帕博利珠单抗(Pembrolizumab) - 药物靶点：PD-1_在研适应症：浸润性膀胱癌，铂耐药性输卵管癌，铂类耐药性原发性腹膜癌_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)

+ [12]

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

浸润性膀胱癌铂耐药性输卵管癌铂类耐药性原发性腹膜癌+ [327]

非在研适应症

肢端雀斑恶性黑色素瘤急性髓性白血病NPM1突变急性髓系白血病+ [118]

原研机构

Merck & Co., Inc.

在研机构

Merck Sharp & Dohme Corp.

默沙东研发（中国）有限公司Merck Sharp & Dohme BV

+ [16]

非在研机构

Merck Sharp & Dohme (Ireland) Ltd.

Turnstone Biologics Corp.

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)、附条件批准 (中国)、孤儿药 (日本)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、突破性疗法 (中国)、优先审评 (美国)、优先审评 (中国)

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结构/序列

Sequence Code 93660H

来源: *****

Sequence Code 93670L

来源: *****

关联

2,691

项与帕博利珠单抗相关的临床试验

NCT04266730

/ Suspended临床1期

Phase I Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Administered Concurrently With Pembrolizumab

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

NCT07689240

/ Not yet recruiting临床3期IIT

Phase III Study of Adjuvant Pembrolizumab vs Active Surveillance After Nephrectomy in Patients With Non-Clear Cell Renal-Cell Carcinoma

This phase III trial compares the effect of pembrolizumab to active surveillance after a surgical procedure to completely or partially remove a kidney (nephrectomy) in improving time without disease in patients with non-clear cell renal cell cancer. 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. Giving pembrolizumab after nephrectomy may be more effective than the usual active surveillance approach for improving time without disease in patients with non-clear cell renal cell cancer.

开始日期2027-02-10

申办/合作机构

National Cancer Institute

NCT07037004

/ 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2027-01-01

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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10,646

项与帕博利珠单抗相关的文献（医药）

2026-12-31·INTERNATIONAL JOURNAL OF HYPERTHERMIA

Focused ultrasound ablation surgery combined with immune checkpoint inhibition in driver-gene wild-type NSCLC with liver metastasis: a feasibility study

Article

作者: Chen, Jinyun ; Wang, Ting ; Ouyang, Bing ; Chen, Li ; Chen, Wenzhi

BACKGROUND:

This single-arm, open-label clinical trial aimed to evaluate the preliminary safety, efficacy and feasibility of focused ultrasound ablation surgery (FUAS) sequential with immune checkpoint inhibitors (ICIs) in patients with driver-gene wild-type non-small cell lung cancer (NSCLC) and liver metastases.

MATERIALS AND METHODS:

Ten eligible patients received two cycles of FUAS sequential with ICIs. The ICIs used include Camrelizumab (7/10), Pembrolizumab (3/10) and Serplulimab used for immune rechallenge (1/10). Follow-up was conducted every 6 weeks ± 3 days, including imaging and hematological assessments. Treatment-related adverse events (AEs) were documented anytime.

RESULTS:

All participants demonstrated stable tolerability and safety in this trial. Immediate post-FUAS ablation rates ranged from 73% to 80%. The median follow-up time is 84 days (IQR, 42-127 days). From baseline to week 18, continuous shrinkage of both hepatic metastatic and target lesions was observed. The DCR of the tumor has reached 80% since the 2nd follow-up (12 weeks), and it remains at 50% until the 4th follow-up (24 weeks).

CONCLUSION:

FUAS sequential with ICIs suggests preliminary safety, activity and feasibility in treating driver-gene wild-type NSCLC patients with liver metastases, further validation is needed.

2026-12-31·Human Vaccines & Immunotherapeutics

Durable response of anaplastic thyroid cancer to pembrolizumab combined with chemotherapy: A case report

Article

作者: Zhuang, Yihan ; Chen, Qiongshan ; Lin, Wen ; Chen, Zipei

Anaplastic thyroid cancer is a notoriously aggressive malignancy with a dismal prognosis, typically associated with a median overall survival of less than one year. Therapeutic alternatives are particularly limited for patients without actionable driver mutations. Here, we report a case of BRAF V600E wild-type, PD-L1-positive (tumor proportion score of 80%) anaplastic thyroid cancer with residual/relapsed disease following surgery and subsequent progression on multi-targeted tyrosine kinase inhibitor therapy. The patient was thereafter treated with a combination of pembrolizumab, nab-paclitaxel and carboplatin, resulting in a sustained near-complete response lasting over 30 months, accompanied by a manageable safety profile. The favorable response in this case suggests that further evaluation of this triplet regimen could be considered for anaplastic thyroid cancer, though this remains a speculative premise requiring validation. Further studies are also needed to clarify the underlying mechanisms of this combination and to identify predictive biomarkers for patient selection.

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 ; Shechtman, Yelena ; Lepage, Stéphanie ; Letendre, Caroline ; Le, Huy ; Dionne, Jeanne ; Bélanger, Karl ; Jamal, Rahima ; 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.

15,004

项与帕博利珠单抗相关的新闻（医药）

2026-07-22

·康方生物Akeso

西方人群及 ITT人群OS 均改善至 HR=0.76，依沃西全球III期HARMONi 研究OS更新，东西方人群疗效高度一致

近日，康方生物（9926.HK）自主研发的全球首创PD-1/VEGF双抗依沃西海外合作伙伴Summit Therapeutics宣布，依沃西全球多中心III期HARMONi研究在2026年6月进行的最新总生存期（OS）分析结果显示：全部意向治疗（ITT）人群OS获益持续改善至HR=0.76；西方人群的OS获益也进一步提升至 HR=0.76。随着随访时间延长，西方人群本次OS HR=0.76的数值，较2025年4月初步分析的0.98，2025年9月更新分析的0.84，实现了持续改善，且与中国开展的HARMONi-A研究的OS获益（HR=0.74，P=0.02）高度一致。依沃西在全球多中心III期研究中进一步明确验证了西方与亚洲人群之间疗效和安全性的一致性。目前，Summit已将这份更新的积极分析结果正式提交美国食品药品监督管理局（FDA），以支持依沃西联合化疗针对第三代EGFR-TKI治疗后进展的EGFR突变非鳞状NSCLC的生物制品许可申请（BLA）审评。该更新分析更详细的数据计划在后续医学会议上公布。本次更新分析时，西方人群中位随访时间延长至23.2个月（亚洲人群于初步分析时已锁定，中位随访32.7个月），大多数西方患者已停止治疗或完成为期两年的依沃西方案治疗。与对照组相比，依沃西联合含铂双药化疗持续展现出积极的OS持续改善，疗效与安全性特征在西方和亚洲患者之间保持一致：全部意向治疗（ITT）人群和西方患者亚组的OS HR均为0.76。 HARMONi最新分析结果的ITT人群OS获益程度（OS HR=0.76）与此前中国III期HARMONi-A研究高度一致（OS HR=0.74），进一步强化了依沃西在跨区域/跨人种的全球临床与中国临床中均具有高度一致的疗效和安全性，凸显了依沃西的全球市场价值。康方生物创始人、董事长、总裁兼首席执行官夏瑜博士表示：我们欣喜地看到，依沃西在全球多中心III期HARMONi研究中的OS获益持续改善，西方人群和亚洲人群患者在获益程度上高度一致，展现了依沃西针对不同人种患者均具有突破性临床价值，凸显了依沃西作为新一代肿瘤免疫基石药物在全球范围内升级肿瘤治疗的巨大潜力，也让我们对依沃西的国际化征程更加充满期待。 Summit总裁兼联合首席执行官 Maky Zanganeh博士表示：这项全球HARMONi研究最新OS分析的积极结果，持续支持依沃西的治疗优势在全球范围内的转化，包括来自北美和欧洲的西方患者。我们已将这份更新的分析数据集提交给FDA，同时我们继续推进依沃西在美国潜在获批的BLA申请工作。 Summit董事长兼联合首席执行官 Robert W. Duggan表示：正如我们一直强调的，依沃西在多种组织学和肿瘤类型中的临床试验数据不断传递出一致的信息：依沃西有机会显著改善癌症患者的生命，依沃西也持续展示出其延长生存期且安全性可耐受的潜力。凭借四项阳性III期研究，以及在全球HARMONi研究中，以OS这一金标准终点证实了亚洲和西方患者之间明确的疗效一致性，我们相信依沃西差异化的双特异性设计，能够代表下一代实体瘤癌症疗法。说明：本文作为康方生物的新闻发布，用于披露公司最新研发进展，并非产品推广广告，不构成相关药物使用或投资建议。关于依达方® （PD-1/VEGF双抗，依沃西）依沃西是康方生物自主研发的、全球首创PD-1/VEGF双特异性肿瘤免疫治疗药物。依沃西首个适应症于2024年5月获得中国国家药品监督管理局批准上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC。依沃西成为全球首个获批上市的“肿瘤免疫+抗血管生成“协同抗肿瘤机制的双特异性抗体新药。同年11月，依沃西被纳入国家医保目录。目前，依沃西一线治疗PD-L1表达阳性的晚期NSCLC的适应症也已经获批上市，在III期临床HARMONi-2研究中，依沃西对比帕博利珠单抗获得决定性胜出阳性结果。2025年12月，依沃西治疗该适应症已被纳入国家医保目录。 2025年，依沃西HARMONi-A研究总生存期(OS)最终分析结果显示：依沃西疗法在无进展生存期(PFS)与总生存期(OS)同时取得具有临床意义和统计学显著性获益。这是依沃西进行的首个III期临床研究OS最终分析，证实了依沃西疗法在PFS和OS方面均具有突破性价值。此外，依沃西联合化疗对比替雷利珠单抗联合化疗一线治疗鳞状NSCLC的头对头III期临床研究也已经取得具有重大临床获益和统计学显著性的OS和PFS显著阳性结果。这证明，无论是在肿瘤免疫领域对比PD-1单药疗法，还是对比PD-1+化疗（当前众多肿瘤治疗最优SOC），还是在肿瘤抗血管生成领域对比VEGF疗法，依沃西疗法都拥有显著的临床突破性，凸显了依沃西在肿瘤治疗中强大的迭代能力。在不断证明自身重大临床价值和迭代临床标准疗法的同时，依沃西也在不断拓展在肿瘤免疫核心适应症的布局: 针对全球发病人数最多的肺癌领域，依沃西已开展8项注册性/III期临床研究，包括一线治疗NSCLC(鳞癌+非鳞癌，vs 帕博利珠单抗+化疗，国际多中心)，一线sq-NSCLC(vs 替雷利珠单抗+化疗)，EGFR-TKI治疗进展的NSCLC(HARMONi-A和HARMONi)，一线PD-L1阳性的NSCLC（vs 帕博利珠单抗），一线PD-L1高表达的NSCLC(vs 帕博利珠单抗)，治疗IO耐药的NSCLC以及cCRT后未进展的局限期小细胞肺癌巩固治疗。针对肿瘤其他核心领域，依沃西一线适应症迅速布局：包括一线胆道癌(vs度伐利尤单抗+化疗)，联合莱法利单抗(CD47)一线PD-L1阳性头颈鳞癌(vs 帕博利珠单抗)的III期临床正在开展。针对冷肿瘤等领域，依沃西一线三阴性乳腺癌获得第四个突破性疗法认定，依沃西一线MSS/pMMR 型结直肠癌（占CRC 发病的95%），以及一线胰腺癌的III期临床研究正在开展。依沃西更多III期临床研究正在筹备中。依沃西还针对其他十多种适应症在全球开展了数十项II期临床研究，这为更多III期临床研究在全球范围内的快速开展提供了扎实的数据支持。关于康方生物康方生物(9926.HK)是一家集研究、开发、生产及商业化全球首创或同类最佳创新生物新药于一体的领先企业。自2012年成立以来，公司始终以患者为中心，以临床价值为导向，打造了独有的端对端康方全方位新药研究开发平台，建立了以Tetrabody双抗/多抗技术、Dual-Shield ADC、Dual-Lock TCE、Tissue-Smart siRNA、细胞治疗及Flex-Nano mRNA等技术为核心的研发创新体系，国际化标准的GMP生产体系和运作模式先进的商业化体系，成为了在全球范围内具有竞争力的生物医药创新公司。公司已开发了50个以上用于治疗肿瘤、自身免疫、炎症、代谢疾病等重大疾病的创新候选药物，近30个新药已进入临床(包括15个双抗/多抗/双抗ADC)，8个新药已在商业化销售，3个新药4个适应症的上市申请处于审评审批阶段。康方生物是全球迄今唯一拥有2个肿瘤免疫双抗新药的制药公司： 2022年6月，公司全球首创的PD-1/CTLA-4双抗卡度尼利获批上市，是全球首个获批的肿瘤免疫治疗双抗新药，也是中国第一个双特异性抗体新药。目前卡度尼利一线治疗胃癌、一线治疗宫颈癌和治疗复发/转移性宫颈癌的适应症已获批，13个注册性/III期临床正在开展。 2024年5月，公司全球首创的PD-1/VEGF双抗新药依沃西获批上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，成为全球首个获批的“肿瘤免疫+抗血管生成”机制双抗新药。同期，依沃西在与全球“药王”帕博利珠单抗的随机、双盲、对照一线治疗PD-L1阳性NSCLC的“头对头”III期临床研究中获得显著阳性结果，依沃西可降低患者疾病进展/死亡风险达49%，依沃西成为全球首个在头对头III期临床研究中证明疗效显著优于“药王”帕博利珠单抗的药物。基于该研究结果，依沃西该项适应症于2025年4月获批上市，成为一线肺癌治疗新的标准治疗方案，为患者提供全新更优的“去化疗”选择。目前依沃西有15项注册性/III期临床已开展/启动，包括5项国际多中心注册性III期临床研究。 2024年12月，卡度尼利和依沃西均通过医保谈判被纳入国家新版医保目录。2025年12月，除派安普利新获批的一线肝细胞癌适应症，康方生物5个自主商业化自研新药的其余全部获批适应症均已纳入国家医保目录。此外，基于公司在肿瘤免疫双抗领域取得的全球领先优势，公司正全力推进IO2.0+ADC2.0全球战略，构建“跨代”式国际竞争优势。目前，公司自主研发的首个双抗ADC药物Trop2/Nectin4 ADC(AK146D1)、新一代Her3 ADC(AK138D1)联合卡度尼利和依沃西治疗实体瘤II期临床研究正在开展。此前，该组合疗法 I 期临床已获美国 FDA 和中国 NMPA 批准开展。后续一系列自研新一代ADC/双抗ADC也将相继进入临床开发阶段。这将助力公司产品组合在全球范围内建立“跨代”式的竞争战略优势。国际市场开发是康方生物核心发展战略，继2015年开中国先河将自主研发的CTLA-4单抗权益许可给默沙东公司之后，2022年12月，公司再次创造中国纪录，以50亿美金+2位数百分比销售提成的方案，将依沃西部分海外权益许可给美国Summit公司，该合作创下了彼时中国新药对外许可的最高交易金额纪录。此外，派安普利单抗治疗鼻咽癌的两项适应症于2025年4月获得美国食品药品监督管理局(FDA)批准上市。公司自身免疫相关疾病及中枢神经系统疾病治疗领域也已全面进入商业化发展阶段：伊努西单抗(PCSK9)治疗高胆固醇血症两项适应症获批销售；依若奇单抗(IL-12/IL-23)、古莫奇单抗(IL-17)治疗中重度斑块状银屑病成人患者适应症获批上市销售；此外，古莫奇单抗和曼多奇单抗(IL-4R)多项III期临床研究成功，正处于上市审评阶段。公司各领域产品协同效应和战略组合力进一步提升。康方生物期望通过高效及突破性的研发创新，开发国际首创及同类药物最佳疗法的新药，为全球患者提供更优疾病解决方案，成为全球领先的生物制药企业。往期推荐数据发布 OS显著阳性，HR=0.66！依沃西联合化疗战胜PD-1联合化疗OS结果在ASCO盛大发布，一线治疗sq-NSCLC 产品动态康方5个新药所有适应症全部谈判成功，纳入国家医保：2个首创双抗新增一线适应症及3个新药首次进医保数据发布 HARMONi-A OS最终分析显示：依沃西达到OS临床终点，取得具有临床意义和统计学显著的OS获益数据发布 HARMONi研究发布：PFS HR=0.52，OS HR=0.79，依沃西2L+ EGFRm NSCLC国际多中心III期产品动态卡度尼利获批第三项适应症：一线宫颈癌全人群产品动态依沃西一线治疗NSCLC获批上市(全球首个对比帕博利珠单抗获显著阳性结果的III期研究）产品动态派安普利2个适应症美国重磅上市！获FDA批准用于晚期鼻咽癌治疗临床进展康方首个双抗ADC(Trop2/Nectin4 ADC)临床入组，“IO+ADC”2.0 迭代战略加速推进临床进展康方非肿瘤领域首个双抗IL-4Rα/ST2(AK139)IND获受理，剑指呼吸系统及皮肤疾病领域临床进展头对头度伐利尤单抗方案，依沃西方案一线治疗胆道肿瘤III期临床完成首例患者入组临床进展全球首个CD47单抗实体瘤III期临床首例入组：依沃西联合莱法利一线治疗HNSCC（对比帕博利珠单抗）数据发布 IGCS 2024 LBA & 《柳叶刀》主刊，卡度尼利1L宫颈癌III期研究PFS和OS双阳性结果重磅发布产品动态卡度尼利第二个适应症获批：一线胃癌全人群数据发布全球首个对比帕博利珠单抗取得显著阳性结果的随机对照大III期研究——依沃西HARMONi-2重磅研究成果在WCLC发表临床进展卡度尼利联合方案治疗uHCC的III期临床研究完成首例患者入组临床进展针对PD-1/L1治疗进展晚期胃癌，卡度尼利+普络西(VEGFR-2)联合疗法Ⅲ期临床完成首例入组数据发布 ASCO Oral & JAMA主刊丨Ⅲ期HARMONi-A研究重磅公布，依沃西疗法有望改变EGFR-TKI进展肺癌全球治疗标准临床进展国际多中心注册性III期研究HARMONi-3中国启动：依沃西单抗联合化疗对比帕博利珠单抗联合化疗1L治疗sq-NSCLC 产品动态高达50亿美金！康方生物与Summit就PD-1/VEGF双抗依沃西达成合作和许可协议

2026-07-22

·癌度

DS-8201联合PD-1的K药物治疗HER2阳性肺癌！

HER2过表达非鳞肺癌一线新选择 DS-8201联合K药III期全国招募瞄准PD-L1＜50%人群 🔑 核心背景 HER2过表达 ≠ HER2突变 HER2突变：约1%-5%（有靶向药） HER2过表达：约20%（一线无专属方案） PD-L1＜50%患者：免疫效果有限，HER2靶点用不上 → 双重困境 💊 研究方案药物：德曲妥珠单抗（DS-8201，HER2 ADC）+ 帕博利珠单抗（K药）阶段：III期（DESTINY-Lung06，CTR20252204）设计：1:1随机 vs 标准化疗+免疫目标：挑战一线标准方案 📊 早期数据（Ib期，22例） cORR 54.5% mDoR 20.2个月 mPFS 15.1个月 ✅ 适合谁？局部晚期/转移性非鳞NSCLC HER2过表达（IHC2+且扩增，或IHC3+） PD-L1 TPS＜50% 初治（未接受过晚期系统性治疗）能提供肿瘤组织供中心检测 ❌ 排除携带HER2突变或其他靶向驱动基因间质性肺病/肺炎病史严重心脏或肺部疾病 🎁 免费用药 | 全国多中心 📞 扫码/私信联系癌度，评估入组资格具体入组资格以研究中心医生评估为准

临床结果临床3期抗体药物偶联物ASCO会议

2026-07-22

·PRNewswire

TuHURA Biosciences to Present at Canaccord Genuity's 46th Annual Growth Conference

TAMPA, Fla., July 22, 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 announced that James A. Bianco, M.D., President and Chief Executive Officer of TuHURA will present at the Canaccord Genuity's 46th Annual Growth Conference taking place in Boston, MA. Canaccord Genuity 46 th Annual Growth Conference To register and view the presentation, please CLICK HERE. An archived webcast of the Canaccord presentation will be available on the Events Page in the Investor Section of TuHURA's website. Additionally, investors and stakeholders are encouraged to view the "Ask Me Anything" interview of Dr. Bianco available HERE. 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 is enrolling patients in its 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 dose escalation/optimization Phase 1b trial in mutNPM1 r/r AML, a molecularly defined subgroup representing approximately 35% of patients with AML. TuHURA is also leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific, bi-functional antibody drug conjugates (ADCs) targeting MDSCs 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 risks relating to the timing and nature of the FDA's response to the Company's re-filed IND for TBS-2025; the risks associated with the timing and results of conducting the planned Phase 1b/2 trial of TBS-2025, including the 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期临床1期

100 项与帕博利珠单抗相关的药物交易

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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,

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适应症	国家/地区	公司	日期
浸润性膀胱癌	欧盟	Merck Sharp & Dohme BV	2026-07-01
浸润性膀胱癌	冰岛	Merck Sharp & Dohme BV	2026-07-01
浸润性膀胱癌	列支敦士登	Merck Sharp & Dohme BV	2026-07-01
浸润性膀胱癌	挪威	Merck Sharp & Dohme BV	2026-07-01
铂耐药性输卵管癌	中国	Merck Sharp & Dohme LLC	2026-06-23
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 Corp.	2026-02-10
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 Corp.	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
卵巢癌	美国	Merck Sharp & Dohme Corp.	2026-02-10
肌层浸润性膀胱癌	美国	Merck Sharp & Dohme Corp.	2025-11-21

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
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
非小细胞肺癌Ⅰ期	临床3期	希腊	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	匈牙利	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	以色列	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	意大利	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	荷兰	Merck Sharp & Dohme LLC	2026-05-04

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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


NCT02617849 (Pubmed \| Oncoimmunology)	临床2期	黑色素瘤	30	Pembrolizumab and Carboplatin/ Paclitaxel	餘構鹽積淵觸蓋餘鹹鏇(構艱糧選獵繭觸憲艱淵) = 鹽壓夢淵壓遞鑰廠繭積選鹹簾齋壓範顧夢簾蓋 (網艱築窪遞鹽構簾積餘 ) 更多	不佳	2026-12-31
NCT05594043 (MK-6598-001, CTgov)	临床1期	晚期恶性实体瘤	39	MK-6598 (50 mg MK-6598)	夢鬱壓鹽膚觸憲積築壓 = 簾鹹簾鏇構顧衊構醖網選網鹽鏇觸製壓築蓋遞 (獵遞鬱願淵構蓋壓蓋憲, 鏇網鹹壓醖艱糧壓獵糧 ~ 顧鹽淵衊顧夢蓋繭遞獵) 更多	-	2026-07-15
				MK-6598 (125 mg MK-6598)	夢鬱壓鹽膚觸憲積築壓 = 願鑰範夢選淵鏇積夢壓選網鹽鏇觸製壓築蓋遞 (獵遞鬱願淵構蓋壓蓋憲, 鑰醖夢醖積願築顧築繭 ~ 衊蓋觸衊網簾鹹製網壓) 更多
NCT03517449 \| NCT03884101 (ENGOT-en9/LEAP-001, Pubmed \| Int J Gynecol Cancer)	临床3期	复发性子宫内膜癌辅助 \| 新辅助	421	Lenvatinib 20 mg once daily+pembrolizumab 200 mg every 3 weeks	網網選憲鹹窪襯築顧夢(築鑰餘憲獵構顧遞製鏇) = 鬱窪製遞顧鬱構簾醖蓋淵願鏇鏇衊觸膚鹽窪襯 (膚獵網鹽艱淵簾廠遞鑰, 14.0 ~ 22.8) 更多	积极	2026-07-01
				Chemotherapy (doxorubicin or paclitaxel)	網網選憲鹹窪襯築顧夢(築鑰餘憲獵構顧遞製鏇) = 醖鹹膚襯醖壓願窪襯鑰淵願鏇鏇衊觸膚鹽窪襯 (膚獵網鹽艱淵簾廠遞鑰, 10.9 ~ 15.5) 更多
NCT04924101 (KEYNOTE-B99, CTgov)	临床2期	广泛期小细胞肺癌	126	MK-4830+Etoposide+Carboplatin+cisplatin+Pembrolizumab (Pembrolizumab + MK-4830 + Chemotherapy)	餘廠艱壓齋衊淵壓鹽鬱 = 壓範願製餘衊製鏇鹽獵蓋觸築鏇憲糧襯襯構鹹 (構選獵選淵積壓鬱襯餘, 鏇窪齋觸夢餘淵觸艱網 ~ 觸淵鑰鏇獵簾構繭遞構) 更多	-	2026-07-01
				Etoposide+Boserolimab+Carboplatin+cisplatin+Pembrolizumab (Pembrolizumab + Boserolimab + Chemotherapy)	餘廠艱壓齋衊淵壓鹽鬱 = 積衊選構鹹淵膚壓艱繭蓋觸築鏇憲糧襯襯構鹹 (構選獵選淵積壓鬱襯餘, 簾遞鹹憲鬱餘觸築壓膚 ~ 範艱壓醖壓築廠憲廠願) 更多
NCT04788043 (CTgov)	临床2期	复发性经典霍奇金淋巴瘤 \| 典型霍奇金淋巴瘤 \| 难治性经典霍奇金淋巴瘤	8	PET/CT+Magrolimab+Pembrolizumab	蓋窪餘鹹繭遞廠鏇選觸 = 製製築製網積夢積膚鹽餘壓製艱衊艱醖淵蓋蓋 (夢鏇網憲蓋製艱艱製衊, 衊蓋蓋廠鏇簾範齋醖繭 ~ 積鬱齋鹽艱選選廠鑰繭) 更多	-	2026-06-30
NCT03924895 (KEYNOTE-866 and KEYNOTE-905/EV-303 \| KEYNOTE-905 \| EV-303 \| MK-3475-905, CTgov)	临床3期	肌层浸润性膀胱癌	595	Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])+Pembrolizumab (Arm A: Pembrolizumab + Surgery)	憲鑰蓋願鏇糧壓艱築顧(窪獵構廠鏇廠襯鏇鏇觸) = 壓餘積網網淵構廠獵繭齋鏇網積鬱蓋鏇製窪願 (夢製鹹獵製遞鏇繭窪夢, 壓鹹網範鏇積願醖積窪 ~ 醖鹹鏇鏇廠餘構鹹製鏇) 更多	-	2026-06-30
				Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) (Arm B: Surgery Alone)	繭鑰齋鑰襯網艱範簾鏇(鹹窪選膚齋鑰構鹽選範) = 築製淵遞製願糧蓋願選蓋膚網遞鏇艱構顧觸鬱 (鹹夢廠夢淵鑰衊選廠憲, 壓餘鏇製遞製簾艱築繭 ~ 鏇顧夢構窪鹹憲餘遞窪) 更多
NCT05204290 (CTgov)	早期临床1期	硬膜外肿瘤	1	Stereotactic Body Radiation Therapy+Pembrolizumab	選遞壓範顧醖餘衊構膚(獵憲觸襯積膚艱顧積襯) = 選鑰鬱築壓鏇鏇製築選繭構觸憲遞膚膚遞鏇膚 (築餘壓觸醖願觸簾鑰範, 齋餘艱艱餘廠顧糧鏇遞 ~ 簾鏇齋憲壓鏇鹽鑰糧構) 更多	-	2026-06-29
NCT02886585 (CTgov)	临床2期	脑转移瘤	101	PET/CT+Pembrolizumab (Previously Untreated Brain Metastases-Cohort A)	衊廠鏇憲觸憲遞製淵繭 = 廠願積齋繭積網積鹹獵獵築觸壓膚蓋襯鏇顧廠 (壓觸繭夢醖膚鏇膚齋鑰, 鹽顧衊膚淵選憲鹹製築 ~ 顧繭憲膚鏇衊蓋獵艱積) 更多	-	2026-06-26
				PET/CT+Pembrolizumab (Progressive Brain Metastases-Cohort B)	衊廠鏇憲觸憲遞製淵繭 = 觸餘鏇範願鹹範廠築願獵築觸壓膚蓋襯鏇顧廠 (壓觸繭夢醖膚鏇膚齋鑰, 窪鏇窪鏇餘壓網餘範鏇 ~ 觸鑰鑰憲壓鬱廠衊繭簾) 更多
NCT04740307 (KEYSTEP-004 \| MK-1308A-004, CTgov)	临床2期	晚期肝细胞癌	116	Pembrolizumab/Quavonlimab+Pembrolizumab+Lenvatinib	襯繭構鏇淵積鹽鏇鏇構 = 遞憲艱膚淵鑰築膚憲廠襯選鏇衊鬱鏇願憲鹽壓 (鏇壓構範網糧夢艱鬱壓, 淵築網繭選網淵憲醖淵 ~ 餘鏇簾壓顧衊壓願積遞) 更多	-	2026-06-23
NCT04929392 (CTgov)	临床2期	食管腺癌 \| 胃食管交界处癌 \| 食管鳞状细胞癌 ... 更多	3	External Beam Radiation Therapy+Carboplatin+Paclitaxel+Pembrolizumab+Lenvatinib Mesylate	網簾選窪鑰糧壓憲齋齋 = 鹹壓齋選醖積襯衊餘範遞製顧範鹽製餘鏇選餘 (糧製製衊餘憲艱廠觸窪, 網膚簾襯獵壓鹽鏇網膚 ~ 窪夢繭鹹廠鬱淵齋範遞) 更多	-	2026-06-23