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

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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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9,896

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 ; Qian, Feng ; Johnson, Geoffrey ; Tang, Yuexin ; Bensimon, Arielle G. ; Adkins, Douglas ; Zheng, Dandan ; Benjamin, Kimberly ; Tzontcheva, Anjela ; 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 ; 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.

13,103

项与帕博利珠单抗相关的新闻（医药）

10 小时之前

·药明康德

全球药企研发投入TOP 15榜单揭晓！

近日，行业媒体Endpoints News发布了全球生物医药企业研发投入TOP 15榜单，本文将结合公开资料为读者解析上榜企业扩展研发管线的战略布局，旨在通过这些企业的创新动向展现整个产业的发展趋势。点击文末“阅读原文/Read more”，即可访问原始榜单页面。 ▲研发投入最高的15家生物医药公司（数据来源：参考资料[1]）默沙东默沙东持续通过研发与收购扩展研发管线。今年3月，该公司斥资约67亿美元收购了Terns Pharmaceuticals，获得治疗慢性髓系白血病的创新疗法。自2019年初以来，默沙东已在癌症领域完成总额约150亿美元的并购。尽管肿瘤学仍然占据主导地位，但默沙东也一直扩展其他疾病领域的研发管线。例如，该公司收购了开发抗病毒药物的Cidara Therapeutics和开发慢性阻塞性肺病（COPD）新药的Verona Pharma。其口服PCSK9药物enlicitide decanoate近期在3期临床试验中显示出降低低密度脂蛋白胆固醇的积极结果。抗体偶联药物（ADC）sacituzumab tirumotecan正在接受FDA审评。默沙东的KRAS G12C抑制剂calderasib（MK-1084）和治疗炎症性肠病（IBD）的tulisokibart（MK-7240）已经进入3期临床开发阶段。罗氏罗氏的口服布鲁顿酪氨酸激酶（BTK）抑制剂fenebrutinib近期在治疗原发进展型多发性硬化症（PPMS）的首个大型3期临床试验中获得积极结果。其在研口服选择性雌激素受体降解剂（SERD）giredestrant正在接受美国FDA的审评，联合everolimus用于治疗成人雌激素受体（ER）阳性、人表皮生长因子受体2（HER2）阴性、携带ESR1突变，且在既往内分泌治疗后出现复发或疾病进展的局部晚期或转移性乳腺癌患者。罗氏的阿尔茨海默病疗法trontinemab目前处于3期临床开发阶段，这是一款新一代抗淀粉样蛋白药物，通过增加药物的脑渗透性，能够更快速清除淀粉样蛋白。在肥胖治疗领域，罗氏通过以27亿美元收购Carmot Therapeutics获得CT-388，这是一款GLP-1/GIP受体双重激动剂。罗氏还在与Zealand Pharma合作开发amylin类似物petrelintide。阿斯利康阿斯利康研发的COPD药物tozorakimab近期在两项3期研究中获得积极结果，这是一款靶向IL-33的抗体。通过10亿美元收购EsoBiotec获得的体内CAR-T疗法在一组多发性骨髓瘤患者中也获得了令人鼓舞的数据。目前，阿斯利康有超过100项3期临床试验正在进行中，在2026年约有20项试验有望获得数据。除了上述疗法，阿斯利康的研发管线还包括口服PCSK9药物AZD0780、在2期研究中取得成功的口服GLP-1药物elecoglipron、8款自主研发ADC、放射性配体药物、下一代免疫肿瘤学双特异性抗体、靶向BCMA/CD19的AZD0120、基因疗法以及新的T细胞衔接器平台。礼来礼来已经在肥胖治疗领域获得突破，FDA今年批准了口服小分子肥胖疗法orforglipron，商品名为Foundayo。其研发管线中的retatrutide是一款新一代三重激素受体激动剂。该分子可同时激活GIP、GLP-1和胰高血糖素受体。在阿尔茨海默病治疗方面，礼来的remternetug是一款皮下注射的新一代抗淀粉样蛋白药物，处于后期开发阶段。它有望与当前已上市药物一样清除淀粉样蛋白，但采用自我注射方式有望显著提升患者使用的便利性。在收购方面，礼来斥资63亿美元收购Centessa Pharmaceuticals及其睡眠障碍药物cleminorexton（ORX750），该药正在针对发作性睡病和嗜睡症开展2期研究。收购Scorpion Therapeutics获得的PI3Kα抑制剂STX-478加强其肿瘤学产品管线。在体内CAR-T疗法开发方向上，礼来通过收购Kelonia Therapeutics进一步加码。强生强生与Protagonist Therapeutics联合开发的口服多肽疗法Icotyde（icotrokinra）已经获得美国FDA批准，用于治疗银屑病。强生以146亿美元收购Intra-Cellular公司获得的Caplyta去年获得FDA批准，作为辅助疗法治疗重度抑郁障碍。强生管线中另一款备受关注的药物是JNJ-4804，同时靶向IL-23和TNF。该药目前处于2期临床试验中，正在针对溃疡性结肠炎、银屑病关节炎和克罗恩病进行开发。强生在2025年底达成协议，以30.5亿美元收购Halda Therapeutics。该公司由耶鲁大学的Craig Crews教授创立，其基于调节诱导接近靶向嵌合体平台开发的在研药物有望在多种癌症类型中克服耐药性，同时减少对健康细胞的影响。诺华诺华的研发管线中，抗体疗法ianalumab针对B细胞驱动的自身免疫疾病，在干燥综合征和原发免疫性血小板减少症（ITP）中持续获得积极数据。诺华计划于2026年在全球范围内递交ianalumab的上市申请。该公司与Ionis Pharmaceuticals联合开发的反义寡核苷酸疗法pelacarsen旨在选择性降低脂蛋白（a）的水平，3期临床试验数据预计在今年下半年首次公布。诺华去年秋天同意以120亿美元收购Avidity Biosciences，获得用于治疗1型强直性肌营养不良症的delpacibart etedesiran和用于面肩肱型肌营养不良症（FSHD）的delpacibart braxlosiran，以及治疗杜氏肌营养不良症的delpacibart zotadirsen。今年3月，该公司斥资约30亿美元从Synnovation Therapeutics公司获得一款泛突变选择性PI3Kα抑制剂SNV4818，用于治疗HR+/HER2-转移性乳腺癌及其他实体瘤。SNV4818设计上旨在避开健康细胞中的野生型PI3Kα，精准靶向癌细胞中的突变版本。这可能降低药物毒性，促进组合疗法的开发。辉瑞辉瑞通过收购Metsera获得的减重疗法PF-08653944近期在2b期临床试验中获得积极的顶线结果。这是一款超长效的GLP-1受体激动剂，有望通过每月一次给药实现有效减重。在癌症研究方面，辉瑞通过收购Seagen获得多款ADC疗法。其中Padcev与Keytruda联用，在针对适合接受以顺铂为基础的化疗的肌层浸润性膀胱癌（MIBC）患者的3期临床试验中达到主要终点。其他在研ADC疗法包括靶向HER2的disitamab vedotin，以及靶向整合素β6的sigvotatug vedotin，后者有望用于治疗多种实体瘤。 GSK GSK公司靶向B7-H4抗原的抗体偶联药物mocertatug rezetecan近期在治疗铂耐药卵巢癌或子宫内膜癌的1b期临床试验中获得积极数据，在铂耐药卵巢癌患者中达到62%的确认客观缓解率（cORR），在复发或晚期子宫内膜癌患者中的cORR达到67%。GSK表示将直接启动多项3期临床试验。这款ADC来自GSK与翰森制药（Hansoh Pharma）达成的授权合作。另一款同样来自翰森制药的ADC药物risvutatug rezetecan已获得FDA授予的突破性疗法认定，治疗广泛期小细胞肺癌。 GSK与Ionis Pharmaceuticals联合开发的反义寡核苷酸疗法bepirovirsen的新药申请已经获得FDA授予的优先审评资格。它具有功能性治愈乙肝的潜力。百时美施贵宝 Iberdomide和mezigdomide是两款处于后期开发阶段的分子胶靶向蛋白降解剂。美国FDA已经受理iberdomide的新药申请，而mezigdomide在治疗复发或难治性多发性骨髓瘤（RRMM）患者的3期临床试验SUCCESSOR-2中获得积极结果。这两款药都属于cereblon E3连接酶调节剂（CELMoD）类型，第三款CELMoD药物golcadomide正在针对大B细胞淋巴瘤开展3期研究。百时美施贵宝的其他研发项目还包括pumitamig，它是与BioNTech合作开发的PD-L1/VEGF-A双特异性抗体。百时美施贵宝以41亿美元收购了RayzeBio公司，获得靶向放射性药物RYZ101。艾伯维在癌症领域，艾伯维的BCMA/CD3双特异性T细胞衔接器etentamig（ABBV-383）于2024年首次进入3期临床试验给药，通过沉默Fc活性，研究人员希望延长该药半衰期，从而将给药间隔拉长至每四周一次。该公司的pivekimab sunirine是一款靶向CD123的ADC，已于去年秋天向FDA递交上市申请，用于治疗母细胞性浆细胞样树突状细胞肿瘤（BPDCN）。艾伯维斥资21亿美元收购了专注于开发体内CAR-T疗法的Capstan Therapeutics公司。这一领域正在得到越来越多的关注。赛诺菲赛诺菲的双特异性纳米抗体lunsekimig近期在针对中重度哮喘患者和慢性鼻窦炎伴鼻息肉患者的两项2期临床试验中获得积极结果。Lunsekimig由五个连接的抗体片段构成，旨在同时阻断胸腺基质淋巴细胞生成素（TSLP）和白细胞介素-13（IL-13）两条炎症信号通路，这两条通路被认为是哮喘及相关疾病中导致组织损伤的重要炎症驱动因素。该公司与再生元合作开发的Dupixent持续拓展适应症，2025年新增获批用于慢性阻塞性肺疾病、大疱性类天疱疮及慢性自发性荨麻疹等适应症，体现其在2型炎症相关疾病领域持续扩展治疗版图的潜力。 2025年，赛诺菲完成对Blueprint Medicines的收购，将治疗系统性肥大细胞增多症（SM）的药物Ayvakit纳入罕见病产品管线。诺和诺德诺和诺德的CagriSema目前正在接受美国FDA的审评，它是一款由长效胰淀素类似物cagrilintide（2.4 mg）和司美格鲁肽（2.4 mg）组成的固定剂量联合疗法，设计为每周一次皮下注射给药。该公司治疗肥胖症的研发管线中还包括zenagamtide（曾名为amycretin），这是一款同时作用于GLP-1受体和胰淀素受体的单分子双靶点药物，计划今年以口服和注射两种版本启动3期研究。诺和诺德还拥有UBT251，这是一款GLP-1、GIP和胰高血糖素受体三重激动剂。诺和诺德的ziltivekimab是一款靶向IL-6的单克隆抗体。它目前在多项3期临床试验中接受评估。其中，ZEUS研究旨在探索ziltivekimab是否能降低动脉粥样硬化、慢性肾病且存在残余炎症风险患者的心血管事件发生率。HERMES研究正在评估它在射血分数保留型心力衰竭患者中的疗效，这类患者群体也已知存在残余炎症风险，且该风险会促进疾病进展。ARTEMIS研究评估患者因急性心肌梗死入院后立即接受ziltivekimab治疗的效果。其目的是观察立即阻断炎症是否能改善急性冠状动脉综合征患者的预后并降低未来心血管事件的发生率。安进安进公司的肥胖症药物MariTide是一款抗体偶联多肽，将GLP-1受体激动作用与GIP受体拮抗作用相结合。2期临床试验结果显示，它能在肥胖或超重患者中平均将体重减轻约20%。目前，MariTide在多项3期临床试验中接受检验。安进开发的siRNA疗法olpasiran在一项2期试验中，可使动脉粥样硬化性心血管疾病合并高脂蛋白a——Lp（a）水平升高患者的Lp（a）浓度降低约92%，且疗效可持续超过一年，该疗法目前已进入3期临床阶段。今年年初，安进以8.4亿美元收购英国生物技术公司Dark Blue Therapeutics，获得一款潜在“first-in-class”的小分子靶向蛋白降解剂。这款降解剂能够靶向降解MLLT1和MLLT3，它们在驱动特定急性髓系白血病的发生方面起到重要作用。再生元再生元公司的基因疗法Otarmeni（lunsotogene parvec，DB-OTO）近日获得美国FDA的批准，用于治疗经分子检测确认存在OTOF基因双等位基因变异、耳蜗外毛细胞功能保留，且既往未接受人工耳蜗植入的儿童及成人感音神经性听力损失患者。该公司的siRNA疗法cemdisiran在治疗全身性重症肌无力（gMG）的3期临床试验中获得积极结果，再生元已于今年第一季度向美国FDA递交监管申请。在肥胖领域，其GDF8抗体trevogrumab在2期临床试验中可显著降低伴随GLP-1激动剂治疗的瘦体重流失。吉利德科学吉利德科学的单片复方制剂bictegravir/lenacapavir的新药申请近日获得FDA授予的优先审评资格，预计在今年8月27日之前完成审评。同时，吉利德利用收购持续扩充研发管线，该公司收购了合作伙伴Arcellx，获得在研CAR-T细胞疗法anitocabtagene autoleucel。该公司斥资约31.5亿美元收购了Tubulis公司，获得靶向NaPi2b的抗体偶联药物TUB-040，以及靶向5T4的抗体偶联药物TUB-030。吉利德还收购了Ouro Medicines，获得靶向BCMA和CD3的T细胞衔接器gamgertamig。参考资料： [1] The R&D 15: The stakes needed to play in the world's biggest drug research groups require very deep pockets. Retrieved May 4, 2026, from https://endpoints.news/the-rd-15-how-pharmas-top-companies-spent-won-and-lost-on-drug-research/ 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。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

13 小时之前

·PRNewswire

Inhibrx To Host Webcast Presentation to Provide Clinical Update on INBRX-106 HexAgon Study in First Line HNSCC

– Event to be webcast live on Monday, May 11, 2026, at 5:30 a.m. PT – SAN DIEGO, May 8, 2026 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases, today announced that it will host a live webcast presentation on Monday, May 11, 2026 at 5:30 a.m. Pacific Time to provide interim results from the randomized, first-line Phase 2 portion of the HexAgon study, which is evaluating the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC). Investors may join via the web: or may listen to the call by dialing (1-888-880-3330). Please refer to Inhibrx or the conference ID 1841482 when calling in. Following the webcast, the presentation may be accessed through a link on the "Events and Presentations" section of Inhibrx's website. The webcast will be available for 60 days following the event. Following the presentation, Inhibrx will also update its corporate presentation within the "Investors" section of its website at . About INBRX-106 INBRX-106 is a hexavalent agonist targeting OX40 (CD134), a costimulatory receptor on T-cells. Utilizing Inhibrx's proprietary single-domain antibody (sdAb) platform, INBRX-106 is designed to achieve the high-order receptor clustering necessary for robust T-cell activation and survival, a feat that has eluded traditional bivalent antibody approaches. About Inhibrx Biosciences, Inc. Inhibrx Biosciences is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates. Inhibrx Biosciences utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx Biosciences was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx Biosciences acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of Inhibrx Biosciences. Following such transactions, Inhibrx Biosciences' current clinical pipeline of therapeutic candidates includes ozekibart and INBRX-106, both of which utilize multivalent formats where the precise valency can be optimized in a target-centric way to mediate what we believe to be the most appropriate agonist function. For more information, please visit . Investor and Media Contact: Kelly Deck, CFO [email protected] 858-795-4260 SOURCE Inhibrx Biosciences, Inc. 21% more press release views with Request a Demo

临床2期并购临床结果

19 小时之前

·山西白求恩医院肿瘤中心

一项评估LAT010与帕博利珠单抗的联合治疗在局部晚期或转移性实体瘤患者中的耐受性、药代动力学和有效性的剂量递增和剂量扩展的临床研究”

我院正在开展一项由冯慧晶教授作为主要研究者，徕特康（苏州）生物制药有限公司申办的“一项评估LAT010与帕博利珠单抗的联合治疗在局部晚期或转移性实体瘤患者中的安全性、耐受性、药代动力学和有效性的开放性、剂量递增和剂量扩展的临床研究”。本研究计划共入组9-42例参与者。本研究已经获得我院伦理委员会的批准。如果符合下述条件，将有可能参加本研究：剂量递增和剂量扩展研究主要入组标准： 1)签署知情同意书时年龄18~80岁，性别不限。 2)为经组织病理学或细胞学确诊的局部晚期或转移性实体瘤患者（如为非鳞非小细胞肺癌，则须证实无EGFR/ALK/ROS1敏感突变），且满足以下条件之一：标准治疗后进展；不能耐受标准治疗；因各种原因无法获得标准治疗。 3)ECOG评分标准表现状况评分为0或1分。 4)预期生存期 ≥12周。 5)根据RECIST 1.1评估标准，患者至少有一个可测量病灶，如果既往接受过局部治疗（放疗、消融、血管介入等）的病灶是唯一病灶，则必须有局部治疗后该病灶疾病进展的明确影像学依据。 6)主要器官功能在首次给药前7天内，符合下列标准，包括检测前7天内未接受过成分输血、人粒细胞集落刺激因子（G-CSF）、促血小板生成素（TPO）、促血小板生成素受体激动剂、白介素-11和促红细胞生成素（EPO）等支持治疗。 7)既往抗肿瘤治疗毒性反应恢复至 ≤1级。 8)具有生育能力的女性患者或伴侣有生育能力的男性患者同意自签署知情同意书开始至末次给药后 ≥90天期间采用高效避孕措施。育龄期和绝经 <12个月的女性患者必须在首次给药前7天内进行妊娠测试且结果为阴性。 9)从筛查期开始，在整个研究期间，以及在最终研究药物给药后至少90天内，男性患者不得捐献精子。剂量扩展研究入组标准还包括： 10)患者必须符合以下标准：愿意并能接受肿瘤基线活检。如果患者有残留的肿瘤块，则可用存档的活检样本（经冷冻或福尔马林固定）作为基线样本。对于无法获得活体肿瘤组织的患者，如既往进行过PD-L1检测，则收集其检测结果。如果符合下述条件，无法参加本研究：剂量递增和剂量扩展研究主要排除标准 1)已知对试验用药品制剂的任何成分或IL-2或抗PD-1/PD-L1抗体过敏，或既往因帕博利珠单抗或同类药物发生的药物相关AE而永久停药者，或既往因IL-2或同类药物发生的药物相关AE而永久停药者。 2)患者有既往治疗的严重irAE病史，定义为需要皮质类固醇治疗的4级不良事件或需要皮质类固醇激素治疗 >10 mg/天或同等剂量的泼尼松治疗 >12周的3级不良事件。 3)需要治疗的严重或无法控制的心脑血管疾病：NYHA心功能分级 >1 级； 4)已知患有慢性阻塞性肺疾病（COPD）且一秒末用力呼气容积（FEV1）为预计正常值的30%或以下。。 5)已知中度或重度持续性哮喘，或过去2年内有哮喘病史，或目前有任何分类的不受控制的哮喘。 6)既往和目前有间质性肺炎（包括药物性）、放射性肺炎、尘肺、肺纤维化史或肺功能严重受损等肺部疾病；活动性肺结核，正在接受抗结核治疗或者首次给药前1年内接受过抗结核治疗者。 7)首次给药前28天内参加过任何治疗性临床研究，且入组接受治疗。 8)首次给药前6个月内接受过任何与IL-2相关的治疗；首次给药前14天或5个半衰期（以较长者为准）内使用过免疫调节药物，包括但不限于胸腺肽、IL-15、干扰素等。 9)首次给药前120天内接受过嵌合抗原受体T细胞免疫疗法（CAR-T）治疗或化疗；首次给药前28天接受过内分泌治疗、靶向治疗（小分子靶向治疗洗脱期为14天或5个半衰期，以较长者为准）、免疫治疗（免疫调节药物见排除标准7）、肿瘤栓塞术等；首次给药前14天内接受放疗，为控制症状进行的姑息性放疗允许在首次给药前至少7天完成；首次给药前7天内曾接受已批准适应症用于抗肿瘤的中药治疗。经研究者评估患者可以入组的情况除外。 10)已知或筛选期有症状的活动性中枢神经系统（CNS）转移或癌性脑膜炎。 11)首次给药前28天内接受过大型手术，或首次给药前7天内接受过小手术，或存在未愈合的伤口、溃疡或骨折，或需要在研究期间接受择期手术者（诊断性活检、插入血管通路装置除外）。 12)存在其他未治疗的活动性原发性恶性肿瘤须排除。但首次给药前72小时内存在活动性细菌、病毒或真菌感染（定义为表现出与感染相关的持续体征/症状，尽管使用适当的抗生素或其他治疗仍无改善），或需要抗生素静脉用药（IV）。 13)首次给药前90天内出现显著临床意义的出血。首次给药前30天内出现严重或不愈合的伤口、瘘管、皮肤溃疡或不愈合骨折。首次给药前6个月内存在腹瘘、胃肠穿孔、腹腔内脓肿或急性胃肠道出血病史。患者在首次给药前30天内接种了活病毒疫苗（注：季节性流感灭活疫苗除外）。 14)患有活动性自身免疫性疾病或炎性疾病。 15)患有复制性人类免疫缺陷病毒感染、活动性或未控制的乙型肝炎感染或丙型肝炎感染。非活动性的乙型肝炎病毒（HBV）携带者或已治愈的丙型肝炎患者可以入组。接受治疗的非复制性疾病患者入组也是可以接受的。 16)患者正在接受皮质类固醇 >10 mg/天的泼尼松或等效药物的治疗。 17)患者已进行器官移植或正在接受全身免疫抑制治疗。 18)患者患有研究者认为不适合参与本研究的严重疾病或研究者认为可能干扰研究药物评估或患者安全性或研究结果解释的任何情况，如患者患有器官系统功能障碍、精神疾病或药物滥用、不利的医疗状况或社会状况，研究者认为这些疾病或器官系统功能紊乱、医疗条件或社会状况可能会干扰患者签署知情同意书（ICF）的能力、对患者合作和参与研究的能力产生不利影响、或者影响对研究结果的解释。 19)研究者认为患者有不适合参与本研究的用药史或其他过敏史。 20)患者在首次给药前7天内进行的妊娠检测结果为怀孕或正在哺乳期内。 21)患者不愿意或无法遵守方案要求。如果想了解本研究的更多信息，请与下列人员联系：联系人：杨主任联系电话：13835167829 本招募广告可能以下列形式进行发布：报纸、海报、易拉宝、传单、微信或公共网络平台

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

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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

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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	-	Merck Sharp & Dohme LLC	2026-05-11
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
铂耐药性卵巢癌	临床3期	加拿大	Mural Oncology, Inc.	2022-01-10
铂耐药性卵巢癌	临床3期	捷克	Mural Oncology, Inc.	2022-01-10
铂耐药性卵巢癌	临床3期	法国	Mural Oncology, Inc.	2022-01-10

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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	襯艱範網膚憲願鑰餘構(積顧窪製蓋鑰繭製廠積) = 憲觸襯廠艱鹽窪製網積壓遞艱簾鑰網膚觸膚願 (憲壓構鑰夢鬱淵蓋顧鏇 ) 更多	不佳	2026-12-31
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)	簾顧範積鬱齋醖網積蓋 = 襯蓋鹹膚窪齋獵願鏇網齋蓋顧鹽夢醖鹽衊範鏇 (窪簾餘壓網衊襯鏇繭製, 餘糧鬱遞壓壓遞簾艱鹽 ~ 鏇網鏇鬱壓淵鬱選網獵) 更多	-	2026-05-05
				Pembrolizumab (Part A - Escalation Dose)	範膚獵膚襯顧積鏇鹹壓(選獵願選範憲網餘簾夢) = 製糧憲鑰築觸鹹醖鏇鏇鏇鹽醖願鬱襯製獵衊淵 (衊鑰衊顧鑰衊鬱憲壓膚, 憲淵淵鬱膚簾壓艱衊製 ~ 醖膚鏇衊醖淵窪壓範製) 更多
NCT03752333 (CUPem, CTgov)	临床2期	原发部位不明恶性肿瘤	35	Pembrolizumab	築壓簾蓋鏇構鏇襯選製 = 憲積鬱鏇積築齋齋鹹淵餘網鹹選獵鹹淵鏇餘齋 (壓遞鏇築選積窪鏇願鑰, 簾窪廠製鹽鹽繭網醖繭 ~ 餘淵夢衊構艱製憲衊獵) 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	蓋願鏇艱鏇鹽蓋廠鏇夢(淵餘蓋範蓋壓繭鑰壓積) = 願鬱廠鹽糧襯製窪繭憲衊網觸膚淵築衊廠餘鬱 (憲顧範構構廠製鹽繭願, 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	觸蓋糧淵艱膚繭襯築艱 = 糧襯襯構簾鹽選鏇遞鑰鹽願廠簾願蓋餘簾糧獵 (糧積齋壓構醖糧齋遞鹽, 廠壓網願築艱獵顧鹹製 ~ 鏇齋衊範艱選衊鬱遞鑰) 更多	-	2026-05-01
NCT03867084 (KEYNOTE-937 \| MK-3475-937, CTgov)	临床3期	肝细胞癌	959	Pembrolizumab (Pembrolizumab)	鹹廠簾獵鬱壓齋鹹窪築(構醖範鏇鬱製壓積遞夢) = 憲衊糧糧窪艱襯製鏇壓鏇衊膚蓋鏇艱壓獵觸餘 (鏇繭襯鑰淵艱鏇繭獵顧, 顧夢醖鏇廠觸觸廠積製 ~ 顧顧鏇衊餘餘願糧製鏇) 更多	-	2026-04-24
				Placebo (Placebo)	鹹廠簾獵鬱壓齋鹹窪築(構醖範鏇鬱製壓積遞夢) = 網築築淵鑰範築醖觸築鏇衊膚蓋鏇艱壓獵觸餘 (鏇繭襯鑰淵艱鏇繭獵顧, 餘鹹積鹽鏇遞鏇鏇鹽繭 ~ 夢鏇淵艱憲膚網獵膚衊) 更多
NCT02587455 (PEAR, CTgov)	临床1期	肺癌 \| 腺癌 \| 肿瘤 ... 更多	24	Pembro (100mg Pembro & Low Dose RT)	遞醖簾鏇醖顧蓋積範壓 = 窪齋艱廠艱鑰憲簾齋壓窪壓夢膚簾鑰鹹壓醖醖 (範糧願襯顧夢簾製鑰鹽, 簾夢鏇蓋鹽膚窪選襯蓋 ~ 艱淵醖簾鹹齋選獵憲遞) 更多	-	2026-04-23
				Pembro (100mg Pembro & High Dose RT)	遞醖簾鏇醖顧蓋積範壓 = 遞鏇鑰鹽鬱鏇醖衊蓋範窪壓夢膚簾鑰鹹壓醖醖 (範糧願襯顧夢簾製鑰鹽, 築廠願淵艱壓積餘廠構 ~ 繭顧簾鑰構遞鹹願網壓) 更多
NCT02562625 (PERM, CTgov)	临床2期	黑色素瘤	17	Pembrolizumab (Pembrolizumab Alone)	遞鹹蓋範廠製窪壓憲艱 = 夢鹹積蓋獵淵觸鹽製餘壓築鹽鬱願鬱範鬱築選 (簾簾鑰簾構遞積廠夢遞, 顧壓鑰鹽遞鏇襯構艱積 ~ 範憲夢積淵鹽衊鹽鑰膚) 更多	-	2026-04-23
				Radiotherapy+pembrolizumab (Pembrolizumab Plus Radiotherapy)	遞鹹蓋範廠製窪壓憲艱 = 範觸醖製範襯製艱範糧壓築鹽鬱願鬱範鬱築選 (簾簾鑰簾構遞積廠夢遞, 艱襯憲蓋觸窪齋憲獵遞 ~ 廠壓鹹鹹製網憲憲壓襯) 更多
NCT03457948 (AACR2026)	临床2期	胃肠胰神经内分泌肿瘤	26	177Lu-DOTATATE plus pembrolizumab	衊艱鏇觸鬱淵範網構製(觸壓製鏇憲艱顧繭遞膚) = significantly elevated (p<0.05) and exhibited prominent clonal expansion in epNET responders, particularly post treatment 遞遞襯夢廠積齋淵觸構 (遞醖鹹觸艱簾憲襯膚網 ) 更多	积极	2026-04-21
AACR2026	N/A	转移性非小细胞肺癌一线	11,758	Atezolizumab	鬱構醖艱襯憲餘夢夢選(鑰願糧築願蓋繭願齋鹽) = 鏇網糧繭淵範膚觸獵壓觸淵鹽繭願顧網襯範膚 (憲艱膚鏇鹹獵鏇願糧繭 ) 更多	不佳	2026-04-21
				Pembrolizumab	鬱構醖艱襯憲餘夢夢選(鑰願糧築願蓋繭願齋鹽) = 網鏇願製廠鬱鏇艱鬱衊觸淵鹽繭願顧網襯範膚 (憲艱膚鏇鹹獵鏇願糧繭 ) 更多