This phase II trial compares the effect of adding a probiotic 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 probiotic supplement 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]

NCT06543576

/ Not yet recruiting临床1/2期IIT

A Prospective Cohort Study of Integrating Radiotherapy Into Chemotherapy With Pembrolizumab and Bevacizumab in Newly Diagnosed Stage IVB Cervical Cancer

This phase I/II trial tests the safety and effectiveness of receiving external beam radiation therapy (EBRT) and brachytherapy along with chemotherapy, consisting of cisplatin and paclitaxel, and immunotherapy, consisting of bevacizumab and pembrolizumab, for the treatment of patients with stage IVB cervical cancer. EBRT is type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving EBRT and brachytherapy along with chemotherapy and immunotherapy may be a safe and effective way to treat patients with stage IVB cervical cancer.

开始日期2026-01-31

申办/合作机构

Jonsson Comprehensive Cancer Center

[+1]

NCT06669572

/ Not yet recruiting临床2期IIT

A Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and/or Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.

The purpose of this study is to gather information on the safety and effectiveness of lenvatinib combined with pembrolizumab in anal/rectal cancer that has spread to other parts of the body and will not respond to standard care.

开始日期2026-01-13

申办/合作机构

The University of Chicago

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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10,637

项与帕博利珠单抗相关的文献（医药）

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 ; Abdelaziz, Ahmed H. ; Pöllinger, Bernadette ; 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.

2025-12-31·OncoImmunology

Clinical impact of cancer cachexia on the outcome of patients with non-small cell lung cancer with PD-L1 tumor proportion scores of ≥50% receiving pembrolizumab monotherapy versus immune checkpoint inhibitor with chemotherapy

Article

作者: Katayama, Yuki ; Kijima, Takashi ; Hasegawa, Isao ; Kawachi, Hayato ; Iwasaku, Masahiro ; Date, Koji ; Yamada, Tadaaki ; Shimose, Takayuki ; Nakao, Akira ; Okada, Asuka ; Harada, Taishi ; Tokuda, Shinsaku ; Nishioka, Naoya ; Tamiya, Motohiro ; Morimoto, Kenji ; Tanimura, Keiko ; Shiotsu, Shinsuke ; Goto, Yasuhiro ; Takayama, Koichi ; Tamiya, Nobuyo ; Negi, Yoshiki ; Chihara, Yusuke ; Takeda, Takayuki

This retrospective, multicenter cohort study aimed to determine whether cancer cachexia serves as a biomarker for determining the most effective treatment for patients having non-small-cell lung cancer (NSCLC) with high programmed death ligand 1 (PD-L1) expression treated with immune checkpoint inhibitors (ICIs) alone or combined with chemotherapy (ICI/chemotherapy). We included 411 patients with advanced NSCLC with a PD-L1 tumor proportion score of ≥50%. The patients were treated with pembrolizumab monotherapy or ICI/chemotherapy. Cancer cachexia was defined as a weight loss of >5% of the total body weight or a body mass index of <20 kg/m² coupled with an additional weight loss of >2% within 6 months before starting treatment. Eighty-five (21%) patients met the cancer cachexia criteria. Overall survival (OS) was significantly shorter in patients with cachexia than in those without cachexia in both the pembrolizumab monotherapy group (17.2 vs. 35.8 months, p < 0.001) and the ICI/chemotherapy group (27.0 months vs. not reached, p = 0.044). However, after stratifying by cancer cachexia status, no significant difference in OS was observed between the pembrolizumab monotherapy and chemoimmunotherapy groups, regardless of cachexia. In conclusion, ICI/chemotherapy offers limited benefits for NSCLC patients with high PD-L1 expression and concurrent cancer cachexia. Considering the frailty associated with cachexia, ICI monotherapy may be preferred to ICI/chemotherapy for these patients. New interventions that can better address the negative prognostic impact of cachexia in patients treated using ICIs with or without chemotherapy remain warranted.

8,596

项与帕博利珠单抗相关的新闻（医药）

2025-07-26

·药研发

【药研日报0726】恒瑞医疗载药微球技术获美国专利

「本文共：9条资讯，阅读时长约：3分钟」政策与监管1.恒瑞医疗载药微球技术获美国专利。恒瑞攻克"粒径均一性"卡脖子工艺，微球粒径变异系数稳定控制在5%以内（传统工艺＞15%），提升肝癌介入治疗精准度，加速进口替代。2.楚天科技11层生物复合膜打破欧美垄断。一次性细胞培养袋成本较进口产品降低30%，层析填料通过FDA备案，设备出口至40余国，国际业务收入占比达35%。3.诺未生物完成数千万元B1轮融资。资金用于推进宫颈癌前病变疫苗NWRD08 II期临床及肝癌核酸药NWRD06临床研究，核心技术平台STARi临床前肿瘤痊愈率达92%。4.2025上半年中国创新药License-out交易额近660亿美元。超越2024年全年总额，占全球交易近50%，三生制药PD-1/VEGF双抗以12.5亿美元首付款刷新出海纪录。5.创新药临床试验审批迈入"30日时代"。NMPA新规优化流程，优先支持国家重点品种及国际多中心试验，较2014年平均14个月大幅提速。6.湿疹新药泽立美价格下调63%。全球首款非激素儿童湿疹药本维莫德乳膏零售价从980元/支降至360元/支，获美国皮肤病学会（AAD）"强烈推荐"。7.自免领域国产研发井喷。IL-17A靶点超10款药物进入III期临床，2024年BD出海交易13项创纪录，千亿美元市场中国力量崛起。8.云南白药核药INR102注射液启动I/IIa期临床。首例受试者入组，用于治疗PSMA阳性转移性去势抵抗性前列腺癌（mCRPC），临床前研究显示安全窗口宽、抗肿瘤活性显著。9.卫材中国肝癌联合疗法获批上市。仑伐替尼联合帕博利珠单抗及经动脉化疗栓塞（TACE），用于不可切除的非转移性肝细胞癌，III期试验中国患者中位无进展生存期达16.6个月（全球人群14.6个月）。股市资讯7月25日A股医药公司涨幅TOP 3振东制药（300158）+14.2%主要影响因素：创新药管线进展积极，3日内累计涨幅超40%，市场预期其核心品种临床数据即将披露。三元基因（837344）+14.0%主要影响因素：干扰素新药临床数据超预期，推动市场对创新药出海潜力乐观。康泰医学（300869）+20.0%主要影响因素：呼吸机海外订单激增，叠加医疗器械集采政策优化利好。7月25日A股医药公司跌幅TOP 3万孚生物（300482）-4.5%主要影响因素：行业政策延续影响，集采中标价低于预期，市场担忧利润空间压缩。大博医疗（002901）-3.8%主要影响因素：二季度器械出口增速放缓，财报预告显示业绩承压。乐普医疗（300003）-3.2%主要影响因素：行业政策不确定性，高值耗材集采范围扩大传闻引发抛售。7月25日港股医药公司涨幅TOP 3维立志博-B（新股）+120%主要影响因素：首日上市，聚焦肿瘤免疫新药研发，因市场热度推动估值溢价，触发暴涨。药明生物（02269）+7.0%主要影响因素：ADC/CDMO订单放量，叠加行业复苏预期及集采政策优化时代天使（06699）+6.5%主要影响因素：隐形矫治器海外销售增长超50%，国际化布局获市场认可。7月25日港股医药公司跌幅TOP 3开拓药业-B（09939）-9.1%主要影响因素：乳腺癌III期临床失败后续影响延续，研发进展受挫。康希诺生物-B（06185）-5.3%主要影响因素：新冠疫苗存货减值担忧发酵，半年报预亏拖累情绪。三生制药（01530）-4.7%主要影响因素：核心产品未纳入地方医保增补，销售预期下调。评审动态7月25日新药临床试验申请IND7月新药上市申请NDA（申请类型为新药或进口，不包括仿制&已有国家标准）END

财报引进/卖出临床3期疫苗临床2期

2025-07-25

·GlobeNewswire-Health Care

Evaxion to present two-year clinical efficacy data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 at the ESMO Congress 2025

COPENHAGEN, Denmark, July 25, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, will be presenting two-year clinical efficacy data from its phase 2 trial with lead compound EVX-01 at the European Society for Medical Oncology (ESMO) Congress 2025 to be held in Berlin, Germany, from October 17-21, 2025. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). The trial has yielded numerous convincing data already, including interim one-year data presented at the ESMO Congress in September 2024. Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology™ platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). “We are delighted to have the two-year data from the EVX-01 phase 2 trial accepted for presentation at the ESMO Congress 2025. As one of the most important and prestigious medical oncology conferences in the world, the congress will be a great place for us to present the data to a large audience, including potential partners,” says Birgitte Rønø, CSO and interim CEO of Evaxion. The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Presentation details Abstract Title:EVX-01, a personalized cancer vaccine, induces potent T-cell responses and durable disease control in advanced melanoma: 2-year follow-upAbstract#:#6308Presentation#: 1516MOTrack: Mini oral session: Investigational immunotherapyLocation:Nuremberg Auditorium - Hall 5.2Date/Time:October 17 at 14:10 - 14:15 CESTPresenter:Dr. Muhammad Adnan Khattak, Director, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, WA, Australia About EVX-01 EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset. EVX-01 is a personalized therapy designed with our AI-Immunology™ platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors. In the completed phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses, with two complete and six partial responses. In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology™ predictions was observed, underlining the predictive power of the platform. Contact information Evaxion A/SMads KronborgVice President, Investor Relations & Communication+45 53 54 82 96mak@evaxion.ai About Evaxion Evaxion is a pioneering TechBio company based upon its AI platform, AI-Immunology™. Evaxion’s proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology™, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Evaxion is committed to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology™ platform and vaccine pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

疫苗临床2期免疫疗法临床结果

2025-07-25

·今日头条

2万一针的“活体药”NK细胞能治哪些癌？一文搞懂适用范围与疗效

作为让广大癌症患者满怀期待的免疫疗法新“焦点”，NK细胞素有“人体抗癌第一道防线”的美誉。其单次治疗成本约2万~4.5万元，显著低于目前已上市的CAR-T疗法、TIL疗法、TCR-T疗法等，因此被誉为免疫治疗领域的“性价比之王”，这一消息也在病友群中引发了热烈关注！那么，NK细胞疗法真的能治好肿瘤吗？它适用于哪些癌种呢？下面小编将为您详细解答。一、NK细胞为何能杀伤肿瘤细胞？自然杀伤细胞（Natural killer cells，NK细胞）是由造血干细胞分化而来的先天免疫细胞，作为人体第三类淋巴细胞，它不仅能直接杀伤肿瘤细胞，还能通过调节肿瘤微环境发挥抗癌与抗病毒的双重作用，堪称人体对抗癌细胞的“天然斗士”！作为免疫监视的第一道防线， NK细胞在全身血管内持续巡逻，能第一时间识别并锁定体内异常细胞（如癌细胞、感染细胞、衰老细胞等），是公认的抗癌、抗感染“前沿哨兵” 。更重要的是，它无需依赖抗原递呈过程（即无需“提前通报”），可直接激活并释放颗粒酶、穿孔素等杀伤介质，精准消灭癌细胞，堪称奋战在抗癌一线的“先行军” ！既然人体天然存在NK细胞，为何癌症患者还需外源性补充？主要原因有二：一是肿瘤生长可能阻碍NK细胞在骨髓内的正常分化与成熟；二是受癌细胞侵害，体内残存的NK细胞“战斗力”会下降，难以有效识别和消灭癌细胞。因此，通过外源性补充NK细胞，既能增加患者体内NK细胞的数量，又能增强其杀伤活性，从而提升治疗效果——无论在实体瘤还是血液肿瘤领域，它都展现出广谱抗癌的强大潜力！相信随着研究的不断深入，这道“天然抗癌防线”将为更多患者带来生命的希望与对抗病魔的力量，未来值得期待！ ▼自然杀伤（NK）细胞正在攻击癌细胞 ▲图源“nature portfolio”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除二NK细胞疗法能治疗哪些癌症？近二十年来，NK细胞疗法凭借显著潜力，逐渐成为白血病治疗领域的重要探索方向，目前已有超过100项相关临床研究正在推进。不仅如此，在乳腺癌、肝癌、胃癌、结直肠癌、宫颈癌、胆道癌、甲状腺癌、食管癌等实体瘤治疗中，其临床结果同样令人振奋。这一疗法的持续突破，正为实体瘤与血液肿瘤患者共同点亮新的生命曙光！ · NK细胞治疗的癌症类型 · ▲图源“cell”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除（一）晚期结肠癌：NK细胞联合化疗，5年无进展生存率提升20% 尽管有多种治疗策略可供选择，但晚期结肠癌(CC)患者的预后不佳。为此，研究人员开展了一项“应用自然杀伤细胞（NK）联合化疗，治疗局部晚期结肠癌”的临床研究，共纳入60例患者，将其分为两组，即NK细胞组（27例，接受NK细胞治疗联合化疗）、对照组（33例，接受单纯化疗）。结果显示：NK细胞组的5年无进展生存率（PFS）和总生存率（OS）显著高于对照组， 5年PFS率分别为51.1%（NK细胞组） vs 35%（对照组），P=0.044（详见下图A）。5年OS率分别为72.5%（NK细胞组） vs 51.6%（对照组），P=0.037（详见下图B）。尤其在低分化癌患者和人类白细胞抗原（HLA）-1低表达患者中， NK细胞组的中位无进展生存期优势更为明显：低分化癌患者中两组中位 PFS为23.5个月 vs 12.1个月（P=0.0475）；HLA-1低表达患者中则为 33.1个月 vs 18.5个月（P=0.045）。且整个研究过程中未报告重大不良反应。 ▲图源“CYTOTHERAPY”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除综上，NK细胞疗法联合化疗用于局部晚期结肠癌治疗，可有效降低复发风险、延长患者生存期，且副作用可控，对低分化癌患者的获益尤为突出。（二）肝细胞癌：NK细胞联手冷冻消融全面超越传统方案，中位无进展生存期提升至9.1个月，疾病控制率超85% 肝细胞癌（HCC）作为最常见的原发性肝癌类型，因多数患者确诊时已至晚期，不仅预后较差，治疗选择也十分有限。尽管手术切除是理想治疗方式，但许多患者因合并肝硬化、多发性肿瘤或其他基础疾病而无法手术；全身化疗对晚期HCC患者的生存率提升不明显，放射治疗又会对正常肝脏造成毒性损伤。因此，临床上迫切需要更安全有效的晚期HCC治疗新策略。而NK细胞作为先天免疫系统的核心力量，在癌症早期防御中发挥关键作用。近年研究证实，过继性NK细胞转移对包括肝癌在内的多种癌症展现出良好的抗肿瘤效果；而经皮冷冻消融作为诱导肿瘤坏死的新兴技术，目前已成为无法切除肝细胞癌的优选治疗手段。基于此，研究团队开展了“NK细胞联合同种异体冷冻消融术治疗晚期肝细胞癌”的临床研究。该研究共纳入61例晚期肝细胞癌（HCC）患者，将其分为两组：单纯冷冻消融组（Cryo组，26例）、同种异体NK细胞联冷冻消融组（Cryo-NK组，35例），中位随访时间为8.7个月（3.9～15.1个月）。结果显示：治疗后两组肿瘤体积均明显缩小，其中治疗3个月后Cryo-NK组的肿瘤最大横径显著小于Cryo组（P<0.01）。 Cryo-NK组的有效率（RR）高于Cryo组，分别为60.0% vs 46.1% （P<0.05）；疾病控制率（DCR）也高于Cryo组，分别为85.7% vs 69.2% 。随访期间 Cryo-NK组有9例患者达完全缓解（CR）、而Cryo组仅有5例达CR 。此外， Cryo-NK组的中位无进展生存期（PFS）显著高于Cryo组，分别为9.1个月 vs 7.6个月（P=0.0107，详见下图A）。且接受多次NK细胞治疗的患者中位PFS优于仅接受单次治疗的患者，分别为9.7个月 vs 8.4个月（P=0.0011，详见下图B）。 ▲图源“Oncotarget”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除值得关注的是，两例代表性患者在Cryo-NK治疗3个月后均达到完全缓解（CR）。其中病例1是一位50岁男性，确诊为III期肝细胞癌（HCC），HCC结节最大2.5cm，Cryo-NK治疗后， MRI显示占位性病变无强化，区域轻度萎缩（详见下图A）。 ▲图源“Oncotarget”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除病例2是一位48岁女性，确诊为IV期肝细胞癌（HCC），HCC结节最大5.0cm，治疗后MRI显示病变伴有大面积坏死（详见下图B）。 ▲图源“Oncotarget”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除综上，经皮冷冻消融联合同种异体NK细胞免疫治疗，能显著延长晚期肝细胞癌患者的中位无进展生存期，大幅提升疗效与疾病控制效果，为晚期HCC患者带来了更优的治疗新选择。（三）胆道癌：NK细胞联合帕博利珠单抗，让化疗耐药患者，肝转移显著缩小70%，12个月持续无进展《Cancers(Basel)》期刊报道了一则振奋人心的案例：通过同种异体NK细胞（SMT-NK）联合帕博利珠单抗，成功治疗化疗耐药的晚期胆道癌患者。该患者（患者E0217）是一位76岁女性，确诊肝外胆管癌后，接受了胆总管节段切除术与胆囊切除术。术后四个月，患者出现多处肝转移，随即接受吉西他滨联合顺铂的全身化疗，但治疗后肝脏病灶仍持续进展，遂入组接受SMT-NK细胞+帕博利珠单抗联合治疗。结果令人振奋：治疗后，患者的肝转移病灶体积减少70.4% （如图3E-H所示），且初次治疗后12个月内始终保持无进展状态。 ▲图源“Cancers (Basel)”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除（四）乳腺癌：NK细胞治疗2个月，复发性患者肿块与淋巴结双双缩小近期，我国开展了首个对比自体与同种异体NK细胞治疗复发性乳腺癌的临床试验（NCT02853903），其中一位46岁乳腺癌患者的治疗效果尤为值得关注。 CT扫描显示：治疗前，该患者右乳存在8.0×3.8×5.7cm的软组织肿块（详见下图A），边界不清，增强CT可见中度不均匀强化；NK细胞治疗2个月后，右乳肿块缩小至6.8×3.5×5.8cm （详见下图B），呈轻度不均匀强化。此外，治疗前，腋窝有多枚肿大淋巴结，较大者约2.9×1.7×3.8cm。；而治疗后，腋窝较大的肿大淋巴结也明显缩小。 ▲图源“Dovepress”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除（五）肺癌患者福音：NK细胞联合疗法替代放化疗，肿瘤缩小近一半《美国癌症研究杂志》报道了我国一项NK细胞联合西妥昔单抗治疗晚期非小细胞肺癌（NSCLC）的临床研究（NCT02845856），该疗法可作为放化疗的替代方案。其中一位53岁IVA期男性患者的治疗效果尤为值得关注：经NK细胞联合西妥昔单抗治疗后，肿瘤显著缩小。CT扫描显示，其右肺肿瘤从治疗前的3.5×3.5cm，缩小至治疗后的1.7×1.3cm （详见下图）。 ▲图源“Am J Cancer Res”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除除了非小细胞肺癌外，研究发现NK细胞还可用于治疗小细胞肺癌。阅读原文了解详情：从5年生存率不足1%到肿瘤大退缩！NK细胞疗法改写小细胞肺癌命运（六）卵巢癌：NK细胞+WT1-DC疫苗+纳武单抗，让全身多处转移灶消失、腹水消退《Cureus》近期报道了一则振奋案例：一位晚期卵巢癌伴全身多发转移的患者，经NK细胞+WT1-DC疫苗+纳武单抗联合治疗后，全身多处病灶明显减少，腹水完全消失！该患者为30岁左右女性，确诊时为IV期子宫内膜癌，初期仅接受常规化疗（紫杉醇+卡铂AUC5），但医生评估预后不佳，随即加用免疫细胞联合治疗，方案为化疗+同步多轮WT1-DC疫苗+高活性NK细胞联合治疗。结果显示：治疗前全身PET-CT提示双侧卵巢原发性病灶，同时合并广泛转移，包括腹膜、肝脏、骨骼、肺部等多处转移灶（详见下图1A）。NK+WT1-DC联合治疗第142天复查，原发性肿瘤明显缩小，肺转移灶及腹膜播散灶完全消失，肝转移灶显著缩小（详见下图1B），患者已计划进行原发肿瘤根治性切除术。 ▲图源“Cureus”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除腹水改善方面，腹部CT显示：治疗前患者存在大量腹水（详见下图2A），治疗期间腹水逐步减少；至治疗第56天，腹水较确诊时明显减少，肝转移灶也同步缩小（详见下图2B），这表明NK细胞疗法对控制腹膜播散效果显著。 ▲图源“Cureus”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除此外，第三次NK细胞治疗后，患者癌胚抗原（CEA）、糖类抗原125（CA125）水平明显下降，腹围也显著减小。二、小编寄语 NK细胞能在第一时间发现并启动机体的免疫防御机制，及时发现并将癌细胞扼杀在“摇篮”，是公认的人体抗癌第一道防线。我国在大力发展CAR-T细胞疗法的同时，也没有忽视这款重要的免疫细胞疗法的研发。近期随着两款NK细胞产品——CEL001和NK042的新药IND获批，也标志着我国在肿瘤免疫治疗领域取得了重要进展，为抗癌新技术的研发注入了新的力量！小编也希望这篇文章能让更多癌友了解NK细胞的前沿进展，并期待NK细胞在临床应用中能获得更多的突破，让更多的晚期肿瘤患者获益！三、参考资料 [1]Li L,et al.Adoptive transfer of natural killer cells in combination with chemotherapy improves outcomes of patients with locally advanced colon carcinoma[J]. Cytotherapy, 2018, 20(1): 134-148. https://www.isct-cytotherapy.org/article/S1465-3249(17)30708-9/abstract [2]Lin M,et al.Cryoablation combined with allogenic natural killer cell immunotherapy improves the curative effect in patients with advanced hepatocellular cancer. Oncotarget. 2017 May 11;8(47):81967-81977. https://pmc-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/articles/PMC5669863/ [3]Leem G,et al.Safety and Efficacy of Allogeneic Natural Killer Cells in Combination with Pembrolizumab in Patients with Chemotherapy-Refractory Biliary Tract Cancer: A Multicenter Open-Label Phase 1/2a Trial. Cancers (Basel). 2022 Aug 30;14(17):4229. https://pmc-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/articles/PMC9454779/ [4]Liang S,et al.Comparison of autogeneic and allogeneic natural killer cells immunotherapy on the clinical outcome of recurrent breast cancer. Onco Targets Ther. 2017 Aug 28;10:4273-4281. https://www.dovepress.com/comparison-of-autogeneic-and-allogeneic-natural-killer-cells-immunothe-peer-reviewed-fulltext-article-OTT [5]Liang S,et al.Cetuximab combined with natural killer cells therapy: an alternative to chemoradiotherapy for patients with advanced non-small cell lung cancer (NSCLC). Am J Cancer Res. 2018 May 1;8(5):879-891. https://pmc-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/articles/PMC5992505/ [6]Nagai H,et al.Late-Stage Ovarian Cancer With Systemic Multiple Metastases Shows Marked Shrinkage Using a Combination of Wilms' Tumor Antigen 1 (WT1) Dendritic Cell Vaccine, Natural Killer (NK) Cell Therapy, and Nivolumab[J]. Cureus, 2024, 16(3). https://www.cureus.com/articles/239260-late-stage-ovarian-cancer-with-systemic-multiple-metastases-shows-marked-shrinkage-using-a-combination-of-wilms-tumor-antigen-1-wt1-dendritic-cell-vaccine-natural-killer-nk-cell-therapy-and-nivolumab#!/ [7]https://www-nature-com.libproxy1.nus.edu.sg/articles/d42473-024-00019-0 本文为全球肿瘤医生网原创，未经授权严禁转载

细胞疗法免疫疗法

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外链

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

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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
恶性胸膜间皮瘤	美国	Merck & Co., Inc.	2024-09-17
恶性胸膜间皮瘤	美国	Merck Sharp & Dohme LLC	2024-09-17
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

未上市

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适应症	最高研发状态	国家/地区	公司	日期
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
卵巢上皮癌	临床3期	德国	Merck Sharp & Dohme Corp.	2021-12-13
卵巢上皮癌	临床3期	以色列	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


NCT04904185 (CTgov)	临床1期	转移性黑色素瘤	8	Multiple Antigen Specific Endogenously derived T cells+Fludarabine Phosphate+Cyclophosphamide (Part A)	壓壓顧簾衊鏇襯繭蓋齋 = 窪艱淵鑰積齋淵鹹選鏇膚壓淵獵築選鹽壓醖鏇 (糧淵淵鬱窪構範簾鑰夢, 襯窪鏇鹹願繭願獵淵範 ~ 鬱壓築構願鏇獵糧齋範) 更多	-	2025-07-25
NCT04904185 (CTgov)	临床1期	转移性黑色素瘤	8	Multiple Antigen Specific Endogenously derived T cells+Fludarabine Phosphate+Cyclophosphamide+Pembrolizumab (Part B)	壓壓顧簾衊鏇襯繭蓋齋 = 製夢餘齋鹽膚艱廠齋鑰膚壓淵獵築選鹽壓醖鏇 (糧淵淵鬱窪構範簾鑰夢, 淵鏇糧襯壓遞鏇顧獵襯 ~ 憲蓋選窪蓋簾夢膚衊鹹) 更多	-	2025-07-25
NCT03316872 (PEMRAD, CTgov)	临床2期	晚期肝细胞癌	18	Stereotactic Body Radiotherapy (SBRT)+Pembrolizumab	餘廠構鏇醖糧衊獵艱遞 = 壓範淵鑰淵鹽蓋觸憲夢遞醖蓋壓艱糧鬱壓簾鬱 (憲艱鑰選觸鹹製網顧築, 膚範壓選簾壓鹹憲顧膚 ~ 窪鑰遞夢鑰膚遞夢憲憲) 更多	-	2025-07-25
NCT05308901 (CTgov)	临床2期	葡萄膜黑色素瘤	6	pembrolizumab+Lenvatinib	顧範醖遞製範襯窪齋夢(遞鑰鑰鬱鹽範顧鹹顧願) = 製鏇繭鹽膚鏇鹽蓋獵顧積繭醖鹽壓願鑰選艱齋 (繭艱繭鏇膚艱膚醖夢鹹, 簾鬱壓觸範淵製窪衊憲 ~ 鹹醖願蓋壓積獵鏇蓋鏇) 更多	-	2025-07-25
NCT03833167 (KEYNOTE-630 \| MK-3475-630, CTgov)	临床3期	局部晚期鳞状细胞癌 \| 局部晚期头颈部皮肤鳞状细胞癌	450	Pembrolizumab (Pembrolizumab)	衊憲選蓋鹽鏇獵範鑰繭(壓築壓艱築窪鹹膚廠構) = 廠製鑰築淵窪簾壓餘觸範顧艱鏇構蓋簾獵鬱齋 (鹽齋膚壓餘鏇鹹醖積網, 網鏇夢觸積簾製壓獵衊 ~ 獵觸糧繭鏇艱壓齋鏇鑰) 更多	-	2025-07-22
NCT03833167 (KEYNOTE-630 \| MK-3475-630, CTgov)	临床3期	局部晚期鳞状细胞癌 \| 局部晚期头颈部皮肤鳞状细胞癌	450	Placebo (Placebo)	衊憲選蓋鹽鏇獵範鑰繭(壓築壓艱築窪鹹膚廠構) = 積選遞夢衊壓範觸鹽窪範顧艱鏇構蓋簾獵鬱齋 (鹽齋膚壓餘鏇鹹醖積網, 齋憲窪膚築膚簾簾膚顧 ~ 鬱選衊網淵製簾衊獵簾) 更多	-	2025-07-22
NCT03734692 (CTgov)	临床1/2期	复发性卵巢癌	24	cisplatin+Rintatolimod+Pembrolizumab	鹹鑰糧憲簾衊餘遞構膚 = 鹽糧壓獵窪襯齋醖積積窪鏇膚憲齋衊鏇餘餘餘 (蓋廠艱鑰鬱鑰觸構襯遞, 繭繭醖夢衊鑰鏇膚鬱餘 ~ 廠鹹觸鹹顧壓鬱鬱製艱) 更多	-	2025-07-20
NCT02940496 (CTgov)	临床2期	非小细胞肺癌IIIA期 \| 晚期肝细胞癌 \| 丙型肝炎 ... 更多	15	Pembrolizumab ("ARM A Pembrolizumab (Q3W)")	襯積餘鹹簾構壓齋選餘(簾鑰簾淵遞衊簾糧壓積) = 淵獵獵夢築簾積餘鬱網餘簾繭鑰窪獵積膚鏇夢 (壓襯艱築築繭遞艱觸繭, 膚夢廠觸糧顧鬱網鏇衊 ~ 鬱構觸選齋餘繭膚鑰膚) 更多	-	2025-07-15
NCT02940496 (CTgov)	临床2期	非小细胞肺癌IIIA期 \| 晚期肝细胞癌 \| 丙型肝炎 ... 更多	15	Elbasvir+Grazoprevir+Pembrolizumab ("ARM B Pembrolizumab (Q3W)+Grazoprevir (qd x 12 Weeks)+Elbasvir (QD x 12 Weeks")	網廠憲築積窪遞醖顧積(齋醖願壓網襯鹹鹽鹹艱) = 餘餘壓範壓鹹醖窪壓齋遞願鏇簾選製艱窪願壓 (築積膚鬱鹽糧窪艱構鏇, 餘顧鹹鏇選窪鹹選選窪 ~ 淵憲膚醖廠壓鹽鹽獵糧) 更多	-	2025-07-15
NCT04120454 (CTgov)	临床2期	转移性非小细胞肺癌 \| 复发性非小细胞肺癌 \| EGFR突变的非小细胞肺癌	6	Pembrolizumab+Ramucirumab	憲鏇鑰廠範願願構衊壓 = 膚鹽襯蓋選願顧憲艱餘憲窪網構獵壓艱鏇齋簾 (繭憲餘醖餘鏇憲構鹽廠, 憲鹽鑰網範願顧選膚鏇 ~ 鬱窪網齋繭鬱壓窪窪築) 更多	-	2025-07-11
NCT04306367 (Pubmed \| NPJ Precis Oncol)	临床2期	晚期胆道癌二线 IDH1/IDH2 mutations	13	Pembrolizumab and Olaparib Combination	鹽鹹夢繭簾衊獵窪醖製(繭衊製鏇衊繭鏇獵顧窪) = 廠獵齋鹽蓋齋繭選窪構觸憲襯獵鬱繭醖願夢繭 (糧範糧選遞鑰餘糧繭廠 ) 更多	积极	2025-07-08
NCT03765918 (KEYNOTE-689, Pubmed \| N Engl J Med)	临床3期	头颈部肿瘤新辅助 \| 辅助 programmed death ligand 1 (PD-L1)	-	Pembrolizumab + Standard Care	願築鏇蓋構鏇網鏇窪壓(繭顧衊範鑰鹽醖繭淵遞) = 10.0% of the participants in the pembrolizumab group 糧顧鹹願齋襯齋窪醖餘 (齋憲淵遞壓網衊鏇鑰憲 ) 更多	积极	2025-07-03
NCT03765918 (KEYNOTE-689, Pubmed \| N Engl J Med)	临床3期	头颈部肿瘤新辅助 \| 辅助 programmed death ligand 1 (PD-L1)	-	Pembrolizumab (Standard Care Alone)		积极	2025-07-03
ESMO_GI2025	临床3期	晚期胆道癌	36	Pembrolizumab + Gemcitabine + Cisplatin	鑰壓獵築顧窪願獵廠範(獵餘淵淵蓋憲鹽築積餘) = 餘鬱憲憲繭艱糧襯網構齋夢獵餘鏇鏇範築醖願 (鏇獵獵糧淵積廠餘簾鹹 ) 更多	积极	2025-07-03