HONG KONG, Feb. 28, 2024 /PRNewswire/ -- Akeso (9926.HK) announced that the results of a phase II clinical trial for PD-1/CTLA-4 bispecific antibody（cadonilimab）combined with standard treatment (chemotherapy +/- bevacizumab) as first-line treatment for recurrent/metastatic cervical cancer had been published in the official journal of the American Association for Cancer Research (AACR), Clinical Cancer Research, with an impact factor of 11.5..

香港，2024年2月28日/PRNewswire/--Akeso（9926.HK）宣布，PD-1/CTLA-4双特异性抗体（cadonilimab）联合标准治疗（化疗+/-贝伐单抗）作为复发/转移性宫颈癌的一线治疗的II期临床试验结果已在美国癌症研究协会（AACR）的官方杂志上发表，临床癌症研究，影响因子为11.5。。

The article comprehensively elaborates on the excellent therapeutic effects of cadonilimab as first-line treatment for the whole population of cervical cancer, demonstrating the good safety profile of this treatment regimen. The publication of this article further enriches the evidence-based medicine evidence for the clinical application of cadonilimab..

本文全面阐述了卡多尼单抗作为宫颈癌一线治疗的优秀疗效，证明了该治疗方案的良好安全性。本文的发表进一步丰富了卡多尼单抗临床应用的循证医学证据。。

The study data published in Clinical Cancer Research this time continues to demonstrate the pronounced advantages presented in the data published at the 2022 American Society of Clinical Oncology (ASCO) annual meeting, and with further extension of follow-up time, the efficacy advantage of cadonilimab combined with standard treatment for first-line treatment of recurrent/metastatic cervical cancer becomes more evident.

这次发表在《临床癌症研究》上的研究数据继续证明了2022年美国临床肿瘤学会（ASCO）年会上发表的数据所显示的明显优势，并进一步延长了随访时间，卡多尼单抗联合标准治疗一线治疗复发/转移性宫颈癌的疗效优势变得更加明显。

Once again, it shows the clinical potential of cadonilimab for the entire population of recurrent/metastatic cervical cancer regardless of PD-L1 expression status, with the main research data superior to the data disclosed in current standard of care with immunotherapy-based combination therapy (non-head-to-head)..

它再次显示了卡多尼单抗对整个复发/转移性宫颈癌人群的临床潜力，无论PD-L1表达状态如何，主要研究数据均优于当前基于免疫疗法的联合治疗标准中披露的数据（非头对头）。。

Compared to the data disclosed at ASCO in 2022, the overall objective response rate (ORR) remains at a high level, with the disease control rate (DCR) increasing to 100%, and the complete response (CR) rate further increasing.

与2022年ASCO披露的数据相比，总体客观缓解率（ORR）保持在较高水平，疾病控制率（DCR）增加到100%，完全缓解率（CR）进一步增加。

63.6% of patients experienced tumor reduction of more than 50%. The ORR of the 10mg/kg Q3W dose group (cadonilimab 10mg/kg Q3W + chemotherapy +/- bevacizumab) reached 79.3%, and when combined with bevacizumab, the ORR was as high as 92.3%. The population with PD-L1 CPS <1 accounted for 41.4%, and the ORR of this population was 75.0%, indicating that cadonilimab combined with standard treatment could provide clinical benefit for PD-L1-negative patients..

63.6%的患者肿瘤减少超过50%。10mg/kg Q3W剂量组（卡多尼单抗10mg/kg Q3W+化疗+/-贝伐单抗）的ORR达到79.3%，当与贝伐单抗联合使用时，ORR高达92.3%。PD-L1 CPS<1的人群占41.4%，该人群的ORR为75.0%，表明卡多尼单抗联合标准治疗可为PD-L1阴性患者提供临床益处。。

Cadonilimab combined standard treatment brings excellent long-term survival benefits.

卡多尼单抗联合标准治疗带来了优异的长期生存益处。

The median follow-up time for the cadonilimab 15mg/kg Q3W + chemotherapy group was 20.24 months, the median progression-free survival (mPFS) was 11.10 months, the median overall survival (mOS) was not reached, and the 12-month OS rate was 93.3%. The median follow-up time for the cadonilimab 10mg/kg Q3W + chemotherapy group was 18.3 months, the mPFS was 7.06 months, the mOS was not reached, and the 12-month OS rate was 87.5%.

卡多尼单抗15mg/kg Q3W+化疗组的中位随访时间为20.24个月，中位无进展生存期（mPFS）为11.10个月，中位总生存期（mOS）未达到，12个月OS率为93.3%。卡多尼单抗10mg/kg Q3W+化疗组的中位随访时间为18.3个月，mPFS为7.06个月，未达到mOS，12个月OS率为87.5%。

The median follow-up time for the Cadonilimab 10mg/kg Q3W + chemotherapy + bevacizumab group was 15.01 months, and neither mPFS nor mOS was reached..

卡多尼单抗10mg/kg Q3W+化疗+贝伐单抗组的中位随访时间为15.01个月，未达到mPFS或mOS。。

The safety of cadonilimab combined with standard treatment is manageable, and no new safety signals have been observed.

卡多尼单抗联合标准治疗的安全性是可控的，并且没有观察到新的安全信号。

Reports indicate that in 2020, there were approximately 604,000 new cases of cervical cancer globally, with over 110,000 cases in China. It is estimated that by 2040, the number of deaths from cervical cancer in China will reach 75,000 cases, representing a 26.3% increase compared to 2020. The 5-year survival rate for advanced cervical cancer is only about 17.0%.

报告显示，2020年，全球约有604000例新发宫颈癌病例，中国超过110000例。据估计，到2040年，中国宫颈癌死亡人数将达到75000例，比2020年增加26.3%。晚期宫颈癌的5年生存率仅为17.0%。

In first-line treatment for advanced cervical cancer, chemotherapy+/-bevacizumab is the standard treatment regimen domestically, with limited efficacy and no approved immune combination therapy..

在晚期宫颈癌的一线治疗中，化疗+/-贝伐单抗是国内的标准治疗方案，疗效有限，没有批准的免疫联合治疗。。

Cadonilimab was approved by the China National Medical Products Administration (NMPA) in June 2022 for second-line treatment of recurrent/metastatic cervical cancer. Since its launch, Cadonilimab's outstanding clinical value and good safety profile have been strongly validated in numerous clinical studies and real-world clinical applications.

2022年6月，中国国家医药产品管理局（NMPA）批准卡多尼单抗用于复发/转移性宫颈癌的二线治疗。自推出以来，卡多尼单抗的突出临床价值和良好的安全性已在许多临床研究和现实世界的临床应用中得到了强有力的验证。

It has demonstrated prominent benefits for the entire population of patients with advanced cervical cancer, improving survival rates and quality of life, thus addressing the current important clinical need..

它已经证明对所有晚期宫颈癌患者都有显着的益处，提高了生存率和生活质量，从而满足了当前重要的临床需求。。

In November 2023, an interim analysis of a randomized, double-blind, placebo-controlled phase III study of cadonilimab as first-line treatment for cervical cancer showed that the primary endpoint of progression-free survival (PFS) had been met. Soon, the population of patients with advanced cervical cancer in China will have access to immune combination therapy.

2023年11月，对卡多尼单抗作为宫颈癌一线治疗的随机，双盲，安慰剂对照III期研究的中期分析显示，无进展生存期（PFS）的主要终点已经达到。不久，中国的晚期宫颈癌患者将获得免疫联合治疗。

Additionally, a randomized, double-blind, placebo-controlled Phase III study of cadonilimab combined with chemotherapy as first-line treatment for gastric cancer also met the primary endpoint of overall survival (OS) in the interim analysis, and a new drug application had been accepted by CDE. With positive results from registration trials of cadonilimab in first-line treatments of multiple tumor types, the population benefiting from cadonilimab will rapidly expand, better realizing the clinical value of this cadonilimab for tumor treatment and benefiting more patients..

此外，卡多尼单抗联合化疗作为胃癌一线治疗的随机，双盲，安慰剂对照III期研究在中期分析中也达到了总生存期（OS）的主要终点，并且新药申请已被CDE接受。随着卡多尼单抗在多种肿瘤类型一线治疗中的注册试验取得积极结果，受益于卡多尼单抗的人群将迅速扩大，更好地实现这种卡多尼单抗在肿瘤治疗中的临床价值，并使更多患者受益。。

About Cadonilimab

关于Cadonilimab

Cadonilimab is a first-in-class bispecific antibody targeting both PD-1 and CTLA-4 which is  developed by Akeso. In Jun 2022, the China National Medical Products Administration (NMPA) approved cadonilimab for recurrent or metastatic cervical cancer. Cadonilimab has been included and recommended in multiple clinical practice guidelines such as CSCO.

Cadonilimab是Akeso开发的针对PD-1和CTLA-4的一流双特异性抗体。2022年6月，中国国家医药产品管理局（NMPA）批准卡多尼单抗治疗复发或转移性宫颈癌。卡多尼单抗已被纳入并推荐用于多种临床实践指南，如CSCO。

Cadonilimab has been engaged in more than 60 ongoing clinical trials including investigator-initiated studies..

Cadonilimab已经参与了60多项正在进行的临床试验，包括研究者发起的研究。。

Currently, a phase III study of cadonilimab for first-line treatment of gastric cancer has met its endpoint of OS. A phase III study of cadonilimab has also met one of its primary endpoints of PFS for first-line treatment of recurrent/metastatic cervical cancer (R/M CC).

目前，卡多尼单抗用于胃癌一线治疗的III期研究已经达到了OS的终点。卡多尼单抗的III期研究也达到了PFS一线治疗复发/转移性宫颈癌（R/M CC）的主要终点之一。

About Akeso, Inc.

关于Akeso，Inc。

Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to discovering, developing, manufacturing, and commercializing innovative medicines that address significant medical needs globally. Since our inception , we have established a distinctive and integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the fundamental components, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode..

阿克索（香港交易所代码：09926）是一家商业阶段的生物制药公司，致力于发现、开发、制造和商业化创新药物，以满足全球重大医疗需求。自成立以来，我们建立了以全面的端到端药物开发平台（ACE平台）和双特异性抗体药物开发技术（四体）为基本组成部分的独特而集成的研发创新体系，符合GMP的生产系统和具有先进运营模式的商业化系统。。

Akeso is actively developing a diverse pipeline of over 30 innovative assets in areas such as cancer, autoimmune disease, inflammation, metabolic disease, and other therapeutic fields. Among these, 19 assets have entered the clinical stage, with 3 innovative drugs already approved, NDAs for 4 drugs and 6 indications accepted, and 13 ongoing Phase III studies.

阿克索正在癌症、自身免疫性疾病、炎症、代谢性疾病和其他治疗领域积极开发由30多个创新资产组成的多元化渠道。其中，19项资产已进入临床阶段，已批准3种创新药物，接受4种药物和6种适应症的NDA，以及13项正在进行的III期研究。

Utilizing its proprietary Tetrabody technology, Akeso has successfully developed the first-in-class PD-1/CTLA-4 bispecific antibody drug to the market. Additionally, the company has five other innovative bispecific antibody drugs in the clinical stage, including ivonescimab (PD-1/VEGF), PD-1/LAG-3, TIGIT/TGF-Beta, PD-1/CD73, and claudin18.2/CD47 bispecific antibodies..

Akeso利用其专有的四体技术，成功开发了市场上第一种PD-1/CTLA-4双特异性抗体药物。此外，该公司在临床阶段还有其他五种创新的双特异性抗体药物，包括ivonescimab（PD-1/VEGF），PD-1/LAG-3，TIGIT/TGF-β，PD-1/CD73和claudin18.2/CD47双特异性抗体。。

In June 2022, cadonilimab was approved by the NMPA and became the first commercialized bispecific IO drug globally. Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted marketing approval in China in August 2021. In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics to accelerate global development and commercialization of ivonescimab.

2022年6月，卡多尼单抗获得NMPA批准，成为全球首个商业化的双特异性IO药物。另一种阿克索内部发现并开发的肿瘤学产品penpulimab（一种PD-1抗体）于2021年8月在中国获得上市批准。2022年12月，Akeso与Summit Therapeutics签订了高达50亿美元的合作和许可协议，以加速ivonescimab的全球开发和商业化。

In August, the NDA submission of ivonescimab was accepted by China's NMPA and granted Priority Review. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited..

8月，ivonescimab的NDA提交被中国NMPA接受并获得优先审查。阿克索在香港联合交易所主板上市。。

Contact Akeso Public Relations:PR@akesobio.com

联系Akeso公共关系：PR@akesobio.com

Contact Akeso Business Development :bd@akesobio.com

联系Akeso Business Development：bd@akesobio.com

SOURCE Akeso, Inc.

SOURCE Akeso公司。