A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.

开始日期2025-07-11

申办/合作机构

SWOG

[+2]

NCT06651593 / Not yet recruiting临床2期IIT

Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid Tumors

To study possible biomarkers that may be related to how SAR444881 works (either alone or when combined with cemiplimab) in participants with solid tumors.

开始日期2025-04-15

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+2]

NCT06585410 / Not yet recruiting临床3期

A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)

This study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called programmed cell death-1 (PD-1) on the surface of certain immune cells.
The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.
The study is looking at:
* The side effects cemiplimab might cause
* How well cemiplimab works

开始日期2025-01-28

申办/合作机构

Regeneron Pharmaceuticals, Inc.

100 项与塞普利单抗相关的临床结果

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100 项与塞普利单抗相关的专利（医药）

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451

项与塞普利单抗相关的文献（医药）

2024-12-31·OncoImmunology

Overexpression of CCL-20 and CXCL-8 genes enhances tumor escape and resistance to cemiplimab, a programmed cell death protein-1 (PD-1) inhibitor, in patients with locally advanced and metastatic cutaneous squamous cell carcinoma

Article

作者: Nardone, Valerio ; Formisano, Luigi ; Del Tufo, Sara ; Caraglia, Francesco ; Esposito, Daniela ; Esposito, Alfonso ; D’Ippolito, Emma ; De Falco, Vincenzo ; Argenziano, Giuseppe ; Ciardiello, Fortunato ; Napolitano, Rossella ; Giugliano, Maria Cristina ; Famiglietti, Vincenzo ; Zito Marino, Federica ; Suarato, Gabriella ; Ronchi, Andrea ; Napolitano, Stefania ; Franco, Renato ; Bianco, Roberto ; Cioli, Eleonora ; Troiani, Teresa ; Ciardiello, Davide

Cemiplimab has demonstrated relevant clinical activity in cutaneous squamous cell carcinoma (cSCC) but mechanisms of primary and acquired resistance to immunotherapy are still unknown. We collected clinical data from locally advanced and/or metastatic cSSC patients treated with cemiplimab in two Italian University centers. In addition, gene expression analysis by using Nanostring Technologies platform to evaluate 770 cancer- and immune-related genes on 20 tumor tissue samples (9 responders and 11 non-responders to cemiplimab) was performed. We enrolled 81 patients with a median age of 82 years. After 16.4 months of median follow-up, 12- and 24-months PFS were 53% and 42%, respectively; while 12- and 24-months OS were 71% and 61%, respectively. Treatment was well tolerated. Overall response rate (ORR) was 58%, with a disease control rate (DCR) of 77.8%. The difference between genes expressed in responder versus non-responder patient samples was substantial, particularly for genes involved in immune system regulation. Cemiplimab-resistant tumors were associated with over-expression of CCL-20 and CXCL-8. Cemiplimab confirmed efficacy and safety data in real-life cSCC patients. Overexpression of CCL-20 and CXCL-8 could represent biomarkers of lack of response to immunotherapy.

2024-12-10·Neurology

Immune Checkpoint Inhibitor Myopathy

Review

作者: Mammen, Andrew L. ; Beecher, Grayson ; Pinal-Fernandez, Iago ; Liewluck, Teerin

Immune checkpoint inhibitor (ICI) therapy has revolutionized the treatment of several malignancies, with improved survival. These monoclonal antibodies target immune checkpoints, including cytotoxic T-lymphocyte-associated protein 4 (ipilimumab and tremelimumab), programmed death 1 (nivolumab, pembrolizumab, cemiplimab, and dostarlimab), programmed death ligand 1 (atezolizumab, avelumab, and durvalumab), and lymphocyte activation gene 3 (relatlimab), and effectively augment the immune response against tumor cells. Releasing the brakes on the immune system has consequences, however, in the form of immune-related adverse events (irAEs), which may affect any organ. Neurologic irAEs represent 1%-3% of all irAEs, with immune-mediated myopathy (ICI myopathy) being the most common manifestation. Recent large patient series and systematic reviews have established the key features and highlighted new insights into ICI myopathy. ICI myopathy is characterized by an acute or subacute onset of oculobulbar and/or proximal limb weakness, with or without associated respiratory insufficiency and myocarditis. Creatine kinase elevation is common. Oculobulbar presentations with or without respiratory failure may be misattributed to neuromuscular junction disorders, particularly because acetylcholine receptor antibodies are present in up to 40% of patients; however, an electrodiagnostic evidence of a defect of neuromuscular transmission is often absent even in patients with severe weakness, highlighting that the myopathic process is the driving force behind these presentations. Muscle histopathology commonly demonstrates a unique signature of multifocal clusters of necrotic and regenerating fibers, differentiating ICI myopathy from other autoimmune myopathies. Transcriptomic analysis has uncovered distinct subgroups within ICI myopathy, revealing varying degrees of type 1 and type 2 interferon pathway activation alongside notable upregulation of the interleukin (IL)-6 pathway in affected muscle tissue. This discovery presents a promising avenue for intervention through the use of therapies that suppress the interferon pathway and target IL-6 or its receptor. Despite clinical improvements with immunomodulatory therapy, with corticosteroids the mainstay of treatment, mortality remains high, particularly in those with associated myocarditis or respiratory failure requiring intubation, where mortality occurs in up to 50%. ICI withdrawal can lead to cancer progression and death, highlighting a need for improved approaches to ICI rechallenge, performed in limited patients with variable success to date.

2024-12-01·International Immunopharmacology

A comprehensive review of immune checkpoint inhibitors for cancer treatment

Review

作者: Arafat Hossain, Md. ; Arafat Hossain, Md

Immunology-based therapies are emerging as an effective cancer treatment, using the body's immune system to target tumors. Immune checkpoints, which regulate immune responses to prevent tissue damage and autoimmunity, are often exploited by cancer cells to avoid destruction. The discovery of checkpoint proteins like PD-1/PD-L1 and CTLA-4 was pivotal in developing cancer immunotherapy. Immune checkpoint inhibitors (ICIs) have shown great success, with FDA-approved drugs like PD-1 inhibitors (Nivolumab, Pembrolizumab, Cemiplimab), PD-L1 inhibitors (Atezolizumab, Durvalumab, Avelumab), and CTLA-4 inhibitors (Ipilimumab, Tremelimumab), alongside LAG-3 inhibitor Relatlimab. Research continues on new checkpoints like TIM-3, VISTA, B7-H3, BTLA, and TIGIT. Biomarkers like PDL-1 expression, tumor mutation burden, interferon-γ presence, microbiome composition, and extracellular matrix characteristics play a crucial role in predicting responses to immunotherapy with checkpoint inhibitors. Despite their effectiveness, not all patients experience the same level of benefit, and organ-specific immune-related adverse events (irAEs) such as rash or itching, colitis, diarrhea, hyperthyroidism, and hypothyroidism may occur. Given the rapid advancements in this field and the variability in patient outcomes, there is an urgent need for a comprehensive review that consolidates the latest findings on immune checkpoint inhibitors, covering their clinical status, biomarkers, resistance mechanisms, strategies to overcome resistance, and associated adverse effects. This review aims to fill this gap by providing an analysis of the current clinical status of ICIs, emerging biomarkers, mechanisms of resistance, strategies to enhance therapeutic efficacy, and assessment of adverse effects. This review is crucial to furthering our understanding of ICIs and optimizing their application in cancer therapy.

560

项与塞普利单抗相关的新闻（医药）

2024-11-19

·氨基观察

再生元的中年危机

氨基观察-创新药组原创出品作者 | 黄凯再生元是biotech届眼中的吾辈楷模，没有一家biotech不想成为再生元。“成为中国的再生元”，更是是诸多国内biotech的slogan。但是，这样的再生元也躲不过自己的中年危机。对手的进击、Eylea仿制药的胜利、双抗接二连三的打击，让再生元处在一个极其微妙的阶段。一方面，凭借两款爆款药物，再生元完成了从biotech到big pharma的蜕变，上半年股价不断上涨，成功突破千亿美元门槛，市值最高达1332亿美元。另一方面，市场虽相信再生元研发和平台技术能力的，但新的百亿重磅药物，哪有那么容易？而再生元被寄予厚望的肿瘤业务，并不像自免、眼科那样光鲜，进展也乏善可陈。所以我们看到，当市值冲上千亿美元后，市场对再生元的未来走向，已经有了分歧。而当岌岌可危的增长，碰上专利诉讼失败，不及预期的三季报，进一步放大焦虑，造就了短时间的连续下跌，500亿美元市值随之蒸发。一直以来，当我们谈及大药企的危机，总离不开一个老生常谈的问题：专利悬崖。再生元今日之危机，也与专利悬崖脱不开关系。但如果换个角度，就会发现，big pharma经营之道也是非常重要。对于再生元来说，现有的产品（Eylea、Dupilumab）能够保底一个很高的基础价值，但后续价值如何演绎，还是要看后续研发。而在“弱肉强食”的商业环境中，big pharma的生存之道，要么是通过收购他人来做大自己的规模，要么是一直保留业内最高的研发效率，将对手远远甩开。再生元需要保持自己的研发梦想，同时，也要考虑现实。 / 01 / 跌落千亿过去几年里，再生元持续进击。旧王牌Eylea的稳定输出，新王牌Dupixent迅速成长为百亿级别的重磅药物，带动再生元业绩的持续增长。其中，Eylea在专利悬崖以及罗氏的眼科双抗Vabysmo抢占市场份额的双重冲击下，销售额经历了连续的下滑，而随后凭借高剂量版本的推出（Eylea HD），在今年二季度重回增长。与赛诺菲合作的Dupilumab更是一路高歌猛进。从销售额来看，Dupilumab在2024年上半年的销售额为61.38亿欧元（约66.63亿美元），已经成功超越修美乐，成为了自免新药王。并且，Dupilumab同样在不断拓展适应症，近期COPD适应症已于欧盟获批，大疱性类天疱疮、慢性自发性荨麻疹等适应症的关键临床3期数据也将在下半年读出，Dupilumab正在迎来密集收获期。这也意味着，Dupixent将是一个比Eylea还成功的重磅炸弹，销售峰值预测已经来到200亿美元。于是，我们看到，今年上半年再生元成为美股医药板块，礼来、诺和诺德之外少有的亮点，股价不断上涨，成功突破千亿美元门槛，市值最高达1332亿美元。凭借两款爆款药物，再生元完成了从biotech到big pharma的蜕变，市值一度超越了百时美施贵宝等巨头，紧跟在辉瑞后面。然而，自8月27日股价摸到1211.2美元/股历史高点后，再生元至今跌幅接近40%。短短2个半月时间，几乎腰斩。如今，再生元市值为837亿美元，较高点蒸发500亿美元。翻看再生元的历史K线图，这样连续且陡峭的跌法，在过去几乎是没有过的事情。专利悬崖，是每一家大药企都必须要面对的，从罗氏、赛诺菲、艾伯维到默沙东，莫不如是。市场对于Eylea的专利悬崖也早有预期。那么，为什么在8月高点之后，再生元转头，一路向下？ / 02 / 转型之槛市场都在期待再生元奇迹。然而，接二连三的打击、对手的进击、仿制药的胜利，让再生元处在一个极其微妙的阶段。目前看，未来短时间内Eylea、Dupilumab仍是拉动再生元业绩增长的两个绝对重磅品种。但随着罗氏Vabysmo的强势冲击，以及生物类似药的不断获批，Eylea的市场份额不断被压缩，即使Eylea HD保持高增长，但也被Eylea的下滑大幅冲减。三季报显示，Eylea系列总销售额在第三季度仅增长3%，达到15.4亿美元。进一步加剧市场担忧的是，安进的Eylea生物类似药Pavblu即将进入市场。此前，在诉讼中获胜的安进表示，计划尽快在美国推出Pavblu。这被视作今年美国制药行业最大的排他性损失。尽管再生元似乎对Eylea的表现并不太担忧，CEO在财报电话会议上强调公司的“强劲季度”，三季度收入为37.2亿美元，同比增长11%。包括PD-1单抗Libtayo在内的其他产品增速较快。但是，市场并不买单，这份财报发布当天，其股价大跌9.2%。至于Dupilumab，预期一再拔高，再生元获得的分成也不断增长，但考虑到总增速会被Eylea拖累，且其与赛诺菲“三七”分，目前能为公司贡献业绩的部分还需打个折扣。因此，要想坐稳千亿市值，仅靠这两个产品远无法达到预期。转型迫在眉睫。然而，再生元被寄予厚望的抗肿瘤业务，并不像自免、眼科那样光鲜。目前仅有一款抗肿瘤药物能排上号——Libtayo，但在一众PD-1单抗竞对，双抗也逐渐面世的市场中，也很难撑起再生元的门面。上半年，Libtayo销售额5.61亿美元，第三季度2.89亿美元，在距离首个适应症获批上市的第六年，终于有望突破10亿美元大关。十亿美元分子来之不易。这也是再生元抗肿瘤药物研发的缩影。 Libtayo之后，在抗肿瘤药物的研发布局上，再生元将很大一部分精力投入到双抗研发。2024年对于再生元来说，是非常关键的一年——两款双抗药物距离商业化只差临门一脚。但流年不利，Odronextamab、Linvoseltamab均被FDA拒之门外。尽管这并非是因为疗效和安全性问题，Odronextamab被拒的原因可以归结为FDA重新审视快速审批通道后的结果，Linvoseltamab则是因为不靠谱的第三方制造商。 FDA接连两次的拒绝，对再生元的双抗事业还是造成了一定的打击，也使得其在双抗领域中落后于强生、罗氏和艾伯维。直到8月底，Odronextamab成功在欧盟获批上市，才算迎来一个好消息。某种程度上，当市值冲上千亿美元后，市场对于再生元的未来走向，已经有了分歧。而当岌岌可危的增长，碰上专利诉讼失败，不及预期的三季报，进一步放大焦虑，造就了500亿美元的“惨案”。 / 03 / Big pharma之道这样的极速暴跌之下，有什么变化了吗？没有，一定程度上再生元仍是最优秀的生物科技企业之一。营收还在增长，研发并未懈怠，创始、研发灵魂人物也还在。只是，当大家把预期抬得过高，眼前的繁华会让大家忽视背后的风险，哪怕概率很低。创新药研发，自始至终都是一项风险高、不确定性高的事业。即使有着最优抗体技术的再生元，也不能保证自己的爆品成功率。更何况，在再生元的价值观中，“商业”是次之的，或者说商业是科学价值的附庸。而面对专利悬崖，几乎所有大药企都在不断买买买，希望为自己的未来增加筹码，并试图让投资者相信，下一个营收断层到来时，不会像看起来那么糟糕。再生元依旧保持着自己的节奏。“历史上有很多时候，人们做一些事情是因为他们有很大的商业机会，或是基于一种模棱两可的科学……很多以商业思维驱动业务的人只能看到这个行业已经走到了哪里，却很难看出这个行业应该走向何方……如果我们开发出了一款重要的药物，那么商业方面的问题也就迎刃而解了。这就是为什么永远要以科学为先（science should always lead）。”这是美国再生元的首席科学家George Yancopoulos博士，去年接受媒体采访时所说。这很再生元。在这一信条下，再生元研发出了Eylea、Dupilumab两大爆款。拥有平台技术优势的再生元也不止于此，自2015年之后，再生元几乎每年至少有一款药物（新适应症）获得FDA批准，至今已经上市（获得授权）的产品达11种，临床三期、二期的管线超20个。只是，这尚不能弥补市场对于专利悬崖和增长的焦虑。毕竟，新的重磅炸弹可遇不可求。再生元的经历也告诉我们，从biotech成为big pharma，只需要两款爆款。然而，要想坐稳这个位子，这还远远不够。正如任正非所说，要敢于打破自己的优势形成新的优势，最好的防御就是进攻。其实从艾伯维走出修美乐专利悬崖也能看出，药企保持积极的进攻态势，何其重要。这种进攻，既包括研发、并购，更涉及商业、专利方方面面。当然，再生元近两年也在不断进攻。尽管肿瘤进展乏善可陈，但其也在积极布局其他领域，比如减重、基因疗法等。减重是过去一年的研究热点，再生元则重点关注减重的质量，选择性减少脂肪含量，而减少肌肉含量的流失。目前已经启动了Trevogrumab联合Semaglutide±Garetosmab治疗肥胖症的临床2期研究。此外再生元还差异化布局了GPR75靶点，正在开发siRNA、小分子、抗体等多种靶向GPR75的药物。甚至在研发之外，再生元还做起了风投。4月，其宣布成立风险投资基金Regeneron Ventures，专注于有前景的生物制药、医疗保健和技术公司，其表示将在五年内每年投入1亿美元建立该基金。再生元正在变得更加开放，更加多元。只是，这还有待时间的验证。永远增长，永远焦虑。再生元或许正在试着重新理解big pharma之道。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

并购临床3期临床成功

2024-11-18

·GlobeNewswire-Health Care

Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU)

Nov. 15, 2024 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025. The resubmitted sBLA is supported by data from the multi-trial, LIBERTY-CUPID Phase 3 clinical program (Study A, Study B, and Study C) for Dupixent in CSU. The sBLA adds results from Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Study C, the second LIBERTY-CUPID pivotal trial in biologic-naïve patients, met its primary and key secondary endpoints confirming results seen in the previous Study A. Results showed Dupixent significantly reduced itch and urticaria activity (itch and hives). Safety results in all LIBERTY-CUPID Phase 3 trials were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥5%) compared to placebo were injection site reactions and COVID-19 infection. CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life. More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines. The LIBERTY-CUPID Phase 3 study program evaluating Dupixent for CSU consists of Study A, Study B, and Study C. Study A and Study C were conducted in CSU patients who were uncontrolled on standard-of-care antihistamines while Study B was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab. Dupixent has been approved for CSU in Japan and the United Arab Emirates (UAE) and is also under regulatory review in the European Union based on earlier trial readouts. Outside of Japan and the UAE, the safety and efficacy of Dupixent for CSU has not been fully evaluated by any regulatory authority. Dupixent, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of type 2 inflammation that play a major role in multiple related and often co-morbid diseases. Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, and chronic obstructive pulmonary disease in different age populations. More than 1,000,000 patients are currently being treated with Dupixent globally.1 Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. The content above comes from the network. if any infringement, please contact us to modify.

临床结果上市批准优先审批

2024-11-17

·药明康德

12个月患者总生存率超90%的抗癌联合疗法；治疗慢性HBV感染的表观遗传沉默剂进入临床…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. Cue Biopharma公司公布了其两款新型生物制品的积极临床数据，其中接受CUE-101联用PD-1抑制剂pembrolizumab一线治疗的HPV阳性复发性/转移性头颈部鳞状细胞癌（R/M HNSCC）患者12个月时的总生存率为91.3%。 2. 胸苷酸合成酶抑制剂NUC-3373联用pembrolizumab在一项临床研究中使1名尿路上皮膀胱癌患者的靶病灶缩小了100%。 3. 用于治疗慢性乙肝病毒（HBV）感染的表观遗传沉默剂TUNE-401在新西兰获批进入1b期临床试验。药明康德内容团队整理 CUE-101、CUE-102：公布1期临床试验的新数据 Cue Biopharma公司公布其CUE-101治疗头颈癌和CUE-102治疗WT1阳性癌症的1期临床试验的积极新数据。CUE-101是该公司开发的一款基于白细胞介素-2（IL-2）的T细胞诱导剂，旨在选择性调节和激活HPV阳性T细胞，以提高疗效，同时减少传统免疫疗法的副作用。CUE-102是一种由两个呈递WT1肽的人白细胞抗原（HLA）分子、四个亲和力减弱的IL-2分子和一个效应减弱的人免疫球蛋白G（IgG1）Fc结构域组成的新型生物制品，被开发作为单一疗法治疗WT1阳性复发/转移性癌症患者。截至2024年9月11日的数据，接受CUE-101联用PD-1抑制剂pembrolizumab一线治疗的HPV阳性R/M HNSCC患者的客观缓解率（ORR）为46%，疾病控制率（DCR）为75%，12个月时的总生存率为91.3%，中位总生存期（OS）为21.8个月。在历史研究KEYNOTE-048中，pembrolizumab单药治疗的ORR为19%，12个月时的总生存率为51%，中位OS为12.3个月。在本研究中，1例患者达到完全缓解（CR），10例患者达到部分缓解（PR），以及7例患者获得了超过12周的持久疾病稳定（SD）。接受该一线联合治疗的PD-L1低表达患者的ORR为50%。截至2024年10月29日的数据，接受CUE-102单药治疗的晚期胰腺癌患者的DCR为67%，其中包括肿瘤负荷减少40%的未确认的PR。有证据表明，WT1特异性CD8阳性T细胞受到了选择性刺激和扩增，而非特异性CD8阳性T细胞的总数没有明显增加。 NUC-3373：公布1b/2期联合治疗临床试验数据 NuCana公司公布了其正在进行的1b/2期模块化研究的初步数据，模块1研究评估了NUC-3373联用PD-1抑制剂pembrolizumab治疗晚期实体瘤患者的疗效，模块2研究评估了NUC-3373联用多西他赛治疗肺癌患者的疗效。NUC-3373是一种胸苷酸合成酶抑制剂，由核苷类似物5-氟尿嘧啶衍生而来，可导致DNA损伤。模块1包括12名患有各种实体瘤、已用尽所有其他治疗方案的患者，其中9例患者曾接受过PD-1/PD-L1抑制剂的治疗。接受NUC-3373联用pembrolizumab治疗后，患者实现了显著的肿瘤体积缩小，PFS得到延长。2名患者获得了确认的PR，4例患者达到SD。在疗效可评估人群中，ORR为22%，DCR为67%。其中，1例尿路上皮膀胱癌患者接受联合治疗后靶病灶缩小了100%（非靶病灶依然存在），1例BRAF突变转移性皮肤黑色素瘤患者的靶病灶缩小了81%。此外，NUC-3373联合pembrolizumab的耐受性普遍良好。模块2包括4名非小细胞肺癌（NSCLC）或胸膜间皮瘤患者，这些患者在既往含化疗方案中出现疾病进展或无法耐受。患者在接受NUC-3373联用多西他赛治疗后PFS得到延长，2例患者实现了长期的SD。 TUNE-401：在新西兰获批启动1b期临床试验 Tune Therapeutics公司宣布，该公司已获得新西兰药品和医疗器械安全局（Medsafe）的临床试验申请（CTA）批准，将推进其用于治疗慢性HBV感染的表观遗传沉默剂TUNE-401进入1b期临床试验。 TUNE-401是一款潜在"first-in-class"的表观遗传沉默剂，利用Tune Therapeutics的多功能、模块化TEMPO平台所开发。TUNE-401通过脂质纳米颗粒（LNP）将编码活性、HBV靶向的RNA直接递送至肝细胞。在这些细胞内，所递送的RNA被翻译为表观沉默蛋白，靶向整合入宿主细胞的乙肝病毒DNA（intDNA）和共价闭合环状DNA（cccDNA）。cccDNA是一种独特、游离的环状染色体（episomes），可作为病毒进行复制时的模板，是造成HBV患者多年持续感染的原因之一。临床医生认为，关闭这些cccDNA“病毒工厂”是实现HBV功能性治愈的必要前提。TUNE-401不涉及切割或编辑DNA，其导致产生的活性表观沉默蛋白通过添加甲基基团与DNA结合，以抑制或失活病毒基因，同时保持人类基因的完整性。根据新闻稿，TUNE-401是首个获批进入临床，用以治疗常见传染病的表观遗传疗法。 KVA12123：公布1/2期临床试验数据 Kineta公司公布了其正在进行的1/2期临床试验的最新进展，该试验评估了其新型在研VISTA阻断免疫疗法KVA12123单药或与PD-1抑制剂pembrolizumab联用在晚期实体瘤患者中的治疗效果。KVA12123是一种单克隆抗体疗法，需每周输注两次。通过将独特的表位与优化的IgG1 Fc区相结合，KVA12123单药在临床前模型中显示出强大的肿瘤生长抑制作用，且在临床试验中没有报告细胞因子释放综合征（CRS）。KVA12123已被证明能降低VISTA靶点的风险，并提供了一种新的方法来解决肿瘤微环境中的免疫抑制问题，其作用机制与以T细胞为重点的疗法不同且互补。截至2024年10月18日的数据，接受KVA12123单药治疗并至少进行了一次随访扫描的19例患者中，有13名实现了SD。在许多接受KVA12123单药治疗的患者中观察到持久的临床结果，其中1名此前已接受过六线治疗（包括免疫检查点抑制剂治疗）的NSCLC患者已保持SD状态60周。在接受KVA12123联合pembrolizumab治疗并至少进行了一次随访扫描的9例患者中，1例粘液表皮样癌患者获得了PR，靶病灶缩小了54%，非靶病灶获得了CR；1名免疫检查点抑制剂治疗后进展的肾细胞癌患者达到SD，靶病灶缩小了24%。安全性方面，KVA12123的耐受性良好，单药或与pembrolizumab联用在任何剂量水平上都未出现剂量限制性毒性（DLT）。 IDRX-42：公布1/1b期临床试验的新数据 IDRx公司公布了其用于治疗晚期胃肠道间质瘤（GIST）的在研口服小分子KIT酪氨酸激酶抑制剂IDRX-42的1/1b期临床试验数据。IDRX-42旨在选择性地靶向最常见的KIT突变形式，这些突变要么驱动肿瘤细胞的初始生长、增殖和生存，要么使肿瘤对现有疗法产生耐药性。截至2024年9月30日的数据，87例中位治疗线数为四线、疗效可评估患者的ORR为29%，包括1例CR和24例PR。接受IDRX-42作为二线治疗患者的ORR为53%（8/15），包括1例CR和7例PR，这些患者的中位PFS尚未达到。接受IDRX-42作为三线治疗的患者的中位PFS估计为12.9个月。既往未使用过ripretinib、接受IDRX-42作为≥四线治疗的患者在推荐的1b期剂量下，其中位PFS估计为11.0个月。此外，IDRX-42具有良好的安全性，在推荐的1b期剂量下，8%的患者减少了剂量，没有因治疗伴发不良事件而停药的情况。 APV-527：公布1期临床试验数据 Alligator Bioscience公司和Aptevo Therapeutics公司公布了APV-527用于治疗可能表达肿瘤抗原5T4实体瘤患者的1期临床试验数据。APV-527是一种靶向4-1BB和肿瘤抗原5T4的双特异性抗体，仅在与4-1BB和5T4同时结合时才有活性。此次公布的结果显示，16例疗效可评估的患者中有9例（56%）达到SD，其中，1例结肠癌患者已保持SD超过6个月。最长的SD持续时间发生在一名乳腺癌患者中，该患者进入研究时病情发生进展，目前病情保持稳定，且已参与研究超过11个月。安全性方面，APV-527在所有队列中均表现出积极的安全性和耐受性，尚未观察到严重的肝毒性。肝毒性是其他4-1BB靶向治疗的常见副作用，可导致患者停药。 ELI-002：公布1期临床试验的初步数据 Elicio Therapeutics公司公布了其在研治疗性癌症免疫疗法ELI-002用于治疗接受标准局部治疗后仍有疾病复发风险的KRAS突变驱动实体瘤的1期临床试验的初步结果。ELI-002由AMP修饰的KRAS突变体（mKRAS）肽段，和一种AMP修饰的免疫刺激寡核苷酸佐剂ELI-004组成，经皮下给药靶向淋巴结。它能产生RAS特异性杀伤性T细胞，以攻击术后残留肿瘤细胞，有望延长癌症患者缓解并可预防未来复发。初步数据表明，靶向KRAS突变体的T细胞反应持久且呈剂量依赖性，并诱导了针对患者特异性新抗原的反应。观察到无病生存期（DFS）与T细胞反应强度之间存在相关性。此外，ELI-002的1期安全性及耐受性特征依然良好，未观察到DLT或CRS。 GUBamy：公布1期临床试验数据 Gubra公司公布了长效胰淀素（amylin）类似物GUBamy在单剂量递增（SAD）1期临床试验中获得的积极结果。GUBamy耐受性良好，表现出良好的药代动力学特征，半衰期为11天，支持每周一次的给药方案。此外，单剂量的GUBamy剂量依赖性地降低体重，这一效果在试验期间（6周）内持续存在。在所有高剂量组（3.5-6.0 mg）中，受试者在6周试验期内的平均体重下降约3％，而安慰剂组的体重平均增长约1％。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Tune Therapeutics Moves into Clinical Spotlight with TUNE-401: A First-in-Class Epigenetic Silencer for Hepatitis B. 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Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/11/2978266/0/en/CG-Oncology-Announces-Nature-Medicine-Publication-of-Phase-1b-Study-Results-Evaluating-Cretostimogene-Grenadenorepvec-in-Combination-with-Nivolumab-in-Muscle-Invasive-Bladder-Cance.html [15] Next Generation Gene Therapeutics (NGGT) Announces Positive New Data on NGGT002 for the Treatment of Phenylketonuria (PKU). Retrieved November 15, 2024, from https://www.prnewswire.com/news-releases/next-generation-gene-therapeutics-nggt-announces-positive-new-data-on-nggt002-for-the-treatment-of-phenylketonuria-pku-302300911.html [16] Fate Therapeutics Highlights Cancer-selective, HER2-Targeting Profile of FT825 / ONO-8250 CAR T-cell Product Candidate for Treatment of Advanced Solid Tumors at 2024 SITC Annual Meeting. Retrieved November 15, 2024, from https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-highlights-cancer-selective-her2-targeting [17] Neurogene Reports Positive Interim Efficacy Data from First Four Low-Dose Pediatric Participants in NGN-401 Gene Therapy Clinical Trial for Rett Syndrome. Retrieved November 15, 2024, from https://ir.neurogene.com/news-releases/news-release-details/neurogene-reports-positive-interim-efficacy-data-first-four-low [18] IND for ATA-200, a Gene Therapy for the Treatment of Limb-Girdle Muscular Dystrophy Type 2C/R5 (LGMD2C/R5), cleared to proceed by FDA. Retrieved November 15, 2024, from https://www.businesswire.com/news/home/20241112690214/en/IND-for-ATA-200-a-Gene-Therapy-for-the-Treatment-of-Limb-Girdle-Muscular-Dystrophy-Type-2CR5-LGMD2CR5-cleared-to-proceed-by-FDA [19] Nammi Therapeutics, Inc. Announces First Patient Dosed with QXL138AM in a Phase 1 Study Evaluating Advanced Solid Tumors and Multiple Myeloma. Retrieved November 15, 2024, from https://www.prnewswire.com/news-releases/nammi-therapeutics-inc-announces-first-patient-dosed-with-qxl138am-in-a-phase-1-study-evaluating-advanced-solid-tumors-and-multiple-myeloma-302299498.html [20] Palleon Pharmaceuticals Presents Results from the Phase 1/2 GLIMMER-01 Trial of E-602 in Combination with Cemiplimab in Patients with Solid Tumors at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. Retrieved November 15, 2024, from https://www.businesswire.com/news/home/20241108273263/en/Palleon-Pharmaceuticals-Presents-Results-from-the-Phase-12-GLIMMER-01-Trial-of-E-602-in-Combination-with-Cemiplimab-in-Patients-with-Solid-Tumors-at-the-Society-for-Immunotherapy-of-Cancer-SITC-Annual-Meeting/ [21] Cerevance’s CVN293 Demonstrated Positive Phase 1 Results in Healthy Volunteers. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/11/2978299/0/en/Cerevance-s-CVN293-Demonstrated-Positive-Phase-1-Results-in-Healthy-Volunteers.html [22] Cytokinetics Announces Initiation of Phase 1 Clinical Study of CK-4015089. Retrieved November 15, 2024, from https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-announces-initiation-phase-1-clinical-study-ck-2#:~:text=SOUTH%20SAN%20FRANCISCO%2C%20Calif.%2C%20Nov.%2011%2C%202024%20%28GLOBE,study%20of%20CK-4015089%20%28CK-089%29%20in%20healthy%20human%20participants. [23] EnteroBiotix Announces Positive Ph1b Clinical Results of EBX-102 in Liver Cirrhosis. Retrieved November 15, 2024, from https://www.enterobiotix.com/news/enterobiotix-positive-clinical-results-ebx-102-liver-cirrhosis [24] GenVivo to Present Phase 1 Trial Results for GEN2, A Personalizing Gene Vector Therapy, at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Retrieved November 15, 2024, from https://genvivoinc.com/2024/11/08/genvivo-to-present-phase-1-trial-results-for-gen2-a-personalizing-gene-vector-therapy-at-the-2024-society-for-immunotherapy-of-cancer-sitc-annual-meeting/ [25] Sparian Biosciences Announces Results from the Phase 1 Clinical Trial of First in Class Novel Arylepoxamide Receptor (AEAr) Agonist Analgesic SBS-1000. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/12/2979419/0/en/Sparian-Biosciences-Announces-Results-from-the-Phase-1-Clinical-Trial-of-First-in-Class-Novel-Arylepoxamide-Receptor-AEAr-Agonist-Analgesic-SBS-1000.html [26] Spyre Therapeutics Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for SPY001, Its Novel Half-Life Extended anti-α4β7 Antibody for the Treatment of Inflammatory Bowel Disease, with a Half-Life of >90 Days Supporting the Potential for Both Q3M & Q6M Maintenance Dosing. Retrieved November 15, 2024, from https://www.prnewswire.com/news-releases/spyre-therapeutics-announces-positive-interim-results-from-phase-1-healthy-volunteer-trial-for-spy001-its-novel-half-life-extended-anti-47-antibody-for-the-treatment-of-inflammatory-bowel-disease-with-a-half-life-of-90-days-s-302302014.html [27] Nuvectis Pharma Reports Encouraging NXP800 Interim Data Supporting Ongoing Enrollment in Phase 1b Study in Patients with Platinum-Resistant ARID1a-Mutated Ovarian Cancer. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/14/2981017/0/en/Nuvectis-Pharma-Reports-Encouraging-NXP800-Interim-Data-Supporting-Ongoing-Enrollment-in-Phase-1b-Study-in-Patients-with-Platinum-Resistant-ARID1a-Mutated-Ovarian-Cancer.html [28] Enlivex Announces the Dosing of the First Patient in a Phase I Clinical Trial Evaluating Allocetra in Patients with Psoriatic Arthritis. Retrieved November 15, 2024, from https://enlivex.com/investors/news-releases/enlivex-announces-the-dosing-of-the-first-patient-in-a-phase-i-clinical-trial-evaluating-allocetra-in-patients-with-psoriatic-arthritis/#:~:text=Nes-Ziona%2C%20Israel%2C%20Nov.%2014%2C%202024%20%E2%80%94%20Enlivex%20Therapeutics,an%20affected%20joint%20in%20patients%20with%20psoriatic%20arthritis. 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床2期临床结果免疫疗法临床1期

100 项与塞普利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	塞普利单抗	L01XC33	DB14707

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
基底细胞癌	挪威	Regeneron Pharmaceuticals, Inc.	2019-06-28
基底细胞癌	欧盟	Regeneron Pharmaceuticals, Inc.	2019-06-28
基底细胞癌	冰岛	Regeneron Pharmaceuticals, Inc.	2019-06-28
基底细胞癌	列支敦士登	Regeneron Pharmaceuticals, Inc.	2019-06-28
局部晚期非小细胞肺癌	列支敦士登	Regeneron Pharmaceuticals, Inc.	2019-06-28
局部晚期非小细胞肺癌	挪威	Regeneron Pharmaceuticals, Inc.	2019-06-28
局部晚期非小细胞肺癌	欧盟	Regeneron Pharmaceuticals, Inc.	2019-06-28
局部晚期非小细胞肺癌	冰岛	Regeneron Pharmaceuticals, Inc.	2019-06-28
转移性基底细胞癌	列支敦士登	Regeneron Pharmaceuticals, Inc.	2019-06-28
转移性非小细胞肺癌	挪威	Regeneron Pharmaceuticals, Inc.	2019-06-28
转移性非小细胞肺癌	欧盟	Regeneron Pharmaceuticals, Inc.	2019-06-28
转移性非小细胞肺癌	冰岛	Regeneron Pharmaceuticals, Inc.	2019-06-28
转移性非小细胞肺癌	列支敦士登	Regeneron Pharmaceuticals, Inc.	2019-06-28
非小细胞肺癌	冰岛	Regeneron Pharmaceuticals, Inc.	2019-06-28
非小细胞肺癌	挪威	Regeneron Pharmaceuticals, Inc.	2019-06-28
非小细胞肺癌	列支敦士登	Regeneron Pharmaceuticals, Inc.	2019-06-28
非小细胞肺癌	欧盟	Regeneron Pharmaceuticals, Inc.	2019-06-28
局部晚期头颈部皮肤鳞状细胞癌	加拿大	Sanofi-Aventis Canada, Inc.	2019-04-10
鳞状细胞癌	加拿大	Sanofi-Aventis Canada, Inc.	2019-04-10
皮肤鳞状细胞癌	美国	Regeneron Pharmaceuticals, Inc.	2018-09-28

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
宫颈癌	申请上市	欧盟	Regeneron Pharmaceuticals, Inc.	2022-10-18
转移性非小细胞肺癌	临床3期	中国台湾	Sanofi	2017-05-29
转移性非小细胞肺癌	临床3期	白俄罗斯	Sanofi	2017-05-29
转移性非小细胞肺癌	临床3期	捷克	Sanofi	2017-05-29
转移性非小细胞肺癌	临床3期	巴西	Regeneron Pharmaceuticals, Inc.	2017-05-29
转移性非小细胞肺癌	临床3期	澳大利亚	Regeneron Pharmaceuticals, Inc.	2017-05-29
转移性非小细胞肺癌	临床3期	土耳其	Sanofi	2017-05-29
转移性非小细胞肺癌	临床3期	波兰	Sanofi	2017-05-29
转移性非小细胞肺癌	临床3期	泰国	Regeneron Pharmaceuticals, Inc.	2017-05-29
转移性非小细胞肺癌	临床3期	巴西	Sanofi	2017-05-29

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05208944 (THIO-101, SITC2024) 人工标引	临床2期	非小细胞肺癌	69	THIO 180mg dose +cemiplimab (3rd-line)	(範餘鹽襯壓鏇繭糧繭選) = 鬱襯鬱夢鑰範簾鹹襯齋襯膚網鑰構淵夢獵選範 (壓範顧製選膚顧夢憲醖 ) 更多	积极	2024-11-06
NCT05259696 (GLIMMER-01, SITC2024) 人工标引	临床1/2期	实体瘤	21	E-602 20 mg/kg + cemiplimab 350 mg	(繭簾製齋觸窪簾鹹淵積) = 衊醖範餘網簾獵齋齋觸夢淵廠鬱選膚鏇夢鏇淵 (簾窪蓋鹽鹽膚築繭衊鏇 ) 更多	积极	2024-11-05
NCT04646005 (CTgov)	临床2期	复发性宫颈癌 \| 转移性宫颈癌	113	Cemiplimab+ISA 101b	(齋遞範選夢顧遞製憲網) = 願醖齋鹽製觸遞顧蓋鹹鏇窪膚構淵遞壓廠窪膚 (壓艱顧構構積鬱齋醖網, 窪網鏇壓積襯繭製淵選 ~ 廠網簾遞鏇膚鏇製蓋選) 更多	-	2024-09-19
NCT03005782 (ESMO2024) 人工标引	N/A	黑色素瘤 \|	98	fianlimab 1600 mg + cemiplimab 350 mg	(構襯憲鏇襯網積衊襯鬱) = 鏇簾衊膚鬱廠繭廠糧製獵壓糧構蓋蓋壓廠觸製 (鬱鹹衊構鬱積膚選願鑰 ) 更多	积极	2024-09-14
NCT04722523 (ESMO2024) 人工标引	临床1期	局部晚期头颈部鳞状细胞癌新辅助	30	Cemiplimab + platinum-doublet chemotherapy + cetuximab	(築鬱齋鬱獵淵衊襯願鹹) = 壓築艱糧範廠選壓獵顧醖願積網觸襯餘齋鬱網 (鬱蓋範齋淵壓蓋獵糧鬱 ) 更多	积极	2024-09-14
ESMO2024	N/A	局部晚期非小细胞肺癌	-	Cemiplimab monotherapy	範鹽齋築鹹簾淵鑰淵顧(顧選衊廠獵築簾鏇淵網) = Any-grade treatment-related adverse events (TRAEs) occurred in 98.3% vs 100.0% of pts treated with Cemiplimab monotherapy vs Cemiplimab in combination with chemotherapy 齋製築網夢襯網窪構鑰 (壓簾願選膚築憲範衊構 ) 更多	-	2024-09-14
ESMO2024	N/A	局部晚期非小细胞肺癌	-	Cemiplimab in combination with chemotherapy		-	2024-09-14
ESMO2024	N/A	皮肤鳞状细胞癌	-	Neoadjuvant cemiplimab	(襯範窪齋廠淵廠構齋選) = 25% had ≥1 grade 3 or 4 treatment-emergent adverse event (TEAE) 蓋膚觸網選餘簾糧選顧 (鑰構襯觸鹹壓製選築餘 )	-	2024-09-14
WCLC2024 人工标引	N/A	PD-L1阳性非小细胞肺癌	102	Cemiplimab alone	(膚簾壓衊獵鹽夢艱廠糧) = 願遞鏇範鑰繭獵窪衊鑰壓糧衊膚範觸繭餘繭糧 (選範艱觸獵簾簾鬱鹽艱 ) 更多	积极	2024-09-09
EMPOWER-Lung1 (WCLC2024) 人工标引	临床3期	非小细胞肺癌 PD-L1 ≥50%	565	Cemiplimab	(簾顧繭願襯鏇膚齋窪襯) = 願蓋艱蓋醖選餘鏇憲獵齋願簾選憲範淵製鬱夢 (鏇鬱膚餘齋積範鑰遞窪, 22.1 ~ 31.9) 更多	积极	2024-09-09
EMPOWER-Lung1 (WCLC2024) 人工标引	临床3期	非小细胞肺癌 PD-L1 ≥50%	565	Chemotherapy	(簾顧繭願襯鏇膚齋窪襯) = 鹹膚齋鏇繭觸獵鬱範淵齋願簾選憲範淵製鬱夢 (鏇鬱膚餘齋積範鑰遞窪, 10.5 ~ 16.2) 更多	积极	2024-09-09
NCT04526899 (BNT111-01, GlobeNewswire) 人工标引	临床2期	黑色素瘤	-	BNT111 +cemiplimab	(繭簾淵鹽鹹夢廠構鬱繭) = The trial met its primary efficacy outcome measure, demonstrating a statistically significant improvement in ORR in patients treated with BNT111 in combination with cemiplimab as compared to historical control in this indication and treatment setting. 淵鹹淵壓廠鹹鏇鹽範衊 (觸餘糧遞構艱艱鬱獵憲 ) 达到更多	积极	2024-07-30
NCT04526899 (BNT111-01, GlobeNewswire) 人工标引	临床2期	黑色素瘤	-	BNT111		积极	2024-07-30