更新于：2024-12-21

Pembrolizumab

帕博利珠单抗

更新于：2024-12-21

概要

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)

+ [10]

靶点

PD-1

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤免疫系统疾病感染+ [13]

在研适应症

局部晚期宫颈癌恶性胸膜间皮瘤转移性黑色素瘤+ [523]

非在研适应症

复发性急性淋巴细胞白血病转移性腺癌腺病毒科感染+ [69]

原研机构

Merck & Co., Inc.

在研机构

MSD KK

德琪医药有限公司

Prometheus Laboratories, Inc.

+ [82]

非在研机构

Rainier Therapeutics, Inc.

Targovax Oy

Evelo Biosciences, Inc.

+ [15]

最高研发阶段批准上市

首次获批日期

美国 (2014-09-04),

黑色素瘤

最高研发阶段(中国)批准上市

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

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序列信息

Sequence Code 93660H

来源: *****

Sequence Code 93670L

来源: *****

关联

2,317

项与帕博利珠单抗相关的临床试验

NCT06724042 / Not yet recruiting临床1期

First-in-human Phase 1a/b, Open-Label, Multicenter, Dose Escalation, Optimization and Expansion Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors

This is a first-in-human Phase 1a/b, open-label, multicenter, dose escalation, optimization and expansion study of ISM5939 to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of ISM5939 in patients with advanced or metastatic solid tumors.
The study will be conducted in 3 parts sequentially: Part 1 dose escalation ISM5939 monotherapy, Part 2 dose optimization to determine RP2D of ISM5939 monotherapy, and Part 3 dose expansion in 3 cohorts after initial safety run-in of ISM5939 combination therapy.

开始日期2025-12-30

申办/合作机构

英矽智能(香港)有限公司初创企业

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2025-12-01

申办/合作机构

Evergreen Therapeutics, Inc

NCT06589804 / Recruiting临床3期IIT

Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease

This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. 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. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.

开始日期2025-08-18

申办/合作机构

National Cancer Institute

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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8,949

项与帕博利珠单抗相关的文献（医药）

2025-02-01·Clinical Genitourinary Cancer

Outcomes by Retrospective Eligibility for Maintenance Therapy of Patients With Advanced Urothelial Carcinoma: Post Hoc Analysis of the Phase 3 KEYNOTE-361 Trial

Article

作者: Sella, Avishay ; Mamtani, Ronac ; Chang, Yen-Hwa ; Gravis, Gwenaelle ; Joly, Florence ; Bedke, Jens ; Pino, Alvaro Montesa ; Huillard, Olivier ; Imai, Kentaro ; Şendur, Mehmet A． N. ; Moreno, Blanca Homet ; Lee, Hyo Jin ; Alva, Ajjai ; Gafanov, Rustem ; Xu, Jin Zhi ; Şendur, Mehmet A.N. ; Matsubara, Nobuaki ; Herranz, Urbano Anido ; Şendur, Mehmet A N ; Powles, Thomas

INTRODUCTION:

The phase 3 KEYNOTE-361 trial of first-line pembrolizumab with or without chemotherapy versus chemotherapy alone in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) completed enrollment before the approval of postchemotherapy maintenance avelumab for patients without progressive disease. This post hoc analysis evaluated the outcomes of patients who received chemotherapy alone in KEYNOTE-361 by retrospective eligibility for subsequent maintenance therapy.

PATIENTS AND METHODS:

Patients in the chemotherapy alone arm were retrospectively categorized as maintenance eligible (received ≥4 cycles of chemotherapy and did not die or experience disease progression within 10 weeks of chemotherapy completion), maintenance ineligible (received <4 cycles of chemotherapy or had progressive disease or died within 0-10 weeks after completion of ≥4 cycles of chemotherapy), and indeterminate eligibility for maintenance therapy (if neither maintenance eligible or ineligible). End points included progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 by blinded independent central review and overall survival from randomization (start of chemotherapy).

RESULTS:

Median follow-up was 31.7 months (range, 22.0-42.3). Among 342 patients who received chemotherapy alone, 172 (50.3%) were maintenance eligible, 108 (31.6%) were maintenance ineligible, and 62 (18.1%) had indeterminate eligibility for maintenance therapy. The median progression-free survival was 9.0 months (95% CI 8.4-10.4) in maintenance-eligible patients, 5.1 months (4.2-6.0) in maintenance-ineligible patients, and 2.3 months (1.9-3.8) in the indeterminate group; median overall survival was 23.3 months (95% CI 19.4-26.1), 10.2 months (9.1-11.6), and 5.5 months (3.7-8.5), respectively.

CONCLUSION:

This post hoc analysis suggests that a majority of patients with untreated la/mUC who initiated chemotherapy in a clinical trial may have been considered eligible for maintenance therapy and had favorable survival outcomes compared with those considered maintenance ineligible.

2025-02-01·Annals of Diagnostic Pathology

PD-L1 (22C3) expression and prognostic implications in esophageal squamous cell carcinoma

Article

作者: Chi, Zhikai ; Karamchandani, Dipti M ; Peng, Lan ; Xu, Jing

Programmed cell death-ligand 1 (PD-L1) clone 22C3 is the only Food and Drug Administration-approved companion diagnostic test for pembrolizumab for the treatment of esophageal squamous cell carcinoma (ESCC). However, prior studies conducted in Asia and Europe have used various PD-L1 antibody clones other than 22C3. We aimed to study the expression profile of PD-L1, specifically of clone 22C3, in ESCC and its significance with regards to histological features, clinical parameters, and overall survival in a case series from two large US hospital systems. PD-L1 (22C3) immunohistochemistry was performed on 82 specimens obtained from 75 patients. Electronic medical records were reviewed to obtain the clinical and follow-up data. Of these specimens, 39 % (32/82) were negative for PD-L1 (22C3) expression (combined positive score (CPS) of 0). The remaining 50 specimens were positive, with CPSs ranging from 1 to 100. Treated specimens showed decreased PD-L1 (22C3) expression compared to untreated specimens. In the multivariate Cox proportional hazards regression model, PD-L1 (22C3) expression was shown to be a favorable prognostic factor for overall survival (p = 0.03, hazard ratio 0.16) only when the CPSs were ≥ 25, independent of surgery, definitive chemotherapy and/or radiotherapy, immunotherapy, and initial clinical stages. We performed a comprehensive study to investigate the expression profile of PD-L1 clone 22C3 in the US patients with ESCC. Our analysis showed that PD-L1 (22C3) expression decreased in treated specimens, and a CPS of ≥25 was associated with a favorable prognosis.

2025-02-01·Clinical Genitourinary Cancer

Cost-Effectiveness Analysis of Lenvatinib plus Pembrolizumab or Everolimus as First-Line Treatment for Advanced Renal Cell Carcinoma

Article

作者: Zheng, Huanrui ; Zhang, Jinhua ; Tong, Yao ; Zhou, Jin

BACKGROUND:

Recently, due to its promising efficacy against advanced renal cell carcinoma (RCC), the combination therapy with lenvatinib and pembrolizumab or everolimus has been approved as a first-line treatment for patients with advanced RCC in China and the United States. However, the high costs of combination therapies, especially of those new drugs, may limit their viability as clinical treatment options. Thus, our study aimed to evaluate the cost-effectiveness of using lenvatinib plus pembrolizumab or everolimus as a first-line treatment for patients with advanced RCC from the perspective of the Chinese healthcare system and US third-party payers.

METHODS:

We established a Markov model using TreeAge Pro 2022 software to estimate and compare the cost and effectiveness of the therapy with lenvatinib plus pembrolizumab or everolimus with those of sunitinib therapy for treating advanced RCC based on the clinical data derived from a phase III randomized controlled trial (CLEAR, ClinicalTrials.gov number NCT02811861). Transition probabilities and other data were calculated and obtained by using parametric survival modeling. The direct medical costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were used as economic indicators in this analysis. The robustness of the model was assessed by performing one-way and probability sensitivity analyses (PSA).

RESULTS:

Among the 3 treatment strategies, the sunitinib 1 was the least expensive option. All ICERs were far higher than the thresholds of $38,024 and $100,000 selected for China and the United States, respectively. The ICERs of the therapy with lenvatinib plus pembrolizumab versus sunitinib therapy were 106,749.06 US$/QALY and $414,672.19 US$/QALY in China and the United States, respectively. Thus, among these 2, the former strategy was less cost-effective than the latter. In addition, the ICERs of the lenvatinib plus everolimus treatment vs. sunitinib treatment were $44,353.18 US$/QALY and $292,653.10 US$/QALY in China and the United States, respectively. Thus, among these 2 strategies, the former was less cost-effective than the latter. The total cost of the lenvatinib plus everolimus treatment strategy was lower than that of lenvatinib plus pembrolizumab; however, the former treatment was less effective than the latter.

CONCLUSION:

The treatment with lenvatinib plus pembrolizumab or everolimus is less cost-effective than the sunitinib treatment for patients with advanced RCC in China and the United States.

7,717

项与帕博利珠单抗相关的新闻（医药）

2024-12-20

·小药说药

肿瘤免疫治疗的进化史

1 细胞因子在肿瘤免疫治疗领域的早期发现是细胞因子的作用。细胞因子治疗有着辉煌的过去，它是最早的被FDA批准用于肿瘤的免疫治疗药物，譬如，IFNα-2a (Roferon-A)和IFNα-2b (Intron-A)在1986年被批准用于多种淋巴瘤，高剂量IL-2 (Proleukin)在1992和1998年被批准用于转移性黑色素瘤和肾癌。 1976年，NCI肿瘤细胞生物学实验室的RobertGallo，使用PHA刺激淋巴细胞产生条件培养基培养骨髓细胞，其中90%的T细胞长达9个月的生存维持。在此之前，原代T细胞无法体外培养，是免疫学发展的巨大瓶颈性技术问题。这个未被纯化的成分称之为 T细胞生长因子，也就是IL-2。 1983年，日本癌症研究基金会肿瘤研究中心的Junji Hamuro等人，克隆了IL-2的基因，完成了测序工作。并在小鼠模型中进行研究，发现可以促进同基因肉瘤和黑色素瘤等转移性恶性肿瘤消退。这最终使IL-2成为人类第一个癌症免疫治疗药物。但是因为半衰期短，治疗窗口窄，毒副作用大，且同时刺激Treg活化，限制了其临床使用。 2 检查点抑制剂在IL-2批准不久后，检查点抑制剂脱颖而出，走到癌症研究的前沿。 1987 年，科学家们发现：CD4+或 CD8+的T细胞表面存在的一种免疫球蛋白，被称之为细胞毒性淋巴细胞抗原 4（CTLA-4），CTLA-4的发现为今后所有检查点抑制剂的发现铺平了道路。 James P. Allison博士是最早确定并阐明 CTLA-4 的免疫功能的科学家之一。1996 年，Allison 在小鼠中证实抗CTLA-4 的单抗可促使免疫系统杀伤肿瘤，于是 Ipilimumab 在Allison 博士的实验室诞生了。 1999 年，生物技术公司 Medarex 获得了此抗体的专利。Allison 博士与黑色素瘤临床专家 Jedd D. Wolchok 医生一起，共同开发 Mederax 研发的抗 CTLA-4 抗体治疗黑色素瘤。经过不懈的努力，2011年，ipilimumab获批用于转移性黑色素瘤的治疗，成为第一个用于临床治疗的检查点抑制剂。ipilimumab通过直接阻断CTLA-4，为下游T细胞的活化、增殖和最终的肿瘤破坏开辟了途径。在CTLA-4发现后，Ishida等人于1992年发现了程序性死亡受体-1和程序性死亡配体-1（PD-1/PD-L1）。目前，PD-1/PD-L1抑制剂已经成为肿瘤免疫治疗领域的基石。有多款已上市的PD-1抑制剂，包括nivolumab、pembrolizumab和cemiplimab，以及PD-L1抑制剂atezolizumab、avelumab和durvalumab等。目前有超过2000项针对各种恶性肿瘤的PD-1/PD-L1抑制剂联合用药的试验正在进行中。然而，PD-1的治疗仍然只有10-30%的患者表现出长期，持久的反应，大多数人群缺乏响应，还有获得性耐药以及免疫相关不良事件（IRAE）也是巨大的障碍。克服PD-1治疗局限性的机制之一是针对与肿瘤微环境相关的其他免疫检查点，如LAG-3、TIGIT、TIM-3、VISTA、B7-H3、ICOS和BTLA，这些新型的免疫检查点是治疗实体瘤可行且有前景的选择，目前多项临床试验正在积极研究中。此外，检查点抑制剂的联合治疗，如CTLA-4和PD-1的同时阻断，可以通过不同的机制抑制肿瘤的发展。目前FDA已批准了ipilimumab和nivolumab联合治疗多种恶性肿瘤。然而，毒性增加仍然是许多联合疗法的障碍。 3 抗肿瘤单克隆抗体 Kohler和Milsten凭借杂交瘤技术于1984年获得诺贝尔生理学或医学奖。这一突破促进了许多抗肿瘤单克隆抗体的发展，极大地影响了过去几十年的癌症治疗。自1986年第一个治疗性抗体进入临床以来，治疗性抗体得到了迅速的发展，到目前为止，FDA共批准了近百个治疗性抗体药物，其已成为现代生物医药的重要组成部分。抗体可以通过抗体的Fc结构域与免疫细胞相互作用，靶向并破坏表达特定抗原的肿瘤。根据抗体类别的不同，这种免疫细胞-抗体相互作用可通过多种方式导致肿瘤细胞死亡，包括补体依赖性细胞毒性（CDC）、抗体依赖性细胞毒性（ADCC）和抗体依赖性细胞吞噬作用（ADCP）。虽然单克隆抗体是目前癌症治疗的主流，但仍然存在许多挑战。由于癌细胞的动态特性及其持续的突变，任何获得性抗单克隆抗体的耐药性都会导致治疗失败。抗体偶联药物（ADC）是一种非常有效的策略，它通过一个合理构建的连接子将细胞毒性小分子药物偶联到单克隆抗体上，可以向肿瘤内选择性地输送有效的细胞毒性药物。 2009年gemtuzumab ozogamicin（Mylotarg) 是FDA批准的第一个ADC药物。目前，FDA已经批准上市了14个ADC药物，还有上百个ADC药物正处于临床研究阶段。 2009年，卡利霉素、金盏花素和美登素类药物是用于ADC开发的主要细胞毒素。十年来，这些分子仍然被用作有效载荷进行优化，以获得更好的稳定性和亲水性。新的细胞毒性物质也被开发出来，如PBDs、杜卡霉素和喜树碱衍生物等。抗体工程在10年间也已经取得了相当大的进展，允许更多的位点特异性偶联，提高了ADC的均一性和稳定性。新的第二代和第三代ADC已经进入临床，以期获得更好的治疗效果和安全性。几十种基于半胱氨酸残基、非天然氨基酸或分子工程模式的生物偶联技术也已经在临床前研究获得了验证。此外，更多的肿瘤特异性抗原靶点和肿瘤内细胞毒性药物的释放机制使ADC获得了爆炸式的发展，ADC药物进入了黄金时代。 4 CAR-T细胞疗法嵌合抗原受体（CAR）T细胞治疗为血液系统恶性肿瘤的治疗带来革命性的改变。在20世纪90年代早期，以色列科学家Eshhar与Rosenberg实验室的Hwu合作，运用来源于抗体的单链抗体片段scFv成功构建了3个不同癌症标靶的嵌合抗原受体，第一代CAR-T由此诞生。随后CAR-T技术经历了一代二代的发展，解决了规模化和生产工艺问题，CAR-T终于开始走向市场。第一个CD19靶向的CAR-T细胞（Kymriah）在2017年被批准用于复发性难治性急性淋巴细胞白血病。在过去的七年里，中国出现越来越多的临床试验旨在评估CAR-T疗法的安全性和有效性。仅次于美国，中国是CAR-T疗法研究的主要力量，在全球临床试验中贡献了约33%。迄今为止，中国国家药品监督管理局（CNDA）已批准10余种CAR-Ts产品进行临床试验，其中包括靶向CD19、BCMA和glypican3（GPC3）的CAR-Ts。目前已有2种针对CD19的CAR-T疗法在中国获批上市。 CAR-T细胞治疗虽然在血液肿瘤获得了成功，但是在实体瘤仍然有许多局限性，这种限制的一个关键因素是实体肿瘤细胞的肿瘤相关抗原异质性。实体瘤的另一个困难是CAR-T细胞渗透穿过血管系统并最终到达靶肿瘤的能力。此外，尽管CAR-T细胞具有很高的潜能，但它也具有明显的毒性，包括严重的细胞因子释放综合征（CRS）和严重的神经毒性。另外包括高昂的治疗成本，也限制了CAR-T细胞的广泛应用。目前，针对实体瘤CAR-T细胞治疗的新概念和策略正在出现。这些进展包括通过从肿瘤相关抗原转移到个性化的肿瘤特异性新抗原来更好地选择靶点，通过打破基质屏障来增强T细胞的运输，以及通过靶向TME中的免疫抑制机制使耗竭的T细胞再生。此外，CAR-NK细胞疗法也是一个很有前途的研究领域，与CAR-T细胞相比，CAR-NK细胞具有自己独特的优点，有望提供更好的疗效和安全性。 5 双特异性抗体虽然单克隆抗体已经成为癌症治疗的支柱，但双特异性抗体由于能够同时针对肿瘤细胞或肿瘤微环境中的两个表位，逐渐成为下一代治疗性抗体的一个重要而富有前景的组成部分。目前正在开发中的大多数双抗被设计成通过免疫细胞，特别是细胞毒性T细胞，与肿瘤细胞紧密连接，从而形成一个人工免疫突触，最终导致靶向肿瘤细胞的选择性攻击和裂解。Blinatumomab是第一个被批准的双特异性抗体，同时靶向CD3和CD19, 于2014年被批准用于Ph阴性复发或难治性B细胞急性淋巴细胞白血病。从1997年到2020年，全球共有272项关于bsAbs研究的临床试验。其中29%的研究由中国的制药公司和机构发起，紧随美国之后，排名第二。全球bsAbs临床试验主要集中在I期（n=161）、I/II期、II期和III期试验仍然很少。BsAbs的作用机制包括不同类型。目前国际上bsAb研究的机制主要基于T细胞导向疗法，而中国发起或参与的主要是基于双重免疫检查点阻断。双特异性抗体和CAR-T细胞都被用于T细胞导向的免疫治疗，这两种方法各有利弊。虽然CAR-T细胞对血液系统恶性肿瘤有更好的治疗效果，但它们治疗费用高昂，而且还需要额外的培训。与CAR-T相比，双特异性抗体是“现成的”，因此降低了成本，增加了许多患者的治疗机会。CAR-T细胞和双抗都有副作用，包括细胞因子释放综合征和神经毒性。 6 肿瘤疫苗随着对肿瘤抗原宿主免疫的进一步了解，疫苗诱导免疫治疗理论上成为一种理想的治疗方法。美国国立卫生研究院（NIH）将肿瘤疫苗定义为一系列生物修饰物，通过激活患者体内的免疫系统的能力来控制感染以及抵御疾病，并将其分为两类，一类为预防型，原理类似小时候注射的小儿麻痹症的疫苗，用于健康群体的预防；另一类则为治疗型，通过强化患者的免疫系统来抵抗肿瘤，直接对患者的肿瘤细胞开火，实则为免疫疗法的一种形式。预防性疫苗目前有两种被批准的癌症预防疫苗：人乳头瘤病毒（HPV）疫苗和乙型肝炎病毒（HBV）疫苗。这两种疫苗都以具有致癌潜力的HPV16和HPV18病毒为靶点。治疗性疫苗利用疫苗进行治疗而不是预防在肿瘤学领域是相当独特的，卡介苗（BCG）广泛用于治疗非肌层浸润性膀胱癌（NMIBC），已有40年的历史。 FDA已批准的治疗性癌症疫苗包括Sipuleucel-T，一种树突状细胞为基础的疫苗，用于症状轻微的转移性去势抵抗前列腺癌；以及T-VEC，一种病变内HSV-1衍生的溶瘤病毒疫苗，用于不可切除的复发性黑色素瘤。目前肿瘤免疫治疗疫苗的研究主要是基于新抗原的个性化疫苗。基于新抗原而非传统TAA的疫苗有几个有点。首先，新抗原仅由肿瘤细胞表达，因此可以引发真正的肿瘤特异性T细胞反应，从而防止对非肿瘤细胞的损伤；其次，新抗原是源于体细胞突变的新表位，它有可能绕过T细胞对自身表位的中心耐受，从而诱导对肿瘤的免疫反应；此外，这些疫苗增强的新抗原特异性T细胞反应持续存在并产生免疫记忆，这为长期预防疾病复发提供了可能性。 7 溶瘤病毒溶瘤病毒（OV）治疗一种相当新颖的免疫疗法，其利用实验室改造的病毒攻击和渗透恶性细胞，这些溶瘤病毒通过直接溶解肿瘤细胞以及激活先天性和适应性免疫机制发挥作用。从1949年开始，人们使用不同类型的野生型非减毒病毒进行了许多临床试验。此后不久，OV领域的趋势演变为开发对人类致病性较小的基因修饰病毒，如减毒活疫苗。在过去的20-30年中，这一转变一直延续到使用转基因病毒进行癌症治疗的时代，包括利用病毒基因敲除和/或治疗性转基因敲入。进入21世纪，在许多临床试验得到积极结果之后，OV领域获得了相当大的关注。到目前为止，已经在全球批准了四项OV药物。第一种OV是一种被称为Rigvir的小核糖核酸病毒，在拉脱维亚被批准用于治疗黑色素瘤，但未得到广泛应用。其次，2005年中国批准了一种名为H101的工程腺病毒，用于治疗头颈癌。第三，2015年，美国和欧洲批准了另一种名为Talimogene Laherparepvec（T-VEC）的工程单纯疱疹病毒（HSV-1）OV，用于治疗不可切除的转移性黑色素瘤。最后，在2021年，日本批准了一种改良的单纯疱疹病毒，名为DELYTACT，用于治疗胶质母细胞瘤等脑癌。小结癌症治疗领域的快速变化凸显了免疫疗法所产生的影响，目前的努力方向包括以新的方式重新研究已知的治疗方法，例如将检查点抑制剂与治疗性癌症疫苗相结合。在个性化医疗时代，关键的生物标志物和个体化的基因组测序将引领肿瘤免疫治疗的个性化发展。过继性细胞治疗，包括CAR-T，CAR-NK等，目前正在实体瘤中进行研究。然而，由于实体肿瘤微环境的特殊特征，这一点是极具挑战性的。将检查点抑制（如PD-1/PDL-1阻断）与CAR-T治疗相结合，可能证明是有益的，也正在研究中。肿瘤免疫治疗领域的演变伴随着新型药物的实现和利用的不断扩展，鉴于在这一领域所取得的成就和突破，未来依然有无限可能。参考文献： 1. The Evolution of Cancer Immunotherapy. Vaccines2021, 9, 614. 公众号内回复“ADC”或扫描下方图片中的二维码免费下载《抗体偶联药物：从基础到临床》的PDF格式电子书！公众号已建立“小药说药专业交流群”微信行业交流群以及读者交流群，扫描下方小编二维码加入，入行业群请主动告知姓名、工作单位和职务。

免疫疗法细胞疗法临床研究

2024-12-20

·动脉网

仅靠1个产品获再生元投资，小分子抑制剂研发商Tasca Therapeutics凭什么？

近日，一家名为Tasca Therapeutics的公司完成了5200万美元的A轮融资。 Tasca Therapeutics（以下简称Tasca）是一家生物技术公司，专注于发现和开发在癌症中很重要的自动棕榈酰化靶蛋白的小分子抑制剂。据了解，本次A轮融资由2024年再生元成立的再生元风险投资基金Regeneron Ventures和Cure Ventures领投，Invus Group参投。这笔资金将用于推进Tasca 的新药发现平台，将其主要项目CP-383推进到I/II期临床概念验证研究，并扩大其候选药物管道。作为一家新成立的公司，Tasca为何首次融资就受到再生元及多家知名风投机构的亲睐呢？ 01 超20年药物开发经验，曾参与研发K药 Tasca由 Milenko Cicmil、Xu Wu、David Fisher和Duojia Pan博士联合创办。左起：David Fisher、Milenko Cicmil 图源：Tasca Therapeutics Milenko Cicmil博士目前担任公司的首席执行官（CEO）和董事会成员。他拥有在生物学领域超过20年的药物发现和开发经验，特别是在炎症、自身免疫和肿瘤学方面有着深刻的理解。Cicmil博士曾在益普生、默克和阿斯利康等公司担任研发职位，并为开发首个美国FDA批准的双效抗血小板疗法—Brilinta（替格瑞洛）、中国首个获批用于治疗轻度哮喘的抗炎药的双重联合疗法—Symbicort（布地奈德福莫特罗吸入粉雾剂Ⅱ）以及全球首个获批的抗PD-1疗法—Keytruda（帕博利珠单抗）等药物做出了重要贡献。 Xu Wu博士，拥有超过16年的生物医学研究和药物发现经验。Xu Wu于1997年毕业于北京大学化学院，2005年获Scripps研究所博士学位，师从化学生物学奠基人Peter G. Schultz。他目前在麻省总医院和哈佛医学院担任副教授，已发表多篇研究论文。 David Fisher博士是哈佛医学院的皮肤病学和儿科教授，同时担任黑色素瘤研究学会的主席。该学会是全球最大的专注于黑色素瘤研究的国际学术组织。他的研究重点在于通过基于机器人的高通量筛选技术，对能够渗透皮肤的亲脂性药物进行研究，以识别新的皮肤靶向疗法。这些研究不仅有助于开发改变皮肤色素沉着的药物，还可能对降低皮肤癌风险具有重要意义。 Duojia Pan博士也是Tasca的联合创始人之一，以其在科学领域的杰出成就被选为美国国家科学院院士。他的实验室利用果蝇模型深入研究了Hippo信号通路，为理解该通路在生长控制和疾病中的作用提供了关键分子机制的洞见。 Praveen Tipirneni博士最近被任命为董事会主席。Tipirneni博士曾是Morphic Therapeutics的总裁和CEO，该公司专注于开发慢性疾病的口服整合素疗法，并于2024年7月被礼来公司以大约32亿美元的价格收购。此外，Tasca正着手建立一支由充满激情的科学家组成的团队。据 Cicmil称，他们将于 1 月中旬搬入马萨诸塞州剑桥市的新实验室。 02 基于哈佛医学院研究成果，精确靶向蛋白质位点在生物体内，蛋白质翻译后修饰（PTMs）对蛋白质的结构和功能起着至关重要的作用，增加了其复杂性并完善了其功能。其中，棕榈酰化修饰作为一种重要的蛋白质脂质修饰形式，在细胞信号传导、代谢、凋亡以及疾病的发生发展中扮演着关键角色。然而，由于缺乏明确的蛋白质棕榈酰化修饰位点，这一领域的研究进展受到了极大的阻碍。 Tasca Therapeutics的平台技术基于哈佛医学院科学家的研究成果，采用基于质谱的蛋白质组学技术，并结合专有试剂，旨在识别和绘制蛋白质上的新型脂质结合口袋，尤其是那些经历特定翻译后修饰（自动棕榈酰化auto-palmitoylation）的蛋白质。值得一提的是，自动棕榈酰化这一过程并不需要酶催化。这一平台的核心在于其能够精确识别和表征在独特疏水口袋（新药的潜在结合位点）中自动棕榈酰化的蛋白质位点，这些位点一旦被定位和表征，就可以作为新疗法的独特结合位点，进而开发出能够改变靶蛋白功能的新型治疗药物。 2016年，Tasca联合创始人Wu和Duojia Pan博士等人在《Nature Chemical Biology 》上发表了一篇论文，描述了自动棕榈酰化如何调节人类TEA结构域（TEAD）转录因子。他们的工作提供了早期证明：蛋白质具有可以与脂质基团结合的自催化侧，并且可以被小药物分子靶向。研究小组利用化学探针并研究与棕榈酸酯结合的TEAD的晶体结构，发现脂肪酸的脂质链插入蛋白质上保守的疏水口袋中。基于这些发现，Wu和他的团队建立了一个更广泛的化学蛋白质组学平台，将初步发现扩展到TEAD之外。 Tasca的平台能够识别那些不需要酶催化的自动棕榈酰化过程，这一过程独特地针对蛋白质口袋，形成化学键后再形成共价键。与其他更广泛地靶向蛋白质表面的竞争对手不同，这种针对性的方法使得Tasca能够“进入特定的编码”，即精确靶向特定的蛋白质口袋。 03 已确定1000个蛋白质靶标，最快管线即将进行I/II期临床概念验证研究在应用层面，Tasca 将首先评估其主要候选药物CP-383在小细胞肺癌、结直肠癌、头颈癌和胶质母细胞瘤中的疗效。目前，CP-383在多种癌症类型中显示出优异的疗效，具有成为Best-in-Class和First-in-Class小分子创新药物的潜力。在临床前的体内研究中，CP-383已经证明了其能够穿过血脑屏障（Blood-Brain Barrier），这对于治疗侵袭性脑癌来说是一个重要的突破。公司计划在明年进行I/II期临床概念验证研究，进一步测试CP-383的疗效。此外，Tasca 计划使用人工智能来帮助识别针对蛋白质口袋的抑制剂。通过AI训练出能够理解蛋白质口袋结构的算法，并可以帮助识别靶向它们的药物，以便他们能够更快地识别药物分子。在自动棕榈酰化平台的支持下，Tasca正在构建涵盖多种癌症适应症的创新药物候选管线。 Tasca管线图源：Tasca Therapeutics 据Cicmil介绍，Tasca 已经确定了大约 1000 个经历自动棕榈酰化的蛋白质靶标，其中约三分之二与神经退行性、代谢和自身免疫性疾病相关。看好Tasca的再生元制药公司在小分子抑制剂领域也拥有广泛的研发布局，覆盖眼科、心血管疾病、免疫炎症和肿瘤等多个治疗领域。 2019年，再生元的眼科药物艾力雅（EYLEA）与预充式注射器结合，开发了无菌预充式注射药物，并获FDA批准上市。EYLEA是一种血管内生长因子（VEGF）抑制剂，能控制肿瘤细胞生长并治疗某些眼科疾病。紧接着在2021年，再生元与阿斯利康合作，研究识别针对GPR75的小分子调节剂，旨在治疗肥胖及其相关并发症。此外，Tasca基于质谱蛋白质组学技术在精准肿瘤学领域应用的研究与再生元的精准医疗研发和市场扩展战略相一致，特别是在自动棕榈酰化靶蛋白的小分子抑制剂开发方面取得的进展。据《2024年中国小分子抗肿瘤靶向药物白皮书》，全球小分子抗肿瘤药物市场规模从2017年的360亿美元增长到2023年的843亿美元，期间年复合增长率为15.2%。与此同时，中国市场规模也呈现出迅速增长的态势，从2017年的人民币98亿元增加至2023年的734亿元，期间年复合增长率为39.9%。这一增长趋势预计还将持续，预计2023年至2030年，中国小分子抗肿瘤药市场规模年复合增长率将达到16.0%。随着小分子药物市场规模不断扩展，蛋白质修饰技术的发展以及小分子抑制剂的科研创新。我们相信，未来将有更多基于新机制的药物出现。如果您想对接文章中提到的项目，或您的项目想被动脉网报道，或者发布融资新闻，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

并购

2024-12-20

·iobiotech.com

IO Biotech secures up to €57.5 million in debt financing from the European Investment Bank

Funds expected to be used to advance IO Biotech’s immune-modulating therapeutic cancer vaccines, including potential BLA submission for IO102-IO103 in 2025 Commitment is part of the European Investment Bank’s strategy to support biotech companies with cutting-edge expertise in therapeutic areas such as immuno-oncology Debt facility expected to extend company’s cash runway into the second quarter of 2026 COPENHAGEN, Denmark and NEW YORK, Dec. 20, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating, off-the-shelf therapeutic cancer vaccines today announced that it has entered into a loan facility of up to €57.5 million from the European Investment Bank (EIB), the long-term lending institution of the European Union owned by its Member States. The debt facility includes three committed tranches totaling up to €37.5 million, which will become available if the company satisfies certain conditions, and one uncommitted accordion tranche of €20 million. The company expects the first two tranches to be available for disbursement in the first quarter of 2025. Amy Sullivan, Chief Financial Officer of IO Biotech, commented, “The support from the EIB, which is provided on favorable terms, will help fund the continued development and pre-commercialization of IO102-IO103 and other therapeutic cancer vaccine candidates generated from our T-Win® platform. We expect that the capital drawn from the three committed tranches of the EIB debt facility will extend our cash runway into the second quarter of 2026.” The loan facility is unsecured has no minimum cash covenants and consists of three committed tranches of €10.0 million (Tranche A), €12.5 million (Tranche B), and €15.0 million (Tranche C) totaling €37.5 million, and one uncommitted accordion tranche of €20.0 million. Each committed tranche will become available if the company satisfies certain conditions precedent. The company expects funds from Tranches A and B to be available in the first quarter of 2025. The company has 36 months to satisfy the conditions for Tranche C, which include raising an additional $50 million in cash and submitting an application for marketing authorization for IO102-IO103 in the U.S. or the EU. In addition, as a condition for disbursement of each Tranche of the loan facility, the company has agreed to issue to the EIB warrants to purchase a number of shares of the company’s common stock determined by a formula set forth in a warrant issuance agreement. Each tranche has a maturity of 6 years from its disbursement. The loan is structured with capitalized interest and payment deferred to maturity of each tranche. Van Lanschot Kempen served as financial advisor to the company and Kromann Reumert and Sidley Austin LLP acted as legal counsel to the company. About IO102-IO103 IO102-IO103 is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a Breakthrough Therapy Designation for the treatment of advanced melanoma by the US Food and Drug Administration. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York. For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech). About the European Investment Bank The European Investment Bank (EIB) is the long-term lending institution of the European Union owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals. Forward-Looking Statement This press release 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. Forward-looking statements, including regarding satisfaction of conditions precedent for disbursements from the loan facility, the timing or outcome of primary analysis of the company’s Phase 3 trial, other current or future clinical trials, their progress, enrollment or results, expectations regarding receipt of, and expected purposes for, committed and uncommitted funding provided by the EIB, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. Contact: InvestorsMaryann Cimino, Director of Investor Relations IO Biotech, Inc.617-710-7305mci@iobiotech.com MediaJulie FunestiSalutem917-498-1967Julie.Funesti@salutemcomms.com

疫苗临床2期突破性疗法临床3期

100 项与帕博利珠单抗相关的药物交易

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外链

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

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
局部晚期宫颈癌	中国	Merck Sharp & Dohme LLC	2024-12-06
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
转移性黑色素瘤	中国	Merck Sharp & Dohme LLC	2024-09-10
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
不能切除的胆道癌	加拿大	Merck Sharp & Dohme Corp.	2024-05-09
局部晚期胆管癌	中国	Merck Sharp & Dohme LLC	2024-01-30
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
HER2阳性胃腺癌	列支敦士登	Merck Sharp & Dohme BV	2023-09-06
HER2阳性胃腺癌	挪威	Merck Sharp & Dohme BV	2023-09-06
转移性 HER2 阳性胃食管结合部癌	列支敦士登	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
小肠癌	申请上市	欧盟	Merck Sharp & Dohme Corp.	2022-03-25
胶质母细胞瘤	临床3期	美国	Merck Sharp & Dohme LLC	2024-12-01
胶质母细胞瘤	临床3期	美国	NovoCure GmbH	2024-12-01
KRAS G12C突变非小细胞肺癌	临床3期	美国	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	澳大利亚	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	奥地利	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	比利时	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	巴西	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	加拿大	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	捷克	Eli Lilly & Co.	2023-12-21

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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


NCT03322267 (NCT03322267 \| ###DELETE, CTgov)	临床2期	局部晚期食管鳞状细胞癌	26	pembrolizumab	衊齋構鹹壓壓鏇願壓夢(糧餘繭壓齋醖壓醖窪壓) = 淵醖鏇醖糧簾夢壓鹹製蓋獵醖醖壓積遞鑰獵鑰 (淵構壓膚鏇壓簾廠築遞, 鏇鬱網壓觸鹽醖製積觸 ~ 艱壓獵膚餘鹽醖鑰鹹鹽) 更多	-	2024-12-19
NCT04306367 (CTgov)	临床2期	晚期胆管癌	14	Olaparib+pembrolizumab	衊艱鏇鏇製艱遞窪蓋鹹(壓餘鬱憲鹹願蓋遞齋繭) = 廠觸餘膚廠鹽餘襯遞獵壓鬱鹽壓襯艱繭積鬱鏇 (艱艱積構築製鹽觸憲製, 鏇願窪範蓋製憲構築夢 ~ 淵積網淵願範壓鹽醖構) 更多	-	2024-12-17
NCT04555837 (CTgov)	临床1/2期	转移性头颈部鳞状细胞癌 \| 头颈部鳞状细胞癌 \| 恶性实体肿瘤	24	Alisertib+Pembrolizumab (Phase I)	繭築範鹽窪積觸蓋遞繭(窪窪壓簾壓鬱繭醖鏇窪) = 鹹淵鹹簾範齋構襯築獵鹽蓋糧餘齋構選鹽觸餘 (構觸鹹淵壓窪憲鑰鹽齋, 糧醖積顧壓積築憲醖鏇 ~ 齋網窪遞壓構襯築鏇築) 更多	-	2024-12-16
				Alisertib+Pembrolizumab (Phase II)	鏇範觸構鬱觸網築鑰鏇(糧糧窪願醖鹽襯衊壓願) = 獵餘鏇襯鑰繭壓鬱廠網襯繭構窪淵顧壓鹹繭蓋 (積夢壓齋構淵膚鏇鏇鑰, 遞構積願糧齋窪淵夢憲 ~ 構築選醖繭蓋顧襯遞廠) 更多
NCT04561362 (Duravelo-1, BusinessWire) 人工标引	临床1/2期	转移性尿路上皮癌一线	22	Zelenectide pevedotin 5 mg/m2 weekly + Pembrolizumab 200 mg once every three weeks	鹽鏇構齋憲範蓋壓範觸(壓積壓製襯齋構鹹壓齋) = 選淵醖窪鹹餘夢蓋夢顧製網衊艱選鹹繭膚衊衊 (壓夢襯顧憲窪膚願壓蓋 )	积极	2024-12-12
NCT03632941 (CTgov)	临床2期	HER2阳性乳腺癌	8	VRP-HER2 (VRP-HER2 Vaccine)	網構淵觸醖壓簾範糧遞(壓繭艱窪遞觸顧積觸願) = 簾構鬱範糧鑰選襯築製壓餘簾網範遞遞糧窪鹹 (製顧醖醖鑰範簾網壓壓, 願鏇範鏇壓廠襯築鬱鬱 ~ 簾築製網網網選範鏇醖) 更多	-	2024-12-11
				pembrolizumab (Pembrolizumab)	網構淵觸醖壓簾範糧遞(壓繭艱窪遞觸顧積觸願) = 獵觸網醖範鏇憲糧願餘壓餘簾網範遞遞糧窪鹹 (製顧醖醖鑰範簾網壓壓, 範願範襯憲糧鬱構願艱 ~ 膚觸積廠蓋夢獵顧衊鑰) 更多
NCT02784171 (KEYNOTE-483 \| IND 227, CTgov)	临床2/3期	恶性胸膜间皮瘤	520	cisplatin+pemetrexed (Arm A - Cisplatin/Pemetrexed)	蓋觸衊範選醖夢廠繭壓(願鹽壓廠衊選廠鏇鹽顧) = 壓積繭願構簾積觸鑰鏇觸築鹹鏇鹹膚憲醖繭壓 (獵廠糧鹽壓夢醖糧廠醖, 襯鑰淵願範艱糧選鑰簾 ~ 願衊艱遞鹽選壓衊簾遞) 更多	-	2024-12-10
				cisplatin+pembrolizumab+pemetrexed (Arm B - Cisplatin/Pemetrexed/Pembrolizumab)	蓋觸衊範選醖夢廠繭壓(願鹽壓廠衊選廠鏇鹽顧) = 鏇積廠鏇鹽衊築壓壓鏇觸築鹹鏇鹹膚憲醖繭壓 (獵廠糧鹽壓夢醖糧廠醖, 鏇餘鏇窪製鑰製餘齋艱 ~ 鹹鏇窪糧製夢襯鑰範廠) 更多
NCT03740165 (KEYLYNK-001, Company_Website) 人工标引	临床3期	卵巢上皮癌一线 BRCA non-mutated	-	KEYTRUDA+ LYNPARZA	壓鬱選選艱衊網構觸衊(廠觸選網膚觸壓範簾遞) = met its primary endpoint of progression-free survival. 鏇廠鹽廠夢鹽獵衊憲觸 (遞選窪壓壓願遞餘鬱齋 ) 达到更多	积极	2024-12-09
				KEYTRUDA+ Placebo
ASH2024 人工标引	N/A	结外NK-T细胞淋巴瘤一线	19	Pembrolizumab	膚範醖壓壓範壓鹹壓淵(鹽蓋遞窪繭製簾憲積鬱) = 選壓繭壓簾範齋鹹餘範艱衊積觸範壓餘積積齋 (餘鑰鬱廠廠艱壓遞鹽憲 ) 更多	积极	2024-12-08
				Pembrolizumab (pts with ES disease)	膚範醖壓壓範壓鹹壓淵(鹽蓋遞窪繭製簾憲積鬱) = 膚醖窪範窪淵顧膚簾鏇艱衊積觸範壓餘積積齋 (餘鑰鬱廠廠艱壓遞鹽憲 ) 更多
ASH2024	N/A	典型霍奇金淋巴瘤	-	Pembrolizumab plus COPDAC-28 with RT	簾遞膚選衊廠鬱憲鏇齋(蓋廠夢壓鏇鹽膚繭襯鬱) = 憲醖築製蓋範選鑰築網艱廠淵鹽淵網糧構鏇積 (鏇夢網廠積積構醖遞構, 93 ~ 100) 更多	-	2024-12-08
				Pembrolizumab plus COPDAC-28 without RT	襯積選範顧鹹醖構淵醖(壓鑰獵鏇艱範遞積艱夢) = 鏇觸襯衊廠積築壓觸範淵醖顧糧壓網鬱夢餘鏇 (糧艱願簾醖鹽壓醖選網 )
ASH2024	N/A	典型霍奇金淋巴瘤	-	Pembrolizumab plus AVD and RT	齋積襯襯壓淵製窪範遞(觸網醖醖鏇衊範窪範夢) = treatment-related adverse events (AEs) were reported in 8 patients (80%); grade 3 or 4 treatment-related AEs occurred in 4 patients (40%). No patients discontinued or died due to treatment-related AEs. Seven patients (67%) had pembrolizumab-related AEs, 3 of whom (30%) had a grade 3 event (vomiting, lymphocyte count decreased, white blood cell count decreased). Immune-mediated AEs occurred in 3 patients (30%; all grade 1 or 2 hypothyroidism) 觸廠醖窪鑰願積淵衊蓋 (齋襯構觸艱淵鹹積膚觸 )	-	2024-12-08