瑞弗利单抗(Retifanlimab) - 药物靶点：PD-1_在研适应症：肛管鳞状细胞癌，转移性Merkel细胞癌，肛门鳞状细胞癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Retifanlimab (USAN)、RETIFANLIMAB-DLWR、INCMGA-00012

+ [4]

靶点

PD-1

作用方式

抑制剂

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤感染其他疾病+ [6]

在研适应症

肛管鳞状细胞癌转移性Merkel细胞癌肛门鳞状细胞癌+ [52]

非在研适应症

晚期胰腺腺癌肛管癌HER2阳性胃食管交界处癌+ [19]

原研机构

MacroGenics, Inc.

在研机构

MacroGenics, Inc.

Incyte Corp.Incyte Biosciences International SARL

+ [4]

非在研机构

Actuate Therapeutics, Inc.

权益机构

Incyte Corp.Sagard Healthcare Royalty Partners LP

BriaCell Therapeutics Corp.

+ [5]

最高研发阶段批准上市

首次获批日期

美国 (2023-03-22),

转移性Merkel细胞癌

最高研发阶段(中国)临床3期

特殊审评优先审评 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、优先审评 (澳大利亚)、孤儿药 (澳大利亚)

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结构/序列

Sequence Code 12981416H

来源: *****

Sequence Code 13030670L

来源: *****

关联

65

项与瑞弗利单抗相关的临床试验

NCT07468136

/ Not yet recruiting临床1/2期IIT

Phase I/IIa Trial of Retifanlimab and Difluoromethylornithine (DFMO) in Patients With Progressive High-Grade Glioma

This phase I/II trial tests the safety, side effects best dose and effect of retifanlimab with or without difluoromethylornithine (DFMO) for the treatment of high grade gliomas that are growing, spreading, or getting worse (progressive). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. DFMO is in a class of medications called ornithine decarboxylase (ODC) inhibitors. It works by blocking the action of a substance that signals tumor cells to multiply. This helps stop or slow the spread of tumor cells. Giving retifanlimab with or without DFMO mat be safe, tolerable and/or effective in treating patients with progressive high grade glioma.

开始日期2026-04-24

申办/合作机构

Mayo Clinic

NCT07472322

/ Not yet recruiting临床1/2期IIT

UW26001 Phase I/II Study on the Safety, Tolerability, and Preliminary Efficacy of ASTX727 (Decitabine/Cedazuridine) and Retifanlimab-dlwr in Patients With Advanced Merkel Cell Carcinoma Who Have Progressed on Anti-PD-(L)1 Inhibitor

The goal of this clinical trial is to learn if ASTX727 can be combined with retifanlimab to treat Merkel cell cancer. It will also learn about the safety of combining these drugs. The main questions it aims to answer are:
* Can the combination shrink cancer and lower the chance of the cancer growing or spreading?
* Is the combination better than standard of care for Merkel cell cancer?
Participants will:
* Take oral ASTX727 and retifanlimab through a vein in the arm for about 2 years.
* Visit the clinic once every 2 weeks for checkups and tests

开始日期2026-04-01

申办/合作机构

University of Wisconsin-Madison

NCT07425054

/ Not yet recruiting临床2期IIT

ctHPVDNA Adapted ChemoRadiation +/- Retifanlimab Treatment in Locally-Advanced Anal Cancer (CHART-AC)

This study is for people who have anal cancer and have not yet had treatment. The regular treatment for people who have anal cancer is chemoradiation therapy (CRT). CRT is when chemotherapy and radiation therapy are given at the same time. Studies show that CRT works well to treat anal cancer and prevents many people from needing surgery which may require a colostomy bag. Doctors know that CRT is an effective way to treat anal cancer. But, they are doing studies to find out how much dose of radiation and chemotherapy should be given during the CRT. Higher doses of chemotherapy and radiation could increase the risk of side effects, but lowering the dose of chemoradiation has the risk of not being as effective to treat the cancer. One way to predict whether participants need higher or lower doses of radiation therapy is to do a blood test called ctDNA (circulating tumor DNA) to test for the presence of human papillomavirus (HPV). This test is done at certain times while participants are getting CRT. This has been shown to be a marker for the presence of anal cancer.
In this study, doctors will tailor lower versus higher doses of CRT based on the tumor response that is measured by ctDNA. The purpose of this study is to see if customizing the dose of chemoradiation based on the amount of ctDNA will increase survival in participants with anal cancer and/or decrease the risk of side effects. Some participants in this study whose cancer does not respond as well to the CRT may have the opportunity to receive a drug called Retifanlimab that stimulates the body's immune system. Retifanlimab is approved by the Federal Drug Administration (FDA) for treating anal cancer that is recurrent or metastatic since there is proven benefit in these situations.

开始日期2026-03-01

申办/合作机构

The Case Comprehensive Cancer Center

[+1]

100 项与瑞弗利单抗相关的临床结果

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100 项与瑞弗利单抗相关的转化医学

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100 项与瑞弗利单抗相关的专利（医药）

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25

项与瑞弗利单抗相关的文献（医药）

2026-03-16·Future Oncology

Avelumab real-world use in advanced Merkel cell carcinoma: a systematic review and non-comparative meta-analysis

Review

作者: Moradian, Hoora ; Freitag, Andreas ; Rutherford, Megan ; Kearney, Mairead ; Kwon, Christina ; Lan, Zhiyi

AIM:

Programmed death (ligand) 1 inhibitors (e.g., avelumab, pembrolizumab, and retifanlimab) are first-line treatment options for patients with locally advanced or metastatic Merkel cell carcinoma (MCC). In the absence of comparative and randomized trials, we aimed to systematically identify and synthesize real-world evidence (RWE) on the effectiveness and safety of immunotherapies in patients with advanced MCC.

METHODS & MATERIALS:

MEDLINE and Embase searches were conducted for observational RWE studies in locally advanced or metastatic MCC from January 2017 to December 2023. Avelumab was the only immunotherapy with sufficient data for analysis. Landmark 12-month overall survival (OS) and progression-free survival (PFS) were assessed by meta-analysis.

RESULTS:

Screening of 1731 records identified 37 publications eligible for inclusion (16 unique studies), of which eight were included in the meta-analysis. In line with results from the JAVELIN Merkel 200 trial, pooled 12-month OS rates of 77.7% in stage III and 63.0% in stage IV MCC and 12-month PFS rates of 53.3% and 39.3%, respectively, were estimated. Although safety data were insufficient for meta-analysis, two retrospective studies reported lower adverse event rates than JAVELIN Merkel 200.

CONCLUSIONS:

The results of this study support broader use of avelumab in advanced MCC.

2026-03-01·International Journal of Clinical Oncology

PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in Japan; imlunestrant for breast cancer, tafasitamab for follicular lymphoma, atezolizumab for thymic carcinoma, retifanlimab for anal canal squamous cell carcinoma, and tagraxofusp for blastic plasmacytoid dendritic cell neoplasm

作者: Matsumura, Noriomi

2026-02-01·Cancer research communications

Tumor and Immune Dynamics Following Sequential CDK4/6 and PD-1 Inhibition: Results from a Phase 2 Study in Dedifferentiated Liposarcoma

Article

作者: Reed, Damon R. ; Adamow, Mathew ; D’Angelo, Sandra P. ; Tap, William D. ; Movva, Sujana ; Wong, Phillip ; Avutu, Viswatej ; Desir, Rhoena ; Biniakewitz, Matthew ; Keohan, Mary Louise ; Lefkowitz, Robert A. ; Singer, Samuel ; Chi, Ping ; Koff, Andrew ; Erinjeri, Joseph P. ; Maki, Robert G. ; Kelly, Ciara M. ; Antonescu, Cristina R. ; Bradic, Martina ; Seffar, Evan ; Lee, Jasme ; Shen, Ronglai ; Chan, Jason E. ; Rosenbaum, Evan ; Gularte-Mérida, Rodrigo ; Dickson, Mark A. ; Qin, Li-Xuan ; Banks, Lauren B. ; Gounder, Mrinal M. ; Panageas, Katherine S.

Abstract:

Purpose::

The CDK4/6 inhibitor palbociclib delays progression in patients with advanced dedifferentiated liposarcoma (DDLPS). In carcinoma models, CDK4/6 and PD-1 inhibition induce intratumoral inflammation and synergistic activity. Comprehensive assessment of tumor and host dynamics is needed to understand response and resistance to this combination.

Patients and Methods::

We performed a phase 2 study of palbociclib and the PD-1 inhibitor retifanlimab in advanced DDLPS. Palbociclib was administered 2 weeks prior to retifanlimab. Tumor biopsies were analyzed by single-cell RNA sequencing (scRNA-seq), and peripheral blood by high-parameter flow cytometry. Analyses focused on cell cycle, senescence, and immune-related changes.

Results::

Twelve patients were treated before the study was halted because of a 42% immune-related toxicity rate. The overall response rate was 8.3%, and the disease control rate was 75%. Median progression-free and overall survival rates were 7.1 and 26.8 months, respectively. Nine patients had at least one tumor biopsy analyzed; three had paired. Ten patients had paired blood samples analyzed. Following treatment, tumor cells demonstrated decreased cycling and increased cell-cycle checkpoint activity. Transcriptional scores for senescence increased in cancer cells, as did the proportion of intratumoral T and B cells. A cluster of cells emerged with upregulated cell-cycle genes and downregulated HLA class I, suggesting innate or acquired resistance to treatment. In blood, a subset of CD4+ T cells decreased, whereas expression of LAG-3, ICOS, and CD38 increased in select subsets.

Conclusions::

A palbociclib lead-in prior to retifanlimab had a high rate of immune-related toxicities. Correlative analyses identified changes in tumor and immune cells attributable to treatment. A study of concurrent dosing of the combination is ongoing.

Significance::

In this phase 2 study of palbociclib and retifanlimab, treatment led to immune-related adverse events, halting enrollment. scRNA-seq and flow cytometry revealed cell-cycle suppression, senescence, and T-cell changes. These findings highlight the rationale for this combination and the need for safer dosing strategies in larger cohorts.

209

项与瑞弗利单抗相关的新闻（医药）

2026-03-13

·FiercePharma

FDA fires off another manufacturing-related CRL, this one to Hyloris

The FDA has issued a complete response letter, rejecting Hyloris Pharmaceuticals' antiviral valacyclovir. Last month, the company said its manufacturing facility in Greece did not meet current good manufacturing practice standards according to the FDA. The FDA has rejected Hyloris Pharmaceuticals antiviral valacyclovir, an oral suspension for infections caused by herpes simplex and varicella zoster viruses. In a complete response letter (CRL), the FDA said it identified issues in an inspection of Hyloris’ third-party manufacturer. The U.S. regulator did not specify the problems in the CRL, explaining that they were itemized to a representative of the production facility.The CRL was not a surprise. In a release last month, Belgium-based Hyloris explained (PDF) that the FDA had assigned an official action indicated (OAI) classification to the Greek facility after an inspection. An OAI is the most severe of three FDA inspection classifications, indicating that the plant does not meet current good manufacturing practice (cGMP) standards and requires significant corrective actions.“The manufacturer has a well-established track record of pharmaceutical production and supply, serving multiple clients in regulated markets, including the U.S.,” Hyloris explained in February of the plant. “Following the inspection outcome, the manufacturer has paused the manufacturing of products destined for the U.S. while currently still producing oral dosage forms for markets outside of the U.S.”Hyloris added in February that it was working on a “manufacturing solution” for the product. The original target date for an FDA decision was in October. In the CRL, the FDA said it would need to conduct a cGMP inspection plus a preapproval inspection before approving its new drug application. Additionally, the CRL spelled out that Hyloris needed to provide more safety information from all clinical and nonclinical studies of valacyclovir in all the indications in which it has been tested.Three decades ago, GSK scored FDA approval of Valtrex, a tablet form of valacyclovir, for treating herpes zoster, with subsequent nods to include genital herpes and cold sores. It became available as a generic treatment in 2010. In 2022, the FDA rejected (PDF) another Hyloris candidate because of a packaging problem. A year later, the U.S. regulator signed off on Maxigesic IV, an intravenous post-surgery pain relief medicine. The FDA has sent out several manufacturing-related CRLs recently, including at least two on Feb. 27. One was to Ferring Pharmaceuticals for its human recombinant follicle stimulating hormone Rekovelle. Another was to Incyte for its PD-1 inhibitor Zynyz. The rejection was over inspection findings at its third-party fill-finish facility, a former Catalent plant in Bloomington, Indiana, which is now owned by Novo Nordisk. The massive plant has been cited in several CRLs over the last several months.

上市批准

2026-03-12

·allsci.com

Incyte receives CRL for Zynyz in metastatic lung cancer due to manufacturing facility issues

Incyte Corporation disclosed in a SEC filing dated March 6, 2026, that the US FDA issued a Complete Response Letter (CRL) on February 27, 2026, for the supplemental Biologics License Application for Zynyz (retifanlimab-dlwr) injection (375 mg). The sBLA sought approval for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) in combination with platinum-based chemotherapy. The application was supported by data from the Phase III POD1UM-304 trial, results of which were announced in December 2024. The CRL cited inspection findings in relation to the drug’s manufacturing site as the sole approvability issue, based on a visit to Catalent Indiana, LLC, a third-party fill-finish facility acquired first by Novo Holdings, and in the process of being transferred to Novo Nordisk. The FDA did not raise concerns regarding the efficacy or safety data supporting Zynyz in NSCLC, nor did it cite issues with the third-party drug substance manufacturer. The inspection findings at Catalent Indiana were not specific to Zynyz, indicating the manufacturing compliance matter extends beyond this particular product. Practically, the CRL means Incyte cannot receive approval for this indication until the facility-related issues are resolved to FDA’s satisfaction. Retifanlimab-dlwr is a humanized monoclonal antibody that binds to programmed death receptor-1, blocking its interaction with PD-L1 and PD-L2. This mechanism reactivates T-cell-mediated anti-tumor immune responses. Metastatic NSCLC remains one of the leading causes of cancer-related mortality, and PD-1 checkpoint inhibitors combined with platinum-based chemotherapy have become a standard first-line treatment approach. Several PD-1 and PD-L1 inhibitors, including pembrolizumab and nivolumab, are already approved in this setting. Retifanlimab’s entry would have added another option in a competitive but clinically relevant space. Retifanlimab originated at MacroGenics, Inc., where it was designated MGA012. In November 2017, Incyte entered a global collaboration and license agreement with MacroGenics, obtaining exclusive worldwide development and commercialization rights. MacroGenics received a USD 150 million upfront payment with eligibility for up to $760 million in additional milestones plus tiered royalties. Since that agreement, Incyte has held sole responsibility for regulatory strategy, clinical development, and commercialization. Zynyz received FDA accelerated approval in March 2023 for metastatic or recurrent locally advanced Merkel cell carcinoma, establishing its initial US market presence. The NSCLC sBLA represented Incyte’s effort to expand the label into a larger oncology population. The provided materials do not reference prior CRLs for this specific sBLA or for the original Merkel cell carcinoma BLA. No information was available regarding approvals of retifanlimab in other regulatory jurisdictions such as the EU or Japan. Incyte stated it is working with the FDA and Catalent Indiana to address the CRL and support a potential sBLA resubmission. The resolution timeline depends on Catalent Indiana’s ability to remediate the inspection findings and satisfy FDA requirements, a process over which Incyte has limited direct control. The company did not disclose a projected resubmission date or indicate whether alternative manufacturing arrangements are under consideration. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

引进/卖出临床3期上市批准加速审批临床结果

2026-03-11

·汇聚南药

FDA震怒？！诺和诺德瞒报死亡、中风与自杀倾向，司美、利拉鲁肽遭警告

01 一份致使市值蒸发数十亿的 “重磅”警告信 2026年3月，医药资本市场再度被一只“黑天鹅”惊扰。就在几天前，全球“减肥药之王”诺和诺德的股价在单日内应声下跌超 3%，数十亿美元市值瞬间蒸发。引发这场震荡的，不是临床试验的失败，也不是供应链的断裂，而是一纸来自美国FDA科学调查办公室、长达8页的严厉警告信。来源：警告信警告信原文：FDA对诺和诺德的警告信_原文.pdf 这封标注日期为2026年3月5日的信件，将矛头直指诺和诺德在上市后不良药物反应（PADE，Postmarketing Adverse Drug Experience）报告系统中的“系统性失败”。 FDA指出，在针对其新泽西州总部的合规检查中，发现大量涉及司美格鲁肽（如Ozempic/Wegovy）和利拉鲁肽的严重不良事件——包括中风、自杀倾向甚至死亡——未能按法规在15天内上报。面对这些冰冷的硬数据，最让华尔街感到不安的，是这场合规危机背后的“时间线”。事实上，这并非FDA的突击制裁，而是一场长达一年、最终崩盘的合规拉锯战。据Fierce Pharma披露，FDA早在2025年初就对诺和诺德新泽西州总部进行了审查，并在当年2月下发了‘483表格’（Form 483）。在过去整整一年里，诺和诺德信誓旦旦地向FDA提交了多达7次的整改进度报告。然而，2026年3月的这封警告信无情地扯下了遮羞布。FDA在信中严厉斥责：你们根本没有找到问题的‘根本原因’。这种从483表格直接升级为警告信的举动，传递了一个极其危险的信号：监管层对企业目前的自我纠错能力，已经失去了耐心与信任。来源：fierce Pharma 对此，诺和诺德美国区医疗与监管事务主管Anna Windle在最新的声明中紧急灭火，强调公司‘正迅速且全面地解决警告信中的要求’，并坚信能让FDA完全满意。但市场的疑虑，显然不是一两句公关辞令就能打消的。” 当一款药物跨越了医疗范畴，成为风靡全球的文化现象与超级“现金牛”时，其背后的合规系统能否承受住这泼天的流量？这起风波为全行业敲响了警钟：在医药圈，重磅炸弹药物的护城河不仅是前沿的分子结构，更是看不见、摸不着的“合规基建”。 02 从消失的数据到狂飙的代价剥开迷雾：那些“消失”的严重不良反应与合规红线要理解FDA为何如此愤怒，我们需要先看懂PADE（上市后不良反应报告）的底层逻辑。PADE就像是国家卫生系统的“早期雷达”，而制药企业就是雷达操作员。FDA的《联邦法规》21 CFR 314.80规定得犹如铁律：任何严重且意外的不良事件（ADE），无论你认为它是否与药物直接相关，都必须在获知后的 15个自然日内加急上报。但在诺和诺德的真实操作中，这台雷达却被生生人为“静音”了。根据FDA的警告信披露，诺和诺德的安全数据库中存在大量令人脊背发凉的“漏报”案例： “患者说无关，我们就取消”：在Argus的1331385号病例中，一名使用利拉鲁肽的患者遭遇了中风导致残疾。仅仅因为患者在反馈时随口一句“我觉得这跟药没关系”，诺和诺德的客服/外包团队就直接将这起严重的ADE拒收注销。FDA明确表示：根据美国法规，不良事件必须上报，“无论是否被认为与药物有关”。被遗漏的“致命”细节：在1342548号病例中，一名使用司美格鲁肽的男性患者死亡。这起本该触发15天红色警报的事件，竟然因为“缺乏患者身份标识”被判定为无效报告。然而，FDA的调查员在随后的审查中，直接从原始文件里找出了这名患者的身份信息。 “医疗审查”成了拖延的挡箭牌：另一起涉及司美格鲁肽使用者产生自杀倾向的案例，在数据库中挂着“医疗审查中”的状态长达一个多月，直到FDA调查员进驻现场指出问题后，才被匆匆上报。这种表述在逻辑上是成立的：未及时上报不良事件，不等于药物本身存在致命缺陷（事实上，近期FDA的其他评估并未证实GLP-1与自杀倾向有直接因果关系）。但对于监管机构而言，“瞒报/漏报”的性质往往比“药物有副作用”更具破坏性，因为它摧毁的是监管层对企业监控能力的信任。底层逻辑：狂飙的销量、外包之殇与掉队的“基建” 如果诺和诺德并没有主观恶意去掩盖数据，那为什么会出现如此低级的系统性漏报？透过警告信的字里行间，我们看到了三个深层的商业与机制博弈：第一，销量狂飙与“外包客服”的系统性过载。司美格鲁肽在全球范围内的爆火，带来了几何级数增长的处方量，随之而来的便是海量的患者咨询和不良事件反馈。为了消化这些庞大的数据，诺和诺德将部分患者呼叫中心业务外包给了第三方机构。警告信中明确提到，即便在2023年底诺和诺德更换了外包供应商并进行了整改，由于缺乏对第三方团队的有效监管与深度培训，一线外包人员依然像“没有感情的过滤机器”一样，机械地因为缺少某个字段（甚至不去核对原始文件）就将重磅的安全信号丢进垃圾桶。第二，全球化SOP（标准作业程序）与美国FDA的合规碰撞。在这场合规危机中，暴露了跨国药企的一个通病：监管标准的地域性水土不服。诺和诺德内部的SOP（如Q014048文件）允许在“报告者排除了因果关系”时将不良反应剔除。这种做法可能在部分海外市场的监管框架内是允许的，但在极度严苛的FDA眼中就是“碰红线”。全球统一的内部流程如果未能针对美国21 CFR 314.80法规做定制化适配，摔跟头是迟早的事。第三，不仅仅是药物警戒，一场全方位的‘合规水逆’正在蔓延。如果把视角拉高，你会发现漏报不良反应只是诺和诺德近期合规危机的冰山一角。就在近期，由于Ozempic和Wegovy在市场上的狂飙，诺和诺德还接连收到了两封针对其违规营销的FDA‘无标题信’。更让产业链震动的是后方产能的失火。诺和诺德斥巨资从Catalent手中收购的印第安纳州布卢明顿工厂，近期同样吃到了FDA的警告信。城门失火殃及池鱼，这不仅影响了自家产能，甚至直接导致了合作伙伴Incyte的PD-1抗癌新药（Zynyz）惨遭FDA拒批（CRL）。前端营销踩红线、中端不良反应漏报、后端核心产能受限——当一家制药巨头在整条业务线上接连暴露出合规漏洞时，我们不禁要问：在千亿利润的狂欢下，其管理半径和质量体系的‘基础设施’，是不是真的已经超载了？” 03 前瞻预判—— “减肥药之王”的必修课综合来看，这份警告信不会让司美格鲁肽跌下神坛，也不会引发产品的大规模召回。它更像是一张天价的“违章罚单”，迫使一辆在高速上狂飙的跑车靠边停车，检修它的刹车系统。对于诺和诺德而言，接下来的15天至关重要。他们需要向FDA提交一份不仅停留在纸面，而是从底层IT架构、AI自动化质控到全面收回核心药物警戒业务的系统性整改方案。而对于整个中国乃至全球的创新药产业，这堂课的学费极其昂贵却极具价值：我们往往只把目光停留在“双盲、P值、获批上市”的高光时刻，却忘了当一款药物真正走向数以千万计的普通大众时，上市后的药物警戒与质量合规体系，才是决定其能走多远、活多久的真正底座。重磅炸弹药物的皇冠，必承其重。诺和诺德能否迅速补齐这块短板，化解信任危机，将是我们今年持续追踪的核心焦点。信息来源：药闻天下往期推荐 ! 免责声明 “汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。喜欢的点个“看一看”和"喜欢"吧不然微信推送规则改变，有可能每天都会错过我们哦~

100 项与瑞弗利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11827	-	-	DB15766

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
肛管鳞状细胞癌	美国	Incyte Corp.	2025-05-15
转移性Merkel细胞癌	美国	Incyte Corp.	2023-03-22

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
肛门鳞状细胞癌	申请上市	欧盟	Incyte Biosciences Distribution BV	2026-01-29
非小细胞肺癌	申请上市	美国	Incyte Corp.	-
子宫内膜癌	临床3期	中国	再鼎医药（上海）有限公司	2021-09-20
肛管癌	临床3期	意大利	Incyte Corp.	2020-11-13
转移性非小细胞肺癌	临床3期	中国	Incyte Corp.	2020-09-18
转移性非小细胞肺癌	临床3期	中国	再鼎医药（上海）有限公司	2020-09-18
转移性非鳞状非小细胞肺癌	临床3期	美国	Incyte Corp.	2020-09-11
转移性非鳞状非小细胞肺癌	临床3期	中国	Incyte Corp.	2020-09-11
转移性非鳞状非小细胞肺癌	临床3期	巴西	Incyte Corp.	2020-09-11
转移性非鳞状非小细胞肺癌	临床3期	保加利亚	Incyte Corp.	2020-09-11

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临床结果

适应症

分期

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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


NCT04472429 (POD1UM-303, ESMO_IO2025)	临床3期	肛门鳞状细胞癌一线	308	Retifanlimab + carboplatin-paclitaxel	遞網廠範獵繭窪選鑰簾(膚構積觸襯醖選顧願鹹) = 範範艱衊鑰構醖範淵憲範壓襯鑰窪淵襯鏇鬱獵 (憲糧艱鹽遞膚範範鏇選 ) 更多	积极	2025-11-12
				Placebo + carboplatin-paclitaxel	遞網廠範獵繭窪選鑰簾(膚構積觸襯醖選顧願鹹) = 鹹鏇齋鏇獵齋鑰壓簾窪範壓襯鑰窪淵襯鏇鬱獵 (憲糧艱鹽遞膚範範鏇選 ) 更多
EUCTR2021-005775-39-BE (ESMO2025)	临床2期	PD-L1+	176	Retifanlimab (RETI)	壓簾夢夢窪膚築顧遞蓋(構膚齋積蓋鑰觸網鹹鏇) = 鏇憲製齋願壓膚觸顧醖製顧願襯艱構鹽鹹鏇繭 (襯憲蓋觸膚衊壓鏇襯鏇, 3.5 ~ 9.7) 更多	不佳	2025-10-17
				Retifanlimab + Tuparstobart (doublet tx)	壓簾夢夢窪膚築顧遞蓋(構膚齋積蓋鑰觸網鹹鏇) = 顧蓋觸衊鏇構簾壓廠憲製顧願襯艱構鹽鹹鏇繭 (襯憲蓋觸膚衊壓鏇襯鏇, 3.7 ~ 7.6) 更多
NCT04205812 (POD1UM-304, Pubmed) 人工标引	临床3期	非小细胞肺癌一线	583	Retifanlimab + chemotherapy	鬱遞窪積壓簾製廠壓遞(廠選鏇鏇膚繭遞餘願廠) = 願淵範膚醖壓餘襯網觸製遞鹽蓋餘構蓋齋鑰築 (艱鏇顧構鬱廠積蓋夢觸, 16.2 ~ 21.0) 更多	积极	2025-09-19
				Placebo + chemotherapy	鬱遞窪積壓簾製廠壓遞(廠選鏇鏇膚繭遞餘願廠) = 襯憲鑰艱鹹簾夢艱廠鏇製遞鹽蓋餘構蓋齋鑰築 (艱鏇顧構鬱廠積蓋夢觸, 11.0 ~ 16.7) 更多
NCT03532295 (CTIM-23, CTgov)	临床2期	多形性胶质母细胞瘤 \| 胶质母细胞瘤 \| 复发性胶质母细胞瘤	51	Radiation therapy+Bevacizumab+Retifanlimab (Regimen A: Retifanlimab+RT+bevacizumab)	壓顧鹽鹽繭鑰淵艱鹹鬱 = 構遞顧鹽繭窪淵構餘網鏇夢醖鑰遞窪願簾鏇蓋 (夢鹹夢窪築製糧鏇衊鹽, 醖願衊顧艱鹽觸窪糧衊 ~ 觸構築齋衊選膚選鏇衊) 更多	-	2025-08-07
				Radiation therapy+Bevacizumab+Epacadostat+Retifanlimab (Regimen B: Retifanlimab+RT+bevacizumab+epacadostat)	壓顧鹽鹽繭鑰淵艱鹹鬱 = 鑰願淵壓構醖構繭觸夢鏇夢醖鑰遞窪願簾鏇蓋 (夢鹹夢窪築製糧鏇衊鹽, 蓋餘襯齋夢窪鏇網觸網 ~ 壓膚窪遞遞選範鬱網鬱) 更多
NCT04116073 (CTgov)	临床2期	不能切除性胰腺癌	25	PD-1 antibody+INCMGA00012	築選願壓鹹淵艱繭齋顧 = 壓鬱觸獵膚鑰淵齋選網廠簾淵膚鹽願鹽艱鹹鏇 (顧艱衊餘餘醖製鏇襯鹹, 鹹憲觸顧鏇繭廠願網獵 ~ 觸壓糧選鹹窪製壓獵廠) 更多	-	2025-07-29
NCT05239182 (RiLEY, CTgov)	临床2期	胰腺腺癌 \| 胰腺导管腺癌 \| 晚期胰腺腺癌	7	9-ING-41+Abraxane+Gemcitabine+Retifanlimab	簾製簾夢蓋鏇廠鹽餘鑰 = 襯鹽壓襯觸鬱獵鑰遞積窪壓窪築繭鑰顧夢簾淵 (糧窪壓餘憲鬱廠鹽網蓋, 鹹網積觸築選壓窪簾網 ~ 遞製遞獵製襯繭衊廠醖) 更多	-	2025-07-17
NCT04472429 (POD1UM-303/InterAACT 2, BusinessWire) 人工标引	临床3期	肛管鳞状细胞癌	308	Retifanlimab + Carboplatin + Paclitaxel	觸餘膚鏇艱齋憲憲糧遞(廠願襯範衊蓋憲網衊鏇) = 窪蓋顧齋蓋鑰廠齋製顧鹽糧製膚鏇構顧鏇壓製 (獵遞壓糧獵膚鹹顧艱遞, 7.5 ~ 11.3) 更多	积极	2025-06-14
				Placebo + Carboplatin + Paclitaxel	觸餘膚鏇艱齋憲憲糧遞(廠願襯範衊蓋憲網衊鏇) = 範網構簾鬱憲網選積衊鹽糧製膚鏇構顧鏇壓製 (獵遞壓糧獵膚鹹顧艱遞, 7.1 ~ 7.7) 更多
NCT04472429 (POD1UM-303/InterAACT 2, ASCO2025) 人工标引	临床3期	肛管鳞状细胞癌	308	Retifanlimab + chemotherapy (PD-L1 ≥ 1%)	艱選廠醖獵築艱夢遞選(衊艱網膚繭齋蓋製積範) = 艱繭願艱襯憲餘遞餘壓壓遞廠蓋鏇積鑰窪醖衊 (齋鬱鏇窪艱餘膚蓋鬱構 ) 更多	积极	2025-05-30
				Retifanlimab + chemotherapy (PD-L1 < 1%)	艱選廠醖獵築艱夢遞選(衊艱網膚繭齋蓋製積範) = 衊範淵積壓觸獵衊淵簾壓遞廠蓋鏇積鑰窪醖衊 (齋鬱鏇窪艱餘膚蓋鬱構 )
NCT03599713 (POD1UM-201, ASCO2025)	临床2期	转移性Merkel细胞癌	101	Retifanlimab 500 mg	顧遞糧網夢糧顧鹹壓餘(淵醖鬱積膚網膚襯繭窪) = 齋鏇築積廠壓構齋願鹽鹹鏇繭構鬱繭製繭鑰艱 (簾餘鬱鹽觸觸顧遞鑰鑰 ) 更多	积极	2025-05-30
POD1UM-202 and POD1UM-303/InterAACT-2 (ASCO2025)	N/A	HIV感染 \| 肛管鳞状细胞癌一线 \| 二线 undetectable viral load	20	Retifanlimab	選淵簾窪淵築夢製觸膚(積膚簾願蓋壓構醖築膚) = irAEs and grade ≥3 irAEs were consistent with the non-HIV population 範鬱蓋積鬱獵獵遞壓醖 (醖壓艱築範範願選簾構 ) 更多	积极	2025-05-30
				Retifanlimab with platinum-based chemotherapy