恩沃利单抗(Envafolimab) - 药物靶点：PDL1_在研适应症：MSI-H 实体瘤，晚期恶性实体瘤，结直肠癌_专利_临床

概要

基本信息

药物类型

纳米抗体

别名

ASC-22、ASC22、KN-035

+ [2]

靶点

PDL1

作用机制

PDL1抑制剂(程序性死亡配体1抑制剂)

治疗领域

肿瘤消化系统疾病呼吸系统疾病+ [5]

在研适应症

MSI-H 实体瘤晚期恶性实体瘤结直肠癌+ [20]

非在研适应症

子宫内膜癌食管癌脓毒症+ [1]

原研机构

江苏康宁杰瑞生物制药有限公司

在研机构

TRACON Pharmaceuticals, Inc.

江苏康宁杰瑞生物制药有限公司四川思路康瑞药业有限公司

+ [9]

非在研机构

Sun Yat-Sen Memorial Hospital

最高研发阶段批准上市

首次获批日期

中国 (2021-11-24),

晚期恶性实体瘤结直肠癌MSI-H 癌症+ [1]

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (中国)

登录后查看首次获批时间轴

序列信息

Sequence Code 315610456H

来源: *****

关联

91

项与恩沃利单抗相关的临床试验

NCT04910386 / Not yet recruiting临床2期

A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers

This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers

开始日期2024-06-01

申办/合作机构

四川思路康瑞药业有限公司

ChiCTR2400082574 / Suspended临床2期IIT

Envafolimab combined with GM-CSF and Radiotherapy for the Treatment of Patients with Advanced Solid Malignant Tumors: A Single-Arm, Exploratory Study

开始日期2024-04-15

申办/合作机构-

ISRCTN14298588 / Recruiting临床2期IIT

Neoadjuvant envafolimab plus chemotherapy for locally advanced gastric or gastroesophageal junction adenocarcinoma: a single-arm Phase II trial

开始日期2024-02-26

申办/合作机构-

100 项与恩沃利单抗相关的临床结果

登录后查看更多信息

100 项与恩沃利单抗相关的转化医学

登录后查看更多信息

100 项与恩沃利单抗相关的专利（医药）

登录后查看更多信息

17

项与恩沃利单抗相关的文献（医药）

2024-01-01·Theranostics

Imaging diagnosis and efficacy monitoring by [⁸⁹Zr]Zr-DFO-KN035 immunoPET in patients with PD-L1-positive solid malignancies

Article

作者: Huang, Gang ; Zhang, Yu ; Xu, Jianfeng ; Chen, Liping ; Lin, Jianguo ; Hua, Haiying ; Mao, Yong ; He, Huihui ; Xu, Wenhuan ; Xu, Zhenyu ; You, Qingjun ; Fu, Haitian ; Qi, Xiaowei ; Zheng, Qihuang ; Yu, Chunjing ; Chen, Xiaoping

Rationale: Although programmed death-ligand 1 (PD-L1) inhibitors have achieved efficacy in cancer therapy, their response rate is low. Differences in the prognosis of patients with cancer under anti-PD-L1 treatment are related to the PD-L1 level in tumors. Accurate PD-L1 detection can optimize the accuracy of tumor immunotherapy and avoid ineffective clinical diagnosis and treatments. Methods: We investigated the imaging efficiency and therapy monitoring capacity of [⁸⁹Zr]Zr-DFO-KN035 immunoPET for tumors. We labeled the monodomain anti-PD-L1 antibody KN035 with the radionuclide zirconium-89 and used this tracer for PET imaging. [⁸⁹Zr]Zr-DFO-KN035 uptakes in patients with PD-L1-positive tumors, including primary and metastatic tumors, as well as in normal tissues, were comparatively assessed by using positron emission tomography/computed tomography imaging. Results: In PD-L1-positive patients, [⁸⁹Zr]Zr-DFO-KN035 was sensitive in tumor-targeting imaging and could detect multiple metastatic foci, including multiple bone metastases (tumor-to-muscle ratios of 7.102 and 6.118 at 55 and 120 h, respectively) and lymph-node metastases (tumor-to-muscle ratios of 11.346 and 6.542 at 55 and 120 h, respectively). The needed radioactive dose of [⁸⁹Zr]Zr-DFO-KN035 (55.5-92.5 MBq) used in this study was considerably lower than that of [¹⁸F]FDG (370-555 MBq). [⁸⁹Zr]Zr-DFO-KN035 monitored and predicted the site of adverse reactions in antitumor immunotherapy. Moreover, after antitumor treatment, [⁸⁹Zr]Zr-DFO-KN035 enabled observational imaging for therapeutic efficacy evaluation, which can help predict patient prognosis. Conclusion: [⁸⁹Zr]Zr-DFO-KN035 can be used for the diagnosis and therapy monitoring of PD-L1-positive tumors and provide noninvasive and comprehensive observations for tumor diagnostic imaging, prognosis prediction, and efficacy evaluation.

2023-11-23·Zhonghua zhong liu za zhi [Chinese journal of oncology]

[Occurrence of small cell lung cancer after long-term benefit from envafolimab for advanced MSI-H/dMMR colon cancer].

Article

作者: Liu, C ; Meng, F L ; Zhong, D S ; Guan, S S

2023-10-23·Zhonghua zhong liu za zhi [Chinese journal of oncology]

[A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors].

Article

作者: Xu, S Y ; Gong, Z L ; Yang, N ; Zhou, T ; Lin, L Z ; Zhang, Y ; Lu, N ; Gu, S Z ; Zhong, D S ; Xu, J M ; Chen, W C ; Liu, T S ; Liu, R R ; Shen, L

Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.

491

项与恩沃利单抗相关的新闻（医药）

2024-05-09

·Insight数据库

正大天晴 PD-L1 单抗获批上市，联合安罗替尼一线治疗 ES-SCLC

5 月 9 日，据 NMPA 官网显示，正大天晴 1 类创新药 PD-L1 单抗贝莫苏拜单抗（TQB2450）注射液获批上市，联合盐酸安罗替尼胶囊、卡铂和依托泊苷用于广泛期小细胞肺癌（ES-SCLC）患者的一线治疗（受理号：CXSS2300003）。这也是盐酸安罗替尼胶囊在中国获批的第六个适应症。来自：NMPA 官网贝莫苏拜单抗是正大天晴自主研发的一款 PD-L1 单克隆抗体。据 Insight 数据库显示，这款产品在 2017 年 5 月最初申报临床，同年 10 月获批临床，2018 年 4 月首次公示启动临床，并于去年 1 月申报上市。安罗替尼则是正大天晴研发的新型小分子多靶点酪氨酸激酶抑制剂，2018 年 5 月以来已陆续获批晚期非小细胞肺癌、软组织肉瘤、三线小细胞肺癌、甲状腺髓样癌和分化型甲状腺癌等五个适应症。2023 WCLC 大会上公布的一项随机、双盲、平行对照、多中心的 III 期临床试验显示，截至 2022 年 5 月 14 日，入组接受贝莫苏拜单抗联合安罗替尼、卡铂和依托泊苷四药联合方案治疗的 246 例广泛期 SCLC 患者，中位 PFS 达 6.9 个月，中位 OS 达 19.3 个月，而单纯化疗组分别为 4.2 个月和 11.9 个月，差异显著。上述研究是免疫治疗联合化疗基础上增加抗血管药物治疗模式在广泛期 SCLC 治疗中的首次成功，也是目前已公布数据中 mPFS 和 mOS 最长的治疗方案。除小细胞肺癌外，包括子宫内膜癌、肾细胞癌等多个适应症的联用方案也正在开展临床中。其中，贝莫苏拜单抗与安罗替尼联用治疗复发性或转移性子宫内膜癌的适应症也已于今年 2 月申报上市，并被 CDE 纳入优先审评审批程序。此前，据 Insight 数据库显示，全球范围内已有 7 款 PD-L1 单抗（1 类新药）获批上市，包括阿斯利康的度伐利尤单抗（Imfinzi）、罗氏的阿替利珠单抗（Tecentriq）、默克/辉瑞的 Avelumab（Bavencio），以及 4 款国产 PD-L1 单抗，康宁杰瑞/思路迪的恩沃利单抗、基石药业舒格利单抗、李氏大药厂索卡佐利单抗以及恒瑞阿得贝利单抗。在国内，自 2021 年起 PD-L1 单抗逐渐进入爆发期。短时间内一梯队的恩沃利单抗和舒格利单抗先后获批，紧随其后阿得贝利单抗、索卡佐利单抗以及今日贝莫苏拜单抗获批。此外，科伦塔戈利单抗当前处于上市申请阶段（受理号：CXSS2101052），有望今年上半年获批。封面来源：企业 Logo免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：HebePR 稿对接：微信 insightxb投稿：微信 insightxb；邮箱 insight@dxy.cn多样化功能、可溯源数据……Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

优先审批上市批准临床3期申请上市

2024-05-07

·GlobeNewswire-Health Care

TRACON to Report First Quarter 2024 Financial Results and Provide Corporate Update on May 14, 2024

SAN DIEGO, May 07, 2024 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, announced today that it will report its first quarter 2024 financial and operating results after the close of U.S. financial markets on Tuesday, May 14, 2024. In addition, management will host a conference call to provide an update on corporate activities and discuss the financial results. Date:May 14, 2024Time:4:30 pm Eastern Time (1:30 pm Pacific Time)Conference Call:In order to participate in the live conference call, you must register in advance here: registration link. After registering, you will receive an email with dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call. For those not planning to ask a question of management, the Company recommends listening via the webcast.Webcast:https://traconpharma.com/events-presentations/ A replay of the webcast will be available for 60 days on the website. About TRACON TRACON is a clinical-stage biopharmaceutical company utilizing a cost-efficient, CRO-independent, product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; and TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer. TRACON is actively seeking additional corporate partnerships through a profit-share or revenue-share partnership, or through franchising TRACON’s product development platform. TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the United States or who wish to become CRO-independent. To learn more about TRACON and its product pipeline, visit TRACON’s website at www.traconpharma.com. Company Contact:Investor Contact:Charles TheuerBrian RitchieChief Executive OfficerLifeSci Advisors LLC(858) 550-0780(212) 915-2578ctheuer@traconpharma.combritchie@lifesciadvisors.com

临床1期财报临床2期

2024-05-07

·Insight数据库

PD-(L)1 皮下注射剂赛道「狂飙」：BMS 在美报上市，君实拿下国产首个 III 期

5 月 6 日，BMS 宣布 O 药皮下注射制剂生物制品许可申请（BLA）获 FDA 受理，用于 Opdivo 此前批准上市的所有实体瘤适应症，包括单药治疗、联合伊匹木单抗治疗后的单药维持治疗、与化疗或者卡博替尼联合使用。PDUFA 日期为 2025 年 2 月 28 日。来自：BMS 官网O 药皮下注射制剂由纳武利尤单抗与 Halozyme 专有的重组人透明质酸酶 PH20（rHuPH20）组成。此次上市申请主要基于 III 期临床 CheckMate-67T 研究数据，该研究旨在评估 O 药皮下注射对比静脉输注在既往接受过全身治疗的晚期或转移性透明细胞肾细胞癌（ccRCC）患者中的疗效。研究共纳入 495 名受试者，结果显示，与静脉输注相比，皮下注射剂型在 28 天的时间段内平均血清浓度（Cavgd28）和稳态血清低谷浓度（Cminss）指标上表现出非劣效性，达到共同主要终点。在关键次要终点上，皮下注射与静脉注射 O 药在 ORR 方面表现相似，皮下注射组患者 ORR 为 24.2%，而静脉输注组患者的 ORR 为 18.2%。且在安全性方面，皮下注射与静脉输注两者无明显差异。CheckMate-67T 研究结果来自：Insight 数据库网页版相较于静脉注射剂型，皮下注射制剂独具依从性优势，给药快、便捷性高，可将给药时间大幅缩短，从数小时直接压到以分钟计。各大 MNC 最早自 2015 年开始就已经投入 PD-(L)1 皮下注射剂的研发，尤其是本身拥有同靶点已上市产品的企业。布局企业除 BMS 外，还包括默沙东、罗氏等。全球范围内首个获批上市的 PD-L1 单抗皮下制剂是康宁杰瑞/思路迪/先声药业的恩沃利单抗。不过从海外市场来看，罗氏阿替利珠单抗（SC）于去年 8 月在英国批准上市，今年 1 月获欧盟批准；而在美国，由于生产工艺的更新需求，上市时间将推迟至今年。而此次 O 药的申报上市，有望成为首个获批上市的 PD-1 单抗皮下制剂。默沙东 K 药皮下注射制剂已处于 III 期临床阶段，III 期 MK-3475-A86 试验旨在评估皮下给药与化疗联用，对比静脉给药与化疗联用，一线治疗鳞状和非鳞状 NSCLC，已于上个月完成试验主要指标。同时，默沙东还布局了 K 药+透明质酸酶复方制剂皮下注射剂 MK-3475A，正在开展一线治疗 NSCLC 的 III 期 MK-3475A-D77 临床试验，预计于今年 9 月完成主要指标。辉瑞布局的 Sasanlimab 则针对非肌层浸润性膀胱癌正在开展 III 期，预计今年 6 月完成主要指标。国产企业中，百济、恒瑞、君实等均有布局。进展最快的是君实 JS001sc，是在已上市产品特瑞普利单抗注射液的基础上开发的，刚于上个月月底登记启动了 III 期临床试验，一线治疗非鳞 NSCLC（登记号：CTR20241554），成为国产首个进入 III 期临床的 PD-1 单抗。恒瑞 SHR-1901 属于 PD-1 皮下注射剂。2021 年 8 月，SHR-1901 首次在国内获批临床；正在开展 I 期临床试验。百济替雷利珠单抗皮下注射剂同样在开展 I 期临床，一线治疗 NSCLC（登记号：CTR20233814）。封面来源：站酷海洛 Plus免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：HebePR 稿对接：微信 insightxb投稿：微信 insightxb；邮箱 insight@dxy.cn多样化功能、可溯源数据……Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

临床3期上市批准

100 项与恩沃利单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15769

研发状态

适应症	最高研发状态	国家/地区	公司
晚期恶性实体瘤	批准上市	中国更多	四川思路康瑞药业有限公司更多
MMRD实体瘤	批准上市	中国澳门更多	思路迪生物医药（上海）有限公司更多
MSI-H 癌症	批准上市	中国更多	江苏康宁杰瑞生物制药有限公司更多
慢性乙型肝炎	临床2期	中国更多	歌礼生物科技（杭州）有限公司更多
实体瘤	无进展	美国更多	四川思路康瑞药业有限公司更多

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


NCT04480502 (ENVASARC, GlobeNewswire) 人工标引	临床2期	肉瘤	73	Envafolimab (cohort C)	鹹鬱遞鏇獵構膚膚襯餘(膚選願簾鬱壓齋繭廠範) = 餘觸願蓋鹹製築獵膚醖夢築範餘廠觸鹹淵簾廠 (簾顧鏇壓壓簾鬱繭遞壓 ) 更多	积极	2024-04-03
ESMO_ELCC2024 人工标引	临床2期	非小细胞肺癌一线	29	Envafolimab+Rh-endostatin+platinum-based dual-agent chemotherapy	齋憲鑰廠範鑰襯繭簾範(觸齋餘醖製齋觸蓋網鬱) = 壓艱憲廠襯鏇艱艱網憲鹹製淵鬱窪艱壓淵衊襯 (願糧製齋齋艱觸糧鏇壓, 54.3 - 85.3) 更多	积极	2024-03-20
NCT04480502 (ENVASARC, GlobeNewswire) 人工标引	临床2期	恶性纤维组织细胞瘤 \| 粘液样MFH	46	envafolimab 600mg	餘鏇窪壓淵餘積醖壓願(廠蓋蓋構繭齋夢繭願壓) = 選窪構淵網獵構膚鹽憲廠餘構醖艱鏇艱淵範簾 (獵襯膚鑰淵積鬱獵選簾 ) 更多	积极	2023-12-20
PRNewswire 人工标引	临床2期	慢性乙型肝炎	49	ASC22 1.0 mg/kg	觸顧遞鹽獵鹽積醖遞艱(鏇鹹鏇鏇鹹醖鏇鏇獵襯) = the acceptable safety profile 選範窪鹹襯網簾繭蓋淵 (選窪壓憲窪齋衊憲鹹獵 ) 更多	积极	2023-11-12
PRNewswire 人工标引	临床2期	慢性乙型肝炎	49	placebo		积极	2023-11-12
NCT05024214 (ESMO2023) 人工标引	临床1/2期	晚期恶性实体瘤	24	Envafolimab+ Lenvatinib	-	积极	2023-10-23
NCT05024214 (ESMO2023) 人工标引	临床1/2期	晚期恶性实体瘤	24	Envafolimab+ Lenvatinib (PD-(L)1 resistant NSCLC)	簾繭製衊範構選鏇製鬱(壓選觸餘顧鏇範築選觸) = 襯齋選願夢範範夢鹹艱顧鑰蓋夢膚膚淵襯築製 (餘餘淵齋鏇鬱顧醖憲繭, 6.0 ~ 61.0) 更多	积极	2023-10-23
NCT05148195 (ESMO2023) 人工标引	临床2期	非小细胞肺癌二线	40	Envafolimab + Suvemcitug + Docetaxel (IO treated NSCLC)	襯觸積網壓鬱膚遞顧糧(廠蓋壓鑰觸膚鹹鹽簾選) = 糧夢鹹積範壓蓋製顧獵壓淵遞廠夢顧鹹獵鏇鬱 (築網觸獵餘齋獵鹹齋觸 ) 更多	积极	2023-10-23
NCT05148195 (ESMO2023) 人工标引	临床2期	非小细胞肺癌二线	40	Envafolimab + Suvemcitug + Docetaxel (IO naïve NSCLC)	餘範簾糧積膚鏇觸範築(製獵網積網鏇簾壓製鹽) = 鏇齋餘觸糧構鹽夢積願鏇選範餘廠齋鹹築蓋蓋 (窪簾衊鑰壓醖遞糧襯廠 ) 更多	积极	2023-10-23
NCT05148195 (ESMO2023) 人工标引	临床2期	肝细胞癌二线	20	Suvemcitug+envafolimab	顧衊選廠獵衊遞壓鬱壓(齋鹹壓餘簾夢醖鑰廠夢) = 蓋鹹鑰淵衊積糧齋齋淵壓範鹹齋艱淵積構襯鹹 (淵夢願積夢壓選鬱壓醖 ) 更多	积极	2023-10-23
NCT05397769 (ESMO2023) 人工标引	临床2期	晚期鼻咽癌	36	Envafolimab + Gemcitabine + Cisplatin	夢衊鑰糧範襯選繭鏇遞(餘夢窪憲窪餘艱窪繭醖) = 觸製窪襯襯餘齋顧夢壓餘鑰遞淵鹹醖窪蓋鏇齋 (衊壓鏇衊鑰構廠齋鬱築, 85.5 ~ 99.9) 更多	积极	2023-10-22
NCT05148195 (ESMO2023) 人工标引	临床2期	微卫星稳定型结直肠癌 \| 结直肠癌二线 TP53 mutation \| KRAS \| PI3KCA ... 更多	20	Envafolimab + Suvemcitug + FOLFIRI	壓餘顧壓餘構網鬱蓋顧(觸網構淵願膚構顧淵襯) = 遞鹽艱範齋鏇襯壓窪醖繭積衊願餘膚願鹹構遞 (襯廠餘繭淵構壓廠淵齋, 8.7 ~ 49.1) 更多	积极	2023-10-22
NCT05237349 (ASCO2023) 人工标引	临床2期	PD-L1阳性胃腺癌一线 PD-L1 Expression	9	SOX+Envafolimab	餘鏇願繭艱膚網壓蓋艱(製糧鏇繭積窪範夢積積) = 鏇範衊製窪製獵膚鏇憲鏇艱夢簾壓鹽網構範膚 (襯蓋鹹網醖構願顧憲觸 ) 更多	积极	2023-05-31