A Randomised, Phase II Trial to Evaluate the Efficacy of Ivonescimab, a PD 1/VEGF Bispecific Antibody, Versus FOLFOX as Second Line Therapy for Locally Advanced/Metastatic Biliary Cancers

The object of this trial is to test whether ivonescimab is superior to standard chemotherapy (FOLFOX regimen) for the treatment of patients with advanced biliary tract cancer after failure of a first line of chemotherapy. It is only open to patients who participated in the SAFIR-ABC10 trial (NCT05615818) but did not receive experimental treatment.
Eligible patients will be randomised (2:1) to receive either ivonescimab or FOLFOX. Treatment will be continued until disease progression, or a maximum of 34 cycles of ivonescimab (experimental arm), whichever occurs first.

开始日期2025-01-30

申办/合作机构

UNICANCER

[+2]

NCT06402435 / Not yet recruiting临床2期IIT

A Single-arm, Open, Phase II Clinical Study of SBRT, Chemotherapy, and Ivonescimab Neoadjuvant Therapy for Luminal-type Breast Cancer

Studies have indicated that the improvement in pathological complete response (pCR) is significantly correlated with luminal breast cancer patients' overall survival (OS). Patients with luminal breast cancer have poor efficacy for neoadjuvant chemotherapy. The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of luminal-type breast cancer patients, increasing it from 13-15% to approximately 24%. Therefore, how to further improve the pCR rate of luminal-type breast cancer became the main objective of this study. Stereotactic radiotherapy (SBRT) not only kills tumor cells directly, but also kills the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8+ T cells, a phenomenon known as the abscopal effect. Our research team has recently discovered that the triple therapy model of SBRT + anti-vascular targeting + anti-PD-1 was safe and efficacious in lung cancer patients. Ivonescimab (AK112) is an anti-PD-1/VEGF-A bispecific antibody. In order to improve the pCR, a single-arm, open, phase II clinical study was proposed to explore the safety and efficacy of SBRT+AK112+chemotherapy, a neoadjuvant treatment modality, in the treatment of luminal breast cancer.

开始日期2024-09-01

申办/合作机构

湖北省肿瘤医院

100 项与依沃西单抗相关的临床结果

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100 项与依沃西单抗相关的转化医学

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100 项与依沃西单抗相关的专利（医药）

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项与依沃西单抗相关的文献（医药）

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Reichert, Janice M ; Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

2024-03-01·Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

A Phase 1b Study of Ivonescimab, a Programmed Cell Death Protein-1 and Vascular Endothelial Growth Factor Bispecific Antibody, as First- or Second-Line Therapy for Advanced or Metastatic Immunotherapy-Naive NSCLC

Article

作者: Li, Baiyong ; Luo, Yongzhong ; Zhou, Jin ; Song, Weifeng ; Xia, Yu ; Zhang, Xiaodong ; Hou, Xiaoming ; Zhang, Zhihong ; Ren, Shengxiang ; Su, Chunxia ; Wang, Zhongmin Maxwell ; Dai, Yuanrong ; Meng, Shuyan ; Wu, Fengying ; Zhou, Caicun ; Wang, Lei ; Hu, Yanping ; Yu, Xinmin ; Dong, Xiaorong ; Xiong, Anwen

INTRODUCTION:

This study (HARMONi-5) aimed to evaluate the safety and efficacy of ivonescimab (a bispecific antibody against programmed cell death protein 1 and vascular endothelial growth factor) as first- or second-line monotherapy in patients with advanced immunotherapy-naive NSCLC.

METHODS:

Eligible patients received intravenous ivonescimab 10 mg/kg every 3 weeks (Q3W), 20 mg/kg every 2 weeks (Q2W), 20 mg/kg Q3W, or 30 mg/kg Q3W. The primary end points were safety and objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1.

RESULTS:

At data cutoff (October 5, 2022), 108 patients were enrolled and received ivonescimab. Programmed death ligand-1 tumor proportion score (TPS) was greater than or equal to 1% in 74 patients (68.5%), including 35 (32.4%) with TPS greater than or equal to 50%. The median follow-up was 10.4 months (range: 8.4-10.9 mo). For all patients, ORR and disease control rate were 39.8% and 86.1%, respectively. ORR by TPS was 14.7%, 51.4%, and 57.1% in patients with TPS less than 1%, greater than or equal to 1%, and greater than or equal to 50%, respectively. In the 67 programmed death ligand-1-positive patients receiving first-line ivonescimab, the ORR was 33.3%, 52.6%, 60.0%, and 75.0% at the doses of 10 mg/kg Q3W, 20 mg/kg Q2W, 20 mg/kg Q3W, and 30 mg/kg Q3W, respectively. Grade greater than or equal to 3 treatment-related adverse events (TRAEs) were observed in 24 patients (22.2%). TRAEs leading to treatment discontinuation occurred in one patient (0.9%). TRAEs leading to death occurred in three patients (2.8%) with squamous NSCLC. The occurrence of grade greater than or equal to 3 TRAEs and grade greater than or equal to 3 bleeding events in squamous versus nonsquamous NSCLC patients was 25.5% versus 18.9% and 0.0% versus 1.9%, respectively.

CONCLUSIONS:

Ivonescimab monotherapy was well tolerated and found to have a promising efficacy in patients with advanced or metastatic NSCLC.

CLINICALTRIALS:

gov identifier: NCT04900363.

2023-08-01·EClinicalMedicine

AK112, a novel PD-1/VEGF bispecific antibody, in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC): an open-label, multicenter, phase II trial

Article

作者: Xia, Michelle ; Li, Baiyong ; Zhao, Yuanyuan ; Yang, Yunpeng ; Song, Weifeng ; Zhao, Yanqiu ; Chen, Gang ; Zhang, Weidong ; Zhang, Yu ; Li, Wenting ; Zhuang, Wu ; Zhuang, Li ; Zhou, Ming ; Du, Yingying ; Huang, Yan ; Wan, Yixin ; Chen, Jianhua ; Zhang, Li ; Fang, Wenfeng ; Wang, Zhongmin Maxwell ; Yu, Qitao

Background:

Inhibiting vascular endothelial growth factor (VEGF) function can improve the efficacy of immunotherapy by modulating the tumor immune microenvironment. AK112 is the first-in-class humanized IgG1 bispecific antibody targeting programmed death-1 (PD-1) and VEGF. This study aimed to evaluate the efficacy and safety of AK112 combined with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).

Methods:

This open-label, multicenter, phase II clinical trial was conducted in 11 hospitals in China. Eligible participants were adults aged 18-75 years with locally advanced or metastatic NSCLC, an Eastern Cooperative Oncology Group performance status of 0 or 1, at least one measurable lesion, and an estimated life expectancy of at least 3 months. The participants were categorized into three cohorts based on prior therapy and functional genomic alterations. Patients in cohort 1 were previously untreated advanced NSCLC, had no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene modifications, and received AK112 combined with pemetrexed (500 mg/m²) for non-squamous (non-sq)-NSCLC or paclitaxel (175 mg/m²) for sq-NSCLC plus carboplatin (area under the curve of 5 mg/mL per min) for four cycles, followed by AK112 with pemetrexed for non-sq-NSCLC and AK112 alone for sq-NSCLC as maintenance therapy. The participants in cohort 2 had advanced NSCLC with EGFR-sensitive mutations, failed previous EGFR-tyrosine kinase inhibitor (TKI) therapy, and received pemetrexed plus AK112 and carboplatin for four cycles, followed by pemetrexed plus AK112 as maintenance therapy. The participants in cohort 3 had advanced NSCLC who failed systemic platinum-based chemotherapy and anti-PD-1/programmed death-ligand 1 (PD-L1) treatments and received AK112 plus docetaxel (75 mg/m²). Two dosages of AK112 (10 or 20 mg/kg) were examined in each cohort, and the drug was administered intravenously on day 1 of each 3-week treatment cycle. The primary endpoints were the investigator-assessed objective response rate (ORR) and safety. This study was registered with ClinicalTrials.gov (NCT04736823).

Findings:

Eighty-three patients were enrolled from February 2021 to August 2022 and received the study treatment. Cohorts 1, 2, and 3 had 44, 19, and 20 patients, respectively. The confirmed ORR was 53.5% (23/43) [95% CI, 36.9-67.1], 68.4% (13/19) [95% CI, 43.4-87.4], and 40.0% (8/20) [95% CI, 19.1-63.9] in cohorts 1, 2, and 3, respectively. In cohort 1, the median PFS was not reached, and the 12-month PFS rate was 59.1%. In cohorts 2 and 3, the median PFS were 8.5 [95% CI, 5.5-NE] and 7.5 [95% CI, 2.3-NE] months, and the 12-month PFS rates were 35.5% and 44.5%, respectively. The most common grade ≥3 treatment-related adverse events were decreased white blood cell count [7 (8.4%)], neutropenia [5 (6.0%)], thrombocytopenia [2 (2.4%)], anemia [4 (4.8%)], and myelosuppression [2 (2.4%)].

Interpretation:

AK112 plus platinum-doublet showed promising antitumor activity and safety not only in first-line treatment of advanced NSCLC patients without driver mutation but also in patients with EGFR-functional mutation who failed previous EGFR-TKI therapy and advanced NSCLC patients who failed prior systemic platinum-based chemotherapy and PD-1/PD-L1 inhibitor treatments, suggesting a valuable potential new treatment option for this patient population.

Funding:

Akeso Biopharma, Inc., Zhongshan, China, and National Natural Science Foundation of China.

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·同写意

中国创新药的未来在哪里？

2024医美与器械创新前沿华西论坛，与您共探药企转型之道，解锁消费医疗市场新机遇。10月12日，成都等您来！在中国创新药的悠悠岁月中，Biotech一度在迷雾中徘徊，寻找着那一线生机。如今看来，“出海”布局全球市场，似乎是通往未来的答案。当License out交易井喷，当出海成为新的增长引擎，当越来越多Biotech实现盈利，国内创新药企的日子似乎好了起来。然而，出海之路并非坦途，国产创新药被“退货”的案例比比皆是。这一现象折射出License out交易进入了“深水区”：BD交易“过热”容易导致市场泡沫和资源错配。由此引发了值得深思的问题：中国创新药的未来在哪里？到底该如何出海？什么样的创新药才能实现国际化？ 1 困境与觉醒中国创新药的发展之路，并非一帆风顺。医保控费、资本遇冷、现金流枯竭，尤其是仿创思维、“拿来主义”导致产业过于内卷，中国创新药的问题展露无遗。要知道，每个新药的诞生都伴随着高昂的研发成本与漫长的研发周期。可随着众多药企扎堆于热门靶点，使得同质化竞争严重、市场快速饱和，导致创新药企难以获得理想的回报，面临现金流紧张的困境。面对国内市场空间有限且激烈的竞争环境，众多创新药企如同千军万马过独木桥。由此，布局全球市场成为了必由之路。国产创新药出海的模式包括自主出海、借船出海（License out），其中License out是将自身产品的海外权益或全球权益对外授权许可给外资药企，可获得首付款+里程碑费用+销售分成，现已成为国内Biotech缓解资金压力、加速新药研发的重要途径。近年来，国产创新药License out大手笔频现，交易金额持续攀升：从荣昌生物的纬迪西妥单抗（26亿美元）到康方生物的AK112（50亿美元），再到百利天恒的BL-B01D1（84亿美元），国内创新药出海的纪录一破再破。据医药魔方统计，2023年中国创新药企业通过BD获得的首付款总额达267.64亿元，首次超过IPO渠道募资总额，并且是后者的近两倍。而且，2024年上半年国内药企达成了约42项License out授权合作，累计交易总金额255亿美元，较去年同期增长80%。可见，国内Biotech已经找到了新的出路。毕竟，许多国内创新药企都尝到了依靠BD收入实现盈利的甜头，包括康方生物、和黄医药、亚盛医药、科伦博泰、百利天恒等。 2023年，康方生物实现首次年度盈利，主要得益于产品销售额同比增长48%，以及获得技术授权和技术合作收入约29.23亿元，其中收到Summit就依沃西单抗（AK112，PD-1/VEGF）支付的授权许可首付款5亿美元。 2024年上半年，血液肿瘤领域龙头亚盛医药首次实现盈利，主要来源于产品销售收入和对外合作授权收入，目前已收到武田就耐立克支付的选择权付款7.2亿元和股权投资款项5.4亿元；同期，科伦博泰也实现扭亏，已就多条合作管线收到默沙东总额为9000万美元（约合人民币6.4亿元）的里程碑付款。特别是百利天恒，在收到BMS就EGFR/HER3双抗ADC BL-B01D1支付的8亿美元首付款后，上半年营业收入同比增长超16倍至55.53亿元。一言以蔽之，国内Biotech已经迎来了觉醒时刻。 2 出海即是出路？尽管出海已成为国内创新药企“活下去”的必由之路，但这条路并非只有坦途，也有不少坎坷：国产创新药被退回权益的案例屡见不鲜。这一现象的出现，存在着多重因素：既有市场环境变化的原因，包括竞争者数量增多、外资药企调整战略，也有新药立项时缺乏前瞻性和创新性，未能满足跨国药企对市场潜力的要求，以及新药研发成效不佳，缺乏显著的临床价值。实际上，新药研发本身就是“赌”，License out交易也是一场“赌局”。对于外资药企而言，先支付首付款支持国内创新药企研发新药，之后看新药能否展现出优异的疗效和显著的市场前景，再决定是否继续行使权益、支付金额更高的里程碑付款。反之，国内创新药企在拿到首付款后，不仅能缓解资金压力、继续推进新药研发，后续新药若能顺利研发，就有望拿到更高的里程碑付款以及一定的销售分成，还能借助外资药企打开国际化市场。尽管BD出海不易，仍不乏实现双赢的案例。近年来出现中国创新药撑起美国药企市值的现象，便是有力的证明。例如，Arrivent公司在2021年以“总额8亿美元（其中首付款4000万美元）+一定比例股份”引进艾力斯伏美替尼的海外权益后，不仅完成了两次融资（总金额超3亿美元），还在2024年1月成功登陆美股市场。市场普遍认为，鉴于伏美替尼在国内市场的优异销售表现，艾力斯拿到7.65亿美元的里程碑付款只是时间问题。类似的案例，还有今年成功冲刺美股市场的Alumis。 Alumis于6月上市，IPO规模达2.1亿美元，是今年以来IPO发行规模第三大的Biotech，核心管线是2021年以“6000万美元首付款+1.2亿美元里程碑付款”从海思科引进的TYK2抑制剂ESK001。凭借这款具有同类最佳潜力的药物，Alumis在3年时间累计融资达5.29亿美元（不含IPO融资）。毕竟，TYK2赛道可是成为了香饽饽：BMS的Sotyktu，是全球首款且唯一获批上市的TYK2抑制剂，2023年大卖1.7亿美元，BMS预计其2030年销售额将超过40亿美元；2022年，武田制药以“40亿美元预付款+20亿美元里程碑款”收购了Nimbus的NDI-034858（TAK-279）。最典型的案例，莫过于康方生物和Summit。 2022年底，Summit以总额50亿美元引进康方生物的依沃西单抗在美国、加拿大、欧洲和日本的开发和商业化权益。彼时，Summit的股价仅有1美元左右，与康方生物达成合作后股价在短短几个交易日最高飙升至近6美元。尤其今年5月以来，受依沃西单抗头对头击败K药的亮眼临床数据刺激，Summit股价接连大涨，再加上9月12日宣布获得今年的第二次融资后，当天股价大涨至27.41美元，总市值达近200亿美元。当下的创新药市场，无不希望看到更多类似这样双向奔赴且没有输家的交易。 3 通往未来的答案新型的创新药出海模式NewCo，可谓是海内外药企实现共赢的第二条路。所谓NewCo模式，就是将公司产品管线海外权利授予海外新成立的公司，获得股权及资金支持，同时引入海外基金，搭建国际化团队，实现产品出海。简言之，就是国内创新药企通过技术入股，与海外资本一起攒局。目前，已有不少药企成功借助NewCo模式实现创新药出海，包括艾力斯、恒瑞医药、康诺亚、嘉和生物、岸迈生物。前文所述的艾力斯与ArriVent就伏美替尼达成的海外授权合作，便是“现金+股权”的NewCo模式。今年5月，恒瑞医药将GLP-1类创新药产品组合HRS-7535、HRS9531、HRS-4729在大中华区以外的全球权益授予美国Hercules公司，不仅达成交易总额60亿美元，还将取得Hercules公司19.9%的股权。紧接着7月，康诺亚将2款双抗新药CM512、CM536授予Belenos Biosciences，将获得1.8亿美元交易总额以及Belenos公司30.01%的股权；8月，嘉和生物将CD20/CD3双抗GB261授予TRC 2004，将获得后者数量可观的股权、数千万美元的首付款、高达4.43亿美元的里程碑付款以及销售分成。 NewCo模式的好处在于，国内药企不仅能通过早期管线创造一定价值，又能通过股权，降低自身风险、参与公司决策，并锁定更多远期收益。中国创新药以多种模式频频出海，找到了通往未来的第一个答案。但不同的药企，需根据自身的实际情况灵活决定采用哪种模式。什么样的创新药才能实现国际化？解答这一问题，实际上就是回答中国创新药的未来在哪里？这点从近年来达成的License out交易即可窥见一斑。百利天恒BL-B01D1之所以获得BMS以总额84亿美元（首付款8亿美元）引进，不仅在于源头创新（全球首创且唯一进入临床阶段的HER3xEGFR双抗ADC），而且具有广泛的抗肿瘤活性。据Insight数据库显示，目前BL-B01D1共有7个III期临床正在进行中，包括肺癌、乳腺癌、鼻咽癌、食管鳞癌。此外还有14项II期临床正在进行中，覆盖瘤种超过10个。和黄医药的呋喹替尼能获得武田制药以总额超11亿美元（首付款4亿美元）引进，就在于有扎实的全球多中心临床数据支持，使其能登陆美国市场，且放量速度快于国内市场。呋喹替尼是美国10年来获批的首款且唯一针对三线mCRC的小分子靶向药，并凭借优异疗效被写入NCCN指南。亚盛医药就奥雷巴替尼（耐立克）与武田达成总额13亿美元的授权合作，创下了国产小分子肿瘤药对外BD最高纪录，并获得武田入股，同样在于源头创新思维。耐立克是国内首个且唯一获批上市的第三代BCR-ABL抑制剂，解决了临床空白问题，且疗效和安全性均优于武田的泊那替尼。引进耐立克后，武田便拥有了与诺华的阿思尼布抗衡、巩固CML统治地位的底气。归根结底，唯有具有显著的创新性和临床价值、优异疗效且具有广阔市场前景的创新药，才能实现国际化。而源头创新思维，决定了中国创新药未来的方向。参考文献： 1.各家公司的财报、公告、官微 2.《医药行业创新药出海专题：国际化渐入佳境，洞悉出海潜力管线》，西南证券 3.《创新药出海新模式NewCo：恒瑞、康诺亚、岸迈生物、嘉和生物...》，新康界，2024-09-11 4.平安证券、首创证券研报同写意媒体矩阵，欢迎关注↓↓↓

IPO引进/卖出

2024-09-18

·EndPoints

Keytruda adds new FDA approval for a rare form of mesothelioma

Keytruda is already approved in more than 40 different oncology indications, but its latest label expansion is a first for the cancer blockbuster. Merck announced Wednesday that the FDA cleared the immuno-oncology drug as a first-line treatment, in combination with chemotherapy, for patients with advanced stages of malignant pleural mesothelioma. It’s the first time that Keytruda has been given the green light for the disease in the US in any line of treatment. The approval was based on Phase 2/3 data showing that Keytruda plus chemotherapy reduced the risk of death by 21% when compared with chemotherapy alone. Patients given Keytruda had a median overall survival of 17.3 months, compared with 16.1 for patients who only received chemotherapy. Those survival results were statistically significant. Merck said that the treatment arm “also significantly improved progression-free survival,” but both the treatment arm and the chemotherapy-only arm reported a median PFS of 7.1 months. A spokesperson for the company pointed to the 0.8 hazard ratio as evidence of the “statistically significant improvement in PFS.” The overall response rate for patients given Keytruda was 52%, compared with 29% for those who only received chemotherapy. Merck said the safety profile was similar to that seen in other patients who have received Keytruda in addition to pemetrexed and platinum chemotherapy. The new approval follows a weekend of key I/O-related updates, including some for Keytruda, at the European Society for Medical Oncology. In a form of liver cancer, Merck found that patients staved off disease progression a bit longer when given Keytruda and Eisai’s VEGF inhibitor Lenvima on top of a procedure that directly delivers chemotherapy to the tumor. Patients who only received the procedure plus placebos had a median progression-free survival of 10 months compared to 14.6 in the combo treatment arm. More on the minds of investors is whether or not Summit Therapeutics and Akeso have a viable shot to Keytruda’s throne. The two have recently touted data out of China showing their monoclonal antibody bested Keytruda in patients with lung cancer. Summit, who has US rights to ivonescimab, is currently running a global Phase 3 registrational trial to validate the results.

临床结果临床3期上市批准加速审批

2024-09-18

·康方生物Akeso

依沃西方案一线治疗TNBC优异II期初步数据在ESMO2024发布

近日，在2024年欧洲肿瘤内科学会（ESMO）年会上，康方生物（9926.HK）首次对外发布了公司独立自主研发的PD-1/VEGF双特异性抗体依沃西联合化疗一线治疗局部晚期不可切除或转移性三阴性乳腺癌（TNBC）的研究成果。中位随访时间仅为10个月的初步数据展示了依沃西联合方案在TNBC一线治疗优异的疗效和良好的安全性。该项研究的共同主要研究者的浙江省肿瘤医院王晓稼教授在会议现场做Oral报告。截至2024年5月31日，研究共入组了30例局部晚期不可切除或转移性的TNBC患者， 80%的入组患者为PD-L1表达阴性人群(PD-L1 CPS <10），60%的患者既往接受过紫杉类辅助/新辅助治疗，该比例高于同类靶点药物相关研究。三阴性乳腺癌（TNBC）尽管随访时间较短，数据尚不成熟，但研究依然展现了依沃西方案针对TNBC患者具有优异的无进展生存期（PFS）获益，安全性与既往依沃西相关研究一致。高效的肿瘤缓解和疾病控制依沃西联合方案客观缓解率（ORR）为72.4%，疾病控制率（DCR）为100%，其中完全缓解（CR）率为6.9%。 * 截至发稿，共新增5例肿瘤评估达到PR的患者（其中4例新增可评估均为PR的患者，1例由SD缩小到PR），调整后ORR约为78.8%，DCR为100%。随访时间短，但优异远期生存获益趋势已显随访时间较短，数据尚不成熟，中位无进展生存期（mPFS）为9.3个月（6.24~NE），6个月PFS率为73.3%。在PD-L1 CPS＜1的人群中，ORR为86.7%，mPFS为9.3个月（5.26~NE）。 * 截至发稿，新增2例PD-L1 CPS＜1的患者肿瘤评估达到PR，调整后ORR达 88.2%。在PD-L1 CPS＜10的人群中，ORR为69.6%，mPFS为9.3个月（5.55~NE）。 * 截至发稿，新增5例PD-L1 CPS＜10的患者肿评达到PR，调整后ORR约为77.8%。在PD-L1 CPS≥10的人群中，ORR 为 83.3%，中位 PFS 尚未达到。依沃西联合化疗一线治疗TNBC安全性好最常见的治疗相关不良事件（TRAEs）多数为1-2级，易于管理，与既往相关研究一致。在本研究中未发生因TRAEs导致的停药或死亡。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。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。同时，依达方®联合化疗对比替雷利珠单抗联合化疗一线治疗sq-NSCLC的III期临床研究，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）和依达方®联合化疗对比帕博利珠单抗联合化疗一线治疗sq-NSCLC的国际多中心III期研究正在进行中。此外，依达方®还已经/即将新启动3个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），以及依沃西联合方案一线治疗胰腺癌。总体上，依达方®正通过单药和联合用药在包括肺癌、胰腺癌、乳腺癌、肝细胞癌、结直肠癌等17个适应症领域开展了25+项的临床试验。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，公司打造了独有的端对端康方全方位新药研究开发平台（ACE Platform），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，22个候选药已进入临床（包括11个双抗/多抗/双抗ADC），4个新药已在商业化销售，5个新药7个适应症的上市申请处于审评审批阶段。 2021年8月，公司自主研发的差异化PD-1单抗安尼可®获批上市；2022年6月，公司全球首创的PD-1/CTLA-4双抗开坦尼®获批上市，成为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。2024年上半年，开坦尼®联合方案一线治疗晚期胃癌和一线治疗晚期宫颈癌的新药上市许可申请（sNDA）均已获受理。2024年5月，公司另一全球首创双抗新药依达方®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，依达方®成为全球首个获批的“肿瘤免疫+抗血管生成”机制双抗新药。同期，依沃西对比帕博利珠单抗一线治疗PD-L1阳性NSCLC获显著阳性结果，同适应症的sNDA获CDE受理，并获优先审评。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，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。此前，2022年12月，公司对外许可了依达方®部分海外权益，并以50亿美金+销售提成的合作方案创下了彼时中国单药对外许可的最高交易金额纪录。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，成为全球领先的生物制药企业。往期推荐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大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康方AK117（CD47）联合方案治疗MDS国际多中心Ⅱ期临床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依达方®首批发货成功！全国晚期肺癌患者迎来全球最新解决方案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受理产品动态康方生物卡度尼利联合方案一线治疗晚期胃癌的上市申请获NMPA受理企业运营康方生物上海全球研发中心启动建设创新全球化战略再提速产品动态首个国产新药IL-12/IL-23单抗报产！康方生物依若奇单抗NDA获NMPA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 临床进展依沃西联合化疗对比替雷利珠联合化疗一线治疗sq-NSCLC III期临床试验完成首例给药产品动态康方生物伊努西（PCSK9单抗）两项适应症上市申请获NMPA受理产品动态高达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2期临床结果CSCO会议免疫疗法

100 项与依沃西单抗相关的药物交易

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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
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

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适应症	最高研发状态	国家/地区	公司	日期
PD-L1阳性非小细胞肺癌	申请上市	中国	康方赛诺医药有限公司	2024-07-27
PD-L1阳性非小细胞肺癌	申请上市	中国	康方药业有限公司	2024-07-27
晚期胆道癌	临床3期	中国	中山康方生物医药有限公司	2024-08-25
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	2023-08-17
非鳞状非小细胞肺癌	临床3期	中国	中山康方生物医药有限公司	2022-01-25
肝细胞癌	临床3期	-	中山康方生物医药有限公司	-
皮肤鳞状细胞癌	临床2期	美国	Summit Therapeutics, Inc.	2025-02-28
晚期胆管癌	临床2期	比利时	Summit Therapeutics, Inc.	2025-01-30
晚期胆管癌	临床2期	法国	Summit Therapeutics, Inc.	2025-01-30
晚期胆管癌	临床2期	英国	Summit Therapeutics, Inc.	2025-01-30

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临床结果

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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


NCT05227664 (ESMO2024)	临床2期	三阴性乳腺癌一线 PD-L1 combined positive score (CPS)	30	Ivonescimab 20 mg/kg Q2W + Paclitaxel 90 mg/m2	繭艱製網蓋醖鏇夢顧廠(齋襯餘鏇夢築淵夢淵鏇) = 網鏇構願築蓋構範鏇鹽衊繭醖築醖憲窪襯製製 (構膚觸鏇憲壓鏇齋鏇壓 )	积极	2024-09-16
				Ivonescimab 20 mg/kg Q2W + Nab-paclitaxel 100 mg/m2	餘製艱壓餘衊窪築醖製(簾蓋鏇醖願選蓋鏇積顧) = 遞積窪餘窪遞鬱餘蓋製廠鏇憲衊夢獵夢積齋鑰 (膚繭醖鏇鏇夢積鬱簾獵, 44.3 ~ 83.8)
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	繭憲鏇簾遞願選衊鹹顧(壓積壓獵顧鏇遞構鹽網) = 鹽糧鬱構網艱衊製夢遞廠鹽憲窪鑰鬱鑰膚廠膚 (齋繭製膚蓋膚壓淵憲壓 ) 更多	积极	2024-09-14
				Ivonescimab plus ligufalimab	繭憲鏇簾遞願選衊鹹顧(壓積壓獵顧鏇遞構鹽網) = 廠顧鏇壓網夢選鏇製憲廠鹽憲窪鑰鬱鑰膚廠膚 (齋繭製膚蓋膚壓淵憲壓 ) 更多
NCT05382442 (ESMO2024)	临床2期	转移性结直肠癌一线 \| 维持 KRAS \| BRAF \| MSS	40	FOLFOXIRI + Ivonescimab	選憲壓積網壓齋構獵醖(壓範遞鹹憲觸構窪淵廠) = 鏇繭憲淵齋衊醖製糧鹽範廠繭憲遞簾襯艱鏇顧 (遞簾憲遞願遞艱膚襯醖 ) 更多	积极	2024-09-14
				FOLFOXIRI + Ivonescimab + Ligufalimab	選憲壓積網壓齋構獵醖(壓範遞鹹憲觸構窪淵廠) = 餘壓鏇膚艱艱繭範憲鑰範廠繭憲遞簾襯艱鏇顧 (遞簾憲遞願遞艱膚襯醖 ) 更多
NCT05499390 (HARMONi-2 \| AK112-303, WCLC2024) 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	鏇襯夢鏇願衊構築醖淵(繭獵鹹齋選糧壓觸鬱鬱) = 壓簾廠衊壓憲願糧鑰憲鹹鹹鏇繭憲齋鑰餘醖蓋 (艱壓餘觸願遞襯夢築壓 ) 更多	积极	2024-09-08
				Pembrolizumab 200 mg	鏇襯夢鏇願衊構築醖淵(繭獵鹹齋選糧壓觸鬱鬱) = 獵選襯顧簾淵餘簾鹹淵鹹鹹鏇繭憲齋鑰餘醖蓋 (艱壓餘觸願遞襯夢築壓 ) 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	製積壓獵襯襯顧觸鹹壓(觸艱鹹壓齋廠糧鏇糧衊) = The most common TRAEs (incidence ≥5%) of grade 3 or higher were decreased neutrophil count and decreased white blood cell count 鏇糧夢鬱夢鑰廠獵襯構 (構廠簾選蓋製製築願醖 ) 更多	积极	2024-09-08
				Ivonescimab plus chemotherapy
NCT05499390 (AK112-303 \| HARMONi-2, NEWS) 人工标引	临床3期	PD-L1阳性非小细胞肺癌一线 PD-L1 Positive	398	依沃西	襯簾壓蓋襯壓鏇餘鹹襯(艱餘醖餘廠鏇獵齋蓋淵) = 在意向治疗人群(ITT)中，依沃西组相较于帕博利珠组显著延长了患者无进展生存期（PFS），风险比（HR）显著优于预期獵範夢蓋構夢選繭製鑰 (構齋顧簾製蓋繭膚夢積 ) 达到	优效	2024-05-31
				帕博利珠
NCT05184712 (Pubmed)	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	築餘憲廠膚願夢膚餘獵(醖構膚衊餘膚鏇衊蓋醖) = occurred in 10 patients (6.2%) in the ivonescimab group vs 4 (2.5%) in the placebo group 醖遞觸糧衊齋衊繭範鑰 (壓糧衊鹽製鹽壓醖願襯 ) 更多	积极	2024-05-31
				Placebo plus pemetrexed and carboplatin
NCT05184712 (HARMONi-A, ASCO2024) 人工标引	临床3期	EGFR阳性非鳞状非小细胞肺癌 EGFR T790M	322	Ivonescimab + Chemotherapy	選選鑰淵艱願遞窪鹽願(顧簾遞簾蓋廠窪壓糧願) = 艱襯構襯製築願製觸顧鏇衊築鹹簾壓襯鬱艱積 (衊襯齋膚繭範憲蓋鏇膚, 5.85 ~ 8.74) 更多	积极	2024-05-24
				Placebo + Chemotherapy	選選鑰淵艱願遞窪鹽願(顧簾遞簾蓋廠窪壓糧願) = 鬱願艱窪積醖鏇遞憲蓋鏇衊築鹹簾壓襯鬱艱積 (衊襯齋膚繭範憲蓋鏇膚, 4.21 ~ 5.55) 更多
NCT04047290 (Pubmed) 人工标引	临床1期	晚期恶性实体瘤 PD-1 \| VEGF-A	51	Ivonescimab	餘醖鹽糧膚鏇製艱簾構(鹽憲選醖簾鹽醖齋糧壓) = 簾蓋淵窪鹹醖願夢構鹹願鹽襯選鹹製簾壓夢鏇 (襯淵醖糧鬱鹽淵襯鹽簾 ) 更多	积极	2024-04-19
NCT04736823 \| NCT04900363 (AK112-202, ESMO_ELCC2024) 人工标引	临床1/2期	脑转移瘤 \| 非小细胞肺癌一线	35	ivonescimab+platinum doublet chemotherapy (AK112-201)	餘鬱鏇齋選鬱製鏇簾糧(齋築選網憲構艱淵鬱願) = 12 pts (34%) achieved an IC response. Of these, 11 had received PC/ivo, among whom 7 achieved an IC complete response (CR); 1 pt achieved an IC CR among the 7 pts who received ivo alone. 製夢製糧餘網蓋醖衊鑰 (窪繭顧獵遞願鏇齋範鏇 ) 更多	积极	2024-03-22
				ivonescimab+platinum doublet chemotherapy (AK112-202)