This is a single center, open-label phase I clinical trial designed to determine the safety of personalized and adjusted neoantigen peptide vaccine (PANDA-VAC) administered concurrently with pembrolizumab in subjects with advanced squamous non-small cell lung cancer (NSCLC) or squamous cell carcinoma of head and neck (SCCHN).

开始日期2027-05-20

申办/合作机构

Lineberger Comprehensive Cancer Center

NCT07572123

/ Not yet recruiting临床2/3期IIT

A Two Cohort Randomized Study for Patients With High Risk (Phase II) and Standard Risk (Phase III) Classical Hodgkin Lymphoma in First Relapse

This phase II trial compares the impact of brentuximab vedotin and nivolumab after radiation to standard of care high dose chemotherapy (HDT)-autologous stem cell transplant (ASCT) in standard-risk patients with classic Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). In addition, the phase III trial will compare the effect of pembrolizumab after HDT-ASCT to standard of care HDT-ASCT alone in high-risk patients with relapsed or refractory classic Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. An ASCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving HDT before an ASCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Radiation therapy (RT) uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving brentuximab vedotin and nivolumab after radiation may be safe, tolerable and more effective than standard of care HDT-ASCT in treating patients with standard risk relapsed or refractory classic Hodgkin lymphoma. In addition, giving pembrolizumab after standard of care HDT-ASCT may be safe and tolerable and more effective than HDT-ASCT alone in treating high-risk patients with relapsed or refractory classic Hodgkin lymphoma.

开始日期2026-12-04

申办/合作机构

National Cancer Institute

NCT05077215

/ Not yet recruiting临床3期

A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab vs. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer

This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol).
Approximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors:
* Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer)
* ECOG score at baseline (0 vs 1)
* Geographic region (Asia vs ROW)

开始日期2026-12-01

申办/合作机构

Evergreen Therapeutics, Inc

100 项与帕博利珠单抗相关的临床结果

登录后查看更多信息

100 项与帕博利珠单抗相关的转化医学

登录后查看更多信息

100 项与帕博利珠单抗相关的专利（医药）

登录后查看更多信息

10,239

项与帕博利珠单抗相关的文献（医药）

2026-12-31·Human Vaccines & Immunotherapeutics

Mapping research trends in esophageal cancer immunotherapy: A decade of thematic evolution and emerging priorities

Review

作者: Zang, Qiwei ; Jia, Huijun ; Wei, Hongyu ; Gong, Yifan ; Zhao, Chengguang

Immunotherapy has become a pivotal therapy for various cancers, including esophageal cancer, showing promising potential in improving survival rates and enabling personalized care. However, significant challenges occur in identifying predictive biomarkers, refining combination therapies, and managing immunotherapy-related adverse effects. This bibliometric study analyzed publications related to the use of immunotherapy in esophageal cancer management over a 10-y period (January 1, 2015, to October 14, 2024), retrieved from the Web of Science Core Collection. Keyword co-occurrence and co-citation analyses were performed to identify key contributors, central themes, and influential publications. A total of 545 publications on esophageal cancer immunotherapy were included in the analysis. A sharp increase in publication volume was observed beginning in 2019, with a peak between 2021 and 2023. China emerged as the leading contributor, accounting for 67.7% of the total output, while Zhengzhou University produced the highest number of publications among all institutions. Prominent individual contributors included Ken Kato and Shen Lin. Research hotspots centered on PD-1/PD-L1 inhibitors, combination therapies, and tumor microenvironment modulation. Notably, a clear temporal evolution in research focus was observed, with early studies emphasizing specific immune checkpoint targets and agents (e.g., PD-1, Pembrolizumab, and CTLA-4), followed by a shift toward mechanistic investigations involving the tumor microenvironment, treatment resistance, and prognosis. This study provides a comprehensive view of immunotherapy in the management of esophageal cancer, offering direction for future research and valuable insights for clinical innovation.

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Economic evaluation of perioperative pembrolizumab plus standard of care as treatment for resectable locally advanced head and neck squamous cell carcinoma in the United States

Article

作者: Chafamo, Biruk ; Fernan, Catherine ; Muston, Dominic ; Johnson, Geoffrey ; Qian, Feng ; Tang, Yuexin ; Bensimon, Arielle G. ; Adkins, Douglas ; Zheng, Dandan ; Tzontcheva, Anjela ; Benjamin, Kimberly ; Uppaluri, Ravindra

AIMS:

In the phase 3 KEYNOTE-689 trial (NCT03765918) among patients with resectable locally advanced head and neck squamous cell carcinoma (LA HNSCC), perioperative pembrolizumab (pembrolizumab before surgery, then continued with standard-of-care [SOC] radiotherapy +/- cisplatin after surgery followed by pembrolizumab alone) significantly prolonged event-free survival vs. SOC alone, both in the intention-to-treat population and PD-L1 combined positive score (CPS) ≥1 subgroup. Perioperative pembrolizumab + SOC received Food and Drug Administration approval in June 2025 for resectable LA HNSCC expressing PD-L1 (CPS ≥ 1). The present study evaluated the cost-effectiveness of perioperative pembrolizumab + SOC versus SOC in this indication, from a US healthcare payer perspective.

MATERIALS AND METHODS:

A Markov cohort model with four states (event-free, local recurrence, incurable recurrence/progression, death) was developed to estimate lifetime costs, life years (LYs), and quality-adjusted LYs (QALYs) with 3% annual discounting. Transition probabilities were fitted to patient-level time-to-event data from KEYNOTE-689 through parametric multistate modelling. Costs of initial and subsequent treatment, adverse events, disease management, and terminal care were estimated in 2025$ based on trial results, drug labels, public databases, and literature. Utilities were derived through analyses of EQ-5D-5L data collected in KEYNOTE-689. Deterministic and probabilistic sensitivity analyses were performed.

RESULTS:

Compared to SOC, perioperative pembrolizumab + SOC increased total costs by $82,311 and provided gains of 1.47 QALYs and 1.77 LYs. Incremental cost-effectiveness ratios of perioperative pembrolizumab + SOC vs. SOC were $55,863/QALY and $46,406/LY. Higher initial treatment costs of perioperative pembrolizumab (incurred mainly in Year 1) were partially offset by lower recurrence-related costs. At the typical $150,000/QALY threshold, perioperative pembrolizumab + SOC was cost-effective in 96% of probabilistic simulations.

LIMITATIONS:

Survival extrapolations beyond the available trial period are subject to uncertainty.

CONCLUSIONS:

Perioperative pembrolizumab + SOC was found to be cost-effective versus SOC for the treatment of resectable LA HNSCC with CPS ≥ 1.

2026-12-31·OncoImmunology

A mixed inflammatory peripheral signature defines clinical outcomes in a phase II trial combining pembrolizumab with paclitaxel and carboplatin in melanoma

Article

作者: Cocolakis, Eftihia ; Cailhier, Jean-François ; Lapointe, Réjean ; Thébault, Paméla ; Lepage, Stéphanie ; Shechtman, Yelena ; Letendre, Caroline ; Le, Huy ; Dionne, Jeanne ; Jamal, Rahima ; Bélanger, Karl ; Lambert, Caroline ; Miller Jr, Wilson H.

Checkpoint blockade of PD-1 with pembrolizumab provides long-term survival to a significant proportion of patients with metastatic melanoma. Pembrolizumab has been successfully used in combination with chemotherapy in non-small-cell lung cancer to increase the response rate. This phase II trial combined pembrolizumab with carboplatin/paclitaxel (CP) to assess its safety and efficacy, and to identify correlates of responses. Thirty patients without prior immunotherapy for unresectable/metastatic melanoma were treated with pembrolizumab and CP. Peripheral blood was collected at baseline and after 2 cycles to characterize systemic immune activity by multiplex assays and flow cytometry. Seventy percent of patients received all 4 cycles of CP; 87% received pembrolizumab for 2 y or until progression. Grade 3 and higher adverse events (AEs) occurred in 50% of the patients. The overall response rate (ORR) and disease control rate (DCR) by irRC criteria were 43% and 53%, respectively. Median overall survival (OS) was 23.8 months. Objective response was associated with a lower frequency of naive CD8 T cells and low plasma CCL3 at baseline, along with a larger proportion of mature NK cells and of CD4 T cells expressing BTLA or LAIR-1. Survival rate was higher for patients with lower baseline of IL-6, IL-8, and CD4⁺CD39⁺ T cells. Following treatment, pro-inflammatory soluble factors increased in both responders and non-responders. Addition of CP to pembrolizumab in this study did not appear to result in a response or survival advantage and was less tolerable than immunotherapy alone. Correlative data point to peripheral signals to investigate further as potential biomarkers. Trial registration: clinicaltrials.gov, NCT02617849, registered on December 1st, 2015.

13,269

项与帕博利珠单抗相关的新闻（医药）

8 小时之前

·新药猎人笔记

2030年超万亿重磅药物专利到期！“药王”集体陨落，MNC疯狂自救！

2026年至2030年，全球制药行业正面临历史上规模最大的"超级专利悬崖"。据行业研究机构Evaluate和德勤统计，这期间将有约2,360亿至4,000亿美元的品牌药收入面临专利到期风险，涉及近40种重磅药物（年销售额超10亿美元）。本轮悬崖的规模是2016年上一轮的三倍，其集中程度和时间密度前所未有，将深刻重塑全球制药行业格局。在这场风暴的中心，肿瘤免疫治疗、心血管抗凝、自身免疫疾病和代谢性疾病领域成为重灾区。默沙东的Keytruda（帕博利珠单抗）——全球年销售额超过295亿美元的最畅销抗癌药——将于2028年失去美国专利保护；百时美施贵宝的Eliquis（阿哌沙班，年销120亿美元）和Opdivo（纳武利尤单抗，年销93亿美元）也将在2026-2028年间相继到期。仅这三大药物就占本轮悬崖总风险敞口的近四分之一。面对前所未有的挑战，各大药企正以前所未有的力度推进并购交易、加速研发管线布局并实施生命周期管理策略。2026年第一季度全球生物技术并购总额已达840亿美元，同比增长89%。与此同时，仿制药和生物类似药制造商正迎来黄金发展窗口，预计未来几年将为全球医疗系统节省500亿至800亿美元的年支出。 01 2030年前专利到期的重磅药物我们按时间线梳理2025年至2030年间即将失去专利保护的核心重磅药物。据《GEN》杂志统计，仅前20大面临专利悬崖的药物在2024年就创造了约1,764亿美元的销售额，占2,360亿美元总风险敞口的75%。 2026年：第一波冲击 2025年标志着本轮超级悬崖的序幕。强生的Stelara（乌司奴单抗）是全球免疫学领域的标杆药物，2024年全球销售额约108亿美元。其核心分子专利于2023年9月到期后，强生通过与安进、Alvotech等生物类似药厂商达成和解协议，允许它们于2025年起逐步进入市场。安进的Wezlana和Sandoz的Selarsdi已获FDA批准，Stelara正面临30%-70%的首年收入侵蚀。强生正试图通过将患者向Tremfya（古塞奇尤单抗，专利保护至2030年代初）转化来减缓损失。图源：AI制图再生元/拜耳的Eylea（阿柏西普）是眼科抗VEGF治疗的基石药物，美国年销售额约59亿美元。尽管Eylea HD（8mg高剂量版，2023年获批）拥有延伸至2030年代初的新专利组合，但原版Eylea的生物类似药竞争已在2025年启动，三星Bioepis等产品已获欧洲批准。诺华的Entresto（沙库巴曲缬沙坦，2024年全球销售额超60亿美元）和安进的Prolia（地诺单抗，2024年销售额约40亿美元）也在2025年面临专利到期。Entresto美国核心专利于2025年中期到期后，2026年第一季度销售额已骤降42%。进入2026年，第一波冲击全面加速。BMS/辉瑞的Eliquis（阿哌沙班）作为全球最畅销口服抗凝药，2024年全球销售额超120亿美元。欧洲专利将于2026年5月到期，美国专利保护持续至2026年11月（但由于诉讼和解，仿制药实际上市时间可能延至2028年4月）。据GlobalData预测，到2030年Eliquis销售额将较峰值暴跌92.3%。艾伯维/强生的Imbruvica（伊布替尼）是BTK抑制剂的先驱药物，曾经峰值销售额一度超过百亿美元。其核心化合物专利于2026年到期，但拥有超过165项专利的"专利丛林"可能将部分剂型的独占性延至2032年。图源：AI作图然而面对新一代BTK抑制剂如阿斯利康的Calquence和百济神州的Brukinsa，其已展现出更优的耐受性数据。伊布替尼已经开始在专利到期之前市场已经开始萎缩，去年销售额仅28.7亿美元。 2027年：肿瘤和代谢领域承压 2027年是肿瘤小分子药物和GLP-1受体激动剂领域的承压之年。辉瑞的Ibrance（帕博西利）是全球首个CDK4/6抑制剂，2024年全球销售额约47亿美元。其核心专利将于2027年3月到期，届时至少3家仿制药厂商准备进入市场。然而，Ibrance面临的竞争不仅来自仿制药，还有礼来的Verzenio和诺华的Kisqali在早期乳腺癌中的强势表现——这两款竞品已凭借总生存期优势抢占了大量市场份额。礼来的Trulicity（度拉糖肽）作为GLP-1受体激动剂的重要成员，2024年全球销售额约52亿美元，其核心专利将于2027年到期。不过，礼来已在GLP-1领域实现了代际跃迁—替尔泊肽二型糖尿病和减重两大领域的快速增长，2025年总计销售额超过365亿美元，大幅缓冲了Trulicity到期带来的影响。三星Bioepis等正积极开发Trulicity生物类似药。拜耳/强生的Xarelto（利伐沙班）占全球直接口服抗凝药（DOAC）市场约45%份额，2025年美国销售额约31亿美元。其核心专利将于2026年2月至2027年间陆续到期，欧洲专利格局更为分散——瑞典、比利时等国法院已维持专利有效，而挪威、爱尔兰和英国的专利已被撤销或失效。 2028年：PD-1抑制剂O药/K药迎大考 2028年将是本轮超级悬崖中最具决定性的年份——默沙东的Keytruda（帕博利珠单抗）和BMS的Opdivo（纳武利尤单抗）两大PD-1抑制剂将同时面临专利到期。据《Drug Patent Watch》统计，这三种药物（加上Eliquis）的LOE集中在2026-2028年窗口，将触发"史上最大规模的支付方流动性事件"。 Keytruda是当之无愧的重中之重。2024年全球销售额达295亿美元，占默沙东总收入的约46%-55%。美国核心成分专利将于2028年12月到期。默沙东已投入10亿美元开发皮下注射剂型Keytruda SC（Qlextra），于2024年获FDA批准，试图通过新剂型专利将独占性延至2033年以后。此外，默沙正积极构建固定剂量组合（FDC）专利墙——将Keytruda与VEGF抑制剂、CTLA-4拮抗剂或小分子激酶抑制剂组合，这些FDC专利可延伸至2042年及以后。 BMS的Opdivo是Keytruda最直接的竞争对手，2024年全球销售额约93亿美元。BMS公布的"估计最低市场独占权日期"显示Opdivo美国专利将于2028年到期，欧盟2030年，日本2031年。BMS的策略与默沙东类似：推动Opdivo向联合疗法转化——Opdualag（Opdivo+relatlimab）和Opdivo+Yervoy（伊匹木单抗）组合各自拥有独立的知识产权。BMS还在开发Opdivo皮下注射剂型以延长生命周期。 2028年还有默沙东的Gardasil 9（九价HPV疫苗，年销售额约89亿美元）的关键专利到期，以及罗氏的Ocrevus（奥瑞利珠单抗，年销售额约76亿美元）的欧洲专利到期。Gardasil 9的部分专利将延至2028年，而Ocrevus的美国专利则将持续至2029年。 2029-2030年：自免重磅药物Dupi大考 2029年标志着又一波生物制剂专利悬崖的高峰。强生的Darzalex（达雷妥尤单抗）是全球多发性骨髓瘤治疗的基石药物，2024年全球销售额达117亿美元。其美国成分专利将于2029年到期（欧洲2031年）。Genmab在年报中坦承，预计版税收入将从2029年开始"实质性下降"。不过，强生的皮下注射剂型Darzalex Faspro拥有独立的配方专利，可在核心抗体专利到期后维持差异化定价。安进的Enbrel（依那西普）是生物制剂专利策略的经典案例。其核心成分专利于2012年就已到期，但安进通过从罗氏收购的制造工艺专利（U.S. Patent 8,063,182和8,163,522，分别于2028年11月和2029年4月到期）成功将美国独占性延长了17年。2016年FDA批准的Sandoz生物类似药Erelzi和2019年三星Bioepis的Eticovo均被法院禁令阻止上市。这一"专利丛林"策略为Enbrel创造了超过300亿美元的额外收入保护，但也引发了反垄断诉讼（2026年2月被法院驳回）。诺华的Cosentyx（司库奇尤单抗）2024年全球销售额约52亿美元，美国关键专利将于2029年到期（欧洲2030年）。赛诺菲/再生元的Dupixent（度普利尤单抗），凭借众多Th2型适应症的获批，2025年全球销售额达178亿美元，核心专利将于2030-2031年间到期——这是2030年前悬崖中最后也是最重磅的一击。韩国的大熊制药、钟根堂等多家公司已在积极开发Dupixent生物类似药。 02 各家MNC战略应对专利悬崖 2030年前的超级悬崖正以前所未有的方式重塑全球制药行业。面对专利悬崖，原研药企正运用三大核心技术策略：第一，剂型创新——默沙东投入10亿美元开发皮下Keytruda，将给药时间从30-90分钟静脉输注缩短至7分钟皮下注射，既提升患者体验又延长专利保护；第二，固定剂量组合（FDC）——将专利到期药物与专利期内的药物组合成新产品，Merck的Keytruda+仑伐替尼等FDC专利可延至2042年；第三，专利丛林（Patent Thicket）——Imbruvica拥有165项专利、Enbrel依赖制造专利延长17年独占期，这些策略虽受争议但确实有效。专利悬崖压力也正以前所未有的力度推动行业整合。2026年第一季度，全球生物技术并购交易总额已达840亿美元，较2025年同期的444亿美元大幅增长89%，创下自2019年以来的最佳开局。分析师预计，若当前势头持续，2026年全年生物制药并购总价值或将突破2,500亿美元。 "大型制药公司没有等待八到十年去建立内部管线的奢侈，"Oldenburg Capital Partners创始合伙人Patrice Mesnier指出，"它们不再是为了选择性而购买，而是在购买时间。"礼来、吉利德和默沙东是2026年并购支出最多的三家企业。这种紧迫感源于一个简单的事实：仅靠内部研发无法在规定时间内弥补数百亿美元的收入缺口。默沙东是本轮并购潮中最具代表性的"剁手党"。面对Keytruda（2024年全球销售额295亿美元，占公司总收入的46%-55%）将于2028年到期的严峻现实，默沙东在2025-2026年开启了一场近乎疯狂的收购之旅。 2025年7月，默沙东以约100亿美元收购Verona Pharma，获得已获批的COPD药物Ohtuvayre，拓展心肺疾病管线。2025年11月，又以92亿美元收购Cidara Therapeutics，获取晚期流感预防药物CD388。2026年3月，再以67亿美元收购Terns Pharmaceuticals，获得口服白血病候选药物TERN-701。短短八个月内，默沙东在并购上花费超过260亿美元。此外，默沙东还完成了对Prometheus Biosciences（108亿美元，获得TL1A抗体）、Acceleron Pharma（115亿美元，获得肺动脉高压药物Winrevair）的收购。管理层甚至宣布将Human Health业务分拆为独立的肿瘤学单元和其他专科药物单元，目标是在"2030年代中期"实现超过700亿美元的年收入——这是Keytruda峰值销售（预计2028年350亿美元）的两倍以上。然而，这场疯狂购物也引发了不少质疑。Keytruda的缺口约295亿美元/年，而上述收购合计能否在2030年前弥补这一缺口仍是未知数。正如分析师所言："默沙东不是在买管线，是在买时间。问题是，它买的时间够不够？" 辉瑞在2025-2028年面临严峻的专利到期潮，7款重磅药物集中到期，包括与BMS合作的抗凝药Eliquis（阿哌沙班，2028年到期，2024年销售额约74亿美元）、乳腺癌药物Ibrance（哌柏西利，2027年到期，2024年销售额约50亿美元）、前列腺癌药物Xtandi（恩扎卢胺，2027年到期）、肺炎疫苗Prevnar 13（2026年到期）、免疫药物Xeljanz（托法替布，2026年到期）等，预计2025-2030年间将损失约170-180亿美元年收入。辉瑞的应对策略是亦是"并购驱动增长"。2023年底，公司以430亿美元收购Seagen，一举跃升为ADC（抗体药物偶联物）领域的领导者。Seagen带来的不仅是已上市产品（Padcev等）的收入，更重要的是一个经过验证的ADC技术平台和丰富的在研管线。 2025年11月再以最高100亿美元击败诺和诺德竞得Metsera，获得每周/每月注射GLP-1受体激动剂MET-097i和每月注射胰淀素类似物MET-233i，重返减肥药赛道，目标在2028-2029年推出产品参与预计达1500亿美元的肥胖药物市场。此外，辉瑞还通过引进3SBio的PD-1×VEGF双抗、Nona Biosciences的ADC资产等授权合作补强管线。辉瑞计划到2027年推出至少8个具有重磅潜力的新肿瘤治疗产品。为应对Stelara（乌司奴单抗，2023年专利到期）、Simponi（戈利木单抗，2024年专利到期）、Xarelto（利伐沙班，2025年专利到期）及Darzalex（达雷妥尤单抗，2029年专利到期）等核心产品的专利悬崖，强生近年来展开了一系列密集并购。在免疫学领域，2024年5月强生以8500万美元收购Proteologix，获得靶向IL-13/TSLP的双抗PX128和靶向IL-13/IL-22的双抗PX130，用于特应性皮炎和哮喘；同年12月以约12.5亿美元收购Numab子公司Yellow Jersey Therapeutics，获得靶向IL-4Rα/IL-31的双抗NM26，进一步补强自免双抗管线。在肿瘤学领域，2024年1月强生以约20亿美元收购ADC公司Ambrx，获得靶向前列腺癌的HER2 ADC平台；2025年11月再以30.5亿美元收购Halda Therapeutics，获得其RIPTAC平台和前列腺癌口服靶向药HLD-0915，助力其到2030年实现约500亿美元肿瘤销售额的目标。在神经科学领域，2025年1月强生以146亿美元收购Intra-Cellular Therapies，获得已获批的精神分裂症和双相抑郁药物Caplyta（lumateperone）及CNS管线。此外，在医疗科技板块，强生还以166亿美元收购Abiomed（Impella心脏泵）和131亿美元收购Shockwave Medical（血管内碎石术），以多元化布局对冲制药板块专利到期的收入风险。2025年强生并购总支出约177亿美元，仅次于默沙东，其策略强调平台型资产与产品并重，愿意为潜在平台级资产提前下注为应对Dupixent（度普利尤单抗）2030-2031年的专利悬崖，赛诺菲近年来展开了一系列密集并购： 2023年4月以约29亿美元收购Provention Bio，获得全球首个延缓1型糖尿病发病的疾病修饰疗法Tzield（teplizumab）； 2024年5月以约22亿美元收购Inhibrx，获得α-1抗胰蛋白酶缺乏症替代疗法SAR447537；2025年7月更是以最高95亿美元完成对Blueprint Medicines的收购，拿下已上市的系统性肥大细胞增多症药物Ayvakit（avapritinib）及下一代KIT抑制剂elenestinib和免疫学早期管线BLU-808，后者峰值销售预计可达27亿美元。艾伯维在Humira（阿达木单抗）专利到期前采取了多管齐下的防御策略：一方面通过构建"专利丛林"在美国申请了约250项专利，成功将生物类似药进入美国市场的时间从2016年推迟至2023年，累计创造约2000亿美元收入；另一方面加速推进新一代免疫学药物Skyrizi（IL-23 p19抑制剂）和Rinvoq（口服JAK抑制剂）的商业化，2024年两者合计销售额已接近190亿美元，预计2027年将超越Humira峰值收入，同时通过专利和解将Rinvoq的美国独占期延长至2037年；此外还展开大规模并购，2023年12月一周内以约101亿美元收购ImmunoGen获得ADC平台及Elahere，以约87亿美元收购Cerevel补强神经科学管线，2025年7月再以最高21亿美元收购Capstan Therapeutics布局体内CAR-T技术，目标在Humira生物类似药全面冲击下维持免疫学领导地位并实现治疗领域多元化。诺华在2025年底至2026年初面临公司历史上最大规模专利到期潮，Entresto（沙库巴曲缬沙坦，年销约77亿美元）、Tasigna（尼洛替尼）和Promacta（艾曲泊帕）集中失去专利保护，预计2026年损失约40亿美元销售额。为应对这一冲击，诺华采取了密集并购策略，2025年以来已完成或宣布收购6家公司，包括2024年11月以最高11亿美元收购Kate Therapeutics获得DMD等神经肌肉疾病基因疗法，2025年10月以120亿美元收购Avidity Biosciences获得三个后期AOC RNA疗法项目，2026年3月以最高30亿美元收购Pikavation Therapeutics获得pan-mutant PI3Kα抑制剂SNV4818，以及以最高20亿美元收购Excellergy获得下一代抗IgE抗体Exl-111，全年并购支出约300亿美元；同时依靠现有增长品牌Kisqali（乳腺癌，年销约48亿美元）、Kesimpta（多发性硬化症）、Pluvicto（放射性配体疗法）和Leqvio（降脂siRNA）推动收入增长，预计2026年将有7项关键试验数据读出和28项监管申报，目标到2030年实现约700亿美元收入，年均增长5%-6%。结束语： 2025年至2030年的超级专利悬崖是制药行业进入新世纪以来面临的最严峻考验。约2,360亿至4,000亿美元的品牌药收入——相当于全球药品总支出的六分之一——将在此期间面临专利到期风险。这不仅是单一产品的生命周期终结，更是一场关乎行业格局重塑的深层变革。成功穿越悬崖的企业将具备三个共同特征：一是拥有多元化且具竞争力的研发管线——礼来和诺和诺德凭借GLP-1领域的突破性产品（Mounjaro/Zepbound、Ozempic/Wegovy），几乎完全规避了本轮悬崖的冲击；二是善于通过并购快速补强能力——默沙东、辉瑞的并购速度正在加快；三是在生命周期管理和创新药物格式上保持领先——剂型创新、固定剂量组合和新一代疗法是抵御仿制药侵蚀的核心武器。对于患者和全球医疗系统而言，超级专利悬崖最终将转化为更低廉的药品价格和更广泛的可及性。据估算，到2030年，生物类似药和仿制药的广泛应用将为美国医疗系统每年节省500亿-800亿美元。 2030年不仅是本轮超级悬崖的终点，更是新一轮行业竞争的起点。届时，Keytruda、Opdivo和Dupixent的专利故事将成为历史，而ADC、细胞与基因治疗、RNA疗法、乃至自免小分子/多肽口服药物等下一代治疗模态将主导新的竞争格局。封图：原图Joanna Sadowska制作，下载自中国医药创新促进会

11 小时之前

·生物制品圈

里程碑！全球首个ctDNA指导免疫治疗获批

当地时间5月15日，罗氏正式宣布，其PD-L1抑制剂Tecentriq（阿替利珠单抗）及其皮下制剂Tecentriq Hybreza，已获得美国食品药品监督管理局（FDA）批准，用于膀胱切除术后、经Natera公司Signatera检测确认存在循环肿瘤DNA分子残留病（ctDNA MRD）的肌层浸润性膀胱癌（MIBC）成人患者的辅助治疗。这是全球首个获得FDA批准的ctDNA指导型肿瘤免疫疗法，标志着肿瘤精准治疗正式迈入全新的分子残留病（MRD）时代，为膀胱癌术后治疗提供了全新的精准路径。关键临床数据：死亡风险显著降低41%，疗效明确可期此次新适应症的获批，核心依托于罗氏III期IMvigor011研究的积极数据——该研究也是全球首个通过前瞻性试验，证实ctDNA指导治疗可显著改善MIBC患者生存预后的III期临床试验，其数据说服力备受行业认可。该研究共纳入761例膀胱癌术后患者，对其开展了超过一年的连续ctDNA动态监测，最终筛选出250例ctDNA MRD阳性患者进入核心治疗阶段，这些患者被随机分配至Tecentriq治疗组与安慰剂对照组，接受规范干预。研究结果显示，Tecentriq治疗组表现出显著的生存优势：将患者的疾病复发或死亡风险降低了36% 将膀胱癌特异性死亡风险降低了41% 同步获批的还有Natera公司的Signatera检测，该检测将作为此次新适应症的专属伴随诊断手段，仅ctDNA MRD阳性患者可纳入Tecentriq治疗范围，实现“精准筛选、精准治疗”。从失败到逆袭：罗氏精准化战略转型，打破治疗困局值得关注的是，此次新适应症的成功获批，是罗氏在MIBC治疗领域的一次关键逆袭。早在2020年，Tecentriq针对MIBC的IMvigor010研究，因在未经筛选的全体MIBC术后患者中未能达到无病生存期的主要终点，遗憾宣告失败。此次罗氏彻底调整治疗策略，摒弃传统“一刀切”的粗放治疗模式，转而通过ctDNA MRD检测，精准锁定真正存在复发高风险、且最有可能从免疫治疗中获益的患者群体，精准匹配治疗方案，最终实现了临床研究的成功突破。罗氏首席医学官兼全球产品开发负责人Levi Garraway博士表示：“将我们的癌症免疫疗法Tecentriq与前沿的MRD检测技术相结合，既能更精准地识别出需要积极干预的患者，也能让众多低风险患者避免不必要的治疗及相关副作用，这正是精准肿瘤学的核心价值所在。”改变临床实践：告别“经验性治疗”，迈入精准分层时代肌层浸润性膀胱癌（MIBC）是一种侵袭性极强的泌尿系统恶性肿瘤，目前临床标准治疗方案为膀胱切除术联合辅助化疗，但全球每年有超过15万名接受手术治疗的患者，其中近一半会出现癌症复发，术后治疗的精准性亟待提升。传统临床实践中，医生主要依靠肿瘤分期来判断患者是否需要术后辅助治疗，但这种方式存在明显局限性，难以精准捕捉患者的复发风险。而ctDNA MRD检测可实现“早于影像学”的肿瘤监测，在常规影像学检查发现肿瘤复发之前，就能从患者血液中捕捉到癌症的分子痕迹，为精准判断复发风险提供了可靠依据。膀胱癌倡导网络（Bladder Cancer Advocacy Network）首席执行官Meri-Margaret Deoudes指出：“这一批准将有效解决MIBC术后治疗的不确定性难题，让临床医生能够针对性地为复发风险最高的患者提供个体化治疗，同时让低风险患者免受不必要治疗带来的身体负担与副作用，意义重大。”膀胱癌市场竞争加剧，精准化成核心竞争力作为首个进入膀胱癌治疗领域的PD-L1抑制剂，Tecentriq早在2016年就已获批用于特定尿路上皮癌患者的治疗。此次ctDNA指导下的新适应症获批，进一步强化了其精准治疗优势，也让其在竞争日趋激烈的膀胱癌市场中占据了独特地位。目前，全球各大药企均在膀胱癌领域积极布局PD-1/PD-L1抑制剂，市场竞争持续升温：阿斯利康的Imfinzi（度伐利尤单抗）于去年率先获批，成为首个获得MIBC围手术期适应症的免疫疗法；百时美施贵宝（BMS）的Opdivo（纳武利尤单抗）在2021年已获得MIBC术后辅助治疗适应症批准；默沙东的Keytruda（帕博利珠单抗）与辉瑞的抗体药物偶联物Padcev（恩诺单抗）联合疗法，近期在多个膀胱癌患者人群中取得多项临床试验成功，逐步扩大市场布局。罗氏表示，目前正将这种ctDNA指导的治疗模式，拓展至其他多种实体瘤的临床研究中。业内普遍认为，此次Tecentriq新适应症的获批仅仅是一个开端，未来，分子残留病（MRD）指导的精准治疗，有望成为更多实体瘤的标准治疗模式，推动肿瘤治疗进入更精准、更高效的新时代。参考来源：https://www.fiercepharma.com/pharma/roches-tailored-ctdna-guided-approach-tecentriq-pays-post-surgical-bladder-cancer-nod 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

免疫疗法临床3期

15 小时之前

·PRNewswire

TuHURA Biosciences Reports First Quarter 2026 Financial Results and Provides a Corporate Update

TAMPA, Fla., May 15, 2026 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ: HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today reported financial results for the Company's first quarter ended March 31, 2026, and provided a corporate update. "I am very pleased with the progress we have made this past quarter as we continue to execute upon our corporate and development strategy. Importantly, we recently established a $50 million non-equity-based source of operating capital in the form of credit facility with our largest stockholder on attractive terms for the company allowing us to fund operations beyond anticipated top-line data in our lead IFx-2.0 program," said Dr. James Bianco, President and CEO of TuHURA Biosciences. "With the financing optionality provided by the credit facility, we now look forward to several anticipated key upcoming milestones, including: meeting with the FDA to discuss our IND and development plan for our VISTA inhibitor, TBS-2025, and initiating a Phase 1b/2 trial of TBS-2025 in mutNPM1 r/r AML; selecting our lead ADC for proof-of-concept studies in AML; and completing enrollment in our Phase 3 study of IFx-2.0 in Merkel Cell Carcinoma (MCC)." First Quarter and Recent Corporate Highlights: In April 2026, the company announced a $50 million credit facility and royalty transaction extending its anticipated cash runway into 2028. Under the terms of the loan agreement for the credit facility, TuHURA will have the ability to draw down on the facility on an as-needed basis to fund monthly expenses for ongoing clinical development and operations. The facility bears a 12% annual interest rate on outstanding funds drawn, with interest paid monthly and principal repayment due at a 5-year maturity date for April 21, 2031. Announced Craig Tendler, M.D., will provide strategic, operational and other related services consistent with those of a Chief Medical Officer. Dr. Tendler will continue in his role as a member of the Board of Directors and also work with management to oversee clinical development strategy and operations of the company's pipeline, including its VISTA inhibiting antibody, TBS-2025. Appointed Amanda Garofalo, MSHS, as Senior Vice President of Clinical Operations. Mrs. Garofalo has over 20 years of clinical and development experience and will work closely with Dr. Tendler in overseeing the day-to-day clinical operations. Received FDA Orphan Drug Designation (ODD) for IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma. The ODD designation was based on data from the Company's previously completed Phase 1 study of IFx-2.0, which demonstrated IFx-2.0 to be safe with no serious dose limiting toxicities. Additionally, the study demonstrated that patients refractory to checkpoint inhibitor therapy (anti-PD1) experienced clinical benefit upon subsequent anti-PD1 based treatment. Anticipated Milestones by Program IFx-2.0 (Innate Immune Agonist) 1H 2026: Anticipate Orphan Drug Designation for IFx-2.0 in MCC 2H 2026: Anticipate presenting data at a scientific conference 2H 2027: Complete enrollment in Phase 3 study of IFx-2.0 2H 2027: Anticipate topline results from the Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to Keytruda® (pembrolizumab) in first-line treatment for advanced or metastatic MCC TBS-2025 (VISTA inhibiting mAb) 1H 2026: Planned FDA IND meeting regarding the Phase 1b/2 development plan inNPM1 mut r/r AML, and other molecularly defined subsets 2H 2026: Seek Orphan Drug Designation in AML 2H 2026: Initiate Phase 1b/2 trial of VISTA in mutNPM1 r/r AML MDSC Inhibitors (Bi-specific ADCs) 1H 2026: Select lead ADC for proof-of-concept study in AML 2H 2026: Presentations at key scientific meetings Summary of Financial Results for the First Quarter 2026 Cash and cash equivalents of $6.3 million at March 31, 2026. TuHURA's total common shares outstanding were approximately 63.6 million. Research and development expenses were $5.2 million and $4.6 million for the 3 months ended March 31, 2026, and 2025, respectively. General and administrative (G&A) expenses were $2.3 million and $2.0 million for the 3 months ended March 31, 2026, and 2025, respectively. Net cash outflows from operating activities were ($4.4) million and ($4.7) million for the 3 months ended March 31, 2026, and 2025, respectively. Net cash flows from financing activities were $ 7.2 million and $ (0.5) million for the 3 months ended March 31, 2026, and 2025, respectively. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA is developing TBS-2025, a VISTA inhibiting mAb moving into Phase 1b/2 in mutNPM1 r/r AML, a molecularly defined subgroup of patients with AML. In addition, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific, bi-functional antibody drug conjugates (ADCs) targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit and connect with TuHURA on Facebook, X, and LinkedIn. Cautionary Statement Regarding Forward-Looking Statements This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-Looking Statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases, you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely," or the negative or plural of these words or similar expressions. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include, among others: the risk that funds available under the Company's credit facility may be insufficient to fund the Company's operations and development programs to the extent anticipated; risks associated with conducting the ongoing Phase 3 trial for IFx.20; the risks associated with continuing the development of TBS-2025 and our DOR technologies; risks related to patient enrollment, trial design, data outcomes and regulatory interactions; uncertainty regarding the timing and likelihood of regulatory approvals; and the other risks described from time to time in detail in Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed on March 31, 2026, and TuHURA's other reports and filings with the SEC from time to time, which are available on TuHURA's website and at . The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Investor Contact: Monique Kosse Gilmartin Group [email protected] SOURCE TuHURA Biosciences, Inc. 21% more press release views with Request a Demo

免疫疗法临床3期财报临床结果临床1期

100 项与帕博利珠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
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,

后查看更多信息

适应症	国家/地区	公司	日期
铂类耐药性原发性腹膜癌	欧盟	Merck Sharp & Dohme BV	2026-04-22
铂类耐药性原发性腹膜癌	冰岛	Merck Sharp & Dohme BV	2026-04-22
铂类耐药性原发性腹膜癌	列支敦士登	Merck Sharp & Dohme BV	2026-04-22
铂类耐药性原发性腹膜癌	挪威	Merck Sharp & Dohme BV	2026-04-22
铂耐药上皮性卵巢癌	欧盟	Merck & Co., Inc.	2026-04-02
铂耐药上皮性卵巢癌	冰岛	Merck & Co., Inc.	2026-04-02
铂耐药上皮性卵巢癌	列支敦士登	Merck & Co., Inc.	2026-04-02
铂耐药上皮性卵巢癌	挪威	Merck & Co., Inc.	2026-04-02
错配修复缺陷或微高卫星不稳定性结肠癌	美国	Merck Sharp & Dohme LLC	2026-02-10
肿瘤	美国	Merck Sharp & Dohme LLC	2026-02-10
卵巢癌	美国	Merck Sharp & Dohme LLC	2026-02-10
肌层浸润性膀胱癌	美国	Merck Sharp & Dohme LLC	2025-11-21
局部晚期头颈部鳞状细胞癌	欧盟	Merck Sharp & Dohme BV	2025-10-30
局部晚期头颈部鳞状细胞癌	冰岛	Merck Sharp & Dohme BV	2025-10-30
局部晚期头颈部鳞状细胞癌	列支敦士登	Merck Sharp & Dohme BV	2025-10-30
局部晚期头颈部鳞状细胞癌	挪威	Merck Sharp & Dohme BV	2025-10-30
不可切除的肝细胞癌	中国	Merck Sharp & Dohme LLC	2025-06-10
不可切除的胸膜恶性间皮瘤	欧盟	Merck Sharp & Dohme BV	2025-04-16
不可切除的胸膜恶性间皮瘤	冰岛	Merck Sharp & Dohme BV	2025-04-16
不可切除的胸膜恶性间皮瘤	列支敦士登	Merck Sharp & Dohme BV	2025-04-16

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
复发性铂耐药性卵巢癌	申请上市	美国	Merck & Co., Inc.	2025-10-20
小肠癌	申请上市	欧盟	Merck Sharp & Dohme Corp.	2022-03-25
非小细胞肺癌Ⅰ期	临床3期	美国	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	加拿大	Merck Sharp & Dohme LLC	2026-05-04
微卫星稳定型子宫内膜癌	临床3期	中国	默沙东研发（中国）有限公司	2025-08-31
铂耐药性卵巢癌	临床3期	美国	Mural Oncology, Inc.	2022-01-10
铂耐药性卵巢癌	临床3期	澳大利亚	Mural Oncology, Inc.	2022-01-10
铂耐药性卵巢癌	临床3期	奥地利	Mural Oncology, Inc.	2022-01-10
铂耐药性卵巢癌	临床3期	比利时	Mural Oncology, Inc.	2022-01-10

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


NCT02617849 (Pubmed \| Oncoimmunology)	临床2期	黑色素瘤	30	Pembrolizumab and Carboplatin/ Paclitaxel	選鏇構簾鏇蓋鬱衊壓窪(範築觸遞鏇鬱糧獵餘廠) = 鹽憲艱構鑰製襯醖鬱鏇夢顧糧積鹹鹹繭製憲顧 (醖觸範餘餘簾淵壓淵鬱 ) 更多	不佳	2026-12-31
NCT04165096 (KEYMAKER-U01C \| MK-3475-01C, CTgov)	临床2期	晚期非小细胞肺癌 \| 晚期肺非鳞状非小细胞癌	128	acetaminophen+Boserolimab+Pembrolizumab+diphenhydramine (Pembrolizumab + Boserolimab)	艱憲願窪築衊廠醖鬱夢 = 醖齋艱鏇觸遞遞願衊顧繭衊齋構醖簾餘蓋簾繭 (襯醖蓋鑰艱壓膚膚淵艱, 鑰餘鏇蓋醖壓齋糧壓鏇 ~ 襯襯製鹽鏇艱齋選遞範) 更多	-	2026-05-13
				MK-4830+Pembrolizumab (Pembrolizumab + MK-4830)	艱憲願窪築衊廠醖鬱夢 = 選範醖衊艱醖夢遞鹹襯繭衊齋構醖簾餘蓋簾繭 (襯醖蓋鑰艱壓膚膚淵艱, 積選廠築網壓襯艱鹽醖 ~ 觸窪鹹構積網艱構衊淵) 更多
NCT02841748 (PATHWay study, CTgov)	临床2期	头颈部鳞状细胞癌	100	Pembrolizumab (Pembrolizumab)	選窪衊鹹淵遞選蓋廠鑰 = 繭窪淵衊衊簾鬱鬱膚餘觸壓鬱淵顧夢襯壓糧範 (鹽遞鏇願鹽鬱廠網製齋, 製艱網願築壓餘壓醖網 ~ 糧醖鹹壓顧憲醖鏇網網) 更多	-	2026-05-13
				Placebo (Placebo)	選窪衊鹹淵遞選蓋廠鑰 = 淵繭簾鹹衊製築鹹醖願觸壓鬱淵顧夢襯壓糧範 (鹽遞鏇願鹽鬱廠網製齋, 積獵觸衊鹹衊獵簾鬱繭 ~ 壓艱憲壓網製觸網觸廠) 更多
NCT04414540 (601, CTgov)	临床2期	头颈部鳞状细胞癌 \| 头颈癌转移	21	Metformin Extended Release Oral Tablet+Pembrolizumab (Arm 1: Metformin Before Pembrolizumab)	構窪糧齋範構憲構顧範 = 窪積範膚鏇餘糧艱網積憲餘蓋窪糧艱積憲醖餘 (鑰範簾窪窪鹽願鹽窪觸, 製鏇艱繭鑰觸蓋窪艱淵 ~ 壓夢夢鬱膚餘繭襯鹹繭) 更多	-	2026-05-08
				Metformin Extended Release Oral Tablet+Pembrolizumab (Arm 2: Metformin After Pembrolizumab)	構窪糧齋範構憲構顧範 = 積憲築蓋蓋醖憲獵繭顧憲餘蓋窪糧艱積憲醖餘 (鑰範簾窪窪鹽願鹽窪觸, 製淵範齋餘糧網醖襯衊 ~ 艱蓋壓範鏇簾鹹積膚艱) 更多
NCT02399371 (CTgov)	临床2期	腹膜恶性间皮瘤 \| 恶性胸膜间皮瘤 \| 上皮样间皮瘤，恶性	65	Pharmacogenomic Study+Pembrolizumab	築遞顧窪襯繭選鹽窪憲 = 壓憲選艱憲遞齋膚淵膚鹹繭願膚獵艱蓋艱構鹽 (網鏇壓壓遞鬱繭觸築襯, 醖餘鑰鹽鬱鏇窪範壓積 ~ 積顧獵遞獵網鹽製繭壓) 更多	-	2026-05-08
NCT03144466 (PAPAYA, CTgov)	临床1期	子宫颈腺癌 \| 局部晚期宫颈癌 \| 宫颈癌	1	Pembrolizumab (Part A - Starting Dose)	壓構淵繭獵糧壓齋餘鹹 = 衊齋餘艱廠鹽蓋構糧鹽製鹹窪遞餘構簾淵選淵 (淵鑰選窪鹹艱蓋淵窪積, 鑰襯鬱衊齋醖積願選窪 ~ 繭顧壓鹹餘遞鏇鏇網鬱) 更多	-	2026-05-05
				Pembrolizumab (Part A - Escalation Dose)	觸膚窪構艱選選鏇願憲(艱蓋壓網醖糧網鬱窪襯) = 膚繭網壓選窪顧蓋築糧願艱鹽憲鏇蓋艱繭選糧 (窪獵積簾艱獵築鬱選餘, 築構繭製範製獵觸範齋 ~ 艱鹹廠鏇窪鑰鑰積積糧) 更多
NCT03752333 (CUPem, CTgov)	临床2期	原发部位不明恶性肿瘤	35	Pembrolizumab	齋鹽衊選衊鏇鏇襯範醖 = 糧憲醖蓋襯積構醖獵齋鬱網獵鹹願繭顧艱窪襯 (壓鹹齋壓範願襯蓋構餘, 襯襯築獵鑰窪範鏇窪鹽 ~ 鏇艱繭鏇壓範獵鬱遞遞) 更多	-	2026-05-04
NCT03391973 (Pubmed \| Eur J Cancer)	临床2期	原发部位不明恶性肿瘤一线 MMR \| MSI	27	Pembrolizumab 200 mg	鹹鬱築鏇鹹範鏇醖醖構(壓憲蓋齋醖壓網願鬱鑰) = 艱願衊窪齋築壓鏇壓遞襯糧淵選蓋築繭遞淵鏇 (蓋夢襯製艱鹹繭繭獵構, 2.35 ~ 29.16) 更多	不佳	2026-05-01
NCT02837263 (CTgov)	临床1期	大肠腺癌 \| 肝转移 \| 转移性结直肠癌	15	Stereotactic body radiotherapy (SBRT)+Pembrolizumab	網艱廠鑰蓋襯餘淵簾顧 = 糧繭製鹹鹹鹽膚觸憲網範積衊願糧獵範鹽觸鑰 (鏇顧夢獵廠鏇網蓋糧願, 衊網鏇餘淵積製鏇鹽淵 ~ 鑰範構廠觸衊壓蓋鑰醖) 更多	-	2026-05-01
NCT03867084 (KEYNOTE-937 \| MK-3475-937, CTgov)	临床3期	肝细胞癌	959	Pembrolizumab (Pembrolizumab)	構齋願衊醖網築遞糧淵(網糧餘壓壓夢窪簾廠鬱) = 廠獵窪壓膚餘艱築壓鬱衊窪糧憲夢願夢鏇窪糧 (襯範獵獵蓋繭蓋襯廠膚, 襯願鬱襯遞艱鬱壓夢憲 ~ 網夢觸艱鏇襯憲繭選艱) 更多	-	2026-04-24
				Placebo (Placebo)	構齋願衊醖網築遞糧淵(網糧餘壓壓夢窪簾廠鬱) = 膚醖艱網淵艱憲鑰願選衊窪糧憲夢願夢鏇窪糧 (襯範獵獵蓋繭蓋襯廠膚, 築糧鹽觸願簾淵願壓製 ~ 廠遞製簾鑰衊構範鹽餘) 更多