO

Clinical efficacy and safety of cadonilimab immunotherapy in patients with advanced cervical cancer: A retrospective study

2024 ASCO

Safety and clinical activity of cadonilimab, an anti PD-1/CTLA-4 bispecific antibody, for patients with persistent, recurrent, or metastatic cervical cancer (R/M CC): A retrospective, real-world study

2024 ASCO

An open, prospective, single arm, phase II study of cadonilimab (PD-1/CTLA-4 bispecific antibody) with neoadjuvant chemotherapy in patients with advanced ovarian cancer: Interim analysis from the AK104-IIT-003 study

2024 ASCO

An open-label, single-center phase II trial of cadonilimab (an anti-PD-1/CTLA-4 bispecific antibody) in combination with platinum-based dual-drug neoadjuvant chemotherapy for locally advanced, resectable head and neck squamous cell carcinoma

2024 ASCO

Disitamab vedotin (DV, RC48-ADC) combined with cadonilimab (anti-PD-1/CTLA-4 bispecific antibody) in patients with locally advanced or metastatic urothelial carcinoma (la/mUC): An open-label, single-arm, phase II study

2024 ASCO

Preliminary results from a phase II study to evaluate the efficacy and safety of perioperative disitamab vedotin (RC48-ADC) plus cadonilimab (AK104, PD-1/CTLA-4 bispecific antibody) for HER2-expressing muscle-invasive bladder cancer (MIBC)

2023 《THE LANCET Oncology》

Safety and antitumour activity of cadonilimab, an anti-PD-1/CTLA-4 bispecific antibody, for patients with advanced solid tumours (COMPASSION-03): a multicentre, open-label, phase 1b/2 trial

2022 《Drugs》

Cadonilimab: First Approval

指南推荐

晚期胃癌

《基于PD-L1蛋白表达水平的胃癌免疫治疗专家共识(2023年版)》推荐,

用于PD-L1 CPS<5或阴性人群(强推荐)、PD-L1 CPS≥5人群以及免疫治疗进展后的患者

晚期胃癌

《2024 CSCO免疫检查点抑制剂指南》Ⅲ级推荐(1A类),

以及《2024 CSCO胃癌诊疗指南》注释新增,

开坦尼®联合XELOX用于晚期胃癌(HER2阴性)的一线治疗(无论PD-L1表达状态)

二线及以上晚期鼻咽癌

《2024 CSCO鼻咽癌诊疗指南》Ⅲ级推荐(2B类),

开坦尼®用于既往未接受过PD-1/PD-L1抑制剂治疗的晚期鼻咽癌三线及以上治疗

 

治疗后进展的食管癌

《2024 CSCO食管癌诊疗指南》注释新增,

开坦尼®用于既往治疗后进展的食管鳞癌患者的二线及以上治疗

复发或转移性宫颈癌

《中国临床肿瘤学会(CSCO)宫颈癌诊疗指南(2023)》推荐,

开坦尼®作为复发或转移性宫颈癌二线免疫治疗首位推荐方案

复发或转移性宫颈癌

《妇科肿瘤免疫检查点抑制剂临床应用指南(2023版)》双重推荐,

开坦尼®联合化疗用于持续性、复发性或转移性宫颈癌患者的一线治疗(3类),

和单药用于既往治疗失败的复发或转移性宫颈癌患者的治疗(2A类)

复发或转移性宫颈癌

卫健委《新型抗肿瘤药物临床应用指导原则(2022版)》推荐,

开坦尼®作为治疗复发或转移性宫颈癌的唯一免疫治疗推荐

肝细胞癌

《肝细胞癌免疫联合治疗多学科中国专家共识(2023版)》

中晚期肝细胞癌

《靶向免疫联合局部治疗中晚期肝细胞癌中国专家共识》推荐,

作为中晚期肝癌一线的治疗

复发或转移性宫颈癌

《美国国家综合癌症网络(NCCN)临床实践指南2023.V1:中国版》推荐,

卡度尼利用于复发或转移性宫颈癌全人群二线或后续治疗的首选方案

 

食管鳞癌

《中国食管癌放射治疗指南(2023版)》Ⅲ级推荐(3类),

用于二线及以上食管鳞癌、一线治疗不可切除局晚期、复发或转移性的食管鳞癌

复发或转移性宫颈癌

《中国临床肿瘤学会(CSCO)宫颈癌诊疗指南(2022)》推荐,

开坦尼®作为复发或转移性宫颈癌二线免疫治疗的首位推荐方案