帕博利珠单抗(Pembrolizumab) - 药物靶点：PD-1_在研适应症：输卵管癌，非肌层浸润性膀胱肿瘤，卵巢上皮癌_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+ [12]

在研适应症

输卵管癌非肌层浸润性膀胱肿瘤卵巢上皮癌+ [321]

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+ [128]

原研机构

Merck & Co., Inc.

在研机构

Merck Sharp & Dohme BVMSD KK (Tokyo)

默沙东研发（中国）有限公司

+ [18]

非在研机构

Turnstone Biologics Corp.Merck Sharp & Dohme (Ireland) Ltd.

Eisai GmbH

+ [1]

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

特殊审评加速批准 (美国)、孤儿药 (美国)、优先药物（PRIME） (欧盟)、孤儿药 (日本)、孤儿药 (澳大利亚)、突破性疗法 (中国)、优先审评 (澳大利亚)、优先审评 (美国)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国)

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结构/序列

Sequence Code 93660H

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Sequence Code 93670L

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关联

2,775

项与帕博利珠单抗相关的临床试验

NCT06093425

/ Not yet recruiting临床3期

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating Combination of TST001, Pembrolizumab and Chemotherapy as First-Line Treatment in Subjects With Claudin18.2 Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma

Gastric/GEJ adenocarcinomas are aggressive tumors with a high probability of death. Current treatment guidelines include two-drug cytotoxic chemotherapy with a fluoropyrimidine (mFOLFOX6: capecitabine or fluorouracil) and a platinum-based agent (CapOx: oxaliplatin or cisplatin). In addition, the FDA has approved nivolumab, a PD-1 checkpoint inhibitor, in combination with chemotherapy as first line treatment for advanced or metastatic gastric/GEJ cancer. TST001 is a recombinant humanized monoclonal antibody against Claudin 18.2 (a tumor marker found in gastric/GEJ cancer. In this study, the combination therapy of chemotherapy or chemotherapy and pembrolizumab with and without TST001 could provide additional benefits to the management of these tumors.

开始日期2027-06-30

申办/合作机构

創勝醫藥集團有限公司

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

NCT07843550

/ Not yet recruiting临床1/2期

A Phase 1/2 Trial Of Larotrectinib And Pembrolizumab In Patients With Solid Tumors Previously Treated With Immune Checkpoint Inhibitor Monotherapy

This is a single-center, open-label Phase 1/2 trial evaluating the safety and efficacy of the combination of larotrectinib and pembrolizumab in patients with advanced/metastatic lung adenocarcinoma or melanoma.

开始日期2027-03-01

申办/合作机构

M.D. Anderson International España SA

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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11,022

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: Wang, Ting ; Chen, Jinyun ; 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·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 ; Letendre, Caroline ; Lepage, Stéphanie ; 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.

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.

20,528

项与帕博利珠单抗相关的新闻（医药）

2026-10-31

·今日头条

肿瘤疫苗5年后普及？一针22万美元，普通人打得起吗？

10月28日，在2026中国医药决策者峰会上，广州一家生物医药公司的创始人说了句让人心头一震的话：再过五六年，mRNA肿瘤疫苗就能普遍用在癌症治疗上了。这话传开之后，网上炸开了锅。有人激动得睡不着觉，觉得癌症这回真要被治服了；也有人犯嘀咕：这么金贵的东西，咱普通工薪族掏得起这个钱吗？咱先把丑话说在前头。这疫苗不是防癌针，别以为身体健康去医院挨一针，就能一辈子跟癌症绝缘了。它是给已经得了癌症的病人用的，眼下最拿得出手的成绩，是帮动完手术的黑色素瘤患者防止复发。海外的关键三期试验，研究的正是这批切除了病灶的高危病人。疫苗配上现有的免疫药物一起打，目的就一个：别让癌细胞卷土重来。想让它包打天下？还早着呢。这药到底灵不灵？今年8月，莫德纳和默克两家公司给出了答案。1137名高危黑色素瘤患者参加的三期临床研究，复发或者死亡的风险硬生生降了42%。再看两年的无复发生存率，用疫苗的那组是82.2%，没用的那组只有70.0%，实打实差了12.2个百分点。这个成绩，在抗癌圈里算是相当能打了。不过话得说全乎。同是今年8月，德国的BioNTech却宣布砍掉了一项二期试验，对象是结直肠癌术后病人。专家评估的结论很直白：接着做下去，也改变不了疗效不行的结局。一边是大获全胜，一边是半路折戟，这说明了啥？癌跟癌不一样。黑色素瘤和结直肠癌的免疫环境差着十万八千里，换个病种，方子可能就不管用了。指望一招鲜吃遍天？医学上没这好事。接下来聊聊老百姓最关心的钱袋子。临床试验里，光搭配用的帕博利珠单抗就不便宜，每6周打一次，最多打9次，光这一样在美国标价就超过22.5万美元。注意啊，这还只是“配菜”的钱，疫苗本身、住院、检查，哪样不得花钱？疫苗凭啥卖这么贵？说白了，就是一个萝卜一个坑，一人一份量身定做。每个人的肿瘤突变都不一样，得先取病人的组织样本，做测序比对，再造出对应的mRNA分子。这分子好比一张临时的小纸条，上面写着指令，让身体里的细胞照着做，生成特定的蛋白质标记，好教免疫系统认清谁是敌人。工序精细到这个份上，成本能低吗？今年医学期刊上的综述说，从取样到交货，通常得等6到8周。病人刚下手术台，正是要抢时间的时候，这一等，说不定就把最佳治疗窗口给等没了。老话说得好，薄利多销。传统药厂靠流水线批量生产，量一大成本就摊薄了。可这疫苗呢？订单越多，排产越乱，质检压力越大，规模效应这条路基本走不通。那医保能帮着分担点吗？去年国家医保局和国家卫健委倒是联合发了文件，16项措施给创新药铺路，从研发到支付都照顾到了。可政策是政策，钱是钱。按照2025年版目录的规矩，进了商保创新药目录的药，基本医保不管，能报多少全看商业保险合同怎么写的。药企定价也是两头为难：卖贵了，医保基金和老百姓都吃不消；卖便宜了，研发投入收不回来，往后谁还敢做药？眼下疫苗还没上市，价格八字没一撇，现在谈报销比例，纯属画饼充饥。咱们国内的企业也没闲着。北京立康生命科技的LK101疫苗，2023年就拿到了临床许可；惠正奇的首条管线，计划2027年上半年才进人体试验。这行当周期长、烧钱快，一些初创公司为了活下去，把自家的看家本领拿出来卖——人工智能筛选工具、LNP纳米递送技术，都授权给了同行。这LNP是个啥？打个比方，就是给娇贵的药物指令雇了个保镖，一路护送到细胞里去。可卖技术换来的钱能不能长久，还真不好说。实验室里算法挑位点的准确率有六到七成，听着挺唬人，可试管里灵不等于人身上灵，最终还得看人体试验这份答卷。归根结底，这疫苗想真正飞入寻常百姓家，得闯三关：疗效要过硬，交货要够快，价格要够亲民。哪一关过不去，都是竹篮打水一场空。政策在搭台，科研在拼命，可说一千道一万，医学创新的落脚点，永远是病床上那个眼巴巴等着救命的人。五六年后，咱能不能打上这针、打不打得起？曙光是真看见了，坎儿也真摆在那儿。且走着瞧吧。

疫苗信使RNA临床3期

2026-10-31

·今日头条

ESMO 2026肿瘤大会三大重要进展 2026年欧洲肿瘤内科学会大会上，Moderna、Roche和Amgen公布了备受关注的癌症治疗临床数据： 01｜Moderna × Merck：个性化癌症疫苗取得III期成功 Moderna与Merck共同开发的个性化mRNA癌症疫苗，在黑色素瘤III期

ESMO 2026肿瘤大会三大重要进展 2026年欧洲肿瘤内科学会大会上，Moderna、Roche和Amgen公布了备受关注的癌症治疗临床数据： 01｜Moderna × Merck：个性化癌症疫苗取得III期成功 Moderna与Merck共同开发的个性化mRNA癌症疫苗，在黑色素瘤III期临床试验中取得积极结果。与单独使用Keytruda相比，联合癌症疫苗治疗： * 复发或死亡的相对风险降低42% * 24个月无复发生存率达到82.2%，对照组为70.0% 这意味着，个性化mRNA癌症疫苗正在从早期临床探索走向更大规模的临床验证。 02｜Roche：KRAS靶向治疗取得重要突破 KRAS曾长期被视为难以成药的癌症靶点。此次Roche公布的KRAS G12C抑制剂 divarasib III期临床数据引发关注。与现有KRAS G12C抑制剂Krazati和Lumakras相比： * 疾病进展或死亡风险降低42% * 死亡风险降低44% * 中位总生存期约18个月，对照组约12个月这一结果显示，Roche有机会在已有竞争产品的KRAS靶向治疗市场中取得优势。 03｜Amgen：小细胞肺癌治疗数据获得起立鼓掌 Amgen的双特异性T细胞衔接药物 Imdelltra（tarlatamab），在广泛期小细胞肺癌治疗中取得引人注目的成果。研究将Imdelltra联合AstraZeneca的Imfinzi，用于初始治疗后的维持治疗。与单用Imfinzi相比： * 死亡风险降低58% * 中位总生存期达到21.1个月 * 对照组中位总生存期为12.7个月对于治疗选择有限、预后较差的小细胞肺癌而言，这是一项非常重要的临床进展。 💡 行业观察这次ESMO大会反映出肿瘤治疗领域的三个重要趋势： ① 个性化治疗正在走向临床验证 mRNA癌症疫苗的成功，不仅取决于临床疗效，也取决于能否建立可规模化、可负担的生产体系。 ② 靶向治疗竞争进入疗效升级阶段对于KRAS等已有上市药物的靶点，新进入者需要通过更好的生存获益和安全性证明竞争优势。 ③ 创新药正在向更早治疗阶段拓展从后线治疗向维持治疗或一线治疗拓展，可能同时改变患者获益和药物市场空间。 #ESMO2026# #医药行业# #创新药# #癌症疫苗# #Moderna# #Roche# #Amgen# #肿瘤治疗# #生物医药# #医药行业观察#

临床3期疫苗信使RNA临床结果临床2期

2026-10-31

·ioncology

瞭望前瞻丨SABCS 2026会议首日（12月8日）重要内容速览！

点击蓝字，关注我们编者按第49届圣安东尼奥乳腺癌研讨会（SABCS 2026）将于当地时间2026年12月8-11日在美国得克萨斯州圣安东尼奥举行。作为乳腺癌领域的顶级盛会，SABCS聚焦乳腺癌生物学、病因、预防、诊断及治疗前沿，促进临床、转化与基础研究的深度融合，为全球科研人员提供交流协作与专业成长的平台。日前，SABCS官网已披露本届大会摘要标题。肿瘤瞭望特整理会议首日（12月8日）精彩内容，涵盖研讨会、职业发展论坛、特别会议、教育专场及Mini口头报告等，并将Mini口头报告（Rapid Fire 1和Rapid Fire 2）摘要题目进行整理，以便读者快速了解会议动态，敬请关注后续详细报道！四场研讨会：1、研讨会3：真实世界临床试验设计基础；2、研讨会4：临床AI工具的实践应用；3、研讨会1：超越动物模型-乳腺癌研究的新型替代方法；4、研讨会2：基于人工智能的病理学进展。四场职业发展论坛：1、肿瘤学职业的未来保障：应对新规则的崭新指南；2、迈向成功；3、迈向成功：STEM领域女性的抱负与可持续职业发展；4、职业发展：论文发表入门课。四场特别会议：1、特别会议1：将生活方式医学融入乳腺癌诊疗-科学、策略与技能；2、特别会议2：利用免疫系统预防乳腺癌-新兴疫苗；3、特别会议3：乳腺癌的全球视角——从人群风险到精准诊疗；4、特别会议9：现代减肥药物与乳腺癌。六场教育专场：1、教育专场1：转移性乳腺癌中的生物标志物指导的精准治疗；2、教育专场2：新疗法=新毒性；3、教育专场3：遗传风险与筛查。4、教育专场4：器官特异性转移与全身免疫之间的相互作用；5、教育专场5：浸润性乳腺癌手术范式的选择性消除；6、教育专场6：靶向乳腺癌表观基因组。两场Mini口头报告：1、Rapid Fire 1；2、Rapid Fire 2。专场：Rapid Fire 1 时间：12月8日 4:30 PM-5:30 PM CST 地点：Stars at Night 1-2 摘要号：RF1-1 Zanidatamab as a component of neoadjuvant therapy in HER2+ breast cancer: results from the I-SPY2.2 trial Zanidatamab是HER2阳性乳腺癌新辅助治疗的组成部分：I-SPY2.2研究结果讲者：Anthony D Elias, University of Colorado, Aurora, CO 摘要号：RF1-2 Event-free survival from the randomized phase 2 neohip trial evaluating neoadjuvant taxane, her2-targeted therapy, +/- pembrolizumab in early-stage her2-positive breast cancer 评估早期HER2阳性乳腺癌新辅助紫杉烷类、HER2靶向治疗联合/不联合帕博利珠单抗的随机2期neoHIP试验的无事件生存期讲者：Heather L McArthur, UTSW, Dallas, TX 摘要号：RF1-3 Circulating tumor DNA (ctDNA) dynamics and pathological complete response (pCR) in high-risk HER2+ early breast cancer (eBC) treated with neoadjuvant trastuzumab deruxtecan followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP): A DESTINY-Breast11 (DB-11) analysis 高危HER2阳性早期乳腺癌（eBC）接受新辅助T-DXd序贯紫杉醇+曲妥珠单抗+帕妥珠单抗（T-DXd-THP）对比剂量密集多柔比星+环磷酰胺序贯THP（ddAC-THP）治疗中的循环肿瘤DNA（ctDNA）动态变化与病理完全缓解（pCR）：DESTINY-Breast11 (DB-11) 分析讲者：Shanu Modi, Memorial Sloan Kettering Cancer Center, New York, NY 摘要号：RF1-4 Optimising the duration of trastuzumab in early-stage HER2-positive breast cancer – an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis 优化早期HER2阳性乳腺癌中曲妥珠单抗的治疗持续时间——早期乳腺癌试验协作组（EBCTCG）荟萃分析讲者：Rosie Bradley, University of Oxford, Oxford, United Kingdom 摘要号：RF1-5 A randomized trial of trastuzumab deruxtecan and biology-driven selection of neoadjuvant treatment for HER2-positive breast cancer: First analysis of the ARIADNE trial T-DXd及基于生物学驱动的新辅助治疗选择在HER2阳性乳腺癌中的随机试验：ARIADNE研究的首次分析讲者：Theodoros Foukakis, Karolinska Institute, Stockholm, Sweden 摘要号：RF1-6 Patina (aft-38): palbociclib benefit across key prespecified subgroups in hr+/her2-positive advanced breast cancer – final protocol-specified pfs analysis PATINA (AFT-38)：哌柏西利在HR+/HER2+晚期乳腺癌关键预设亚组中的获益——最终方案规定的无进展生存期（PFS）分析讲者：Otto Metzger, Dana-Farber Cancer Institute, Boston, MA 摘要号：RF1-7 The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab – Outcomes in Patients with HER2+ Metastatic Breast Cancer (MBC) (TBCRC 062) STOP-HER2研究：停止曲妥珠单抗治疗的2期研究——HER2阳性转移性乳腺癌（MBC）患者的结局（TBCRC 062）讲者：Heather A Parsons, Fred Hutchinson Cancer Center, Seattle, WA 专场：Rapid Fire 2 时间：5:30 PM–6:30 PM CST 地点：Stars at Night 1-2 摘要号：RF2-1 Updated Overall Survival (OS) Analysis from the Phase 3 ASCENT-07 Study of Sacituzumab Govitecan in Participants with HR+/HER2- Inoperable, Locally Advanced, or Metastatic Breast Cancer Post Endocrine Therapy 3期ASCENT-07研究更新总生存期（OS）分析：戈沙妥珠单抗用于内分泌治疗后HR+/HER2-不可手术、局部晚期或转移性乳腺癌患者讲者：Hope S Rugo, City of Hope Comprehensive Cancer Center, Duarte, CA 摘要号：RF2-2 Prognostic and predictive value of key immunohistochemistry (IHC) protein biomarker expression levels in the NATALEE trial of adjuvant ribociclib (RIB) and nonsteroidal aromatase inhibitor (NSAI) in hormone receptor-positive/human epidermal growth factor receptor 2−negative early breast cancer (HR+/HER2− EBC) NATALEE研究中关键免疫组化（IHC）蛋白生物标志物表达水平的预后与预测价值：辅助瑞波西利（RIB）联合非甾体芳香化酶抑制剂（NSAI）治疗激素受体阳性/人表皮生长因子受体2阴性早期乳腺癌（HR+/HER2− EBC）讲者：Michael Press, USC, Los Angeles, CA 摘要号：RF2-3 h&E-derived gene-expression multimodal multitask modeling predicts chemotherapy benefit, distant recurrence risk, and 21-gene recurrence score in tailorx 基于H&E染色衍生基因表达的多模态多任务模型预测TAILORx试验中的化疗获益、远处复发风险及21基因复发评分讲者：Joseph Sparano, Icahn School of Medicine at Mount Sinai, New York, CA 摘要号：RF2-4 Genomic Response-Guided Chemotherapy Omission After Neoadjuvant Ribociclib and Endocrine Therapy in High-Risk HR+/HER2− Early Breast Cancer: Updated Results from the Phase II SOLTI-UNICANCER RIBOLARIS Trial 高危HR+/HER2-早期乳腺癌新辅助瑞波西利联合内分泌治疗后基于基因组应答指导的化疗豁免：II期SOLTI-UNICANCER RIBOLARIS研究的更新结果讲者：Milana Arantza Bergamino Sirvén, Hospital Clinic de Barcelona// SOLTI// IDIBAPS, Barcelona, Spain 摘要号：RF2-5 Prospective Validation of Modified PEPI Following Neoadjuvant (Neoadj) Anastrozole (ANA): Five-Year (5y) Recurrence-free Survival (RFS) from Alliance A011106 (ALTERNATE) 新辅助阿那曲唑（ANA）治疗后改良PEPI的前瞻性验证：Alliance A011106（ALTERNATE）研究的5年无复发生存期（RFS）讲者：Cynthia X Ma, Washington University in St. Louis, Saint Louis, MO 摘要号：RF2-6 Cdk2 mediates RB-independent entry into S phase and is a therapeutic target in ER+/RB-deficient, CDK4/6 inhibitor-resistant breast cancer Cdk2介导rb非依赖性进入S期，是ER+/ RB缺陷、CDK4/6抑制剂耐药乳腺癌的治疗靶点讲者：Chang-Ching A Lin, UT Southwestern Medical Center, Dallas, TX 摘要号：RF2-7 Results from KEYNOTE-B49: a phase 3, randomized, double-blind study of pembrolizumab (vs placebo) plus chemotherapy in participants with HR+/HER2− locally recurrent inoperable or metastatic breast cancer KEYNOTE-B49研究结果：帕博利珠单抗（对比安慰剂）联合化疗治疗HR+/HER2-局部复发不可手术或转移性乳腺癌的3期、随机、双盲研究讲者：Peter Schmid, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

疫苗临床2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	L01FF02	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
输卵管癌	澳大利亚	Merck Sharp & Dohme (Australia) Pty Ltd.	2026-07-23
非肌层浸润性膀胱肿瘤	澳大利亚	Merck Sharp & Dohme (Australia) Pty Ltd.	2026-07-23
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	列支敦士登	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
局部晚期非鳞状非小细胞肺癌	申请上市	中国	默沙东研发（中国）有限公司	2026-10-27
局部晚期非鳞状非小细胞肺癌	申请上市	中国	Merck Sharp & Dohme Corp.	2026-10-27
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	日本	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	巴西	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	智利	Merck Sharp & Dohme LLC	2026-05-04

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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


NCT02617849 (Pubmed \| Oncoimmunology)	临床2期	黑色素瘤	30	Pembrolizumab and Carboplatin/ Paclitaxel	網壓醖廠網艱糧憲壓憲(願襯製製鬱觸糧範繭鹽) = 壓蓋齋願製遞簾鏇繭糧遞積鹹襯願築鹽鹹網夢 (範糧網願鹽選醖選餘鑰 ) 更多	不佳	2026-12-31
ACR2026	N/A	肾细胞癌	27,394	ICI (RA)	廠鹹壓範顧顧積鑰鏇願(膚範醖壓製艱鏇壓糧醖) = 鹹築鬱鏇簾醖蓋遞鑰鹹遞衊艱鏇壓壓網構選顧 (蓋齋鏇選觸築選蓋簾醖 ) 更多	积极	2026-11-06
				ICI (non-RA)	廠鹹壓範顧顧積鑰鏇願(膚範醖壓製艱鏇壓糧醖) = 簾構繭憲獵觸鬱願鬱壓遞衊艱鏇壓壓網構選顧 (蓋齋鏇選觸築選蓋簾醖 ) 更多
AASLD2026	临床2/3期	晚期胆道癌一线	3,000	Durvalumab + Gemcitabine + Cisplatin	醖醖鏇簾繭壓鬱壓淵繭(積鹹衊顧積鬱蓋鹽廠鑰): HR = 0.74 (95.0% CI, 0.63 ~ 0.87)	积极	2026-11-05
				Pembrolizumab + Gemcitabine + Cisplatin
AASLD2026	N/A	不可切除的肝内胆管癌 TP53 mutations	41	gemcitabine, cisplatin, and durvalumab (GCD) or gemcitabine, cisplatin, and pembrolizumab (GCP)	鏇積襯積鬱蓋構艱鏇鬱(醖憲鹽夢淵憲襯觸醖製) = 鹽夢積艱遞餘簾廠遞構淵鏇憲醖憲構壓積鏇衊 (簾壓願選鏇簾築衊鑰糧, 4.4 ~ 10.7) 更多	积极	2026-11-05
				gemcitabine, cisplatin, and durvalumab (GCD) or gemcitabine, cisplatin, and pembrolizumab (GCP) (TP53 wild-type ICC)	鏇積襯積鬱蓋構艱鏇鬱(齋遞鹹艱選夢網範糧製) = 願襯壓簾範製衊獵鏇窪鹹襯憲鏇膚範遞夢齋醖 (製網齋醖壓膚鬱衊積淵, 4.4 ~ 10.7) 更多
NCT03598608 (MK-4280-003, Pubmed \| Blood Neoplasia)	临床1/2期	难治性经典霍奇金淋巴瘤 PD-1	34	Favezelimab 800 mg plus Pembrolizumab 200 mg	壓廠壓積築鑰構壓鹽艱(齋遞鏇鏇壓醖鹽網願淵) = 1 of 21 participants experienced a dose-limiting toxicity (grade 4 autoimmune hepatitis) 構鬱範淵鬱廠鹽構糧膚 (積憲遞鏇憲獵鏇鬱襯鏇 ) 更多	积极	2026-11-01
NCT04165083 (KEYMAKER-U01 substudy 01B \| KEYMAKER-U01B \| MK-3475-01B, CTgov)	临床2期	PD-L1阳性非小细胞肺癌	100	MK-4830+Pembrolizumab (MK-4830 + Pembrolizumab)	網顧獵襯遞觸觸觸廠築 = 鏇衊簾獵衊獵願醖憲艱壓壓顧襯繭餘網窪獵範 (築醖醖簾糧選夢餘鹹憲, 壓遞餘餘襯鬱網餘糧廠 ~ 鏇艱範鬱壓衊淵糧廠鑰) 更多	-	2026-10-29
				MK-0482+Pembrolizumab (MK-0482 + Pembrolizumab)	網顧獵襯遞觸觸觸廠築 = 醖簾衊廠鏇選簾憲鬱壓壓壓顧襯繭餘網窪獵範 (築醖醖簾糧選夢餘鹹憲, 醖遞築夢鏇顧網觸簾顧 ~ 廠範糧醖遞鹽齋鑰衊艱) 更多
NCT04643379 (CTgov)	临床2期	转移性头颈部鳞状细胞癌 \| 复发性头颈部鳞状细胞癌	30	Peripheral blood draw+Olaparib+Carboplatin+Pembrolizumab	鹽積壓衊積醖鹹簾遞夢 = 顧製築廠夢淵壓鏇壓鹹選鑰衊鹽網衊簾壓衊夢 (夢鑰鬱築繭廠鏇構齋壓, 餘夢簾襯膚蓋壓鏇製網 ~ 夢衊獵廠鏇繭醖膚簾簾) 更多	-	2026-10-27
ESMO2026	N/A	三阴性乳腺癌新辅助	87	TEC (docetaxel 75 mg/m2, epirubicin 75 mg/m2, cyclophosphamide 500 mg/m2 every 21 days with pegfilgrastim support)	襯醖衊簾鑰壓願齋窪鹹(遞壓壓齋膚遞構壓築選) = 範繭遞壓艱顧製鑰糧鑰簾鏇鏇獵構夢窪積廠選 (構糧遞顧鏇範顧淵鑰願 ) 更多	积极	2026-10-23
				CT-IO (pembrolizumab plus the KEYNOTE-522 regimen)	襯醖衊簾鑰壓願齋窪鹹(遞壓壓齋膚遞構壓築選) = 壓鏇範憲醖範窪積淵願簾鏇鏇獵構夢窪積廠選 (構糧遞顧鏇範顧淵鑰願 ) 更多
ESMO2026	N/A	局部晚期宫颈癌	107	radical concurrent chemoradiotherapy (FIGO 2014 IB2-IIB node-positive)	襯餘艱廠築壓鬱窪鹹夢(製範醖觸網鏇構簾鏇遞) = 餘選窪壓積願鬱夢醖鬱製醖艱鏇淵獵鬱鹹製網 (齋製淵顧夢願繭選齋製 ) 更多	积极	2026-10-23
				radical concurrent chemoradiotherapy (FIGO 2014 III-IVA)	襯餘艱廠築壓鬱窪鹹夢(製範醖觸網鏇構簾鏇遞) = 遞簾鬱觸醖鑰範願觸壓製醖艱鏇淵獵鬱鹹製網 (齋製淵顧夢願繭選齋製 ) 更多
ESMO2026	N/A	头颈部鳞状细胞癌	123	Nivolumab	鑰願鹽壓鹽範構鏇鬱繭(膚鑰願蓋獵鬱廠鑰壓鏇) = 鏇築衊製淵膚糧蓋廠繭艱遞夢鏇網衊餘積繭獵 (齋鏇鏇壓鹹鹹繭餘簾艱 ) 更多	不佳	2026-10-23
				Pembrolizumab	鑰願鹽壓鹽範構鏇鬱繭(膚鑰願蓋獵鬱廠鑰壓鏇) = 膚齋觸繭廠獵鑰獵壓積艱遞夢鏇網衊餘積繭獵 (齋鏇鏇壓鹹鹹繭餘簾艱 ) 更多