Phase II Study Evaluating Ivonescimab in Combination With Chemotherapy for First- and Second-line Treatment of Advanced or Metastatic Gastric and Gastroesophageal Adenocarcinoma Patients

The goal of this clinical trial is to evaluate the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma. The main question it aims to answer is : Does the addition of ivonescimab increase the response to treatment ? Participants will visit the clinic every 2 weeks for checkups, treatment administration and tests for collection of adverse events.

开始日期2025-09-01

申办/合作机构

UNICANCER

[+1]

NCT06809517

/ Recruiting临床1/2期IIT

A Phase I/II Clinical Study of an Intrathecal Combination of PD-1/VEGF Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis.

Leptomeningeal metastasis, characterized by tumor cells infiltrating and proliferating in the subarachnoid space, represents a distinct pattern of central nervous system involvement and is a fatal complication of malignant tumors. This study is a prospective, single-arm phase I/II clinical trial aimed at evaluating the safety and efficacy of intrathecal PD-1/VEGF bispecific antibodies combined with pemetrexed in treating leptomeningeal metastases from solid tumors, with the goal of identifying more effective treatment options.

开始日期2025-09-01

申办/合作机构

广州医科大学

100 项与依沃西单抗相关的临床结果

登录后查看更多信息

100 项与依沃西单抗相关的转化医学

登录后查看更多信息

100 项与依沃西单抗相关的专利（医药）

登录后查看更多信息

项与依沃西单抗相关的文献（医药）

2025-12-31·mAbs

Antibodies to watch in 2025

Review

作者: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

2025-03-01·LANCET

Ivonescimab in advanced NSCLC: is progression-free survival enough, or are overall survival data also needed?

Article

作者: Sankar, Kamya ; Reckamp, Karen L

2025-03-01·LANCET

Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China

Article

作者: Wang, Zhongmin Maxwell ; Shan, Jinlu ; Li, Xingya ; Cheng, Ying ; Yao, Jun ; Chen, Junqiang ; Wang, Jing ; Mei, Xiaodong ; Han, Zhengxiang ; Li, Gaofeng ; Xia, Michelle ; Chu, Qian ; Nie, Ligong ; Zhao, Yanqiu ; Wang, Jinliang ; Zhou, Ming ; Chen, Bolin ; Yu, Xinmin ; Xiong, Anwen ; Sun, Daqiang ; Wang, Lei ; Bu, Qing ; Shi, Qin ; Shang, Yanhong ; Yang, Jie ; Li, Jie ; Zhou, Chengzhi ; Hao, Jiqing ; Ge, Hui ; Huang, Dingzhi ; Li, Baiyong ; Ai, Xiaohong ; Liu, Xuewen ; Wu, Lin ; Lu, Dongmei ; Lin, Yu ; Chen, Jianhua ; Zhou, Caicun ; Zhong, Hua ; Sun, Yulan ; Ji, Yinghua ; Liu, Baogang ; Yang, Hongzhong ; Yao, Jifang ; Hu, Mingxiu

BACKGROUND:

Ivonescimab is a bispecific antibody against programmed cell death protein 1 and vascular endothelial growth factor, yielding promising clinical outcomes for patients with advanced non-small cell lung cancer in early-phase studies. We compared the efficacy and safety of ivonescimab with pembrolizumab in patients with programmed cell death ligand-1 (PD-L1)-positive advanced non-small cell lung cancer.

METHODS:

HARMONi-2 is a randomised, double-blind, phase 3 trial across 55 hospitals in China. Eligible patients were aged 18 years or older and had locally advanced or metastatic PD-L1-positive non-small cell lung cancer without sensitising epidermal growth factor receptor mutations or anaplastic lymphoma kinase translocations and an Eastern Cooperative Oncology Group performance-status of 0 or 1. Patients were randomly assigned (1:1) to receive 20 mg/kg ivonescimab or 200 mg pembrolizumab intravenously every 3 weeks. Randomisation was stratified by histology, clinical stage, and PD-L1 expression. The primary endpoint was progression-free survival (PFS) assessed by a masked independent radiographic review committee per RECIST v1.1 in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT05499390; recruitment is complete, with the trial ongoing and final analysis to be reported later.

FINDINGS:

Between Nov 9, 2022, and Aug 26, 2023, 398 (45%) of 879 screened patients were randomly assigned to receive ivonescimab (n=198) or pembrolizumab (n=200). At the preplanned interim analysis, median PFS was significantly longer with ivonescimab than with pembrolizumab (11·1 vs 5·8 months; stratified hazard ratio [HR] 0·51 [95% CI 0·38-0·69]; one-sided p<0·0001). The PFS benefit of ivonescimab over pembrolizumab was broadly consistent within prespecified subgroups, including patients with PD-L1 tumour proportion score (TPS) 1-49% (HR 0·54 [95% CI 0·37-0·78]) and PD-L1 TPS of 50% of higher (HR 0·48 [0·29-0·79]). Grade 3 or higher treatment-related adverse events occurred in 58 (29%) patients with ivonescimab and 31 (16%) patients with pembrolizumab. Immune-related adverse events of grade 3 or higher were observed in 14 (7%) of 197 patients on ivonescimab and 16 (8%) of 199 patients on pembrolizumab. Ivonescimab demonstrated a manageable safety profile in patients with both squamous and non-squamous non-small cell lung cancer. In patients with squamous cell carcinoma, grade 3 or higher treatment-related adverse events were comparable between the two groups.

INTERPRETATION:

Ivonescimab significantly improved PFS compared with pembrolizumab in previously untreated patients with advanced PD-L1 positive non-small cell lung cancer. Therefore, ivonescimab might represent another treatment option in the first-line setting for PD-L1-positive advanced non-small cell lung cancer.

FUNDING:

Akeso Biopharma.

993

项与依沃西单抗相关的新闻（医药）

11 小时之前

·美中药源

依沃西一线肺癌中国上市

【新闻事件】：今天康方生物PD-1/VEGF双特异性抗体依沃西（Ivonescimab）在中国获得NMPA批准，用于一线治疗PD-L1表达阳性的局部晚期或转移性非小细胞肺癌（NSCLC）。这一批准是基于其与帕博利珠单抗（Pembrolizumab，“K药”）进行的AK112-303/HARMONi-2 III期头对头临床研究的积极结果。尽管试验在无进展生存期（PFS）方面取得了显著优势，总生存期（OS）的期中分析结果尚未达到统计学显著性，这导致了康方生物的海外合作方Summit Therapeutics ($SMMT) 股票出现大幅下跌，引发了市场对于依沃西长期临床价值以及PD-1xVEGF双抗领域的广泛讨论。【药源解析】：HARMONi-2研究是一项III期RCT试验，比较依沃西单药与K药在一线治疗PD-L1阳性NSCLC患者中的疗效和安全性。研究结PFS优势显著，在ITT人群中，依沃西组的中位PFS为11.14个月，而K药为5.82个月。依沃西将疾病进展或死亡风险降低了49%，风险比（HR）为0.51，伴随高度统计显著（P<0.0001）。今天公布的中期分析显示OS有改善趋势，在39%数据成熟度依沃西组相较于K药降低了22.3%的死亡风险（HR=0.777），但并未达到本次期中分析预设严格的统计学显著水平（α=0.0001）。这导致Summit Therapeutics的股价大幅跳水40%，反映了资本市场对于抗肿瘤药物改善OS这一“金标准”的高度关注。依沃西头对头击败K药的PFS数据、加上前几天在sqNSCLC的积极数据，另外此前有罗氏Tecentriq+贝伐单抗的ABCP方案已经获批， PD-1xVEGF双抗在某些场景可以带来优于PD-1单抗疗效应该不是什么意外。至于OS目前没有达到统计显著区分可能受多种因素影响，肺癌是一个恶性程度很高的肿瘤，任何疗法改进OS都十分困难。依沃西作为FIC想逆水行舟在这一重要适应症上头对头击败浴血奋战成为标准疗法的药王K药谈何容易。肿瘤药物PFS与OS收益并非总是强关联、尤其在肺癌，Prasad等人既往的统计分析表明肺癌药物的PFS与OS相关性相对较弱。一是后线治疗会影响最后生存，二是PFS本身只是个代替终点、测量的是影像学上肿瘤停止进展的时间。依沃西显著延长了这一时间，意味着患者可以在更长时间内维持疾病稳定，减少肿瘤相关的症状、提高生活质量。但这段时间内的患者仍然是晚期肿瘤患者，疾病并未被根治甚至并未暂时治愈。转移性肿瘤导致患者死亡的机制是多方面的，并非简单地肿瘤越小死亡几率越低。现在我们也并不是十分清楚肿瘤到底怎么杀死了患者、哪些病灶更致命。肿瘤的部位、侵犯重要器官、引起并发症（如恶病质、感染、出血等）以及患者整体身体状况都决定着预后。因此即使药物能有效控制肿瘤生长（反映在PFS上），也可能无法完全阻止肿瘤对患者生理机能的损害和引发致命并发症、从而影响OS的改善程度。PD-1xVEGF双抗作为一个新兴的治疗类别还处于探索阶段，能否实现OS改善还有待观察。连PFS改进都无法预测OS改善，PD-1抗体+VEGF抗体组合临床表现如何、双抗是否在理论上或临床前组合效果更好、哪种分子形式更优等因素就更难以预测依沃西能否改善OS，肿瘤FIC药物基本都是在临床试验中筛出来的。PFS显著改善本身也是重要进展，如果能在美国人群（HARMONi-3）重现可能因此在美国上市。当然我们希望随着OS数据的成熟依沃西能够显示OS提升，令患者真正受益。

临床3期临床结果上市批准上市后研究引进/卖出

16 小时之前

·PRNewswire

Ivonescimab Receives NMPA Approval for First-Line Treatment of PD-L1-Positive NSCLC, Based on Breakthrough Head to Head Phase III Trial Demonstrating Superior Efficacy Over Pembrolizumab

HONG KONG, April 25, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that its globally first-in-class PD-1/VEGF bispecific antibody, ivonescimab, has received approval from the National Medical Products Administration (NMPA) for its supplementary New Drug Application (sNDA) for use as a monotherapy for the first-line treatment of PD-L1-positive (TPS ≥ 1%) non-small cell lung cancer (NSCLC) in patients who are negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK) gene mutations. This indication marks Ivonescimab's second major approval. The sNDA approval is based on the breakthrough results of the AK112-303/HARMONi-2 Phase III study, which is a randomized, double-blind, controlled study that directly compared ivonescimab with pembrolizumab in first line PD-L1 positive NSCLC. Ivonescimab demonstrated a statistically significant improvement in the trial's primary end point, median progression-free survival (PFS) when compared to pembrolizumab, with a median PFS of 11.14 months, achieving a hazard ratio (HR) of 0.51 reducing the risk of disease progression or death by 49%. An interim analysis of OS conducted at 39% data maturity (α=0.0001), indicated a clinically meaningful improvement in OS with ivonescimab compared to pembrolizumab, with a hazard ratio (HR) of 0.777, reflecting a 22.3% reduction in the risk of death. Ivonescimab is the first therapy to achieve statistically significant positive results in a Phase III trial compared with pembrolizumab in a head-to-head setting. Ivonescimab represents a new, more effective, and safer "chemotherapy-free" option for the first-line treatment of NSCLC. Ivonescimab is the first bispecific antibody approved globally with a dual "cancer immunotherapy + anti-angiogenesis" mechanism. It has already shown significant positive results in three Phase III trials for lung cancer, including 1) treatment for EGFR-TKI-resistant NSCLC, 2) comparison with pembrolizumab in PD-L1-positive NSCLC, and 3) treatment in combination with chemotherapy versus tislelizumab in combination with chemotherapy in squamous NSCLC. Professor Zhou Caicun, principal investigator of the HARMONi-2 trial, director of the Department of Oncology at the Shanghai East Hospital, Tongji University, commented: "The Phase III HARMONi-2 study demonstrated that ivonescimab offers significant improvements in progression-free survival (PFS) and overall survival (OS) compared to pembrolizumab. This breakthrough provides a safer and more effective first-line treatment option for NSCLC, particularly beneficial for patients who need better efficacy or quality of life, or those who are not suitable for chemotherapy due to its side effects. Ivonescimab has also gained widespread recognition in treating EGFR-TKI-resistant NSCLC. The recent Phase III trial combining ivonescimab with chemotherapy, compared to tislelizumab for squamous NSCLC, showed promising positive results. Ivonescimab is now positioned as a new standard of care for both first- and second-line treatment in lung cancer. We are optimistic about its continued success in global Phase III trials and its potential to redefine cancer treatment standards worldwide." Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso, commented: "We are thrilled to announce the approval of ivonescimab as a first-line treatment for PD-L1-positive NSCLC, a major breakthrough in cancer immunotherapy. This milestone is a result of the dedication of investigators, participants, and patients, and we sincerely thank all of them. We also appreciate the regulatory authorities for their efficient and diligent review, which enables us to offer this new treatment to patients in China. Ivonescimab has shown superior efficacy over pembrolizumab in the HARMONi-2 Phase III trial, becoming the first therapy to achieve this globally. Positive results so far from three pivotal Phase III lung cancer trials further establish ivonescimab as a next-gen IO treatment with strong global potential. The clinical data highlights ivonescimab's exceptional efficacy and safety benefits for patients across various cancer types. Beyond lung, ivonescimab has demonstrated promising potential as first-line treatment for other key cancers, including breast, head and neck, biliary tract, and colorectal cancer, supported by, over 12 ongoing Phase III trials. Akeso, along with our partner Summit, are committed to advancing ivonescimab as a cornerstone of global cancer immunotherapy, aiming to provide safer, more effective treatment options for patients worldwide." About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique 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 core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 4 new drugs with 4 new indications are under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. 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期免疫疗法上市批准临床结果抗体药物偶联物

17 小时之前

·康方生物Akeso

依沃西一线治疗NSCLC获批上市，基于全球首个对比帕博利珠单抗获显著阳性结果的III期研究|全球肿瘤免疫迭代性突破

2025年4月25日，康方生物（9926.HK）欣喜地宣布，公司独立自主研发的全球首创PD-1/VEGF双特异性抗体新药依达方®（通用名：依沃西单抗注射液）单药用于PD-L1阳性（TPS≥1%）的表皮生长因子受体(EGFR)基因突变阴性和间变性淋巴瘤激酶(ALK)阴性的局部晚期或转移性非小细胞肺癌(NSCLC)的一线治疗的新药上市申请（sNDA），已获得中国国家药品监督管理局（NMPA）批准上市。一线治疗PD-L1阳性NSCLC是依沃西获批上市的第二个适应症，这让中国患者“率先用上全球最优治疗方案”成为现实。依沃西一线治疗PD-L1阳性NSCLC新适应症的获批上市，是基于依沃西“头对头”帕博利珠单抗的随机、双盲、对照III期临床研究（AK112-303/HARMONi-2）中获得的显著阳性结果：在ITT人群中，依沃西组和帕博利珠组的中位无进展生存期（PFS）分别为11.14个月和5.82个月，PFS HR=0.51（P＜0.0001），依沃西治疗组的疾病进展/死亡风险降低49%；在ITT人群中，在39%成熟度时进行的总生存期（OS）的期中分析（本次分析α分配值仅为0.0001）结果显示，依沃西对比帕博利珠单抗具有显著的临床生存获益，HR=0.777，降低死亡风险22.3%；依沃西是全球首个在头对头“药王”帕博利珠单抗的III期临床研究中获得显著阳性结果的药物；依沃西为一线NSCLC治疗提供了全新、更高效、安全的“去化疗”方案。依沃西是全球首个获批上市的“肿瘤免疫+抗血管生成”机制的双特异性抗体新药。截至目前，依沃西已经在肺癌领域的3项III期研究中获得了显著阳性结果，包括依沃西治疗EGFR-TKI进展的NSCLC，依沃西对比帕博利珠单抗一线治疗PD-L1阳性NSCLC，以及日前刚公布的依沃西联合化疗对比替雷利珠单抗联合化疗一线治疗sq-NSCLC，其中后2项为依沃西疗法对比当前最优SOC（PD-1疗法）的III期研究。HARMONi-2主要研究者上海市东方医院肿瘤科主任周彩存教授表示：我们非常荣幸地同见证了全球首创PD-1/VEGF双特异性抗体新药依沃西一线治疗PD-L1阳性NSCLC适应症的获批上市。依沃西对比帕博利珠单抗的随机、双盲、对照III期HARMONi-2研究，不仅在PFS获得了绝对性的疗效优势，并且获得了显著的临床生存获益，这让我们倍感振奋！这不仅是中国创新药研发史上的重要里程碑，也是全球肿瘤免疫治疗领域的重大突破。HARMONi-2研究以无可辩驳的临床数据，强有力地证实了依沃西单药相较于帕博利珠单抗单药治疗，能够显著延长PD-L1表达阳性NSCLC患者的总生存期和无进展生存期，患者死亡风险和疾病进展风险显著下降，充分展现了"PD-1/VEGF双抗"协同机制的突破性临床价值。依沃西一线治疗NSCLC适应症的获批，为患者提供了全新、更安全、更有效的治疗选择，同时避免了传统化疗的副作用，特别是为那些对疗效和生存质量有更高需求，或者不适合化疗的肺癌患者带来了更优的治疗方案，这正是我们临床医生所期待看到的。值得关注的是，依沃西治疗EGFR-TKI治疗进展nsq-NSCLC上市近一年来已得到临床医生和患者的广泛认可。而近期，继依沃西单药，依沃西联合化疗对比替雷利珠单抗联合化疗一线治疗sq-NSCLC的III期研究也获得了显著阳性结果。这意味着依沃西实现了肺癌一线、二线治疗的覆盖，成为新的标准治疗方案。我们也期待依沃西后续在全球注册III期临床的优异表现，以“中国方案”重塑全球肿瘤治疗标准。康方生物创始人、董事长、总裁兼首席执行官夏瑜博士表示：今天，我们怀着无比激动的心情，迎来了依沃西单抗一线治疗PD-L1阳性NSCLC适应症的获批。这是依沃西推动肿瘤免疫治疗领域迭代发展的里程碑式的突破。感谢所有推动该临床研究的研究者、参与者和积极参与临床试验的患者，也感谢监管部门的严谨高效。在大家的共同努力下，中国率先患者迎来了全新、安全、高效的治疗药物。依沃西连续在3个III期临床研究中都获得了显著阳性结果（其中2项为与PD-1单抗疗法头对头的III期研究），以硬核的临床数据证实了其作为下一代抗肿瘤药物在全球范围内的突破性临床价值和市场竞争力。与此同时，充分的循证医学证据也证明了依沃西在多种重大瘤种中具有卓越的抗肿瘤疗效潜力。目前，依沃西已经在多个肿瘤免疫核心适应症的一线治疗实现了前瞻性布局，开展了近30项临床研究，包括III期临床和II期临床研究，覆盖近20个适应症，为依沃西在全球范围内的临床价值和商业价值兑现创造了领先优势。未来，我们将持续高质量推动依沃西作为肿瘤免疫治疗基石药物的全球价值挖掘，重塑临床治疗格局，为全球更多患者提供更高效、更安全的疾病解决方案。关于依达方®（PD-1/VEGF双抗，依沃西）依达方®（依沃西单抗注射液）是康方生物自主研发的、全球首创PD-1/VEGF双特异性肿瘤免疫治疗药物。依达方®于2024年5月获得中国国家药品监督管理局批准上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，成为全球首个获批上市的“肿瘤免疫+抗血管生成“协同抗肿瘤机制的双特异性抗体新药；同年11月，依达方®及该适应症被纳入2024年国家医保目录。目前，依达方®单药对比帕博利珠单抗单药一线治疗PD-L1表达阳性的晚期NSCLC的III期研究在期中分析中达到了无进展生存期的主要研究终点，获得决定性胜出阳性结果。基于此项研究，依达方®单药一线治疗PD-L1表达阳性的晚期NSCLC已提交sNDA，并获优先审评。依达方®联合化疗对比替雷利珠单抗联合化疗一线治疗鳞状NSCLC的III期临床研究达到无进展生存期（PFS）的主要研究终点，研究结果具有统计学显著获益和重大临床获益。同时，由合作伙伴Summit主导开展的依达方®联合化疗联合化疗用于经第三代EGFR-TKI治疗进展的EGFR突变、局晚期或转移性nsq-NSCLC的国际多中心III期临床研究（HARMONi研究）、依达方®联合化疗对比帕博利珠单抗联合化疗一线治疗鳞状和非鳞状NSCLC的国际多中心III期研究（HARMONi-3研究）和依达方®单药对比帕博利珠单抗一线治疗PD-L1高表达晚期NSCLC的国际多中心临床III期研究（HARMONi-7研究）正在进行中。此外，依沃西新启动4项III期临床研究，包括依沃西联合AK117（CD47）联合方案一线治疗PD-L1阳性头颈鳞癌（vs帕博利珠单抗），依沃西联合方案一线治疗胆道癌（vs度伐利尤单抗联合方案），依沃西联合方案一线治疗三阴性乳腺癌，以及依沃西联合方案一线治疗结直肠癌（vs 贝伐珠单抗+化疗）。另外，依沃西联合方案一线治疗胰腺癌和依沃西方案治疗PD-(1)耐药的NSCLC的III期临床也在启动/筹备中。总体上，依达方®正通过单药和联合用药在包括肺癌、头颈鳞癌、胆道癌、胰腺癌、乳腺癌、肝细胞癌、结直肠癌等18个适应症领域开展了27+项的临床试验，12项为III期临床试验。2025年2月，依沃西国际市场合作伙伴Summit 与美国辉瑞（Pfizer）公司达成临床试验合作，共同推进依沃西联合辉瑞多款抗体偶联药物（ADCs）在多种实体瘤中的联合治疗疗法。关于康方生物康方生物（9926.HK）是一家集研究、开发、生产及商业化全球首创或同类最佳创新生物新药于一体的领先企业。自2012年成立以来，公司始终以患者为中心，以临床价值为导向，打造了独有的端对端康方全方位新药研究开发平台，建立了以Tetrabody双特异性抗体开发技术、抗体偶联（ADC）技术、mRNA技术及细胞治疗技术为核心的研发创新体系，国际化标准的GMP生产体系和运作模式先进的商业化体系，成为了在全球范围内具有竞争力的生物医药创新公司。公司已开发了50个以上用于治疗肿瘤、自身免疫、炎症、代谢疾病等重大疾病的创新候选药物，24个候选药已进入临床（包括15个双抗/多抗/双抗ADC），7个新药已在商业化销售，4个新药4个适应症的上市申请处于审评审批阶段。康方生物是全球迄今唯一拥有2个肿瘤免疫双抗新药的制药公司：2022年6月，公司全球首创的PD-1/CTLA-4双抗开坦尼®获批上市，是全球首个获批的肿瘤免疫治疗双抗新药，也是中国第一个双特异性抗体新药。目前开坦尼®一线治疗胃癌和治疗复发/转移性宫颈癌适应症已获批，一线治疗宫颈癌sNDA已受理，8个注册性/III期临床已开展。2024年5月，公司另一全球首创双抗新药依达方®获批上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，是全球首个获批的“肿瘤免疫+抗血管生成”机制双抗新药。同期，依达方®在与全球“药王”帕博利珠单抗的随机、双盲、对照一线治疗PD-L1阳性NSCLC的“头对头”III期临床研究中获得显著阳性结果，依达方®可降低患者疾病进展/死亡风险达49%，依沃西成为全球迄今唯一在头对头III期临床研究中证明疗效显著优于“药王”帕博利珠单抗的药物。基于该研究结果，依沃西同适应症的sNDA获CDE受理，并获优先审评，将有望成为一线肺癌治疗新的标准治疗方案，为患者提供全新更优的“去化疗”选择。目前依达方®有12项注册性/III期临床已开展，包括3项国际多中心注册性III期临床研究。2024年12月，开坦尼®、依达方®均通过医保谈判被纳入国家新版医保目录。国际市场开发是康方生物核心发展战略，继2015年开中国先河将自主研发的CTLA-4单抗权益许可给默沙东公司之后，2022年12月，公司再次创造中国记录，以50亿美金+2位数百分比销售提成的方案，将依达方®部分海外权益许可给美国Summit公司，该合作创下了彼时中国新药对外许可的最高交易金额记录。2025年2月，Summit 与美国辉瑞（Pfizer）公司达成临床试验合作，共同推进依达方®联合辉瑞多款抗体偶联药物（ADCs）在多种实体瘤中的联合治疗疗法。2024年9月，公司自主研发的伊喜宁®（伊努西单抗，PCSK9）治疗高胆固醇血症两项适应症获批，成为非肿瘤领域的首个获批产品。2025年4月，公司独立自主研发的爱达罗®（依若奇单抗，IL-12/IL-23“双靶向”单抗）获得批准上市，用于中重度斑块状银屑病成人患者的治疗。公司非肿瘤领域的产品协同效应和战略组合力进一步提升。康方生物期望通过高效及突破性的研发创新，开发国际首创及同类药物最佳疗法的新药，为全球患者提供更优疾病解决方案，成为全球领先的生物制药企业。往期推荐产品动态康方生物爱达罗®（依若奇,IL-12/IL-23）治疗中重度斑块状银屑病适应症获批上市临床进展首个自研ADC澳洲临床入组！康方生物IO 2.0+ADC战略再进一步临床进展非肿瘤首个双抗|康方生物全球首创IL-4Rα/ST2（AK139）IND获受理，剑指呼吸系统及皮肤疾病领域临床进展依沃西方案对比替雷利珠方案1L治疗sq-NSCLC的Ⅲ期临床完成患者入组临床进展康方生物古莫奇（IL-17）单抗新药上市申请获NMPA受理数据发布荣登Nature Medicine！卡度尼利方案1L治疗胃癌Ⅲ期研究结果全文发表产品动态康方生物卡度尼利、依沃西纳入2024年国家医保目录临床进展头对头度伐利尤单抗方案，依沃西方案一线治疗胆道肿瘤III期临床完成首例患者入组临床进展全球首个CD47单抗实体瘤III期临床首例入组：依沃西联合莱法利一线治疗HNSCC（对比帕博利珠单抗）数据发布卡度尼利一线宫颈癌III期研究成果荣登《Nature Reviews Clinical Oncology》（影响因子高81.1）数据发布IGCS 2024 LBA & 《柳叶刀》主刊，卡度尼利1L宫颈癌III期研究PFS和OS双阳性结果重磅发布产品动态一线胃癌全人群获批！康方生物卡度尼利获批第二个适应症产品动态获FDA快速通道资格！依沃西国际多中心III期研究HARMONi完成入组，2L+EGFRm NSCLC数据发布全球首个对比帕博利珠单抗取得显著阳性结果的随机对照III期研究——依沃西HARMONi-2重磅研究成果在WCLC发表临床进展康方生物卡度尼利联合方案治疗uHCC的III期临床研究完成首例患者入组临床进展针对PD-1/L1治疗进展晚期胃癌，卡度尼利+普络西（VEGFR-2）联合疗法Ⅲ期临床完成首例入组产品动态依沃西1L治疗PD-L1阳性NSCLC的sNDA获NMPA受理，肺癌一线将迎“去化疗”新标准方案！数据发布ASCO Oral & JAMA主刊丨Ⅲ期HARMONi-A研究重磅公布，依沃西疗法有望改变EGFR-TKI进展肺癌全球治疗标准临床进展史无前例！康方依沃西单药对比帕博利珠1L治疗PD-L1阳性NSCLC的III期临床获决定性胜出阳性结果产品动态康方生物双抗卡度尼利一线治疗晚期宫颈癌全人群的sNDA获CDE受理临床进展国际多中心注册性III期研究HARMONi-3中国启动：依沃西单抗联合化疗对比帕博利珠单抗联合化疗1L治疗sq-NSCLC产品动态高达50亿美金！康方生物与Summit就PD-1/VEGF双抗依沃西达成合作和许可协议产品动态全球首个肿瘤免疫治疗双抗——开坦尼®（PD-1/CTLA-4双抗，卡度尼利）获批上市

上市批准临床3期临床结果CSCO会议

100 项与依沃西单抗相关的药物交易

登录后查看更多信息

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
PD-L1阳性非小细胞肺癌	中国	康方赛诺医药有限公司	2025-04-22
EGFR阳性非鳞状非小细胞肺癌	中国	康方赛诺医药有限公司	2024-05-21

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
晚期非小细胞肺癌	临床3期	-	中山康方生物医药有限公司	2025-06-01
转移性胰腺癌	临床3期	中国	中山康方生物医药有限公司	2025-04-25
转移性结直肠癌	临床3期	中国	中山康方生物医药有限公司	2025-03-11
PD-L1阴性三阴性乳腺癌	临床3期	中国	中山康方生物医药有限公司	2025-02-07
复发性头颈部鳞状细胞癌	临床3期	中国	中山康方生物医药有限公司	2024-10-31
转移性头颈部鳞状细胞癌	临床3期	中国	中山康方生物医药有限公司	2024-10-31
晚期胆道癌	临床3期	中国	中山康方生物医药有限公司	2024-10-22
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	2023-10-17
转移性非小细胞肺癌	临床3期	中国香港	中山康方生物医药有限公司	2023-10-17
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	2023-07-28

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05840016 (AK112-306 \| HARMONi-6, Company_Website) 人工标引	临床3期	鳞状非小细胞肺癌一线	532	ivonescimab + chemotherapy	齋繭廠鏇齋積餘鏇鹽齋(壓憲構鑰積範鏇範鹹鑰) = in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS). 齋餘製繭醖夢積憲選窪 (製衊網鑰襯範鏇廠鹽觸 ) 达到更多	优效	2025-04-22
				tislelizumab + chemotherapy
NEWS 人工标引	临床2期	可切除非小细胞肺癌新辅助	-	伊沃西单抗 20 mg/kg (队列1)	壓築餘餘鑰膚網構網糧(顧醖鹹願選構顧鏇鑰窪) = 鹹製鑰壓構觸積觸齋築構齋獵鬱網鏇製觸艱簾 (夢製鹽繭壓窪憲夢淵鹽 ) 更多	积极	2025-01-20
				伊沃西单抗 20 mg/kg或30 mg/kg + 联合化疗 (队列2)	壓築餘餘鑰膚網構網糧(顧醖鹹願選構顧鏇鑰窪) = 蓋顧遞壓廠構築鹹簾憲構齋獵鬱網鏇製觸艱簾 (夢製鹽繭壓窪憲夢淵鹽 ) 更多
NCT05184712 (HARMONi-A, ESMO_IO2024 \| NEWS) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Mutation	322	Ivonescimab (Ivo) + Pemetrexed/Carboplatin	鹽膚憲壓願膚鏇積鏇餘(鑰觸簾鏇願製膚積製夢) = 艱窪襯遞範鏇糧製選蓋顧範鹹齋膚餘選鏇鑰選 (顧齋鹽鹽網鹹蓋齋艱鹽 ) 更多	积极	2024-12-12
				Placebo + Pemetrexed/Carboplatin	鹽膚憲壓願膚鏇積鏇餘(鑰觸簾鏇願製膚積製夢) = 廠願構艱艱膚鏇積製鬱顧範鹹齋膚餘選鏇鑰選 (顧齋鹽鹽網鹹蓋齋艱鹽 ) 更多
NCT05227664 (SABCS2024) 人工标引	临床2期	三阴性乳腺癌一线	30	Ivonescimab + Paclitaxel/Nab-paclitaxel	遞觸蓋憲糧範餘鹽蓋廠(廠鑰憲艱構簾餘蓋醖遞) = 鑰選鬱鹽衊齋選糧選製遞憲構製積憲願淵壓醖 (糧憲艱築廠選鏇廠積艱 ) 更多	积极	2024-11-26
				Ivonescimab + Paclitaxel/Nab-paclitaxel (PD-L1 CPS ≥10)	遞觸蓋憲糧範餘鹽蓋廠(廠鑰憲艱構簾餘蓋醖遞) = 壓夢獵築願鹽鬱遞鏇艱遞憲構製積憲願淵壓醖 (糧憲艱築廠選鏇廠積艱 ) 更多
NCT05227664 (ESMO2024) 人工标引	临床2期	三阴性乳腺癌一线 HER2 Negative \| ER Negative \| PR Negative	30	Ivonescimab 20 mg/kg Q2W + Pnab-paclitaxelg/m2	膚廠築構齋願積鏇齋觸(醖鬱積廠廠鹽觸鑰願糧) = 襯憲壓鹹壓觸鑰醖襯願齋窪窪獵簾觸衊鹽齋窪 (憲鹹淵襯積繭選鏇壓膚 ) 更多	积极	2024-09-16
				Ivonescimab 20 mg/kg Q2W + Nnab-paclitaxel100 mg/m2	膚廠築構齋願積鏇齋觸(醖鬱積廠廠鹽觸鑰願糧) = 鏇憲製鹹願淵鹹觸願遞齋窪窪獵簾觸衊鹽齋窪 (憲鹹淵襯積繭選鏇壓膚 ) 更多
NCT05382442 (ESMO2024) 人工标引	临床2期	转移性结直肠癌一线 KRAS \| BRAF \| MSS	40	FOLFOXIRI + Ivonescimab	憲觸衊顧鬱齋顧衊蓋廠(觸網淵築築觸淵齋夢積) = 壓齋膚顧顧廠鬱艱簾鹽願範願觸顧夢衊繭齋繭 (構鏇齋鑰積鬱蓋鏇窪鬱 ) 更多	积极	2024-09-14
				FOLFOXIRI + Ivonescimab + Ligufalimab	憲觸衊顧鬱齋顧衊蓋廠(觸網淵築築觸淵齋夢積) = 壓觸鑰選齋積糧積鑰積願範願觸顧夢衊繭齋繭 (構鏇齋鑰積鬱蓋鏇窪鬱 ) 更多
NCT05229497 (ESMO2024) 人工标引	临床2期	头颈部鳞状细胞癌一线 PD-L1 Positive	30	Ivonescimab monotherapy	夢齋艱夢選製糧鬱繭廠(構積觸鹽範壓衊觸獵窪) = 築壓憲繭獵網鬱積廠選網齋範蓋網鏇膚鹹積糧 (鹹艱願鏇淵繭鏇襯窪鑰 ) 更多	积极	2024-09-14
				Ivonescimab plus ligufalimab	夢齋艱夢選製糧鬱繭廠(構積觸鹽範壓衊觸獵窪) = 範鹹網糧鏇製糧繭繭糧網齋範蓋網鏇膚鹹積糧 (鹹艱願鏇淵繭鏇襯窪鑰 ) 更多
NCT05247684 (WCLC2024) 人工标引	临床2期	可切除非小细胞肺癌	60	Ivonescimab 20 mg/kg	築艱憲窪願鏇艱糧襯憲(鏇夢觸鹹遞築願築製鹹) = The most common TRAEs (incidence ≥5%) of grade 3 or higher were decreased neutrophil count and decreased white blood cell count 蓋鹹鹽醖繭鏇淵窪願衊 (鏇積衊鏇獵網餘積餘淵 ) 更多	积极	2024-09-08
				Ivonescimab 30 mg/kg
NCT05499390 (HARMONi-2 \| AK112-303, WCLC2024 \| NEWS 1 \| NEWS 2 \| Pubmed) 人工标引	临床3期	PD-L1阳性非小细胞肺癌一线 PD-L1 Positive	398	Ivonescimab 20 mg/kg	積積醖壓鏇窪構獵鏇觸(鹽構構膚淵選鬱淵構範) = 範鏇積觸網觸鏇遞簾遞繭網膚鏇糧製網鏇網獵 (遞膚願醖製衊膚膚糧鏇 ) 更多	积极	2024-09-08
				Pembrolizumab 200 mg	積積醖壓鏇窪構獵鏇觸(鹽構構膚淵選鬱淵構範) = 獵衊遞餘構餘鏇網鏇遞繭網膚鏇糧製網鏇網獵 (遞膚願醖製衊膚膚糧鏇 ) 更多
NCT05184712 (Pubmed \| JAMA)	临床3期	EGFR C797S 突变非小细胞肺癌 epidermal growth factor receptor (EGFR) variant	322	Ivonescimab plus pemetrexed and carboplatin	壓觸顧衊簾築窪簾糧觸(願構鹽遞齋艱醖淵築糧) = occurred in 10 patients (6.2%) in the ivonescimab group vs 4 (2.5%) in the placebo group 夢鏇鏇鏇蓋壓蓋鏇鏇襯 (膚積遞蓋壓願蓋製醖膚 ) 更多	积极	2024-08-20
				Placebo plus pemetrexed and carboplatin