帕博利珠单抗(Pembrolizumab) - 药物靶点：PD-1_在研适应症：不可切除的肝细胞癌，不可切除的尿路上皮癌，晚期子宫内膜癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Lambrolizumab、Pembrolizumab (Genetical Recombination)、Pembrolizumab (genetical recombination) (JAN)

+ [11]

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

肿瘤免疫系统疾病感染+ [13]

在研适应症

不可切除的肝细胞癌不可切除的尿路上皮癌晚期子宫内膜癌+ [347]

非在研适应症

NPM1突变急性髓系白血病转移性腺癌晚期结直肠腺癌+ [90]

原研机构

Merck & Co., Inc.

在研机构

Merck Sharp & Dohme BV

默沙东研发（中国）有限公司

Merck Sharp & Dohme Corp.

+ [13]

非在研机构

Viralytics Pty Ltd.

权益机构

Nektar Therapeutics

NeoImmuneTech, Inc.

Canada Pension Plan Investment Board

+ [80]

最高研发阶段批准上市

首次获批日期

美国 (2014-09-04),

黑色素瘤

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)、优先药物（PRIME） (欧盟)、优先审评 (中国)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、附条件批准 (中国)、孤儿药 (日本)

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结构/序列

Sequence Code 93660H

来源: *****

Sequence Code 93670L

来源: *****

关联

2,523

项与帕博利珠单抗相关的临床试验

NCT07061977

/ Recruiting临床3期IIT

NRG-GY037: A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab Versus Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer

This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding induction chemotherapy to the usual treatment of chemotherapy and radiation followed by maintenance may be more effective in treating patients with high risk, locally advanced cervical cancer.

开始日期2026-06-26

申办/合作机构

National Cancer Institute

NCT07061964

/ Recruiting临床2期IIT

Single Arm Phase II Study of Bladder Preservation With Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (BRIGHT)

This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.

开始日期2026-06-01

申办/合作机构

National Cancer Institute

NCT07037004

/ Not yet recruiting临床2期IIT

Impact of Microbiome Modulation With CBM588 in Combination With Pembrolizumab for Adjuvant Therapy of High-Risk, Resected Renal Cell Carcinoma (RCC)

This phase II trial compares the effect of adding a Live Biotherapeutic Product called CBM588 to pembrolizumab versus pembrolizumab alone in preventing return of disease (recurrence) after surgery for patients with renal cell cancer. Pembrolizumab is an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies such as pembrolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for the treatment of renal cell cancer after surgery. Research has shown that changes to the composition of the healthy bacteria in the body (the microbiome), may improve a patient's response to treatment with immunotherapy. CBM588, a Live Biotherapeutic Product (LBP) containing a bacteria called Clostridium butyricum, has been shown to improve outcomes in patients treated with immunotherapy for other types of cancer. Adding CBM588 to treatment with pembrolizumab after surgery may cause changes in the microbiome that improve patient response to treatment and reduce disease recurrence, compared to pembrolizumab alone.

开始日期2026-05-04

申办/合作机构

City of Hope National Medical Center

[+1]

100 项与帕博利珠单抗相关的临床结果

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100 项与帕博利珠单抗相关的转化医学

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100 项与帕博利珠单抗相关的专利（医药）

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10,438

项与帕博利珠单抗相关的文献（医药）

2026-02-01·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Targeting colorectal cancer liver metastasis through repurposing metabolic and immune inhibitors: A theoretical study

Article

作者: Lahiri, Aditya ; Datta, Aniruddha ; Mondal, Madhurima

Liver metastasis from colorectal cancer is a major cause of death in patients with advanced colorectal cancer (CRC) and remains a difficult challenge in oncology. In spite of commendable developments in medical inventions, the complexity and poor prognosis of metastatic stage, alliterative strategies are required to address Colorectal cancer liver metastasis (CRLM). This paper presents a computational study on drug repurposing for CRLM using a Boolean Network model. We comprehensively analyze CRLM signaling pathways such as WNT, PI3K/AKT/mTOR, MAPK, Hedgehog, TGF-β, NF-kB, NOTCH and HGF and target them with metabolic and immune inhibitors. This study utilizes a computational analysis to evaluate single and multi-agent treatments across scenarios involving single and multiple genetic mutations. Our findings highlights the efficacy of metabolic inhibitors such as Simvastatin, Metformin, and predict compatible partner drugs to enhance their efficacy. Additionally, we predict possible improvements for CRLM treatment using an immunotherapy drug like Pembrolizumab. Overall, this paper suggests potential combinations requiring experimental validation for drug repurposing to improve CRLM treatment outcomes.

2026-01-01·TALANTA

Biosimilarity and advanced structural characterization of monoclonal antibodies charge variants using capillary zone electrophoresis and mass spectrometry

Article

作者: Joomun, Rania ; Gahoual, Rabah ; Alez-Martin, Lola ; François, Yannis-Nicolas ; Mignet, Nathalie ; Houzé, Pascal

Monoclonal antibodies (mAbs) structural complexity arises from their macromolecular nature and their propensity to undergo post-translational modifications (PTM), potentially leading to the formation of charge variants. Capillary zone electrophoresis (CZE) showed to be particularly relevant for their analysis, however the selectivity provided by CZE separation is not completely elucidated. In this work, CZE-UV analysis was used to characterize charge variants for biosimilars products corresponding to infliximab. Results demonstrated the possibility to identify faint variations between the different products showing its applicability to contribute to mAbs biosimilarity assessment. Enzymatic treatment allowed to attribute the origin of infliximab charge variants. CZE-UV analysis of pembrolizumab showed that none of the five charge variants separated were originating from C-terminal lysine residues and/or N-glycans. To enable further identification, an analytical strategy was developed to achieve CZE-UV fraction collection and enrichment of mAb charge variants followed by systematic offline characterization in CE coupled to tandem mass spectrometry (MS/MS). CE-MS/MS experiments allowed the identification of different types of PTMs such as N-terminal pyroglutamic acid formation and asparagine deamidation for charge variant fractions correlated with decreased mobility. In addition, for the first time succinimide intermediate formation could be successfully characterized using CE-MS/MS data, which could be correlated to increased mobility. Thus, the CZE-UV separation resulted from the synergistic effect of several simultaneous PTMs affecting the apparent mobilities of the charge variants. As a consequence, experiments illustrated the relevance and potential of intact mAbs analysis using CZE-UV to provide an overview of the structural diversity of therapeutic mAbs.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

The cost-effectiveness of treatment for high-risk, early-stage, triple-negative breast cancer in Egypt: an analysis of neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant single-agent pembrolizumab

Article

作者: Haiderali, Amin ; Huang, Min ; Pöllinger, Bernadette ; Abdelaziz, Ahmed H. ; Kassem, Loay ; Akyol Ersoy, Burcu ; Elsisi, Gihan Hamdy

OBJECTIVE:

The cost-effectiveness of neoadjuvant pembrolizumab + chemotherapy followed by adjuvant pembrolizumab compared to neoadjuvant chemotherapy plus placebo followed by adjuvant placebo was assessed in high-risk, early-stage, triple-negative breast cancer patients from an Egyptian societal perspective over a lifetime horizon.

METHODS:

A 4-state Markov cohort model was developed to compare the cost-effectiveness of pembrolizumab + chemotherapy/pembrolizumab vs chemotherapy alone for the treatment of high-risk, early-stage, triple-negative breast cancer. The model simulated the clinical course of high-risk, early-stage, triple-negative breast cancer across four health states: event-free survival, locoregional recurrence, distant metastasis, and death. Clinical inputs for the simulation were derived from modeling of efficacy and safety data collected in the KEYNOTE-522 trial. Direct medical costs and indirect costs were reported in 2022 Egyptian pounds (EGP) and converted to US dollars ($). Probabilistic and deterministic sensitivity analyses were conducted to assess the robustness of model results.

RESULTS:

Compared with chemotherapy alone, pembrolizumab + chemotherapy/pembrolizumab led to expected gains of 2.92 life years and 2.25 quality-adjusted life years, respectively, while increasing overall treatment costs by EGP 491,695 ($102,436). Incremental costs per year gained were EGP 218,285 ($45,476) per quality-adjusted life year and EGP 168,223 ($35,046) per life year, both of which were lower than the 2022 Egyptian cost-effectiveness threshold of EGP 398,439 ($83,008). The findings of sensitivity analyses indicated that the model was robust across a range of inputs and assumptions.

CONCLUSIONS:

In Egypt, pembrolizumab + chemotherapy/pembrolizumab is a cost-effective treatment for high-risk, early-stage, triple-negative breast cancer when considering health-related quality-of-life and years of life gained.

9,334

项与帕博利珠单抗相关的新闻（医药）

19 小时之前

·新浪医药

头对头击败明星大药！6款国产创新药 III 期成功

在国产创新药崛起背后，头对头临床试验无疑是最关键的试金石。虽然难度和风险很高，但相应的回报也是巨大的。正如百济神州泽布替尼，通过头对头击败伊布替尼，彻底打开了国际市场。今年上半年，泽布替尼全球销售收入 125.27 亿元，同比增长 56.2%。头顶 BIC 光环，泽布替尼在美国市场的销售额已经连续两个季度位居 BTK 抑制剂市场首位，且领先优势正在扩大，未来有望成为全球最畅销的 BTK 抑制剂。在泽布替尼之后，也有不少创新药正面挑战明星大药（2024 年销售额超过 10 亿美元）成功，比如玛仕度肽（信达）、依沃西单抗（康方）、博度曲妥珠单抗（科伦博泰）、XKH004（丽珠医药）等。本文将具体介绍一下这些头对头挑战成功的 III 期临床试验，供参考。玛仕度肽 vs. 司美格鲁肽今年 10 月 27 日，信达宣布，玛仕度肽头对头司美格鲁肽 III 期 DREAMS-3 研究达到主要终点（NCT06184568）。这是全球首个在糖尿病治疗领域 GCG/GLP-1 双受体激动剂与司美格鲁肽开展头对头比较的 III 期临床研究。 DREAMS-3 是一项多中心、随机、开放标签 III 期临床研究，入组经单纯饮食运动干预伴/不伴二甲双胍单药治疗血糖、体重控制不佳的中国早期 2 型糖尿病（病程＜10年）合并肥胖受试者 349 例。这些入组受试者平均年龄 42.4 岁，平均病程 1.8 年，平均基线糖化血红蛋白[HbA1c] 8.02%，平均基线体重 90.47kg，平均基线 BMI=32.98 kg/m2，按照 1：1 比例随机接受玛仕度肽 6mg 或司美格鲁肽 1mg 治疗 32 周（常规治疗期）。完成常规治疗期后，原接受玛仕度肽治疗的受试者根据体重达标情况，分配至玛仕度肽不同剂量继续治疗 24 周（研究扩展期）。主要终点为第 32 周时 HbA1c＜7.0% 且体重较基线下降 ≥10% 的受试者比例。来源：丁香园 Insight 数据库结果显示，在中国 2 型糖尿病合并肥胖受试者中，第 32 周时，玛仕度肽组 HbA1c＜7.0% 且体重较基线下降 ≥10% 的受试者比例为 48.0%，优效于司美格鲁肽组（21.0%，P值＜0.0001）。此外，第 32 周时，玛仕度肽组和司美格鲁肽组 HbA1c 较基线变化均值分别为 −2.03% 和 −1.84%，体重较基线平均百分比降幅分别为 10.29% 和 6.00%（P 值均＜0.05）。安全性方面，研究期间玛仕度肽整体安全性特征与既往临床研究一致，未发现新增安全性信号。胃肠道不良反应是最常见的不良事件，多为轻度或中度。依沃西单抗 VS. 帕博利珠单抗 2024 年 9 月，康方生物在 WCLC 大会上发布了 PD-1/VEGF 双抗依沃西单药对比帕博利珠单抗单药一线治疗PD-L1表达阳性（PD-L1 TPS≥1%）的局部晚期或转移性非小细胞肺癌（NSCLC）的注册性 III 期临床研究（HARMONi-2/AK112-303）的重磅研究数据。这是全球首个对比 K 药取得显著阳性结果的随机对照大 III 期研究。 HARMONi-2 入组初治晚期 EGFR/ALK 阴性 NSCLC 患者 398 例，随机接受依沃西单抗 20 mg/kg 或帕博利珠单抗 200 mg Q3W 治疗。治疗直至疾病进展、毒性不可耐受或治疗期满 24 个月。主要研究终点为 PFS，关键次要终点为 OS。来源：丁香园 Insight 数据库结果显示，在ITT人群中，依沃西组和帕博利珠组的中位 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 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%。安全性方面，依沃西整体安全性优异，与既往相关研究保持一致。在鳞状非小细胞肺癌人群中，依沃西与帕博利珠单抗 ≥3 级 TRAE 发生率相当（22.2% vs 18.7%）。在接受依沃西治疗的患者整体生活质量与接受帕博利珠单抗治疗的患者相当。 LZM012 VS. 司库奇尤单抗今年 7 月，丽珠医药宣布，其 1 类创新生物药 LZM012 用于中重度斑块型银屑病治疗的 Ⅲ 期 LZM012-III 研究成功达到主要终点。作为中国首个、全球范围内第二个完成 III 期临床试验的 IL-17A/F 双靶点抑制剂，LZM012 在本项研究中直接采用头对头研究设计，对标司库奇尤单抗。 LZM012-III 研究共纳入 925 例受试者，按 1:1:1 比例接受 LZM012 320mg Q4W、LZM012 12 周前 Q4W→12 周后 Q8W、司库奇尤单抗 300mg，持续 4 周（第 0、1、2 和 3 周），之后（第 4 周开始）Q4W，治疗期 52 周。研究主要终点为第 12 周 PASI 100 应答率，次要研究终点包括第 52 周 PASI 100 应答率、第 12 周 PASI 90、sPGA0/1 应答率、第 4 周 PASI 75 应答率等。来源：丁香园 Insight 数据库结果显示，LZM012 组第 0 周给药 1 次后第 4 周 PASI 75 应答率即可达 65.7%，司库奇尤对照组 W0/1/2/3 给药，第 4 周 PASI 75 应答率为 50.3%，即 LZM012 仅需首次一针即可获得高于司库奇尤四针方案的应答率。LZM012 组第 12 周 PASI 100 应答率为 49.5%，司库奇尤对照组为 40.2%；LZM012 组第 12 周 PASI 90 和 sPGA0/1 应答率＞80%，PASI 75 应答率＞95%。 LZM012 320 mg Q4W 和 320 mg Q8W 两种维持给药方案下，银屑病患者可持续提升获益，第 52 周 PASI 100 应答率分别为 75.9% 和 62.6%，司库奇尤 300 mg Q4W 的数据为 61.6%。安全性方面，短期和长期安全性数据均显示 LZM012 与对照组各类不良事件发生率相当，不良事件谱相似。博度曲妥珠单抗 VS. 恩美曲妥珠单抗今年 10 月中下旬，科伦博泰在 ESMO 大会上公布了博度曲妥珠单抗头对头对比恩美曲妥珠单抗的 III 期 KL166-Ⅲ-06 研究数据。 KL166-Ⅲ-06 是一项随机、开放、对照、多中心Ⅲ期临床试验，旨在评估博度曲妥珠单抗对比 T-DM1 在既往接受过曲妥珠单抗和紫杉类药物治疗的 HER2 阳性不可切除或转移性乳腺癌患者中的有效性和安全性。研究共纳入 365 例患者，按 1:1 随机分组接受博度曲妥珠单抗或 T-DM1 治疗，主要终点为盲态独立中心评审（BICR）评估的 PFS，次要终点为 OS、研究者评估的 PFS、安全性等。来源：丁香园 Insight 数据库结果显示，博度曲妥珠单抗组的 mPFS 为 11.1 个月 (vs. T-DM1 组 4.4 个月)，显著降低 61% 的疾病进展或死亡风险（HR 0.39, 95%CI 0.30-0.51, p < 0.0001），且在所有亚组中均观察到一致的获益趋势。客观缓解率（ORR）高达 76.9%（vs. T-DM1 组 53.0%)，在既往接受过 1L 治疗的患者人群中，博度曲妥珠单抗组 ORR 高达 77.4%。安全性方面，博度曲妥珠单抗总体安全性可管理，最常见的≥3 级不良事件（TRAEs）为眼部相关不良反应，主要表现为角膜疾病、干眼症和视物模糊等；而 T-DM1 组最常见的≥3 级 TRAEs 包括血小板计数下降和中性粒细胞减少等。与 T-DM1 相比，博度曲妥珠单抗在血液学毒性（如血小板减少）、肝毒性（转氨酶升高）以及间质性肺病/肺炎（ILD/p）的发生率上更低，且胃肠道耐受性良好。 DB-1303 VS. 恩美曲妥珠单抗今年 9 月 5 日，映恩生物宣布，经独立数据监察委员会评估，与对照组相比，DB-1303/BNT323 用于既往接受曲妥珠单抗和紫杉烷类治疗的 HER2 阳性不可切除或转移性乳腺癌患者的 III 期临床试验已达到 PFS 主要研究终点。这是一项在中国进行的随机、对照、开放标签、多中心的 III 期临床试验，旨在评估 DB-1303 相较于 T-DM1 在既往接受曲妥珠单抗和紫杉烷类治疗的 HER2 阳性不可切除或转移性乳腺癌患者中的疗效和安全性。该研究共入组 228 例受试者，随机分组接受 DB-1303 Q3W 和恩美曲妥珠单抗 Q3W 治疗。主要终点是 BICR 根据 RECIST v1.1 标准评价的 PFS。次要终点包括 OS、研究者评估的 PFS 等。具体数据尚未公布。 BAT5906 VS. 雷珠单抗今年 6 月，百奥泰宣布，AT5906（一款重组人源化单克隆抗体创新药物）对比雷珠单抗用于新生血管性年龄相关性黄斑变性（w-AMD）的关键注册 III 期临床成功达到预设的主要研究终点（CTR20221092）。这是一项随机、双盲、平行对照的 III 期临床试验，旨在比较 BAT5906 与雷珠单抗在 w-AMD 患者中的临床疗效和安全性。该研究共入组 488 例受试者，主要终点是与基线相比，两组受试者研究眼第 52 周最佳矫正视力（BCVA）的变化值。结果显示，该研究达到主要终点，其中 BCVA 自基线至第 52 周提高 >15 个字母的受试者比例，BAT5906 组显著优于雷珠单抗对照组，即 BAT5906 治疗后患者疗效非常明显的比例显著高于雷珠单抗。黄斑中心凹视网膜厚度（CRT）自基线至第 52 周的变化值，BAT5906 组显著优于雷珠单抗对照组，即 BAT5906 抑制视网膜新生血管渗漏或降低炎症活跃程度明显优于雷珠单抗。来源： Insight 数据库加入读者交流群： —精彩回顾— 我国启动全球最大规模尿液HPV筛查研究针对红斑狼疮！阿斯利康首创生物制剂 III 期成功恒瑞乙肝「突破性疗法」来袭 ADC之后，ABC来了全球首例！中国医生体内CAR-T成功治疗狼疮商务合作：杨小雨 15210041717

临床3期临床结果

2025-10-28

·Firstwordpharma

Merck & Co.'s Welireg notches wins in kidney cancer combo studies

Merck & Co. announced positive results Tuesday from two separate Phase III combination trials evaluating its HIF-2α inhibitor Welireg (belzutifan) in kidney cancer patients in both post-immunotherapy and post-surgical settings.In the LITESPARK-011 study, which enrolled 708 patients whose disease had progressed on or after anti-PD-1/L1 therapy, the combination of Welireg plus Eisai's oral multiple receptor tyrosine kinase inhibitor (TKI) Lenvima (lenvatinib) demonstrated significant improvement in progression-free survival compared to Exelixis' Cabometyx (cabozantinib), meeting the primary endpoint. The dual oral regimen also met its key secondary goal of objective response rate.'Trend' for OSHowever, Merck said the other primary endpoint of overall survival (OS) showed only a "trend toward improvement" and did not reach statistical significance at the interim analysis. Further OS data are expected at a subsequent analysis per protocol.Safety profiles of both drugs were consistent with previously reported studies, and no new safety signals were observed.Still, doubts persist about whether pairing HIF-2α inhibitors with TKIs deliver true synergistic effects or simply additive activity. "I think we still need to demonstrate the real benefit and any synergy between TKIs and HIF-2α inhibitors. [Welireg] may turn out to be a useful agent, and its toxicity profile is quite good, which makes it easier to consider in combination with another drug. But I'm not convinced there is true synergy," a US key opinion leader said in FirstWord's recent KOL Insight - Renal Cell Carcinoma report, expressing disappointment with earlier Welireg monotherapy data. For more, see – Spotlight On: Evolving treatment trends in RCC.Post-nephrectomyThe second trial, LITESPARK-022, evaluated Welireg combined with Merck's anti-PD-1 antibody Keytruda (pembrolizumab) in the adjuvant setting following nephrectomy in 1841 clear cell RCC patients. The combination demonstrated statistically significant and clinically meaningful improvement in disease-free survival compared to Keytruda plus placebo. OS, a key secondary measure in the trial, is still being evaluated.The companies plan to present detailed data from both studies at upcoming medical meetings and discuss the findings with regulatory authorities. The ongoing Phase III LITESPARK-012 trial is testing the addition of Welireg to Keytruda plus Lenvima in the first-line advanced RCC disease setting. It is expected to wrap next October, according to ClinicalTrials.gov.Welireg was approved by the FDA in late 2023 for advanced RCC patients previously treated with PD-1/L1 and VEGF-targeted therapies based on head-to-head data from the Phase III LITESPARK-005 trial comparing it and to mTOR blocker everolimus.

临床3期临床结果上市批准临床2期

2025-10-28

·医药观澜

速递丨晚期子宫内膜癌患者：仑伐替尼联合帕博利珠单抗治疗获持久5年生存获益

10月27日，卫材（Eisai）和默沙东（MSD）联合宣布，长期随访数据持续显示，对于在任何治疗情境下至少接受过一种先前铂类方案治疗的晚期子宫内膜癌患者，由卫材研发的口服多受体酪氨酸激酶抑制剂（TKI）仑伐替尼联合默沙东的抗PD-1疗法帕博利珠单抗较化疗具有持久获益。基于评估仑伐替尼联合帕博利珠单抗对比化疗（由医生选择多柔比星或紫杉醇治疗）的3期309/KEYNOTE-775试验的五年随访数据得出的这一研究结果，已在德国柏林举行的2025年欧洲肿瘤内科学会（ESMO）大会海报展示环节中公布。在关键性3期309/KEYNOTE-775试验中，针对错配修复功能正常（pMMR）的晚期子宫内膜癌患者，五年期仑伐替尼联合帕博利珠单抗的总生存率（OS）达16.7%，而单纯化疗组仅为7.3%。在错配修复功能正常（pMMR）亚组患者中，五年期总生存期（OS）结果与全人群研究结果一致：仑伐替尼联合帕博利珠单抗组的总生存率为19.9%，而单纯化疗组为7.7%。基于2021年3期研究309/KEYNOTE-775试验的主要分析结果，仑伐替尼联合帕博利珠单抗在美国获批用于治疗经FDA批准检测确认的pMMR或非微卫星不稳定高表达(MSI-H)晚期子宫内膜癌患者，这些患者在任何治疗场景下接受过全身治疗后出现疾病进展，且不适合接受根治性手术或放疗。该联合方案在欧盟及日本获批用于特定晚期或复发性子宫内膜癌患者，无论其错配修复状态如何。仑伐替尼在欧盟获批用于晚期肾细胞癌治疗。参考资料：[1]晚期子宫内膜癌：仑伐替尼+帕博利珠单抗5年生存获益持久. From https://www.prnasia.com/story/508814-1.shtml免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床3期临床结果上市批准免疫疗法

100 项与帕博利珠单抗相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D10574	帕博利珠单抗	L01XC18	DB09037

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
不可切除的肝细胞癌	中国	Merck Sharp & Dohme LLC	2025-06-10
不可切除的尿路上皮癌	欧盟	Merck Sharp & Dohme BV	2024-07-25
不可切除的尿路上皮癌	冰岛	Merck Sharp & Dohme BV	2024-07-25
不可切除的尿路上皮癌	列支敦士登	Merck Sharp & Dohme BV	2024-07-25
不可切除的尿路上皮癌	挪威	Merck Sharp & Dohme BV	2024-07-25
晚期子宫内膜癌	美国	Merck Sharp & Dohme LLC	2024-06-17
MSI-H 子宫内膜癌	美国	Merck Sharp & Dohme LLC	2024-06-17
错配修复缺陷子宫内膜癌	美国	Merck Sharp & Dohme LLC	2024-06-17
晚期胃癌	日本	MSD KK (Tokyo)	2024-05-17
复发性胃癌	日本	MSD KK (Tokyo)	2024-05-17
不能切除的胆道癌	加拿大	Merck Sharp & Dohme Corp.	2024-05-09
晚期胆道癌	中国	Merck Sharp & Dohme LLC	2024-01-30
局部晚期胆管癌	中国	Merck Sharp & Dohme LLC	2024-01-30
胃腺癌	挪威	Merck Sharp & Dohme BV	2023-12-20
HER2阴性胃癌	美国	Merck Sharp & Dohme LLC	2023-11-16
可切除非小细胞肺癌	美国	Merck Sharp & Dohme Corp.	2023-10-16
HER2阳性胃腺癌	欧盟	Merck Sharp & Dohme BV	2023-09-06
HER2阳性胃腺癌	冰岛	Merck Sharp & Dohme BV	2023-09-06
HER2阳性胃腺癌	列支敦士登	Merck Sharp & Dohme BV	2023-09-06
HER2阳性胃腺癌	挪威	Merck Sharp & Dohme BV	2023-09-06

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
肌层浸润性膀胱癌	申请上市	美国	Merck & Co., Inc.	2025-10-23
复发性铂耐药性卵巢癌	申请上市	美国	Merck & Co., Inc.	2025-10-20
局部晚期头颈部鳞状细胞癌	申请上市	美国	Merck Sharp & Dohme LLC	2025-02-25
小肠癌	申请上市	欧盟	Merck Sharp & Dohme Corp.	2022-03-25
卵巢上皮癌	临床3期	美国	Merck Sharp & Dohme Corp.	2021-12-13
卵巢上皮癌	临床3期	日本	Merck Sharp & Dohme Corp.	2021-12-13
卵巢上皮癌	临床3期	比利时	Merck Sharp & Dohme Corp.	2021-12-13
卵巢上皮癌	临床3期	加拿大	Merck Sharp & Dohme Corp.	2021-12-13
卵巢上皮癌	临床3期	哥伦比亚	Merck Sharp & Dohme Corp.	2021-12-13
卵巢上皮癌	临床3期	丹麦	Merck Sharp & Dohme Corp.	2021-12-13

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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


NCT03728972 (CTgov)	临床2期	外周T细胞淋巴瘤 \| 结外NK-T细胞淋巴瘤 \| NK细胞淋巴瘤	19	Pembrolizumab (Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II))	鹹餘觸鹹淵廠選艱簾觸 = 艱夢餘網觸醖壓獵醖壓構夢鏇淵鹽積築膚艱窪 (築鏇膚艱膚獵蓋憲蓋網, 遞積衊衊鏇餘範蓋艱構 ~ 築築簾選襯鏇鑰壓壓餘) 更多	-	2025-10-23
				Pembrolizumab (Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV))	鹹餘觸鹹淵廠選艱簾觸 = 膚衊鏇蓋壓範膚網鹹遞構夢鏇淵鹽積築膚艱窪 (築鏇膚艱膚獵蓋憲蓋網, 構壓網繭構鬱憲膚鬱窪 ~ 遞鏇積餘襯夢艱鏇築廠) 更多
NCT03049618 (CTgov)	临床2期	复发性头颈癌 \| 非小细胞肺癌IIIA期 \| 复发性头颈部鳞状细胞癌 ... 更多	42	Laboratory Biomarker Analysis+Recombinant EphB4-HSA Fusion Protein+Pembrolizumab (Head and Neck Cancer Cohort)	鬱壓網願網遞簾鑰積繭 = 觸壓顧製鏇壓憲醖艱觸艱願窪獵構築廠鏇築選 (網網製築壓築觸製窪鏇, 鏇膚衊積醖壓醖衊鬱範 ~ 顧壓醖糧觸鏇顧願顧蓋) 更多	-	2025-10-22
				Laboratory Biomarker Analysis+Recombinant EphB4-HSA Fusion Protein+Pembrolizumab (Non-Small Cell Lung Cancer Cohort)	鬱壓網願網遞簾鑰積繭 = 糧選淵蓋選範憲衊糧廠艱願窪獵構築廠鏇築選 (網網製築壓築觸製窪鏇, 繭鬱構膚膚齋醖鹹淵鹹 ~ 鑰齋蓋鏇齋艱窪獵顧遞) 更多
NCT02220894 \| NCT02142738 \| NCT03486873 \| NCT01295827 \| NCT01905657 (KEYNOTE-042, ESMO2025) 人工标引	N/A	非小细胞肺癌	3,162	Pembrolizumab (PD-L1 any TPS + KEYNOTE-001)	觸夢範遞襯廠憲憲艱鑰(窪窪壓遞鹽襯範壓鬱糧) = 憲艱簾齋選構選膚範顧顧壓衊齋壓蓋製鹽窪衊 (鑰艱襯齋網範鹹蓋夢遞, 8.5 ~ 14.5) 更多	积极	2025-10-17
				Pembrolizumab (PD-L1 TPS ≥50% + KEYNOTE-001)	觸夢範遞襯廠憲憲艱鑰(窪窪壓遞鹽襯範壓鬱糧) = 顧簾築窪襯壓鹹鹹構醖顧壓衊齋壓蓋製鹽窪衊 (鑰艱襯齋網範鹹蓋夢遞, 13.1 ~ 26.5) 更多
NCT03425643 (KEYNOTE-671, ESMO2025) 人工标引	临床3期	可切除非小细胞肺癌新辅助	797	Pembrolizumab 200 mg + Chemo + surgery →  adjuvant Pembrolizumab	衊艱糧選廠鑰網鬱鹽廠(製顧蓋鹹壓醖顧衊製齋) = 製鏇鹽鏇簾選顧艱醖鏇夢醖夢網範廠齋顧淵鬱 (觸餘築醖獵鑰壓淵蓋膚, 38.0 ~ NR) 更多	积极	2025-10-17
				Placebo + Chemo + surgery →  adjuvant Placebo	衊艱糧選廠鑰網鬱鹽廠(製顧蓋鹹壓醖顧衊製齋) = 遞繭廠築壓廠衊積憲繭夢醖夢網範廠齋顧淵鬱 (觸餘築醖獵鑰壓淵蓋膚, 14.8 ~ 22.1) 更多
NCT05116189 (ENGOT-ov65/KEYNOTE-B96, ESMO2025 \| BusinessWire) 人工标引	临床3期	复发性铂耐药性卵巢癌 PD-L1 Expression	643	pembrolizumab 400 mg IV Q6W + weekly paclitaxel ± bevacizumab	願糧築築醖艱鏇選蓋築(築糧願餘夢簾顧選廠襯) = 簾夢顧製鏇艱鑰齋壓壓鑰網簾繭襯襯範觸製壓 (鬱憲襯簾獵鑰膚鹹簾衊 ) 达到更多	积极	2025-10-13
				placebo + weekly paclitaxel ± bevacizumab	願糧築築醖艱鏇選蓋築(築糧願餘夢簾顧選廠襯) = 鬱鏇鹹觸顧選繭餘鬱簾鑰網簾繭襯襯範觸製壓 (鬱憲襯簾獵鑰膚鹹簾衊 ) 达到更多
NCT02621151 (CTgov)	临床2期	肌层浸润性膀胱尿路上皮癌	60	External Beam Radiation Therapy+Gemcitabine+pembrolizumab	淵顧糧齋遞醖繭繭顧鬱 = 鏇襯繭觸願憲鹽鏇願顧選遞繭壓獵獵醖鬱壓鑰 (選襯鏇遞淵廠蓋艱蓋積, 襯觸顧憲鹽醖壓鬱餘構 ~ 窪襯積築壓網範齋製鏇) 更多	-	2025-10-07
NCT03978624 (LCCC1827, CTgov)	临床2期	肌层浸润性膀胱癌	20	Procedure/Surgery+Pembrolizumab (A: Pembrolizumab Alone)	鏇壓鑰窪夢觸醖憲窪製(獵艱範遞夢鏇憲願憲遞) = 蓋齋鹽鏇獵鬱鑰夢糧鏇糧構築獵遞艱廠築網鏇 (艱鬱醖醖衊憲積壓糧憲, 範獵醖鹹鹹廠衊積鹽艱 ~ 鬱鬱範鏇積醖鑰獵鏇選) 更多	-	2025-10-07
				Procedure/Surgery+Pembrolizumab+Entinostat (B: Pembrolizumab Plus Entinostat)	鏇壓鑰窪夢觸醖憲窪製(獵艱範遞夢鏇憲願憲遞) = 齋窪膚選範夢廠憲鹹鹽糧構築獵遞艱廠築網鏇 (艱鬱醖醖衊憲積壓糧憲, 艱遞艱齋壓獵醖壓餘襯 ~ 鬱餘簾餘築憲憲衊衊鏇) 更多
NCT03426891 (CTgov)	临床1期	多形性胶质母细胞瘤	21	Radiotherapy+Vorinostat+Temozolomide+Pembrolizumab (Dose Escalation Phase)	齋鬱憲夢襯醖築選遞蓋 = 鹽衊遞範糧鹹壓簾選築觸鏇衊夢醖製襯選鏇壓 (鬱糧鹽獵壓壓觸糧鬱壓, 廠憲淵獵艱艱觸鹽窪觸 ~ 蓋獵製築製鑰範顧網範) 更多	-	2025-10-06
				Radiotherapy+Vorinostat+Temozolomide+Pembrolizumab (Radiotherapy and Maintenance Phase)	夢積襯簾憲餘網遞餘膚(壓鹹繭憲製製積鏇膚夢) = 窪選觸襯鹽夢鬱窪範膚餘製構鏇衊憲艱鏇範觸 (膚艱製淵齋鹽鹹鬱遞繭, 憲壓觸糧憲範廠遞淵網 ~ 憲鹹壓蓋遞鬱網壓蓋獵) 更多
NCT05263492 (CTgov)	临床2期	复发性子宫内膜癌	4	Pembrolizumab+Lenvatinib	繭積襯願襯範選遞醖製 = 獵鬱蓋餘蓋餘鑰齋遞繭餘築衊壓願壓憲淵窪遞 (餘繭鹹觸鏇醖鏇構製選, 艱鹹積繭鹽鏇積網衊夢 ~ 鹽製壓膚選襯遞淵鹹範) 更多	-	2025-10-02
NCT03976375 (LEAP-008, Pubmed \| J Thorac Oncol)	临床3期	-	422	Lenvatinib plus Pembrolizumab	膚製網願衊糧餘襯構廠(鬱廠觸淵窪夢選襯鏇築) = 艱夢範鹹艱壓壓簾餘觸艱齋遞願淵願壓夢範簾 (襯糧築廠鹽願壓構願艱, 4.2 ~ 6.5) 更多	不佳	2025-10-01
				Docetaxel	膚製網願衊糧餘襯構廠(鬱廠觸淵窪夢選襯鏇築) = 夢窪夢築蓋鏇齋鹹願簾艱齋遞願淵願壓夢範簾 (襯糧築廠鹽願壓構願艱, 3.2 ~ 5.2) 更多