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

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

开始日期2026-06-01

申办/合作机构

National Cancer Institute

NCT07037004

/ Not yet recruiting临床2期IIT

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

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

开始日期2026-05-04

申办/合作机构

City of Hope National Medical Center

[+1]

NCT05806385

/ Not yet recruiting临床1/2期IIT

Local Therapy Optimization by Grouping Immune-modulation With Cryoablation (LOGIC) for High Risk Breast Cancers

Summary Points:
1. High Risk Breast Cancers: Triple negative cancer is considered high risk due to high rate of local and systemic failure. Newer innovative treatment strategies are needed to improve systemic control of disease and survival.
2. Immune system modulation: is an emerging modality in cancer treatment. Tumor antigens can stimulate T cells to identify and destroy cancer cells. Cancers express "altered self" antigens that tend to induce weaker responses than the "foreign" antigens expressed by infectious agents. Thus, immune stimulants and adjuvant approaches have been explored widely. Opportunities to develop effective cancer vaccines may benefit from seminal recent advances in understanding how immunosuppressive barricades are erected by tumors to mediate immune escape. This concept is precisely applicable to triple negative breast cancer due to their antigenicity. Checkpoint inhibitors are an attractive method for treatment of high-risk breast cancers. However, to leverage the efficacy of checkpoint inhibition, approaches are needed to enhance delivery of cancer antigens to the T cells.
3. Cryoablation: offers an efficacious and safe method to enhance tumor antigen presentation to the immune cells while destroying the primary tumor. This ablation method is superior by virtue of antigen preservation in situ despite toxicity to the tumor cell. Impact of cryoablation in enhancing immunological responses in tumor microenvironment are well established; however, cryoablation can also cause tumor antigen tolerance via non-specific stimulation of T cells.
4. Rationale for combining cryoablation and checkpoint inhibitors: Since checkpoint inhibitors curtail the tolerance developed by tumor antigens, and cryoablation enhances antigen presentation and T cell recruitment, it is intuitive that combination of these two approaches presents an ideal opportunity to leverage the benefits of both approaches while curtailing the limitations of either. Therefore, the investigators hypothesize in this study that their combination will improve the response rate and the degree of response.

开始日期2026-03-01

申办/合作机构

Texas Tech University Health Sciences Center

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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10,722

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 ; Pöllinger, Bernadette ; Abdelaziz, Ahmed H. ; Kassem, Loay ; Akyol Ersoy, Burcu ; Elsisi, Gihan Hamdy

OBJECTIVE:

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

METHODS:

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

RESULTS:

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

CONCLUSIONS:

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

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 ; Hasegawa, Isao ; Kijima, Takashi ; Kawachi, Hayato ; Iwasaku, Masahiro ; Date, Koji ; Yamada, Tadaaki ; Shimose, Takayuki ; Nakao, Akira ; Okada, Asuka ; Harada, Taishi ; Tokuda, Shinsaku ; Morimoto, Kenji ; Nishioka, Naoya ; Tamiya, Motohiro ; 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.

8,992

项与帕博利珠单抗相关的新闻（医药）

2025-09-26

·艾美达医药咨询

创新药销售表现来了

中国创新药产业迅速崛起，终端销售表现如何？ 01 中国创新药全球竞争力凸显中国创新药在研数量冲到全球第一。从具体数据看，在ADC赛道，中国占比达56%，超过其他国家；双抗领域，中国占比50%，与其他地区平分秋色；细胞疗法、溶瘤病毒、多抗、放射性药物领域，中国占比也分别达46%、39%、38%、34%，均处于全球领先梯队。不过基因疗法，中国占比33%，美国46%；小核酸药物中国占比25%，未来仍有发展潜力。此外，在双抗、ADC、细胞疗法、多抗、溶瘤病毒、mRNA疫苗、放射性药物赛道上，中国的占比都超过了欧洲和日本。在基因疗法和PROTAC（蛋白降解剂）领域，中国也远超欧洲和日本，略低于美国。中国创新药已经从 “跟跑” 逐渐转向“并跑”，甚至在部分领域实现“领跑”。数据来源：医药魔方 02 中国创新药受海外市场青睐中国企业的优势赛道在出海交易中凸显巨大优势。多个ADC品种的海外授权不仅给企业带来可观的财务回报，更为中国创新药企赢得国际声誉。图2：Lisense out交易类型（以数量统计）数据来源：医药魔方，统计截至为2025年8月22日 03 创新药终端销售格局趋势及变化创新药在中国市场的终端销售表现又如何呢？本文从医院销售和DTP药房两个渠道来观察。从2022年第三季度到2025年第一季度的环比增长数据来看，医院销售市场有一定波动。2022年第四季度环比增长-8.01%，出现下滑；2023年第一季度又迎来大幅反弹，环比增长达22.44%；之后的几个季度，增长速度有所放缓，在2023年第三季度、2024年第四季度和2025年第一季度出现小幅负增长。变化可能和医院采购周期、政策调整以及患者用药需求的阶段性变化有关。数据来源：药智网；说明：统计范围为境内生产创新药的医院销售数据来源：中康CMH-DTP市场监测再来看看院外市场的表现。从2022年第三季度到2025年第一季度，DTP药房销售环比增长始终保持在14%以上，大部分季度在18%左右；2022年第三季度、2023年第一季度更是达到22.6%的高增长；2025年第一季度，DTP药房销售额达233亿元，同比增长15.0%，创新药在DTP市场保持双位数增长态势。数据来源：中康CMH-DTP市场监测 2025年第一季度DTP药房销售TOP10品种中，排名第一的是奥希替尼，EGFR靶点明星产品，主要用于治疗肺癌，保持稳定领先地位；排名第二的是司库奇尤单抗，常用于治疗银屑病等自身免疫性疾病；排名第三的是帕博利珠单抗，相比上一个周期排名上升2位，表现出色；度普利尤单抗和曲妥珠单抗排名也上升了2位；而阿美替尼、贝伐珠单抗、伏美替尼和安罗替尼的排名有所下降；胸腺法新的排名上升幅度最大——上升6 位，成为榜单“黑马”。政策通过审批加速、医保扩容等为创新药铺路。随着商保补充机制、医院考核改革等配套措施落地，预计未来几年，创新药在医院市场的份额将快速提升，成为驱动医疗健康产业升级的核心力量。在院外市场，结合产品生命周期，企业将进一步锁定在DTP药房具备增长潜力的品种。随着人们健康意识提高和对优质药物需求的增加，慢病类创新药——如癌症、高血压、糖尿病、类风湿关节炎等慢性病在DTP药房的销售前景非常广阔。转载自赛柏蓝免责声明本文系转载，仅做分享之用，不代表平台观点。图片、文章、字体等版权均属于原作者所有，如有侵权请告知，我们会及时处理。

疫苗抗体药物偶联物细胞疗法信使RNA核酸药物

2025-09-26

·今日头条

2025 ESMO中国主场时刻：十款新药横扫肺癌、胃癌、肝癌等六大癌种

2025年欧洲肿瘤内科学会（ESMO）年会将于10月17-21日在德国柏林召开。作为欧洲最负盛名、最具影响力的肿瘤学会议，其内容涵盖从基础研究到肿瘤免疫治疗的最新发现，从肿瘤护理到姑息治疗的临床实践，从罕见癌症诊疗到药物批准进展等多个维度。值得一提的是，在大会最新公布的“重磅突破摘要”（Late-Breaking Abstract，LBA）中，中国学者主导的研究表现亮眼：入选数量创历史新高，共23项研究跻身LBA行列，其中3项更入选最高学术等级的“主席论坛（Presidential Symposium）”。这些研究覆盖肺癌、乳腺癌、胃癌、尿路上皮癌等高发瘤种，囊括核药、抗体药物偶联物（ADC）、免疫联合疗法等前沿方向，显著彰显了中国创新药在国际肿瘤学界的突破与影响力。下面，全球肿瘤医生网医学部将为大家梳理本次会议中中国LBA研究的关键信息摘要，以供癌友们参考。我们坚信，每一项研究突破都在拉近“癌症可治”的梦想，每一份坚持都将铸就生命的奇迹！ 2025 ESMO硬核清单！十款国产创新药硬核登场，横扫肺癌、乳腺癌、胃癌、宫颈癌、肝癌等六大癌种 ▲截图源自“ESMO” 肺癌领域：国产双抗头对头Ⅲ期胜出 PART 1 （一）摘要号：LBA4（依沃西单抗）讲者：陆舜 | 上海交通大学医学院附属胸科医院。意义：首个国产双抗在Ⅲ期研究中头对头战胜PD-1单抗，有望重新定义晚期肺鳞癌一线标准。研究名称（英文/中文） Title: Phase III Study of Ivonescimab plus chemotherapy versus Tislelizumab plus chemotherapy as First-line Treatment for advanced squamous non-small cell lung cancer（HARMONi-6，AK112-306）（HARMONi-6：探索依沃西单抗联合化疗对比替雷利珠单抗联合化疗作为晚期鳞状非小细胞肺癌一线治疗的III期研究）。药物简介依沃西单抗（Ivonescimab，AK112）是我国自主研发的一款全球首创PD-1/VEGF双特异性抗体新药，凭借“肿瘤免疫+抗血管生成”双靶点协同的创新机制，既能有效阻断PD-1与PD-L1/L2的结合，又能精准抑制VEGF与受体的相互作用，为肺癌治疗开辟了全新选择。 ESMO前沿数据抢先看 HARMONi-6研究是ivonescimab（依沃西单抗）在肺癌领域取得积极成果的第三次Ⅲ期临床试验，核心价值在于为突破贝伐珠单抗治疗鳞状非小细胞肺癌（sqNSCLC）的局限性提供了关键证据。该试验共纳入532名患者，其中约63%为中心型鳞状细胞癌。中期分析结果显示：在意向治疗（ITT）人群中，ivonescimab联合化疗的无进展生存期（PFS）显著优于替雷利珠单抗（tislelizumab）联合化疗；且这一获益具有广谱性，在PD-L1阳性与PD-L1阴性人群中均体现出临床意义。安全性方面，ivonescimab未出现新的安全信号，即便在占比高达63%的中心型鳞癌患者中仍保持良好表现，进一步凸显其突破贝伐珠单抗治疗局限的潜力，有望增强免疫疗法在非小细胞肺癌中的临床获益。此前，另一项III期HARMONi-2试验（NCT05499390）的结果已在国际顶级医学期刊《柳叶刀》发表，针对先前未接受治疗的局部晚期或转移性PD-L1阳性非小细胞肺癌（NSCLC）患者，进一步印证了ivonescimab的显著疗效。结果显示：ivonescimab组中位PFS达11.1个月，远超帕博利珠单抗（pembrolizumab）组的5.8个月，使患者中位PFS显著延长近5.3个月，以压倒性优势刷新该类患者的治疗标准。 ▲图源“Lancet”，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）摘要号：LBA66（恩沙替尼）讲者：岳东升 | 天津医科大学肿瘤医院。意义：ALK抑制剂的突破，若无病生存期（DFS）显著延长，该药或成为术后辅助治疗的新选择。研究名称（英文/中文） Ensartinib as adjuvant therapy in patients (pts) with stage IB–IIIB ALK-positive (ALK+) non-small cell lung cancer (NSCLC) after complete tumor resection: the phase III randomized ELEVATE trial（恩沙替尼作为IB–IIIB期ALK阳性非小细胞肺癌患者肿瘤完全切除后的辅助治疗：III期随机ELEVATE试验）。药物简介恩沙替尼（Ensartinib，X-396，贝美纳®）是贝达药业控股子公司Xcovery研发的一款ALK抑制剂，同时也是首个进入 ALK 阳性 NSCLC 术后辅助治疗 III 期临床的中国原研药物。2024年12月18日获美国FDA批准，用于成人先前未接受过ALK抑制剂治疗的间变性淋巴瘤激酶（ALK）阳性局部晚期或转移性非小细胞肺癌的治疗。 ESMO前沿数据抢先看《肿瘤前沿》曾报道过一个应用恩沙替尼治疗EML4-ALK融合阳性IIIA期非小细胞肺癌（NSCLC）的振奋案例。该患者是一位60岁女性，确诊左下肺腺癌，分期为IIIA期（cT2aN2aM0，TNM第9版），且存在EML4-ALK融合基因。经恩沙替尼新辅助治疗3个月后，患者达到部分缓解（PR），胸部CT显示肿瘤体积缩小50%，纵隔淋巴结亦部分缩小（详见下图）。此次欧洲肿瘤内科学会（ESMO）大会将公布恩沙替尼作为首个聚焦中国原研ALK抑制剂，用于术后辅助治疗的III期注册研究数据，有望填补更广泛早期ALK阳性NSCLC人群的治疗空白！ ▼新辅助治疗前后左肺腺癌胸部CT图像 ▼新辅助治疗前后胸部淋巴结CT图像 ▲图源“Front Oncol”，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（三）摘要号：LBA5（芦康沙妥珠单抗-肺癌）讲者：张力 | 中山大学肿瘤防治中心。意义：若数据阳性，芦康沙妥珠单抗可能成为TROP2阳性实体瘤的重要治疗选择。研究名称（英文/中文） Sacituzumab tirumotecan (sac-TMT) vs platinum-based chemotherapy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) following progression on EGFR-TKIs: results from the randomized, multi-center phase 3 OptiTROP-Lung04 study（芦康沙妥珠单抗对比铂类化疗应用于EGFR-TKI经治进展的EGFR突变非小细胞肺癌：随机、多中心III期OptiTROP-Lung04研究结果）。药物简介芦康沙妥珠单抗（SKB264，代号：Sac-TMT，商品名：佳泰莱®）是中国科伦博泰生物依托其享誉国际的OptiDCADC研发平台开发的代表性创新药物，为靶向TROP2的抗体药物偶联物（ADC）。TROP2是一种广泛表达于多种上皮肿瘤表面的跨膜糖蛋白，在非小细胞肺癌（NSCLC）治疗领域被视为极具潜力的靶点。 2025年3月10日，该药获国家药品监督管理局（NMPA）批准上市，用于治疗经表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）和含铂化疗治疗失败的局部晚期或转移性EGFR突变非小细胞肺癌（NSCLC）成人患者。至此它也成为了首款中国原创的用于肺癌治疗的TROP2新型抗体偶联药物（ADC）。 ESMO前沿数据抢先看 2025年美国临床肿瘤学会（ASCO）大会曾公布代号为OptiTROP-Lung03的关键临床研究结果。该研究共纳入43例经多线治疗的局部晚期或转移性非小细胞肺癌（NSCLC）患者，其中22例为EGFR-TKI耐药患者，且45.5%接受过第三代EGFR-TKI治疗。数据显示，研究总体客观缓解率（ORR）为43.6%；而在EGFR突变亚组中，患者接受芦康沙妥珠单抗单药治疗的ORR高达60%，同时伴随显著的生存获益——中位缓解持续时间（DoR）达8.7个月，中位无进展生存期（PFS）长达11.5个月，中位总生存期（OS）达22.7个月，12个月和18个月OS率分别高达81.0%和76.2%。这表明，芦康沙妥珠单抗单药治疗对EGFR突变患者的获益更为显著。此次欧洲肿瘤内科学会（ESMO）大会将进一步更新OptiTROP-Lung04研究的最新数据，让我们拭目以待！乳腺癌领域：TROP2-ADC中国Ⅲ期登顶 PART 2 （四）摘要号：LBA23（芦康沙妥珠单抗-乳腺癌）讲者：樊英 | 中国医学科学院肿瘤医院。意义：国产TROP2-ADC首次在欧洲主舞台发布阳性Ⅲ期结果，填补中国ADC药物在国际乳癌一线空白。研究名称（英文/中文） Sacituzumab tirumotecan (sac-TMT) vs investigator's choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): results from the randomized, multi-center phase 3 OptiTROP-Breast02 study[芦康沙妥珠单抗（sac-TMT）对比研究者选择的化疗（ICC）治疗既往经治局部晚期或转移性HR阳性/HER2阴性（HR+/HER2-）乳腺癌（BC）：随机、多中心III期OptiTROP-Breast02研究结果]。药物简介芦康沙妥珠单抗除了治疗肺癌外，还可用于乳腺癌的治疗。2025年5月16日，该药被中国国家药监局药品审评中心（CDE）纳入优先评审，用于成人既往接受过内分泌治疗，且在晚期或转移性阶段接受过其他系统治疗的不可切除局部晚期或转移性激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）乳腺癌的治疗。好消息是，目前该药已启动临床招募。阅读原文了解详情：【ADC药物】新一代靶向药SKB264（芦康沙妥珠单抗）终于启动临床！现正急招乳腺癌患者！ ESMO前沿数据抢先看早在2023年ESMO大会上，曾公布过芦康沙妥珠单抗治疗HR+/HER2阴性转移性乳腺癌（mBC）的I/II期临床数据（NCT04152499）。结果显示：客观缓解率（ORR）为36.8%，疾病控制率（DCR）高达89.5%；中位缓解持续时间（DoR）为7.4个月（4.2-14.9+个月），6个月DoR率80%；中位无进展生存期（PFS）为11.1个月（95%CI：5.4，13.1），6个月PFS率高达61.2%。（五）摘要号：LBA25（库莫西利）讲者：宋尔卫 | 中山大学孙逸仙纪念医院。意义：若数据优于现有CDK4/6抑制剂，可能为内分泌治疗提供新策略。研究名称（英文/中文） Culmerciclib Plus Fulvestrant as First-Line Treatment for HR+/HER2- Advanced Breast Cancer: A Phase 3 Trial (CULMINATE-2)[Culmerciclib（库莫西利）联合氟维司群一线治疗 HR+/HER2-晚期乳腺癌：一项III期试验 (CULMINATE-2)]。药物简介库莫西利胶囊（Culmerciclib，TQB3616）是正大天晴研发的一款新型CDK2/4/6抑制剂，对CDK2、CDK4、CDK6激酶均有抑制作用，尤其对CDK4激酶抑制能力较强，有望解决当前CDK4/6抑制剂的耐药难题。 2025年7月9日，该药的第2项适应症上市申请获受理，新增适应症为联合氟维司群注射液，用于HR+/HER2-局部晚期或转移性乳腺癌患者的初始内分泌治疗。 ESMO前沿数据抢先看据悉，库莫西利联合氟维司群一线治疗HR+/HER2-乳腺癌的III期临床研究（TQB3616-III-02），已完成独立数据监测委员会（IDMC）规定的方案中期分析，判定有效性达到预设的优效性阈值。联合治疗总体安全且耐受性良好。胃癌领域：PD-1/CTLA-4双抗再下一城 PART 3 （六）摘要号：LBA78（安尼妥单抗）讲者：徐建明 | 中国人民解放军总医院。研究名称（英文/中文） KN026 in combination with chemotherapy for previously treated HER2 positive gastric or gastroesophageal carcinomas (GC/GEJC): Interim analysis of KC-WISE [KN026联合化疗治疗既往接受过治疗的HER2阳性胃癌或胃食管交界癌（GC/GEJC）：KC-WISE研究的中期分析]。药物简介安尼妥单抗（KN026）是康宁杰瑞自主研发的新型HER2靶向双特异性抗体，核心优势在于可同时结合HER2的两个非重叠表位，实现对HER2信号的强效阻断。2025年9月11日，其新药上市申请获中国国家药品监督管理局正式受理，适应症为与化疗联合，用于至少接受过一种含曲妥珠单抗联合化疗的系统性治疗失败后、HER2阳性的局部晚期、复发或转移性胃/胃食管结合部腺癌。它也成为了首个提交上市申请的国产HER2双抗，填补了国产HER2双抗在胃癌治疗赛道的上市申请空白。好消息是，目前该药正在针对乳腺癌等实体瘤开展临床招募。阅读原文了解详情：【HER2药物】新一代靶向药KN026联合HB1801终于启动临床，现急招乳腺癌患者！ ESMO前沿数据抢先看 2024年，国际期刊《肿瘤学年鉴》公布了安尼妥单抗（KN026）联合化疗治疗无法切除或转移性HER2阳性胃癌/胃食管结合部癌（GC/GEJC）临床研究（NCT05427383）的振奋数据。结果显示：经独立评审委员会（IRC）确认，客观缓解率（ORR）为40.0%（95%CI：23.9-57.9）；疾病控制率（DCR）达80.0%（95%CI：63.1-91.6），其中14例达部分缓解（PR）、8例达病情稳定（SD）。中位无进展生存期（PFS）为8.6个月（95%CI：3.78-13.11），中位总生存期（OS）为13.2个月（95%CI：10.58-20.53）。（七）摘要号：LBA83（RC118）讲者：余一祎 | 复旦大学附属中山医院。意义：CLDN18.2 作为胃癌治疗领域的新兴靶点，其与免疫治疗的联合策略有望有效克服临床耐药难题。研究名称（英文/中文） RC118 (CLDN18.2-targeted ADC) combined with PD-1 blockade or RC148 (PD-1/VEGF bispecific antibody) for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (la/m G/GEJA)[RC118（CLDN18.2靶向ADC）联合PD-1抑制剂或RC148（PD-1/VEGF双特异性抗体）治疗局部晚期/转移性胃癌/胃食管交界腺癌（la/m G/GEJA）]。药物简介 RC118是一款靶向Claudin18.2的ADC药物，已用于治疗局部晚期不可切除或转移性恶性实体瘤。 ESMO前沿数据抢先看此次ESMO大会将公布RC118联合PD-1抑制剂/双抗，用于局部晚期或转移性胃癌/胃食管交界腺癌，探索CLDN18.2高表达人群的疗效。尿路上皮癌领域：国产HER2-ADC冲击一线 PART 4 （八）摘要号：LBA7（维迪西妥单抗）讲者：盛锡楠 | 北京大学肿瘤医院。意义：HER2低表达（IHC1+）患者首次在UC治疗中显示临床获益，可能扩大HER2靶向治疗的适用人群。若阳性，将成为全球首个HER2-ADC联合免疫一线治疗尿路上皮癌的Ⅲ期证据。研究名称（英文/中文） Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression（维迪西妥单抗联合特瑞普利单抗对比化疗应用于HER2表达局部晚期或转移性尿路上皮癌一线治疗）。药物简介维迪西妥单抗（Disitamab Vedotin，爱地希®）是由荣昌制药研发的一款靶向HER2的ADC药物，同时也是我国首个治疗尿路上皮癌且靶向HER2的ADC药物。由新型人源化抗HER2抗体、微管抑制剂MMAE、可裂解连接子组成。2021年6月9日，获中国国家药监局（NMPA）批准，作为二线治疗用于既往接受过含Pt化疗的局部晚期或转移性HER2阳性尿路上皮癌、至少两种全身化疗方案的HER2阳性局部晚期或转移性胃癌的治疗。 ESMO前沿数据抢先看《临床肿瘤学杂志》曾报告过维迪西妥单抗Ⅱ期临床研究的振奋数据。该研究共入组107例HER2阳性、且至少接受过一线全身化疗后病情出现进展的局部晚期或转移性尿路上皮（UC）患者。结果显示：总体缓解率（ORR）高达50.5%（95%CI，40.6~60.3）。中位总生存期（OS）长达14.2个月（95%CI，9.7~18.8），中位无进展生存期（PFS）为5.9个月（95%CI，4.3~7.2），中位缓解持续时间为7.3个月（95%CI，5.7~10.8）。宫颈癌领域 PART 5 （九）摘要号：LBA38（卡瑞利珠单抗）讲者：吴小华 | 复旦大学附属肿瘤医院。研究名称（英文/中文） Phase 3 study of camrelizumab plus famitinib versus platinum-based chemotherapy as first-line therapy for recurrent or metastatic cervical cancer（卡瑞利珠单抗联合法米替尼对比铂类化疗一线治疗复发性或转移性宫颈癌的III期研究）。药物简介卡瑞利珠单抗（camrelizumab，艾瑞卡®）是恒瑞医药自主研发的一款人源化 PD-1 单克隆抗体2025年5月21日，该药第十个适应症获中国药监局批准，与“苹果酸法米替尼”联合，用于既往接受含铂化疗失败的复发或转移性宫颈癌的治疗！ ESMO前沿数据抢先看全球知名期刊《柳叶刀》曾发表过卡瑞利珠单抗治疗局部晚期宫颈癌Ⅱ期NACI研究（NCT04516616）的振奋数据。结果显示：客观缓解率（ORR）高达98%（95%CI：92-100），其中19%（16例）达到完全缓解（CR），79%（67例）实现部分缓解（PR）。肝癌领域 PART 6 （十）摘要号：LBA52（诺法利单抗）讲者：任正刚 | 复旦大学附属中山医院。研究名称（英文/中文） Nofazinlimab combined with lenvatinib versus placebo plus lenvatinib as first-line therapy for unresectable or metastatic hepatocellular carcinoma: a phase 3, randomized, double-blind, multiregional study (CS1003-305) [Nofazinlimab联合仑伐替尼对比安慰剂联合仑伐替尼对比作为不可切除或转移性肝细胞癌一线治疗：一项III期、随机、双盲、多中心研究（CS1003-305）]。药物简介诺法利单抗（Nofazinlimab）是基石药业研发的一款靶向人类程序性细胞死亡蛋白1（PD-1）的人源化重组IgG4单克隆抗体，其核心作用机制为阻断PD-1与其配体PD-L1、PD-L2的相互作用。 2020年7月，该药获美国食品药品监督管理局（FDA）授予孤儿药资格（ODD），适应症为治疗肝细胞癌（HCC）患者。目前，nofazinlimab正针对实体瘤领域开发相关治疗方案。 ESMO前沿数据抢先看 CS1003-305是一项全球多中心、双盲、随机3期注册临床试验，核心目的是评估诺法齐利单抗（Nofazinlimab）联合仑伐替尼，对比安慰剂联合仑伐替尼治疗不可切除晚期肝细胞癌患者的疗效与安全性。2022年3月，该研究已顺利达成预定的患者入组目标。此前，在2022年美国临床肿瘤学会（ASCO）年会上，曾披露过CS1003-102研究的1b期数据。针对中国不可切除肝细胞癌患者的分析显示，诺法齐利单抗联合仑伐替尼作为一线治疗具有良好疗效与可控安全性：客观缓解率（ORR）达45.0%；截至数据截止日期，中位缓解持续时间（DoR）尚未达到（范围：4.2至18.7+个月），中位无进展生存期（PFS）为10.4个月。小编寄语过去十年，癌症治疗领域取得了长足进步，显著延长了晚期癌症患者的生存期。在2025年ESMO大会上，中国研究更是呈现出三大鲜明特点：一是核药与ADC（抗体药物偶联物）成为新的研发焦点；二是免疫联合治疗向新辅助、辅助治疗阶段延伸；三是生物标志物驱动的精准治疗实现快速发展。这些研究不仅充分展现了中国创新药的研发实力，更有望推动全球肿瘤治疗指南的更新迭代。随着中国药企在国际多中心试验（MRCT）中参与度的持续提升，未来或将有更多中国原研药物改写全球癌症临床实践。参考资料 [1]Xiong A,et al.Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China[J]. The Lancet, 2025, 405(10481): 839-849. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02722-3/abstract [2]Zhang H,et al.Ensartinib as a neoadjuvant therapy for stage IIIA non-small cell lung cancer patients with EML4-ALK fusion: a case report and literature review. Front Oncol. 2025 Feb 25;15:1474997. https://pmc.ncbi.nlm.nih.gov/articles/PMC11893432/ 本文为全球肿瘤医生网原创，未经授权严禁转载

临床3期抗体药物偶联物免疫疗法引进/卖出临床成功

2025-09-25

·PRNewswire

Judy Wang, MD is Lead Author of Manuscript Detailing Investigational Treatment to Improve Immunotherapy Outcomes for Patients with Advanced Cancers

FORT MYERS, Fla., Sept. 25, 2025 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) Associate Director of Drug Development Judy Wang, MD is lead author of a phase 1/2 study manuscript detailing an investigational treatment regimen aimed at boosting patient response to immunotherapy by supporting the gut microbiome. The trial results, "Phase 1/2, open-label study of oral bacterial supplementation (EDP1503) plus pembrolizumab in participants with advanced or metastatic microsatellite-stable colorectal cancer, triple-negative breast cancer, and checkpoint inhibitor–relapsed tumors" are published in the August 2025 issue of Investigational New Drugs. Continue Reading Dr. Judy Wang of Florida Cancer Specialists & Research Institute leads study on cancer immunotherapy. Dr. Wang noted, "While immune checkpoint inhibitors have helped many people with cancer, some patients don't respond or may stop responding over time. One reason this can happen is that the gut microbiome and other factors can affect how well the treatment works." The study, conducted at sites in the U.S. and Canada between 2018 and 2021, investigated the safety, tolerability, and efficacy of combining an oral bacterial supplement (EDP1503) alone and in combination with pembrolizumab (KEYTRUDA®) in patients with advanced MSS colorectal cancer, triple negative breast cancer, and checkpoint inhibitor-relapsed tumors. The authors concluded: "EDP1503 was considered generally safe and well tolerated as monotherapy and in combination with pembrolizumab, and it demonstrated clinical benefit as a combination regimen in a subset of subjects. Emerging anti-tumor activity warrants further large prospective studies." Additionally, the authors noted: "Comparing studies of live bacterial biotherapeutics can be challenging because of the variability of bacterial strains tested, treatment dosage, and treatment duration… Regardless, ongoing studies are evaluating oral bacterial supplementation to improve immunotherapy response." "Every clinical trial deepens our understanding of cancer and paves the way for better treatments, improved patient care, and brighter outcomes for patients worldwide," said Manish R. Patel, MD, FCS medical director of drug development. This study was made available through a partnership with Sarah Cannon Research Institute, one of the world's leading clinical research organizations that helps bring innovative treatment options to FCS patients. FCS provides ongoing access to more than 150 clinical trials within 29 FCS clinics and three early-phase Drug Development Units (DDUs) located in Sarasota and Central Florida. In recent years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with FCS participation, prior to approval, and many of these therapies began as Phase 1 or first-in-human clinical trials at FCS DDUs. View the abstract: About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program. FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. In fact, before receiving FDA approval, the majority of new cancer drugs in the U.S. were first made available to patients through participation in clinical trials at FCS. Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes. SOURCE Florida Cancer Specialists & Research Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法临床研究

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
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

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
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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临床结果

适应症

分期

评价

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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


NCT02220894 (KEYNOTE-042, FDA_CDER) 人工标引	临床3期	PD-L1阳性肺癌一线	1,873	Pembrolizumab 200 mg every 3 weeks (TPS ≥1%)	淵齋鬱遞積齋壓鏇簾願(艱醖蓋蓋淵遞廠選醖襯) = 艱鑰壓網選鹹鑰鏇艱鹽鬱廠築顧襯製艱觸遞鏇 (壓製鹹網繭窪憲選鑰襯, 13.9 ~ 19.7) 更多	-	2025-09-19
				Chemotherapy (TPS ≥1%)	淵齋鬱遞積齋壓鏇簾願(艱醖蓋蓋淵遞廠選醖襯) = 醖簾願遞顧選獵蓋襯壓鬱廠築顧襯製艱觸遞鏇 (壓製鹹網繭窪憲選鑰襯, 11.3 ~ 13.3) 更多
NCT02362594 (KEYNOTE-054, FDA_CDER) 人工标引	临床3期	黑色素瘤辅助	1,019	Pembrolizumab 200 mg every 3 weeks	獵淵製鑰顧鏇鏇願鹹鏇(繭蓋壓齋獵醖願襯顧鑰) = 獵醖獵顧鑰鬱範醖鬱繭窪糧範獵衊製築廠醖餘 (糧夢廠獵獵顧鏇糧餘鏇 ) 更多	积极	2025-09-19
				Placebo	獵淵製鑰顧鏇鏇願鹹鏇(繭蓋壓齋獵醖願襯顧鑰) = 網觸襯顧壓觸獵淵鹽窪窪糧範獵衊製築廠醖餘 (糧夢廠獵獵顧鏇糧餘鏇 ) 更多
NCT04224740 (HERCULES, Pubmed \| JAMA Oncol)	临床2期	阴茎肿瘤一线	33	Pembrolizumab plus platinum-based chemotherapy	壓糧憲築艱繭積艱獵襯(願顧襯網繭淵鑰鑰壓淵) = 簾範壓繭觸蓋餘獵窪繭憲簾艱簾蓋衊窪鬱鑰簾 (憲醖鏇蓋構襯鹹蓋鏇艱, 22.9 ~ 57.9) 更多	积极	2025-09-18
NCT04383743 (CTgov)	临床2期	非肌层浸润性膀胱尿路上皮癌 \| 肌层浸润性膀胱癌	17	Radical Cystectomy+Doxorubicin+cisplatin+Pembrolizumab+Vinblastine Sulfate+Methotrexate	廠夢製範製網夢鹹窪艱 = 網壓艱構齋蓋艱遞蓋積顧窪積鏇構範積齋夢糧 (積顧簾鬱廠繭醖選築齋, 範構鏇顧襯鹽鹽網獵選 ~ 窪繭鏇鏇獵憲製製繭鹹) 更多	-	2025-09-18
NCT05036681 (CTgov)	临床2期	转移性肿瘤 \| 转移性子宫内膜恶性肿瘤	9	Futibatinib+Pembrolizumab	醖築願鏇範觸顧顧襯壓 = 衊構獵觸繭鬱範廠蓋鑰憲構鏇繭遞鑰製鏇齋遞 (築積襯鹹艱鑰窪憲糧鏇, 廠鏇繭鑰壓齋範願膚艱 ~ 範艱蓋鑰餘製廠選衊醖) 更多	-	2025-09-17
NCT03307759 (SABRseq, CTgov)	临床1期	转移性非小细胞肺癌	13	Radiotherapy (SABR)+Pembrolizumab (SABR Plus Pembrolizumab)	遞繭夢網餘餘範艱範醖 = 鹹顧膚製鏇積廠選壓醖廠簾築鬱範齋鹹餘糧網 (顧醖繭構鏇憲鑰糧構鏇, 積淵夢鬱積餘窪觸廠衊 ~ 齋願製構獵遞膚衊觸衊) 更多	-	2025-09-15
				Radiotherapy (SABR)+Pembrolizumab (Pembrolizumab Plus SABR)	遞繭夢網餘餘範艱範醖 = 夢鹹構齋範餘糧範夢範廠簾築鬱範齋鹹餘糧網 (顧醖繭構鏇憲鑰糧構鏇, 遞築壓簾範膚構襯蓋選 ~ 膚醖製餘壓繭糧淵遞繭) 更多
NCT03740165 (MK-7339-001 \| KEYLYNK-001 \| GOG-3036 \| ENGOT-ov43, CTgov)	临床3期	原发性腹膜癌 \| BRCA 突变卵巢癌 \| 铂类耐药性原发性腹膜癌 ... 更多	1,367	Olaparib+Carboplatin+Paclitaxel+Docetaxel+Pembrolizumab+Bevacizumab (Carboplatin + Paclitaxel + Pembrolizumab + Olaparib)	遞廠鹹範製齋夢獵鑰壓(觸壓艱鑰鹹鏇製齋鹽願) = 鏇顧積夢衊膚製製顧蓋簾糧蓋餘餘蓋齋積遞夢 (繭襯構蓋鹹築窪餘襯壓, 獵鏇壓夢顧網繭窪顧衊 ~ 壓憲壓繭觸餘蓋構壓築) 更多	-	2025-09-12
				Placebo for olaparib+Carboplatin+Paclitaxel+Docetaxel+Pembrolizumab+Bevacizumab (Carboplatin + Paclitaxel + Pembrolizumab)	遞廠鹹範製齋夢獵鑰壓(觸壓艱鑰鹹鏇製齋鹽願) = 蓋憲醖壓鬱襯淵壓觸餘簾糧蓋餘餘蓋齋積遞夢 (繭襯構蓋鹹築窪餘襯壓, 構餘淵蓋繭窪網憲蓋製 ~ 繭積醖遞獵繭壓鏇鹽壓) 更多
WCLC2025	N/A	非小细胞肺癌一线	414	Pembrolizumabpembrolizumab (Weight-based pembrolizumab dosing)	淵糧觸鑰艱顧觸範鏇膚(壓襯積糧餘淵顧憲簾齋): P-Value = 0.056 更多	积极	2025-09-09
				Pembrolizumabpembrolizumab (Standard fixed dose pembrolizumab)
WCLC2025	临床2/3期	恶性胸膜间皮瘤	440	Chemotherapy + Pembrolizumab	衊餘窪構膚糧製觸積淵(構鏇鹽鏇餘膚鏇築鹽觸): HR = 0.85 (95.0% CI, 0.67 ~ 1.08) 更多	积极	2025-09-09
				Chemotherapy
NCT03347617 (CTIM-33, CTgov)	临床2期	多形性胶质母细胞瘤	52	Laboratory Biomarker Analysis+Ferumoxytol+Pembrolizumab	簾憲獵構鏇窪壓觸積製 = 遞鹽窪窪壓選艱糧襯築鹹獵廠觸簾鑰遞積夢顧 (繭衊選醖鹽繭淵選繭壓, 艱構壓鑰鏇鏇窪衊壓遞 ~ 醖鬱積選膚願網齋窪網) 更多	-	2025-09-09