This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.

开始日期2025-05-30

申办/合作机构

Alliance for Clinical Trials in Oncology

[+1]

NCT06680258 / Not yet recruiting临床3期

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of TPST-1120 in Combination With Atezolizumab Plus Bevacizumab Compared With Placebo Plus Atezolizumab Plus Bevacizumab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma (HCC) Not Previously Treated With Systemic Therapy

The goal of this clinical trial is to determine if TPST-1120 in combination with atezolizumab and bevacizumab helps patients to live longer compared to atezolizumab and bevacizumab alone (the standard of care treatment) in adult patients with hepatocellular carcinoma that cannot be removed by surgery or has spread outside of the liver (called metastatic). The trial also will study the safety and side effects of the drug combination compared to the standard of care treatment. Other questions the trial aims to answer include:
1. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the time that patients are alive and cancer is not growing (progression free survival) compared to atezolizumab and bevacizumab
2. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the shrinking of cancer (the overall response rate) compared to atezolizumab and bevacizumab
Trial participants will be randomly assigned to take one of the following:
1. TPST-1120 3 tablets (600 mg) by mouth twice a day every day along with atezolizumab 1200 mg intravenously every 3 weeks and bevacizumab 15 mg/kg intravenously every 3 weeks
2. Placebo (look-alike that does not contain study drug) 3 tablets by mouth twice a day every day along with atezolizumab 1200 mg intravenously once every 3 weeks and bevacizumab 15 mg/kg intravenously once every 3 weeks
Trial participants will receive routine and trial-specific cancer care from their study doctor including
* visits to the clinic every 3 weeks for physical examination, labs and questions about health and symptoms
* measurement of their cancer by CT scan every 9 weeks.
Trial participants can stop study treatment at any time they choose and for any reason. They also can continue to receive study treatment for as long as the treatment is controlling cancer growth and they are tolerating the drug effects.

开始日期2025-03-29

申办/合作机构

Tempest Therapeutics, Inc.

[+1]

NCT06294548 / Not yet recruiting临床1/2期IIT

A Phase Ib/II, Dose Escalation and Dose Expansion Study of Valemetostat Tosylate (DS-3201b) with Atezolizumab and Bevacizumab in Advanced Hepatocellular Carcinoma (HCC)

This is a phase Ib/II, dose escalation and dose expansion study of valemetostat (DS-3201) with atezolizumab and bevacizumab in patients advanced Hepatocellular carcinoma (HCC) who did not receive prior systemic therapy for advanced HCC.

开始日期2024-12-31

申办/合作机构

The University of Alabama at Birmingham

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100 项与阿替利珠单抗相关的专利（医药）

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项与阿替利珠单抗相关的文献（医药）

2024-12-31·Human vaccines & immunotherapeutics

Exploration of genetic characterization in hyperprogressive disease after immunotherapy retreatment in a patient with LCNEC: A case report

Article

作者: Chen, Jialu ; Yang, Jiayao ; Zhang, Yao ; Shou, Liumei ; Shu, Qijin ; Shao, Tianyu

Immune checkpoint inhibitors (ICIs) have emerged as a promising therapeutic option for large cell neuroendocrine carcinoma (LCNEC). However, various studies have suggested a potential risk of hyperprogressive disease (HPD) in patients receiving ICI, which might be associated with gene alterations. Here, this is the first report on an unknown primary LCNEC patient who had achieved a long-term response from ICI treatment (atezolizumab), but developed HPD after tumor progression due to receiving another ICI agent (serplulimab). The mutation region of FAT4, SMARCA4, CYLD, CTNNB1, and KIT was altered prior to serplulimab treatment compared to before atezolizumab treatment. This case suggested a potential association between these mutated genes and HPD. Patients with the aforementioned genes should caution when selecting ICI treatment. These findings required further confirmation in a larger study cohort.

2024-12-31·Cancer biology & therapy

Understanding and overcoming resistance to immunotherapy in genitourinary cancers

Review

作者: Yildirim, Ahmet ; Kalemoglu, Ecem ; Evans, Sean T ; Jani, Yash ; Bilen, Mehmet Asim ; Jansen, Caroline S

The introduction of novel immunotherapies has significantly transformed the treatment landscape of genitourinary (GU) cancers, even becoming the standard of care in some settings. One such type of immunotherapy, immune checkpoint inhibitors (ICIs) like nivolumab, ipilimumab, pembrolizumab, and atezolizumab play a pivotal role by disturbing signaling pathways that limit the immune system's ability to fight tumor cells. Despite the profound impact of these treatments, not all tumors are responsive. Recent research efforts have been focused on understanding how cancer cells manage to evade the immune response and identifying the possible mechanisms behind resistance to immunotherapy. In response, ICIs are being combined with other treatments to reduce resistance and attack cancer cells through multiple cellular pathways. Additionally, novel, targeted strategies are currently being investigated to develop innovative methods of overcoming resistance and treatment failure. This article presents a comprehensive overview of the mechanisms of immunotherapy resistance in GU cancers as currently described in the literature. It explores studies that have identified genetic markers, cytokines, and proteins that may predict resistance or response to immunotherapy. Additionally, we review current efforts to overcome this resistance, which include combination ICIs and sequential therapies, novel insights into the host immune profile, and new targeted therapies. Various approaches that combine immunotherapy with chemotherapy, targeted therapy, vaccines, and radiation have been studied in an effort to more effectively overcome resistance to immunotherapy. While each of these combination therapies has shown some efficacy in clinical trials, a deeper understanding of the immune system's role underscores the potential of novel targeted therapies as a particularly promising area of current research. Currently, several targeted agents are in development, along with the identification of key immune mediators involved in immunotherapy resistance. Further research is necessary to identify predictors of response.

2024-12-31·OncoImmunology

ADA/CD26 axis increases intra-tumor PD-1 ⁺ CD28 ⁺ CD8 ⁺ T-cell fitness and affects NSCLC prognosis and response to ICB

Article

作者: Panetta, Mariangela ; D'Andrea, Daniel ; Visca, Paolo ; Sperduti, Isabella ; Nisticò, Paola ; Campo, Giulia ; Frisullo, Giuseppe ; Franzese, Ornella ; Palermo, Belinda ; Taje, Riccardo

Improving cancer immunotherapy efficacy hinges on identifying key T-cell populations critical for tumor control and response to Immune Checkpoint Blockade (ICB). We have recently reported that while the co-expression of PD-1 and CD28 is associated with impaired functionality in peripheral blood, it significantly enhances T-cell fitness in the tumor site of non-small cell lung cancer (NSCLC) patients. To uncover the underlying mechanisms, we explored the role of CD26, a key player in T-cell activation through its interaction with adenosine deaminase (ADA), a crucial intra/extracellular enzyme able to neutralize local adenosine (ADO). We found that an autocrine ADA/CD26 axis enhances CD8⁺PD-1⁺CD28⁺ T-cell function, particularly within an immunosuppressive environment marked by CD39 expression. Then, we interrogated the TCGA and OAK datasets to gain insight into the prognostic/predictive potential of our findings. We identified a signature predicting overall survival (OS) in LUAD patients and response to atezolizumab in advanced LUAD cases. These findings suggest promising avenues for therapeutic intervention targeting the ADA/CD26 axis.

1,862

项与阿替利珠单抗相关的新闻（医药）

16 小时之前

·ioncology

例例在望丨首例DLL3阳性肺类癌患者对Tarlatamab有治疗反应的报告

点击蓝字关注我们例例在望微专辑扫描二维码可查看更多内容 Tarlatamab是一种靶向DLL3的双特异性T细胞接合剂，已迅速成为晚期广泛期小细胞肺癌（SCLC）的后线治疗的新标准。本文介绍一名转移性非典型类癌患者的病例，该患者在既往接受多种治疗后疾病进展，DLL3蛋白高表达，并对Tarlatamab治疗有临床应答。该病例表明，Tarlatamab可能是其他肺神经内分泌癌的有效选择。肺类癌是肺神经内分泌肿瘤的一种罕见亚型，约占成人肺恶性肿瘤的1-2%。根据有丝分裂计数和有无坏死，肿瘤被分为“典型类癌”（低级别）或“非典型类癌”（中级别）。典型类癌通常惰性生长，转移发生率不高，而非典型类癌可能更具侵袭性，肿瘤生长和播散更快。对于被诊断为转移性肺类癌的患者，指南推荐的治疗方案很少，而且通常治疗缓解率较低[1,2,3]。DLL3表达通常见于高级别神经内分泌癌，例如小细胞肺癌（SCLC），但DLL3表达也发生于30%-40%的肺类癌[4]。因此，新型DLL3靶向药为SCLC以外的肺神经内分泌癌患者的有效治疗带来了新希望。例如，研究显示obrixtamig（DLL3靶向T细胞接合剂）治疗10名大细胞神经内分泌癌患者，其中7名产生客观缓解[5]。本文报告一例对多种疗法均耐药的转移性非典型类癌病例，其肿瘤强烈表达DLL3，并对Tarlatamab治疗产生强烈的临床反应。病例介绍一名61岁的女性，无吸烟史，既往有甲状腺功能减退症病史，在过去十个月内出现咳嗽和呼吸困难加重。胸部CT扫描发现一个5 cm肿块侵入纵隔，累及支气管，隆突下淋巴结肿大。利用超声支气管镜（EBUS）对右主支气管内肿块和隆突下淋巴结进行活检，发现肿瘤，最初诊断为小细胞肺癌。随后，患者来到弗吉尼亚大学癌症中心就诊。脑部MRI发现一个2 mm病变，性质不确定。FDG-PET/CT显示已知胸部肿块为高代谢，左肾上腺小结节存在不确定的摄取。多学科胸部肿瘤委员会一致认为可能是IV期（广泛期）疾病，因此给予患者卡铂、依托泊苷和阿替利珠单抗治疗。鉴于患者从不吸烟，在开始全身治疗前一天，介入肺病学部门开展进一步检查，并进行了更多活检和右主支气管清创。病理学结果更符合非典型类癌（中等Ki-67增殖指数[30%]，RB基因保留，p53表达野生型）。血清嗜铬粒蛋白A升高至158。PET/dotatate显示原发病变和右锁骨上淋巴结的摄取增加，而没有其他部位摄取的确凿证据。值得注意的是，左肾上腺没有异常摄取。患者被诊断为IIIC期非典型类癌，需要局部疾病控制，没有肿瘤转移的确凿证据。患者从第2周期开始同步放疗，并停用阿替利珠单抗。化疗和放疗完成后，CT显示肿瘤大小无变化，但有右主支气管的软组织增厚，并伴有咳嗽加剧。患者再次接受了支气管镜检查，包括肿瘤清创和氩气刀。右主支气管组织显示非典型类癌残留，EBUS活检显示转移性类癌，Ki-67为16.4%。鉴于存在残留病灶，患者开始每月注射长效释放奥曲肽（LAR）。不幸的是，在开始使用奥曲肽四个月后，PET/Dotatate显示发生多处新的骨转移和新的左腋窝淋巴结增大。对左腋窝淋巴结进行活检并证实为非典型类癌转移。脑部MRI发现10个新的转移瘤，均≤1cm。在患者初次确诊后11个月（图1），基于其癌症具有侵袭性临床特征和先前文献记录的肺类癌中DLL3表达，患者开始接受Tarlatamab治疗。治疗开始后进行了DLL3免疫组化检查，结果显示100%的细胞均强烈表达（图2）。图1 图2 在Tarlatamab治疗第1周期第3天，针对脑转移瘤接受了立体定向放射外科（SRS）治疗。Tarlatamab治疗6周后CT显示产生治疗反应，左腋窝淋巴结从1.5 cm缩小到0.9 cm，左肾上腺结节从1.3 cm缩小到0.5 cm（图3，A-D）。先前放疗的右侧气管旁肿块从2.4 cm缩小到1.9 cm，隆突下淋巴结从1.6 cm缩小到1.1 cm。第12周的PET/Dotatate成像（图3E-F）显示右肺门肿块、左肾上腺结节和左腋窝淋巴结进一步减小。右侧气管旁的标准摄取值（SUV）从基线6.4降至4.7，左腋窝从2.2降至1.3，左额颅骨病变从2.4降至1.2。不幸的是，脑部MRI发现了两个非常小的新病变，采用SRS治疗第二疗程，并继续使用Tarlatamab。在前四个疗程的Tarlatamab治疗中，没有发生细胞因子释放综合征（CRS）或免疫效应细胞相关神经毒性综合征（ICANS）。第1疗程期间出现了1级疲劳，现已缓解，1级味觉障碍一直持续存在。图3 讨论今年5月，FDA加速批准Tarlatamab用于治疗在铂类化疗期间或之后疾病进展的广泛期小细胞肺癌，为SCLC患者的治疗带来了革命性的变化。鉴于除SCLC外的其他临床侵袭性神经内分泌肿瘤的有效疗法有限，有必要将这种新研发的疗法应用于可能受益的患者。虽然DLL3表达高可能在本病例中对Tarlatamab的治疗活性产生了影响，但尚不清楚产生临床获益需要什么水平的DLL3。一些病例报告（包括本病例）显示这类新疗法治疗非典型类癌的临床活性有前景（尽管随访时间有限），为开展进一步研究提供了依据，进而扩大这些新疗法的适应症。结论本病例证明，Tarlatamab在表达DLL3的非典型类癌患者中具有临床活性。该病例凸显了需要进一步研究Tarlatamab在治疗方案有限的罕见肺神经内分泌癌中的应用。参考文献（上下滑动可查看） 1. Yao JC, Fazio N, Singh S, et al. Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract （RADIANT-4）: a randomised, placebo-controlled, phase 3 study. Lancet. 2016 Mar 5;387（10022）:968-977. doi: 10.1016/S0140-6736（15）00817-X. 2. Chong CR, Wirth LJ, Nishino M, et al. Chemotherapy for locally advanced and metastatic pulmonary carcinoid tumors. Lung Cancer. 2014;86（2）:241-6. doi: 10.1016/j.lungcan.2014.08.012. 3. Crona J, Fanola I, Lindholm DP, et al. Effect of temozolomide in patients with metastatic bronchial carcinoids. Neuroendocrinology. 2013;98（2）:151-5. doi: 10.1159/000354760. Journal Pre-proof 4. Xie H, Boland JM, Maleszewski JJ, et al. Expression of delta-like protein 3 is reproducibly present in a subset of small cell lung carcinomas and pulmonary carcinoid tumors. Lung Cancer. 2019 Sep:135:73-79. doi: 10.1016/j.lungcan.2019.07.016. 5. Wermke M, Gambardella V, Koboki Y, et al. Phase I Trial of DLL3/CD3 IgG-Like T-Cell Engager BI 764532 in Patients with DLL3-Positive Tumors: Patients with LCNEC. IASLS 2024 World Conference on Lung Cancer. San Diego, CA. September 7-10, 2024. Abstract: OA10.05. （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。

免疫疗法

2024-11-08

·医脉通

2024进博会 | 多层次保障助力新生论坛暨多元生态合作仪式盛大召开！探索更多创新支付可能，缓解患者经济负担，优化诊疗体验

金秋送爽，丹桂飘香。2024年多层次保障助力新生论坛暨多元生态合作仪式于2024年11月7日在上海国家会展中心隆重召开，恰逢第七届中国国际进口博览会（简称“进博会”）期间。此次论坛聚焦于解决当前疾病诊疗过程中的难题，旨在实现患者的可支付性和药物的可及性，减轻患者家庭的经济负担，推动我国多层次医疗保障体系的进一步完善，实现医者、医疗、医保、医药和商业保险等多方的共同受益。本次会议特别邀请了临床专家和患者分享在诊疗与支付方面的真实故事，同时也邀请了保险公司和健康管理公司，共同参与多元生态合作仪式，携手为患者提供更具创新性的多元支付解决方案。罗氏制药中国多元生态合作启动仪式 “先患者之需而行”，罗氏始终将患者的需求放在首位罗氏制药中国全国市场准入负责人、副总裁罗丹发表开幕致辞。作为医药服务供给方之一，罗氏制药中国始终秉承“先患者之需而行”的理念，致力于提供全面的创新药物解决方案，并积极参与多层次医疗保障体系建设，探索与完善各类支付创新模式。罗氏制药中国积极与生态合作伙伴共同探索多元化的准入模式，以满足患者多样化的需求。在过去几年中，致力于推动创新药物纳入各地的惠民保和商业保险目录，旨在为患者提供用药保障，减轻经济负担。在患者全病程管理方面，罗氏制药中国与科技公司紧密合作，利用数字技术为患者提供最佳的临床诊疗和支付路径。展望未来，希望能够深化战略合作，共同构建多元化的患者支付体系，为患者和中国的健康事业贡献更多力量。罗氏制药中国全国市场准入负责人、副总裁罗丹致辞执灯者——创新支付犹如黑暗中的明灯，照亮患者的诊疗之路医疗保障是深化医药卫生体制改革的重要任务之一，在保障人民群众健康方面发挥着至关重要的作用。近年来，国家推出了一系列利好政策，以促进创新药物的蓬勃发展。一支关于医患创新支付的纪录片——《执灯者》揭开了整场活动的序幕。片中的主人公，肺癌患者代表奚叔叔及其主治医生复旦大学附属中山医院呼吸科副主任医师张勇教授，淋巴瘤患者代表周女士的主治医生王教授，以及血友病患者家属代表袁女士齐聚会议现场，进一步分享了他们的故事，传递了在医疗保障体系下重获新生的患者们的真实心声。奚叔叔回忆起被诊断为肺癌时的心情，感到无比焦虑和无助，既担心自己的健康状况，又忧虑经济压力。经过四次化疗后，张医生建议他使用阿替利珠单抗，每月需注射一针。奚叔叔作为一名退休老人，儿子平时不在身边，他的生活主要依靠养老金，高昂的治疗费用令他倍感压力。后来，他在张医生的帮助下参加了沪惠保，免疫治疗总费用十几万元，保险报销了绝大部分。奚叔叔深刻体会到了社会的温暖与支持，以及国家的全面保障，这极大增强了他战胜病魔的信心。在慈善捐助和惠民保的双重保障下，他的经济负担得以减轻，能够更安心地接受治疗。张勇教授指出，奚叔叔是一位早期小细胞肺癌患者，术后需要进行免疫巩固治疗。然而，他所需要的免疫治疗药物（阿替利珠单抗）尚不在国家医保范围内。因此，在治疗时，我们主动与奚叔叔进行沟通，询问他是否参与了相关保险，最终指导他通过沪惠保进⾏报销，从而帮助他获得最⼤程度的经济⽀持。目前，肿瘤药物的新药上市种类日益增多，速度也在不断加快。然而，每一款新药的研发和制造都需要巨额资金。因此，在药物上市初期，患者通常需要自费，这使得药物价格相对昂贵。许多患者在经济上面临一定的困难，且部分药物并不在医保范围之内。因此，提前参与惠民保和互惠保成为一个非常好的选择，这类保险手续简单，理赔迅速。也希望未来能够推出更多医疗保险，以便将一些更新的药物纳入保障范围，让患者更快地接触到新的治疗方案，避免因病致贫的现象。张勇教授现场发言（左右滑动查看更多）王教授表示，周女士在2024年5月被确诊为急性弥漫性大B淋巴瘤，当时肿瘤细胞已广泛扩散，病情较为严重。我们为她制定了临床一线治疗方案，包括使用利妥昔单抗和CD79b靶向药物。经过一段时间的治疗后，病灶成功清除。在治疗过程中，我们始终关注周女士的经济状况，主动询问她是否参与了保险，并帮助她获取相关的报销信息，以减轻她的经济压力。不幸中的万幸是周女士之前购买了重疾险，这份保险为她的治疗提供了100%的费用覆盖，所有的住院、检查、用药、手术和后续自体干细胞移植费用均得到了报销。看到周女士能够全力以赴对抗疾病，而不必担心经济问题，作为医生，我们感到非常欣慰。在此也呼吁更多患者关注自己的经济风险，积极参与惠民保和商业保险，以为自己建立更全面的保障。袁女士回忆，孩子在8个月大时被诊断为血友病A重型，初期采用VIII因子预防治疗，但频繁的静脉注射给孩子带来了不适。后来，了解到艾美赛珠单抗这款皮下注射药物，并经过协调，在常州第一人民医院成功实施该治疗，从而大大提高了治疗的舒适性。在使用该创新药物的过程中，最初依靠江苏医惠保和常州惠民保进行报销，有效减轻了经济负担，使我们能够坚持使用艾美赛珠单抗，确保了孩子的治疗效果。随后，由于惠民保政策的调整，我们参与了宸汐发起的“友爱相伴”项目，这进一步帮助降低了自费药物的费用，使我们能够持续承担药物的支出，为孩子们的健康保驾护航，让他们在同龄人中可以自由的奔跑！引航者——聚焦患者所需，携手迈向多元合作新征程在国家医疗改革的宏伟蓝图中，“1+3+N”多层次医疗保障体系犹如一座坚实的桥梁，连接着亿万家庭的健康与希望。这一体系由“补充医疗保险、医疗救助和基本医疗保险”三大支柱构成，共同抵御疾病风险。作为重要补充，惠民保像桥梁上的便民通道，以“带病参保”、“低保费”和“普惠公平”的特点为亿万家庭提供福音。截至2024年上半年，惠民保已在全国30个省级行政区的约176个城市上线，累计发布项目近300个，投保人次约3亿。罗氏制药中国作为医疗创新的先行者，积极参与惠民保的长期发展，提出优化顶层设计和提升保障待遇等建议，并将其创新自费药品纳入超过百城的惠民保特药目录。惠民保惠及淋巴瘤、肺癌、肝癌、乳腺癌和血友病等多种疾病患者，践行真正的惠民服务，让创新药物触手可及。此外，罗氏制药中国致力于为每位患者提供优质关怀，通过与保险公司、再保公司、医疗科技公司等携手，结合最新的数字化技术，为医生及患者提供更好的治疗方案和更优更便捷的支付路径，通过惠民保、患者福利、专病险、商保医疗险等多元模式，为患者带来多项福音。此次有幸邀请生态合作伙伴、太平洋健康保险公司副总经理郭超、泰康在线保险公司副总裁丁峻峰、中再寿险公司产融创新事业部总经理张楚、镁信健康科技公司首席创新官冯昊、圆心科技医药控股总经理张焕昌、思派健康科技公司健保创新服务事业群副总裁施涌、宸汐健康科技公司医药事业部总经理余晶逸等，与罗氏罗氏制药中国全国市场准入负责人副总裁罗丹、罗氏制药中国新兴管线副总裁兼血液治疗领域负责人是豪、罗氏制药中国肺癌治疗领域负责人唐宏毅以及日健中外市场部总监大门久志等，共同点亮生态合作之光。未来罗氏制药中国将继续探索以创新驱动商业模式，确保创新药物和服务更广泛地惠及社会，与多方合作伙伴携手，共同创造全病程管理服务的创新业态，满足人们日益增长的健康需求，携手志同道合之士，共铸健康中国的未来。罗氏制药中国多元生态合作启动仪式点亮大屏幕这不仅仅是一次简单的触碰，更是我们对未来的承诺，象征着在医疗保障事业上的共同编织的美好愿景。随着屏幕上那道光悄然汇聚并扩散开来，仿佛在诉说着我们的合作如同晨曦般温暖，照亮医保的每一个角落，温暖每一位患者的心灵。每一缕光辉，都蕴含着我们对生命的敬畏与关怀，传递着希望与爱的力量。至此，活动在这份温情和期待中圆满结束，留下的不仅是回忆，更是对未来的无限憧憬。 -THE END- 医脉通是专业的在线医生平台，“感知世界医学脉搏，助力中国临床决策”是平台的使命。医脉通旗下拥有「临床指南」「用药参考」「医学文献王」「医知源」「e研通」「e脉播」等系列产品，全面满足医学工作者临床决策、获取新知及提升科研效率等方面的需求。

高管变更

2024-11-08

·Firstwordpharma

Daiichi teams up with Alteogen in $300M deal for subcutaneous Enhertu

Daiichi Sankyo is tapping Alteogen and its hyaluronidase technology to formulate a subcutaneous (SC) version of the Tokyo pharma's blockbuster antibody-drug conjugate (ADC) in a deal worth up to $300 million. Alongside partner AstraZeneca, Daiichi markets Enhertu (fam-trastuzumab deruxtecan-nxki) for a wide range of cancers including breast, lung, and gastric. In April, the ADC won accelerated approval from the FDA for HER2-positive solid tumours. Under the deal, Daiichi will pay $20 million upfront for an exclusive licence to Alteogen's ALT-B4 hyaluronidase to develop SC Enhertu. The Korean firm is also eligible for $280 million in milestones, plus royalties. If successful, Enhertu could become the first SC ADC. While antibody developers have begun to embrace hyaluronidase technology for SC formulations of traditionally infused biologics, the movement previously had not touched on ADCs. In September, Roche's Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) became the first injectable PD-L1 inhibitor available in the US. The SC version is co-formulated with a proprietary recombinant human hyaluronidase in-licensed from Halozyme to enable a seven-minute administration.Alteogen's Hybrozyme platform boosts the absorption of a biologic by swapping in an enzyme that improves its enzymatic activity and thermal stability. The company has signed three other biopharma deals for its hyaluronidase technology.

抗体药物偶联物引进/卖出上市批准加速审批

100 项与阿替利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10773	阿替利珠单抗	L01XC32	DB11595

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
晚期非小细胞肺癌	欧盟	Roche Registration GmbH	2024-07-25
晚期非小细胞肺癌	冰岛	Roche Registration GmbH	2024-07-25
晚期非小细胞肺癌	列支敦士登	Roche Registration GmbH	2024-07-25
晚期非小细胞肺癌	挪威	Roche Registration GmbH	2024-07-25
乳腺癌	加拿大	F. Hoffmann-La Roche Ltd.	2024-03-13
肺泡软组织肉瘤	美国	Genentech, Inc.	2022-12-09
PD-L1阳性非小细胞肺癌	日本	Chugai Pharmaceutical Co., Ltd.	2022-05-26
BRAF V600 突变阳性黑色素瘤	美国	Genentech, Inc.	2020-07-30
晚期肝细胞癌	欧盟	Roche Registration GmbH	2017-09-20
晚期肝细胞癌	冰岛	Roche Registration GmbH	2017-09-20
晚期肝细胞癌	列支敦士登	Roche Registration GmbH	2017-09-20
晚期肝细胞癌	挪威	Roche Registration GmbH	2017-09-20
晚期三阴性乳腺癌	欧盟	Roche Registration GmbH	2017-09-20
晚期三阴性乳腺癌	冰岛	Roche Registration GmbH	2017-09-20
晚期三阴性乳腺癌	列支敦士登	Roche Registration GmbH	2017-09-20
晚期三阴性乳腺癌	挪威	Roche Registration GmbH	2017-09-20
广泛期小细胞肺癌	欧盟	Roche Registration GmbH	2017-09-20
广泛期小细胞肺癌	冰岛	Roche Registration GmbH	2017-09-20
广泛期小细胞肺癌	列支敦士登	Roche Registration GmbH	2017-09-20
广泛期小细胞肺癌	挪威	Roche Registration GmbH	2017-09-20

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
1型糖尿病	申请上市	中国	Provention Bio, Inc.	2024-08-28
膀胱癌	申请上市	中国	Roche Holding AG	2019-02-25
子宫内膜癌	临床3期	英国	Hoffmann-La Roche Ltd.	2023-10-25
淋巴组织增生性疾病	临床3期	英国	Hoffmann-La Roche Ltd.	2023-10-25
黑色素瘤	临床3期	英国	Hoffmann-La Roche Ltd.	2023-10-25
MSI-H 癌症	临床3期	英国	Hoffmann-La Roche Ltd.	2023-10-25
Turcot综合征	临床3期	英国	Hoffmann-La Roche Ltd.	2023-10-25
肌层浸润性膀胱癌	临床3期	美国	Hoffmann-La Roche, Inc.	2021-05-03
肌层浸润性膀胱癌	临床3期	中国	Hoffmann-La Roche, Inc.	2021-05-03
肌层浸润性膀胱癌	临床3期	日本	Hoffmann-La Roche, Inc.	2021-05-03

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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


NCT04091217 (ML41186, CTgov)	临床2期	黏膜黑色素瘤	43	Atezolizumab+Bevacizumab	襯鹹鬱構餘壓顧廠網鑰(鹹淵鑰遞膚簾製積醖醖) = 窪膚廠餘廠壓範鏇觸窪鹹壓淵襯選憲艱糧廠繭 (餘鑰壓製餘選憲鹽糧醖, 選範糧醖顧簾膚繭壓網 ~ 鑰願選夢選膚淵襯鏇廠) 更多	-	2024-10-24
NCT04661150 (CTgov)	临床2期	HER2阳性胃癌 \| 胃食管交界处腺癌	42	Trastuzumab+Atezolizumab+Oxaliplatin+Capecitabine (Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin))	齋願糧選窪齋鹽窪鹽顧(膚選鏇膚獵廠選鏇網廠) = 獵蓋艱製積鬱糧積繭淵鏇繭構夢憲膚鬱醖蓋築 (鬱窪醖選構網鹽壓積遞, 膚簾糧淵憲製簾鏇鏇憲 ~ 獵網鹽窪廠衊選製鹹獵) 更多	-	2024-10-17
				Trastuzumab+Oxaliplatin+Capecitabine (Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin))	齋願糧選窪齋鹽窪鹽顧(膚選鏇膚獵廠選鏇網廠) = 淵醖壓膚鏇壓簾壓鏇鏇鏇繭構夢憲膚鬱醖蓋築 (鬱窪醖選構網鹽壓積遞, 範獵餘選積衊獵鏇獵齋 ~ 簾構顧糧襯夢醖衊願網) 更多
NCT05091567 (IMforte, Company_Website) 人工标引	临床3期	广泛期小细胞肺癌维持	-	Zepzelca + atezolizumab	選顧襯選膚顧醖築襯壓(膚夢製膚齋衊鹹糧鏇顧) = statistically significant improvement 獵鏇廠觸鑰淵簾鹽鑰膚 (壓鹹餘繭鹹網顧鹹網淵 ) 更多	积极	2024-10-16
				atezolizumab
NCT03526900 (ATEZO-BRAIN, CTgov)	临床2期	转移性非小细胞肺癌 \| 非鳞状非小细胞肺癌 \| 脑转移瘤	40	atezolizumab	鹽憲鏇窪選鹹顧願積簾(襯衊糧蓋蓋憲網製鬱網) = 艱廠淵艱廠廠觸繭廠鹹膚夢襯窪觸糧顧夢鏇構 (構獵網觸壓構選顧築齋, 願範築蓋鹹願觸網願夢 ~ 膚獵窪憲獵鬱蓋襯蓋蓋) 更多	-	2024-10-09
NCT05315713 (CTgov)	临床1/2期	滤泡性淋巴瘤 \| 难治性B细胞淋巴瘤	8	Mosunetuzumab SC+tocilizumab+Tiragolumab	鬱繭遞鬱醖鏇鹹繭襯範(築鏇築壓築憲憲鏇醖醖) = 糧壓衊膚蓋壓築選鹽憲觸鏇鹽顧構淵餘願範糧 (艱鏇網願鹹窪襯蓋餘齋, 鏇衊遞襯夢壓遞醖夢夢 ~ 淵範鬱艱選窪積憲遞廠) 更多	-	2024-10-04
NCT03148418 (IMbrella A, Pubmed \| Lung Cancer) 人工标引	临床3期	广泛期小细胞肺癌一线	26	Atezolizumab (3-year)	齋憲衊構齋鑰憲壓鹹廠(襯觸壓艱鹹築餘構艱廠) = grade two hypothyroidism was reported 築憲構積獵鑰遞鬱簾鹹 (糧築鬱繭鹹製淵醖選鬱 ) 更多	积极	2024-10-01
				Atezolizumab (4-year)
EUCTR2018-000257-45-DE \| NCT05052099 (COMBATBIL, ESMO2024) 人工标引	临床1/2期	晚期胆道癌二线	35	mFOLFOX6, bevacizumab and atezolizumab	壓製衊範醖衊壓齋鏇糧(壓憲築簾積願窪窪顧淵) = 齋衊餘齋遞醖廠網鬱選廠憲構遞窪淵觸窪獵築 (淵獵鹹淵構膚鏇蓋鏇鑰 ) 更多	积极	2024-09-16
ESMO2024 人工标引	N/A	晚期肝细胞癌一线	7,038	Atezolizumab plus bevacizumab (A+B)	醖淵襯選觸鏇艱衊鏇願(繭醖積觸獵餘鬱淵糧製) = 鏇獵製鏇憲窪淵醖壓廠繭憲淵糧窪遞選選積鏇 (鹹選蓋艱憲衊膚衊網鹽 )	积极	2024-09-16
				Lenvatinib (L)	醖淵襯選觸鏇艱衊鏇願(繭醖積觸獵餘鬱淵糧製) = 衊衊範壓簾鏇獵膚製鑰繭憲淵糧窪遞選選積鏇 (鹹選蓋艱憲衊膚衊網鹽 )
NCT04602078 (SOGUG-AUREA, ESMO2024) 人工标引	临床2期	尿路上皮癌	66	Split-dose cisplatin + gemcitabine + atezolizumab	觸膚顧遞選範餘積齋製(鹽鑰鏇襯築願獵壓廠齋) = 鬱齋構願糧網範繭衊膚簾願鏇觸淵壓夢獵繭鏇 (夢積繭廠艱衊襯膚夢選, 36 ~ 61) 更多	积极	2024-09-15
NCT03237780 (ESMO2024) 人工标引	临床2期	尿路上皮癌	33	Eribulin 1.4mg/m2 + Atezolizumab 1200mg/m2	餘淵獵選憲壓鬱網廠顧(顧憲蓋繭鏇築憲夢積鬱) = 餘製壓壓顧糧積壓鬱壓鬱觸鑰鏇膚簾鹹選鬱鏇 (壓襯艱夢壓襯製憲憲齋 )	积极	2024-09-15
				Atezolizumab 1200mg/m2	餘淵獵選憲壓鬱網廠顧(顧憲蓋繭鏇築憲夢積鬱) = 襯憲範餘範獵積鏇衊積鬱觸鑰鏇膚簾鹹選鬱鏇 (壓襯艱夢壓襯製憲憲齋 )