This is a Single-center, Single-arm, Phase II, Prospective Clinical Study Planning to Enroll 30 Patients With Advanced Renal Cell Carcinoma. Eligible Patients, After Signing the Informed Consent Form and Passing the Screening Process, Will Receive Envafolimab + Axitinib Treatment Until Disease Progression or Intolerable Toxicity (Treatment Duration Not Exceeding 24 Months). Clinical Tumor Imaging Assessments Will be Conducted Every 12 Weeks During the Treatment Process According to the RECIST V1.1 Criteria. Safety Will be Assessed Using CTCAE 5.0, With Adverse Events Recorded From Each Treatme

Introduction:
This document explains a clinical research study conducted at Peking Union Medical College Hospital. The study aims to evaluate a new combination treatment - Envafolimab (an immunotherapy) and Axitinib (a targeted therapy) - for patients newly diagnosed with advanced kidney cancer (specifically, clear cell Renal Cell Carcinoma or RCC). This information is designed to help patients, their families, and healthcare providers understand the study's purpose, procedures, potential benefits and risks, and what participation involves.
1. What is the Study About?
* The Problem: Advanced kidney cancer (RCC) that has spread (metastatic) or cannot be removed by surgery (unresectable) is challenging to treat. While treatments exist, researchers are always looking for more effective and manageable options, especially for patients who haven't had prior systemic (whole-body) anti-cancer therapy.
* The New Approach: This study combines two types of drugs:
* Envafolimab: An "immunotherapy" drug given as an injection under the skin (subcutaneous). It works by blocking a protein called PD-L1 on cancer cells or immune cells. Blocking PD-L1 helps the patient's own immune system recognize and attack the cancer cells more effectively.
* Axitinib: A "targeted therapy" drug taken as a pill twice daily. It works by blocking signals (VEGF receptors) that cancer cells use to grow new blood vessels, essentially starving the tumor of its blood supply.
* The Goal: To find out if giving Envafolimab and Axitinib together is safe and effective as the first treatment for patients with advanced kidney cancer. Researchers want to see how well the combination shrinks tumors, controls the cancer, and how long patients live without their cancer getting worse, while carefully monitoring side effects.
* Study Design:
* Phase II: This is an early stage of testing in patients, focusing mainly on how well the treatment works and its safety profile in a specific group.
* Single-Arm: All participants in this study will receive the same combination treatment (Envafolimab + Axitinib). There is no separate group receiving a different treatment or placebo for comparison in this particular study.
* Single-Center: Currently being run at Peking Union Medical College Hospital (but could potentially expand).
* Participants: Plans to enroll about 30 patients.
* Treatment Duration: Patients receive treatment as long as it's working (tumor isn't growing) and they can tolerate the side effects, for up to a maximum of 2 years.
2. Key Information for Patients & Families:
* Who Might Qualify? You may be eligible to participate if you:
* Are between 18 and 75 years old.
* Have been diagnosed with advanced clear cell kidney cancer (unresectable or metastatic).
* Have NOT received any prior systemic anti-cancer treatment (like chemotherapy, immunotherapy, or other targeted therapies) for your advanced kidney cancer.
* Have tumors that can be measured on scans (CT or MRI).
* Are relatively active and able to care for yourself (ECOG performance status 0 or 1: meaning you are either fully active or restricted in physically strenuous activity but ambulatory and able to do light work).
* Have adequate organ function (healthy enough bone marrow, liver, kidneys, heart) as determined by blood tests.
* Are expected to live at least 6 more months.
* Understand the study and agree to follow the procedures and attend all visits.
* Who Would Not Qualify? You would likely not be eligible if you:
* Have another active cancer besides the kidney cancer being studied.
* Have had previous systemic treatment for your advanced kidney cancer.
* Have known severe allergies to similar drugs or components of Envafolimab/Axitinib.
* Have an active autoimmune disease needing strong medication (like high-dose steroids or immunosuppressants) within the last 2 years. (Hormone replacements like thyroid meds are okay).
* Are taking high-dose steroids (except inhaled/nasal) or other immune-suppressing drugs shortly before starting.
* Are using traditional Chinese medicine or immunomodulators within 2 weeks before joining.
* Have serious uncontrolled heart problems (like recent heart attack, severe heart failure, unstable angina, significant irregular heartbeats).
* Have uncontrolled fluid build-up needing drainage (like large amounts of ascites or pleural effusion).
* Are pregnant, breastfeeding, or unwilling to use highly effective contraception during the study and for 6 months after.
* Have significant psychiatric, substance abuse, or other medical/social issues that the research team believes would interfere with the study.

开始日期2025-09-01

申办/合作机构

北京协和医院

NCT07142863

/ Not yet recruiting临床2期IIT

Single-arm Prospective Clinical Study of PD-L1 Antibody Envafolimab Combined With Neoadjuvant Chemotherapy in Patients With Stage IIb Resectable Osteosarcoma

Given that osteosarcoma typically presents at an early age and predominantly affects pediatric and adolescent populations, early control of disease progression and the opportunity for complete tumor resection are particularly crucial. Postoperatively, patients can regain functional mobility through prosthetic implantation and artificial joint reconstruction, thereby preventing premature loss of mobility in young patients. This study aims to explore the efficacy and safety of neoadjuvant treatment with the PD-L1 antibody envafolimab in combination with standard chemotherapy in patients with resectable stage IIb osteosarcoma, and to assess whether this combined regimen can increase the proportion of patients achieving complete tumor resection.

开始日期2025-08-25

申办/合作机构

上海市第一人民医院

NCT06772233

/ Not yet recruiting临床2期IIT

A Phase II, Open-label, Multicenter, Randomized Controlled Clinical Trial Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment.

This study is a multicenter, prospective, randomized controlled Phase II clinical trial. The primary endpoint is to evaluate the efficacy and safety of regorafenib combined with envafolimab compared to physician's choice in patients with metastatic gastrointestinal stromal tumors harboring KIT exon 17 mutations who have failed standard treatments.

开始日期2025-07-30

申办/合作机构

北京大学

100 项与恩沃利单抗相关的临床结果

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100 项与恩沃利单抗相关的转化医学

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100 项与恩沃利单抗相关的专利（医药）

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项与恩沃利单抗相关的文献（医药）

2025-09-01·JOURNAL OF CONTROLLED RELEASE

A super-long-acting anti-PD-L1 nanobody fused to elastin-like polypeptide for triple-negative breast cancer immunotherapy

Article

作者: Gao, Weiping ; Yang, Zhaoying ; Zhang, Fan ; Sun, Yuanzi ; Yao, Qiongqiong

The limited tumor penetration of monoclonal antibodies or the rapid renal clearance of nanobodies hamper their application in cancer immunotherapy. Through genetic engineering, we fuse a thermosensitive elastin-like polypeptide of ELP(V) with a nanobody of KN035 that binds specifically to human programmed cell death protein ligand 1 (PD-L1) to generate a conjugate of KN035-ELP(V) for triple-negative breast cancer (TNBC) therapy. The high affinity of KN035-ELP(V) enables it to efficiently block the interaction of PD1 and PD-L1. A single intraperitoneal administration of KN035-ELP(V) leads to the in situ generation of a sustained-release depot, showing a circulating half-life that is 276.4-fold and 5.1-fold longer than those of KN035 and KN035 fused with fragment crystallizable (KN035-Fc), respectively. Additionally, KN035-ELP(V) outperforms KN035 and KN035-Fc in term of accumulation and penetration in tumor tissue. Compared to KN035 and KN035-Fc treatments, a single injection of KN035-ELP(V) induces a durable and efficient antitumor immunity in TNBC-bearing mice, resulting in improved anti-tumor efficacy with reduced adverse effects. Therefore, KN035-ELP(V) is promising as a super-long-acting anti-PD-L1 nanobody for efficient cancer immune checkpoint blockade therapy.

2025-09-01·ONCOLOGIST

Combination therapy for platinum-resistant ovarian cancer: a novel at-home regimen with envafolimab, lenvatinib, and etoposide

Article

作者: Ji, Feng ; Lin, Hao ; Ding, Bo ; Shen, Yang ; Xu, Jingyun ; Zhao, Xiang ; Yu, Tianxiang ; Qiu, Shanhu ; Zheng, Shiya

Abstract:

Background:

Effective and tolerable treatment for patients with platinum-resistant recurrent ovarian cancer remains a great challenge in clinical practice. This study aimed to evaluate the efficacy and safety of envafolimab, the first subcutaneously administered programmed death ligand 1 (PD-L1) inhibitor, combined with lenvatinib and etoposide in patients with platinum-resistant recurrent ovarian cancer.

Methods:

This was an open-label, single-arm, phase 2 trial (ENLEN-OC-001). Patients with platinum-resistant recurrent ovarian cancer were eligible for inclusion who were administered envafolimab subcutaneously on day 1 and lenvatinib and etoposide orally on days 1-14, with 21 days as a cycle. After 6-10 cycles, envafolimab and lenvatinib were taken as maintenance therapy until intolerable toxicity, disease progression, withdrawal of consent, or finishing 24 months of treatment. The primary endpoint was objective response rate (ORR), and the secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

Results:

Of the screened 28 patients, 21 were included, with 18 being assessed for the efficacy and safety. The ORR was 44.4% (95% CI 21.5%-69.2%), and the DCR was 83.3% (95% CI 58.6%-96.4%). The median PFS was 10.2 months (95% CI 5.6-not applicable [NA]), and the median OS was 21.3 months (95% CI 6.8-NA). The most common grade 3/4 adverse events were leukopenia (27.8%) and thrombocytopenia (16.7%). No serious adverse events or treatment-related deaths were reported. No changes were observed in the depression, anxiety, and quality of life following treatment.

Conclusion:

Envafolimab combined with lenvatinib and etoposide showed promising efficacy and tolerable safety for patients with platinum-resistant recurrent ovarian cancer.

ClinicalTrials.gov identifier:

NCT05422183

2025-06-01·Thoracic Cancer

Safety and Efficacy of the First Subcutaneous ICI, Envafolimab, in the Treatment of Advanced Lung Cancer Patients: A Real‐World Study

Article

作者: Zhang, JieLi ; Wang, Hanping ; Yang, Yulong ; Zhang, Xiaotong ; Rui, Meng ; Si, Xiaoyan ; Zhou, Yunzhi ; Zhang, Li ; Wang, Mengzhao ; Zhao, Qiuhong ; Dou, Zixuan ; Cui, Xiaoxia ; Wang, Li

ABSTRACT:

Background:

Envafolimab is a novel immune checkpoint inhibitor (ICI) with several advantages due to its subcutaneous administration. Phases I and II randomized controlled trials have demonstrated promising efficacy in treating colorectal and gastric cancer. However, the safety and efficacy of Envafolimab in patients with advanced lung cancer remain to be investigated.

Methods:

This retrospective, multicenter, open‐label, single‐arm cohort study examined real‐world medical data from patients treated at four medical centers to assess the safety and efficacy of Envafolimab in treating patients with advanced lung cancer. The primary safety outcome was Envafolimab‐related treatment‐emergent adverse events (TEAEs) and immune‐related adverse events (irAEs). The primary efficacy outcomes included overall survival (OS) and progression‐free survival (PFS). Then, the relationship between clinical parameters and prognosis was investigated using univariate and multivariate regression analyses. Furthermore, the impact of tumor EGFR driver mutation status and PD‐L1 expression on prognosis was explicitly explored in patients with nonsmall‐cell lung cancer (NSCLC).

Results:

The cohort comprised 58 patients with a median follow‐up time of 8.3 months (from March 1, 2022, to March 7, 2024). Envafolimab‐related TEAEs and irAEs were observed in 53.4% and 27.6% of patients, respectively. No specific clinical factors were identified as being associated with irAEs. The median OS was 8.5 months (95% confidence interval [CI] 6.2–10.8), and the median PFS was 6.1 months (95% CI 3.8–8.3). For 47 patients with NSCLC, factors including ECOG PS > 2 (HR: 2.91, p = 0.015), Stage IV tumor (HR: 3.43, p = 0.043), and nonfirst‐line Envafolimab treatment (HR: 3.27, p = 0.026) were associated with poor prognosis.

Conclusion:

Envafolimab demonstrates a tolerable safety profile and favorable efficacy. With its subcutaneous formulation, Envafolimab shows promising potential for treating advanced lung cancer.

587

项与恩沃利单抗相关的新闻（医药）

2025-10-16

·江苏康宁杰瑞生物制药有限公司

世界乳腺癌防治月 | 以创新之力守护生命之花

世界乳腺癌防治月 Breast Cancer Awareness Month 乳腺癌（Breast Cancer）是一种起源于乳腺上皮细胞异常增殖的疾病，是全球也是中国女性群体中最常被诊断出的恶性肿瘤。据国际癌症研究机构（IARC）2024年发布的数据，2022年全球乳腺癌新发病例数高达231万，中国新发病例数达35.7万，严重威胁着患者的身心健康。尽管发病率持续上升，但乳腺癌是可防可治的。控制体重、积极锻炼、减少激素暴露与限制酒精摄入等生活方式的改善，有助于降低患病风险；而“早发现、早诊断、早治疗”更是患者获得长期生存和更好生活质量的关键。每年10月是世界乳腺癌防治月，10月18日被设立为防治乳腺癌宣传日。这项由世界卫生组织倡导的全球行动，旨在提升公众对乳腺疾病的认知，推动科学预防和及时干预。康宁杰瑞密切关注肿瘤领域未满足的临床需求，致力于为患者提供突破性创新药物。在乳腺癌治疗领域，公司自主研发的HER2双特异性抗体药物安尼妥单抗注射液（研发代号：KN026），能同时结合HER2的两个非重叠表位，阻断HER2信号，相较于曲妥珠单抗和帕妥珠单抗联用，安尼妥单抗对HER2阳性肿瘤细胞有更强的抑制杀伤。目前安尼妥单抗针对一线HER2阳性乳腺癌及HER2阳性乳腺癌新辅助适应症的两项Ⅲ期临床研究正在稳步推进。康宁杰瑞基于安尼妥单抗迭代的HER2双抗偶联药物（ADC）JSKN003，设计上进一步践行精准医疗理念，较同类ADC药物，JSKN003具有更好的血清稳定性、更强的旁观者杀伤效应及更好的安全性，有望为存在HER2表达的乳腺癌患者带来新的希望。目前，JSKN003治疗HER2低表达乳腺癌、HER2阳性乳腺癌的两项Ⅲ期临床研究也在顺利开展。展望未来，康宁杰瑞将继续在“健康中国2030”战略指引下，依托自身领先的核心技术平台，拓展具有显著差异化优势的产品管线，深化在乳腺癌领域的药物创新与联合疗法探索，为全球健康事业贡献科技力量。康宁杰瑞是一家以创新驱动、聚焦肿瘤治疗领域的生物制药公司。2019年12月12日，公司在香港联交所主板上市（股票代码：9966.HK）。康宁杰瑞依托自主研发的单域抗体、双特异性抗体、糖基定点偶联、连接子载荷、双载荷偶联及高浓度皮下制剂等核心技术平台，构建了具有差异化创新和国际竞争力的产品矩阵，覆盖抗体偶联药物（ADC）、双抗及单域抗体等前沿领域。公司已有1款产品获批上市，恩沃利单抗注射液KN035（商品名：恩维达®，全球首个皮下注射PD-(L)1抑制剂），在肿瘤治疗的便捷性和可及性上做出了重大突破；HER2双抗KN026（安尼妥单抗注射液）针对二线及以上HER2阳性胃癌的上市申请已获国家药品监督管理局（NMPA）受理；4款双抗ADC药物已进入临床阶段，并且正快速推进以双载荷ADC为代表的下一代ADC新药管线。目前公司已与石药集团、ArriVent、Glenmark等合作方达成多项针对产品或技术平台的战略合作。 “康达病患，瑞济万家”。康宁杰瑞致力于解决未满足的临床需求，开发高效、安全、具有全球竞争优势的抗肿瘤药物，以“中国智造”的抗癌方案惠及全球患者。欢迎访问公司网站：www.alphamabonc.com 前瞻性陈述本新闻稿包含与我们未来业务、财务表现和涉及康宁杰瑞未来事件相关的声明，这些声明或构成前瞻性陈述。此类陈述包括预测和估计及关联的基本假设、有关潜在可能性的计划和期望的陈述，以及有关未来活动、运营及表现的陈述。这些陈述或可用诸如"预期"、"期待"、"预计"、"打算"、"计划"、"相信"、"寻求"、"估计"、"将"或类似含义的词语来标识。此类陈述基于康宁杰瑞管理和业务运营的当前某些假设，且受包括但不限于政治、经济、法律环境和商业环境等多种风险和不确定性的影响，康宁杰瑞的实际经营结果、表现或业绩可能较相关前瞻性陈述中明确或暗含的描述呈现（正面或负面）变化。除适用法律的要求外，无论出于新信息、未来事件还是其他原因，康宁杰瑞均无义务公开更新任何前瞻性陈述，且不为无法实现该等前瞻性陈述而承担责任。医药信息声明康宁杰瑞不推荐任何已获批或正在研发的药品/适应症临床使用，本文所包含的任何信息不应被看作是任何药物的申请、推广或广告。

临床3期抗体药物偶联物

2025-10-09

·生物制药小编

未来纳米抗体的专利战可能往在这个方向打

纳米抗体（Nbs）是从骆驼科动物或某些软骨鱼类的重链抗体中提取的单域抗体片段（VHH）。与传统抗体相比，Nbs 具有体积小、稳定性高、亲和力强、易改造等优势，尤其在靶向传统抗体难以触及的表位方面表现突出。自2018年起，已经有多个纳米抗体药物或相关药物获批上市（如赛诺菲的Caplacizumab、康宁杰瑞的Envafolimab、Ablynx的Ozoralizumab、传奇生物的Cilta-cel）。不过，对于其技术发展的未来方向和流行趋势比较缺乏了解。近日，一组来自重庆理工大学，澳门大学，大连医科大学的联合研究团队通过对BCMA纳米抗体技术的专利全景分析，试图构建出一副关于BCMA纳米抗体的全景蓝图，通过挖掘专利数据，进一步分析了针对BCMA Nbs的专利序列和结构特性，研究人员认为，这一研究将促进Nbs的药物开发和未来专利战略策略。数据挖掘该研究利用了Derwent Innovation数据库（德温特世界专利索引），通过构建基于纳米抗体及其变体的检索策略，共检索到12,619个DWPI专利家族（59,839条专利记录）。由于一般来说，BCMA相关专利主要涉及自免，癌症和传染病，大多数专利内容归类为治疗、诊断和生产，为了确保尽量消除疫情这个黑天鹅事件而导致的发表偏移，研究人员专门排除了SARS-CoV-2相关的专利。经过系统筛选和过滤后，研究人员最终确定2,812个关键专利家族（15,363条专利记录）用于进一步分析。分析这些专利的数据表明，自从在2018年首个Nb药物获得批准后，专利数量显著增加。Nb相关技术分为九类，大多数专利(93%)与前五类相关:单克隆Nbs、多特异性Nbs、重组蛋白、细胞疗法和基于VHH的缀合物。中国和美国在专利申请数量上领先，是专利出版物的主要目的地，其次是欧洲、日本、澳大利亚和加拿大。（如下图所示）而在主要专利权人方面，Sanofi（2018年赛诺菲39亿欧元收购比利时纳米抗体公司Ablynx）持有最多专利；其他包括GSK、Merck、Legend Biotech等；学术机构如VIB、VUB、Ghent University也占据重要地位。自从比利时科学家Cécile Casterman、Raymond Hamers和Serge Muyldermans发现Nb抗体以来，比利时一直是Nb创新的关键国家。值得注意的是，传奇生物被认为是第九个开发出首个基于VHH的CAR-T细胞疗法的受让人，这代表了基于细胞免疫疗法Nb的重大进步。数据网络分析通过构建专利引用网络，研究还揭示了纳米抗体技术的创新生态和关键专利。比如说，最具影响力（被引用最多）的专利是WO1994004678A1（Nb的原始发现专利），作为纳米抗体技术的奠基性专利，该专利对后续创新产生了深远影响，最初就是由由VUB的Cécile Casterman和Raymond Hamers于1994年提交。后来VUB的技术转化诞生了Ablynx，Ablynx自然也在多项专利的技术流动中处于核心地位。序列特征分析有介于传奇生物基于Nb抗体的BCMA CAR-T已经获批，研究人员认为这一里程碑时刻给了分析BCMA Nbs的必要性，因为这不仅仅是证明了Nbs的治疗潜力，还表明Nbs还可f以再更多领域（细胞治疗）进行应用。研究人员发现，针对BCMA的专利主要集中在单价/多价Nbs和细胞疗法上。这里，他们总共选择了39个BCMA相关序列进行分析。研究表明，这些CAR-T的CDR区存在保守 motifs，这些保守残基可能在抗原结合和结构稳定性中起关键作用。研究人员还比较了序列同一性。他们发现，这样一个有趣的事实，一些具有不同序列的Nbs可能共享相似的结构。这或许是一种有趣的“殊途同归”。在修饰位点分析中，研究人员发现，CDR与FR区域的修饰位点分布存在显著差异。CDR2易发生天冬氨酸异构化（AIS），可能影响结合；FR2易发生甲硫氨酸氧化（MOE），可能影响稳定性。最后研究人员使用了AlphaFold3去预测纳米抗体及其与BCMA抗原的结合模式，预测显示Nb主要结合BCMA的中央结构域（如E12, L18, H19等残基）；由于不同专利中的Nb可能竞争相同表位……所以到时候可能在这些地方出现专利战…… 总结总的来说，这项研究为未来Nbs的专利战可能需要注意的事项提供了先见之明，比如说针对BCMA的专利主要集中在单价/多价Nbs和细胞疗法上。一些企业在Nb上的开发过程中可能需要注意抗原表位的竞争，这关系到对手会不会进行专利战。参考来源： Xu, J., Wang, Y., Yuan, N., Hu, G., & Hu, Y. (2025). Exploring the nanobody patent landscape: a focus on BCMA sequences and structural analysis. mAbs, 17(1). https://doi.org/10.1080/19420862.2025.2560893

免疫疗法细胞疗法并购专利到期上市批准

2025-09-29

·同写意

PD-(L)1江湖，开启技术迭代新赛事

PD-(L)1药物的竞争，已进入下半场。近期，FDA批准了默沙东旗下PD-1抑制剂Keytruda Qlex皮下注射疗法，用于12岁及以上人群，适应症与Keytruda静脉输注制剂已获批的适应症一致。 Keytruda Qlex是由K药（pembrolizumab）和Alteogen开发的透明质酸酶变体berahyaluronidase alfa结合而成的配方，据悉，该剂型的中位注射时间仅需约2分钟。此次批准是基于临床试验MK-3475A-D77的结果，研究显示，在未经治疗的转移性NSCLC患者中，皮下Keytruda Qlex组和静脉输注Keytruda组的ORR分别为45.4% vs 42.1%；mPFS分别为8.1个月vs 7.8个月，两组的mOS均未达到。在Keytruda Qlex之前，全球已有三款皮下PD-(L)1药物获批：罗氏阿替利珠单抗（PD-L1）——Tecentriq Hybreza、BMS纳武利尤单抗（PD-1）——Opdivo Qvantm，以及康宁杰瑞/思路迪的恩沃利单抗（PD-L1）。除此之外，恒瑞医药、百济神州、君实生物等PD-(L)1玩家均有对此布局。除了给药方式的优化外，PD-(L)1的下一步，更是集中在新型药物的迭代上，中国药企在这一方向的进展尤其亮眼。 TONACEA 01 双抗技术带来新的转折点早在PD-(L)1抑制剂出现后，研究者们就发现，单药对肿瘤患者的治疗应答率仅在20%左右。为了突破疗效瓶颈，业界开始探索各种联合方案：PD-(L)1+化疗、PD-(L)1+靶向药物、PD-(L)1+免疫检查点抑制剂等。当这些方案被探索殆尽，双抗技术的崛起，带来了新的转折点。目前，PD-(L)1/VEGF双抗的研发炙手可热，其中突出代表，是康方生物的依沃西单抗（AK112）。基于独特的结构，依沃西单抗连接在Fc部分的VEGF scFv，使整个分子对PD-1的亲和力显著增强超18倍，极大提升了对PD-1/PD-L1信号通路的阻断效果，同时PD-1 Fab也使整个分子对VEGF的亲和力增强超4倍，从而强化了对VEGFR信号通路的阻断能力。在与K药“头对头”的HARMONi-2研究中，针对PD-L1阳性（PD-L1 TPS≥1%）、不伴EGFR突变/ALK重排的晚期NSCLC患者，依沃西单抗凭借显著的PFS获益击败了K药（11.1个月vs 5.8个月），而且在ORR、DCR上均优于K药。凭借扎实的临床疗效，依沃西单抗带火了PD-(L)1/VEGF双抗赛道。目前，全球约有超30款PD-(L)1/VEGF双抗处于研发阶段，其中超75%来自中国。默沙东、辉瑞、BMS等MNC更是通过引进中国管线来快速入局这一赛道，体现了肿瘤免疫治疗进化的新方向。国产PD-(L)1/VEGF双抗出海交易（来源：公开资料） PD-(L)1/VEGF双抗之外，同时靶向4-1BB、TGF-β、CTLA-4的研发也在如火如荼。例如，4-1BB主要表达于活化的cd8+效应T细胞上，作为T细胞共刺激分子，能够重新激活凋亡的T细胞并大量扩增，减少抗原特异性免疫细胞的清除以及增强免疫记忆方面发挥重要作用。 PD-(L)1/4-1BB双抗既可以阻断PD-(L)1免疫抑制通路，又可以通过4-1BB激活免疫细胞，从而达到解除免疫抑制和激活免疫抗肿瘤的协同效应。在此布局的维立志博，旗下LBL-024是一款PD-L1/4-1BB双抗。今年ASCO会议上，维立志博公布了LBL-024联合化疗治疗肺外神经内分泌癌（EP-NEC）一线疗法的Ib/II期临床数据。结果显示，在52例患者中，ORR达到75.0%，DCR高达92.3%；进一步亚组分析显示，泌尿生殖系统NEC、胰腺NEC、SCLC、食管NEC患者ORR分别为100.0%、83.3%、100.0%、77.8%，这一疗效远超传统化疗方案的历史数据（30%-55%）。维立志博之外，国内天境生物、齐鲁制药、普米斯生物、中国生物制药/F-STAR、信达生物、百奥泰等均有相关动作。国内部分在研PD-(L)1/4-1BB双抗（来源：公开资料） PD-(L)1/TGF-β双抗也是一个比较有潜力的组合。今年8月，正大天晴的PD-1/TGF-β双功能融合蛋白TQB2868在国内启动了III期研究，这是全球首个进入III期临床阶段的PD-1/TGF-β双抗，适应症为“癌中之王”胰腺癌。之前的II期临床数据显示，在联合安罗替尼和化疗一线治疗胰腺癌的试验中，中位随访5.9个月时，mPFS和mOS均尚未达到，6个月PFS率和6个月OS率分别为86%和95%。ORR为63.9%（n=36），其中23例患者达到PR，DCR为100%。此外，该联合方案安全耐受性良好。恒瑞医药的SHR-1701是一款PD-L1/TGF-β双抗，在胃癌一线治疗III期研究中，取得了阳性结果，并已向监管部门递交上市申请。华东医药则开发了PD-L1/VEGF/TGF-β三靶点抗体融合蛋白DR30206，I期临床结果显示，DR30206具有明确的作用机制和抑制肿瘤生长的作用，且具有良好的安全性。华东医药之外，国内普米斯生物和启愈生物也布局了PD-L1/VEGF /TGF-β 三靶点靶向药物，目前公开的信息有限。另外，2025年以来，中国在PD-1/CTLA-4双抗领域迎来爆发式进展。 CTLA-4主要在免疫反应早期（主要在淋巴结中）调节T细胞增殖，而PD-1则在免疫反应后期（主要在外周组织中）抑制T细胞，同时抑制这两个靶点，可以增强免疫治疗疗效。因此PD-1/CTLA-4双抗有望通过机制协同和给药优化，在疗效与安全性之间取得更优平衡。今年以来，国内康方生物的卡度尼利单抗、齐鲁制药的QL1706等多款PD-1/CTLA-4双抗药物频频迎来利好。其中，卡度尼利单抗自2025年1月1日起，正式纳入医保；6月，获得NMPA批准，联合含铂化疗±贝伐珠单抗用于持续性、复发性或转移性宫颈癌的一线治疗。 QL1706于今年6月开启了联合贝伐珠单抗一线治疗晚期卵巢透明细胞癌疗效的 III 期临床研究。此前该产品还启动了联合贝伐珠单抗用于肝细胞癌和胃癌的临床研究。双抗之外，基石药业还开发了PD-L1/VEGF/CTLA-4三抗药物CS2009，今年7月，其全球多中心I/II期临床研究在澳大利亚和中国启动。 TONACEA 02 下一个关键力量：PD-L1 ADC 就在双抗研发如火如荼的同时，多款新型ADC产品披露了出色的疗效数据，使得PD-(L)1+ADC组合成为如今热点之一。而创新型PD-L1 ADC药物，自带“IO+ADC双重优势”，成为引领肿瘤免疫治疗变革的下一个关键力量。复宏汉霖的PD-L1 ADC药物HLX43，在今年ASCO会议上展现了硬实力。在难治性肿瘤患者中，HLX43在Phase 1a、Phase 1b均显示高ORR且带来PFS获益的趋势。具体来说，Phase 1a的最终ORR为36.8%（n=21），mPFS为4.2个月；Phase 1b中难治性NSCLC患者的ORR为38.1%（n=21），DCR为81%，mPFS为5.4个月。目前，复宏汉霖正在推动HLX43往前线的治疗。辉瑞的 PD-L1 ADC药物PF-08046054 于今年8月正式启动III期临床试验，成为全球首个迈入III期阶段的PD-L1 ADC。之前研究显示，PF-08046054在1.5mg/kg 剂量下，30例经治NSCLC患者的ORR为 26.7%。目前押注PD-(L)1 ADC赛道的药企不多，且研发仍处于早期阶段，后续行业动态值得持续关注。 TONACEA 03 PD-(L)1激动剂，开启新蓝海 PD-(L)1抑制剂改变了肿瘤治疗格局，另一边，免疫检查点的“一体两面”，也使得PD-1激动剂有望剑指自免大蓝海。目前，全球范围内处于临床阶段的PD-1激动剂并不多。曾经礼来的的PD-1激动剂Peresolimab，一度被给予厚望。在治疗类风湿关节炎（RA）的临床IIa期研究中，Peresolimab达到了主要终点和部分次要终点，但其ACR50（较基线缓解50%人群比例）和ACR70响应方面并无显著优势，并且安全性存疑，最终礼来终止了该药物的研发。不过今年3月，AnaptysBio宣布旗下PD-1激动剂Rosnilimab治疗RA的IIb期临床取得成功，公司股价因此大涨30%。期待后续临床结果能继续保持优异的疗效和安全性。国内金赛药业开发了PD-1激动剂GenSci120，今年1月刚开始临床试验启动，适应症为成人系统性红斑狼疮（SLE）、成人原发性干燥综合征、炎症性肠病和类风湿关节炎。最终PD-1激动剂能否在自免赛道闯出一条路，我们拭目以待。 PD-(L)1靶点经过多年探索，目前在双抗、ADC、激动剂领域仍然是“历久弥新”。同时PD-(L)1成药性的进阶之路，也是中国创新药产业升级的微观映射。在新技术开发上，国内部分药企已实现与国际并跑，创新质量实现了显著跃升，期待中国药企在PD-(L)1竞争下半场早日弯道超车。参考： 1.https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection. 2.Effectiveness of Etoposide and Cisplatin vs Irinotecan and Cisplatin Therapy for Patients With Advanced Neuroendocrine Carcinoma of the Digestive System: The TOPIC-NEC Phase 3 Randomized Clinical Trial. 3.Initial safety and efficacy of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in combination with pembrolizumab in patients with recurrent or metastatic (R/M) HNSCC. doi.org/10.1200/JCO.2025.43.16_suppl.6033.

临床结果上市批准免疫疗法上市后研究临床3期

100 项与恩沃利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15769

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
结直肠癌	中国	四川思路康瑞药业有限公司	2021-11-24
MSI-H 实体瘤	中国	四川思路康瑞药业有限公司	2021-11-24

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
非小细胞肺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2023-11-27
非小细胞肺癌IIIB期	临床3期	中国	四川思路康瑞药业有限公司	2023-11-17
局部晚期直肠癌	临床3期	中国	浙江大学医学院附属邵逸夫医院（浙江省邵逸夫医院）	2023-04-01
胆管癌	临床3期	中国	四川思路康瑞药业有限公司	2018-04-16
胆管癌	临床3期	中国	苏州康宁杰瑞生物科技有限公司	2018-04-16
转移性胆道癌	临床3期	中国	苏州康宁杰瑞生物科技有限公司	2018-04-16
转移性胆道癌	临床3期	中国	四川思路康瑞药业有限公司	2018-04-16
转移性胆囊癌	临床3期	中国	苏州康宁杰瑞生物科技有限公司	2018-04-16
转移性胆囊癌	临床3期	中国	四川思路康瑞药业有限公司	2018-04-16
晚期胆道癌	临床3期	-	思路迪生物医药（上海）有限公司	-

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临床结果

适应症

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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


NCT05422183 (ENLEN-OC-001, Pubmed \| Oncologist)	临床2期	铂耐药性卵巢癌	18	Envafolimab + Lenvatinib + Etoposide	鏇憲壓積艱艱襯遞膚鬱(夢糧鹽鏇範製鏇鏇醖構) = 廠廠壓鹽製觸鑰齋願憲願遞衊鬱鏇簾淵廠襯窪 (壓繭積範衊襯餘積糧願, 21.5 ~ 69.2) 更多	积极	2025-09-01
NCT04891198 (ASCO2025) 人工标引	临床2期	晚期恶性实体瘤 TMB-High	70	Envafolimab (tTMB≥13 mut/Mb)	觸壓積願膚簾構顧鹽網(艱簾願繭廠積簾膚餘糧) = 獵築夢顧鹽製憲糧醖鑰窪廠獵夢醖簾網遞顧顧 (願鹹願艱齋範鏇網憲鹽, 15.6 ~ 55.3) 更多	积极	2025-05-30
NCT04891198 (ASCO2025) 人工标引	临床2期	晚期恶性实体瘤 TMB-High	70	Envafolimab (tTMB<13 mut/Mb)	觸壓積願膚簾構顧鹽網(艱簾願繭廠積簾膚餘糧) = 壓積鹹憲衊鹹夢艱鬱夢窪廠獵夢醖簾網遞顧顧 (願鹹願艱齋範鏇網憲鹽, 0.5 ~ 14.8) 更多	积极	2025-05-30
NCT05243355 (ASCO2025)	临床2期	鳞状非小细胞肺癌一线	33	Envafolimab + Rh-endostatin + Paclitaxel + Cisplatin	膚繭鑰願獵蓋蓋廠構淵(鏇範積憲蓋積簾餘夢構) = 繭膚遞襯淵餘網觸鹹顧構淵鹽網鑰觸餘鬱襯獵 (獵襯願膚繭衊願鑰繭築, 43.0% ~ 83.3%) 更多	积极	2025-05-30
ASCO2025	N/A	晚期恶性实体瘤 dMMR \| microsatellite instability high (MSI-H)	17	Envafolimab monotherapy	醖構願襯顧蓋壓範選鬱(製獵鹽選餘艱糧積繭獵) = 獵範鬱構鬱製齋壓簾襯糧憲襯鏇網廠網衊遞窪 (廠鑰簾鏇糧齋選壓遞淵 ) 更多	积极	2025-05-30
NCT05828381 (Phase II study, ASCO2025)	临床2期	局部晚期食管鳞状细胞癌新辅助	32	Envafolimab + Albumin-bound Paclitaxel + Cisplatin	繭鹽糧簾獵網鏇襯淵積(艱夢繭醖願餘膚製築製) = One patient occurred cerebral hemorrhage 鑰選窪簾構艱鬱選積鏇 (構積憲獵齋繭網餘鬱艱 ) 更多	积极	2025-05-30
NCT05910034 (ASCO2025)	临床2期	非小细胞肺癌二线 PD-1 inhibitors	25	Trilaciclib+Envafolimab+Docetaxel	餘壓選壓製艱範窪窪鏇(齋鏇膚淵構鬱簾壓淵願) = Hematological toxicity occurred in 17/25 (68%) pts during the first cycle, with a lower incidence in cohort A compared to cohorts B and C 鏇艱獵淵鏇築鏇製範糧 (衊鏇壓積齋鹹獵願窪鹽 ) 更多	积极	2025-05-30
NCT05910034 (ASCO2025)	临床2期	非小细胞肺癌二线 PD-1 inhibitors	25	Docetaxel+Envafolimab		积极	2025-05-30
ChiCTR2100044981 (ASCO2025)	临床2期	广泛期小细胞肺癌一线	32	Envafolimab + Carboplatin + Etoposide	鬱夢範製艱淵糧願鏇觸(積鑰糧鹽範顧鹹齋範願) = 製憲鏇憲壓鬱憲膚壓構積衊淵遞構膚鹽襯醖壓 (夢餘鬱齋選醖簾齋鑰淵, 4.83 ~ 7.67) 更多	积极	2025-05-30
NCT06030934 (ASCO_GI2025) 人工标引	临床2期	晚期胃食管交界处腺癌二线 Microsatellite Stable (MSS) \| HER2 Negative	30	Envafolimab + Lenvatinib + Albumin Paclitaxel (Pts who never received PD-1 or PD-L1 inhibitors before)	蓋憲夢獵獵遞簾艱糧願(顧鬱構構膚鬱選襯壓獵) = 蓋憲醖顧鑰願構醖遞窪簾網壓鏇艱選糧鏇顧獵 (廠壓醖構繭製顧齋鏇醖 ) 更多	积极	2025-01-23
NCT06030934 (ASCO_GI2025) 人工标引	临床2期	晚期胃食管交界处腺癌二线 Microsatellite Stable (MSS) \| HER2 Negative	30	Envafolimab + Lenvatinib + Albumin Paclitaxel (Pts have failed first-line PD-1 antibody combined chemotherapy, with optimal efficacy as or above stable disease)	蓋憲夢獵獵遞簾艱糧願(顧鬱構構膚鬱選襯壓獵) = 簾築壓觸繭衊願淵醖鏇簾網壓鏇艱選糧鏇顧獵 (廠壓醖構繭製顧齋鏇醖 ) 更多	积极	2025-01-23
NCT05529355 (ESMO_ASIA2024) 人工标引	临床2期	非小细胞肺癌末线 \| 二线	20	Envafolimab 150mg + Chemotherapy/Anti-VEGF	壓簾繭簾鹹餘鏇構遞範(壓糧蓋壓淵選醖淵範齋) = 鹽廠艱壓築鬱選醖廠願構網醖淵鏇鬱艱築簾醖 (鑰觸遞選蓋積淵壓憲齋 ) 更多	积极	2024-12-07
ChiCTR2200055407 (Pubmed)	临床2期	肝细胞癌一线	36	仑伐替尼+恩沃利单抗	餘鏇窪鹹簾積壓繭願鏇(範窪鹹範網簾膚鹹鬱遞) = 蓋廠鹹齋蓋鬱餘膚製願齋製網衊鏇簾餘網顧鑰 (窪鹽糧夢憲壓顧構襯窪 ) 更多	积极	2024-12-01