培美曲塞二钠(Pemetrexed Disodium Hydrate) - 药物靶点：DHFR x GART x TYMS_在研适应症：转移性非鳞状非小细胞肺癌，不可切除的胸膜恶性间皮瘤，非鳞状非小细胞肺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

MTA、Multitargeted antifolate、PEMETREXED

+ [31]

靶点

DHFR x GART x TYMS

作用机制

DHFR抑制剂(二氢叶酸还原酶抑制剂)、GART抑制剂(GAR转化酶抑制剂)、TYMS抑制剂(胸苷酸合成酶抑制剂)

治疗领域

肿瘤呼吸系统疾病其他疾病+ [1]

在研适应症

转移性非鳞状非小细胞肺癌不可切除的胸膜恶性间皮瘤非鳞状非小细胞肺癌+ [22]

非在研适应症

腺癌晚期乳腺癌晚期癌症+ [83]

原研机构

Eli Lilly & Co.

在研机构

Janssen Research & Development LLCActavis Group PTC ehf.

Eli Lilly & Co.

+ [26]

非在研机构

Genentech, Inc.

Novartis AG

GSK Plc

+ [6]

最高研发阶段批准上市

首次获批日期

美国 (2004-02-04),

恶性胸膜间皮瘤

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、优先审评 (中国)、孤儿药 (美国)

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结构

分子式C20H35N5Na2O13

InChIKeyPXQGZQUWLRLNRX-MYXYZBIASA-N

CAS号357166-29-1

关联

1,220

项与培美曲塞二钠相关的临床试验

NCT06522360 / Not yet recruiting临床2期IIT

Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightStar-2)

The goal of this clinical research study is to learn if the combination of brigatinib and either local consolidation therapy (such as radiotherapy or surgery) or chemotherapy (pemetrexed and carboplatin) can help to control the disease compared with brigatinib alone. The safety of these combinations will also be studied.

开始日期2025-12-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT06632327 / Not yet recruiting临床3期IIT

Perioperative Versus Adjuvant Systemic Therapy in Patients With Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG

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]

NCT06726265 / Not yet recruiting临床3期

TACTI-004, a Double-Blinded, Randomized Phase 3 Trial in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Receiving Eftilagimod Alfa (MHC Class II Agonist) in Combination with Pembrolizumab (PD-1 Antagonist) and Chemotherapy.

The purpose of this study is to compare eftilagimod alfa (efti) in combination with pembrolizumab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) among adults with metastatic non-small cell lung cancer (NSCLC).
Participants will receive either efti plus standard treatment (pembrolizumab and platinum doublet chemotherapy) or placebo plus standard treatment and will be treated for up to 2 years.

开始日期2025-03-01

申办/合作机构

Immutep SAS

[+1]

100 项与培美曲塞二钠相关的临床结果

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100 项与培美曲塞二钠相关的转化医学

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100 项与培美曲塞二钠相关的专利（医药）

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6,608

项与培美曲塞二钠相关的文献（医药）

2025-01-01·SCIENCE OF THE TOTAL ENVIRONMENT

Sequestration process and mechanism of U(VI) on montmorillonite-aspergillus niger composite

Article

作者: Li, Ping ; Mei, Huiyang ; Geng, Rongyue ; Liang, Jianjun ; Zhang, Beihang ; Fan, Qiaohui ; Qiang, Shirong

The existence state and spatiotemporal evolution process of uranium in mineral-microbe complex systems are important factors that constrain its ecotoxicity. This study investigated the sequestration of U(VI) by montmorillonite-Aspergillus niger (MTA) composite using bioassay and spectroscopies approaches. The results demonstrate that the sequestration process and mechanism of U(VI) on MTA differ substantially from those of individual components. Under neutral conditions, the sorption of U(VI) decreased from 92.4 ± 4.6 % on MT to 73.2 ± 2.4 % on MTA4 and 74.9 ± 6.3 % on MTA10, respectively, while the stability of U(VI) species on MTA increased obviously compared to MT. In the case of MTA formed over 4 days (MTA4), the biosorption effect of A. niger hyphae dominated the sequestration of U(VI). In contrast, for MTA formed over 10 days (MTA10), the interactions between MT and A. niger became more pronounced, and the hyphae of Aspergillus niger played a pivotal role in U(VI) sequestration, immobilizing U(VI) through complexation with organic ligands and bioreduction reactions. The high expandability of MT facilitated the penetration of extracellular polymeric substances (EPS) from A. niger into its interlayer of MT, enhancing U(VI) complexation and reduction. These processes significantly contributed to the effective sequestration of U(VI) by the MTA composite.

2025-01-01·NEW PHYTOLOGIST

mRNA ADENOSINE METHYLASE promotes drought tolerance through N⁶‐methyladenosine‐dependent and independent impacts on mRNA regulation in Arabidopsis

Article

作者: Ng, Pei Jia ; Li, Yongfang ; Gregory, Brian D. ; Bhat, Susheel Sagar ; Tiwari, Shalini ; Ganguly, Diep R. ; Sunkar, Ramanjulu

Summary:

Among many mRNA modifications, adenine methylation at the N6 position (N6‐methyladenosine, m6A) is known to affect mRNA biology extensively. The influence of m6A has yet to be assessed under drought, one of the most impactful abiotic stresses.We show that Arabidopsis thaliana (L.) Heynh. (Arabidopsis) plants lacking mRNA ADENOSINE METHYLASE (MTA) are drought‐sensitive. Subsequently, we comprehensively assess the impacts of MTA‐dependent m6A changes during drought on mRNA abundance, stability, and translation in Arabidopsis.During drought, there is a global trend toward hypermethylation of many protein‐coding transcripts that does not occur in mta. We also observe complex regulation of m6A at a transcript‐specific level, possibly reflecting compensation by other m6A components. Importantly, a subset of transcripts that are hypermethylated in an MTA‐dependent manner exhibited reduced turnover and translation in mta, compared with wild‐type (WT) plants, during drought. Additionally, MTA impacts transcript stability and translation independently of m6A. We also correlate drought‐associated deposition of m6A with increased translation of modulators of drought response, such as RD29A, COR47, COR413, ALDH2B, ERD7, and ABF4 in WT, which is impaired in mta.m6A is dynamic during drought and, alongside MTA, promotes tolerance by regulating drought‐responsive changes in transcript turnover and translation.

2024-12-31·Gut microbes

Article

作者: Chuang, Hsiao-Li ; Lyu, Qiang ; Liu, Po-Yu ; Zou, Hsin-Bai ; Chang, Hsin-Yuan ; Cheng, Wan-Ju ; Hsu, Cheng-Chih ; Sung, Li-Kang ; Chen, Rou-An ; Wu, Hsin-Yi ; Wu, Wei-Kai ; Liu, Lihong ; Wu, Ming-Shiang

Dietary patterns and corresponding gut microbiota profiles are associated with various health conditions. A diet rich in polyphenols, primarily plant-based, has been shown to promote the growth of probiotic bacteria in the gastrointestinal tract, subsequently reducing the risk of metabolic disorders in the host. The beneficial effects of these bacteria are largely due to the specific metabolites they produce, such as short-chain fatty acids and membrane proteins. In this study, we employed a metabolomics-guided bioactive metabolite identification platform that included bioactivity testing using in vitro and in vivo assays to discover a bioactive metabolite produced from probiotic bacteria. Through this approach, we identified 5'-methylthioadenosine (MTA) as a probiotic bacterial-derived metabolite with anti-obesity properties. Furthermore, our findings indicate that MTA administration has several regulatory impacts on liver functions, including modulating fatty acid synthesis and glucose metabolism. The present study elucidates the intricate interplay between dietary habits, gut microbiota, and their resultant metabolites.

1,205

项与培美曲塞二钠相关的新闻（医药）

2024-12-23

·复宏汉霖

专家说 | 周彩存教授：人群广获益，攻坚脑转移，斯鲁利单抗为驱动基因阴性晚期非鳞状NSCLC患者一线治疗提供全新选择

2024年12月初，复宏汉霖公司自主研发的创新型抗PD-1单抗斯鲁利单抗正式获得国家药品监督管理局（NMPA）批准，联合培美曲塞和卡铂用于表皮生长因子受体（EGFR）和间变性淋巴瘤激酶（ALK）基因阴性的不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌（nsq-NSCLC）一线治疗。这是斯鲁利单抗在中国获批的第五项适应症；由此，继广泛期小细胞肺癌（ES-SCLC）、鳞状非小细胞肺癌（sq-NSCLC）后，斯鲁利单抗适应症全面覆盖晚期肺癌一线治疗，将以其高效价比优势造福广大中国患者。值此重要时刻，我们有幸邀请到全球肺癌领域重要开拓者和领军人物、斯鲁利单抗ASTRUM-004研究Leading PI、同济大学附属东方医院周彩存教授接受专访，解析NSCLC免疫治疗突破原因，解读斯鲁利单抗在NSCLC领域的关键数据，分享NSCLC脑转移治疗优化策略和未来前行方向。本文整理访谈精粹，以飨读者。机制转化，新药迸发 ——免疫治疗为NSCLC领域带来划时代进步 01 近年来，免疫治疗作为快速发展的新型抗肿瘤治疗手段，全面改写了晚期NSCLC的治疗格局。作为肺癌领域的权威专家，您认为免疫治疗在NSCLC领域能取得重大突破的因素有哪些？周彩存教授：免疫治疗在NSCLC领域取得重大突破，是诸多因素共同作用的结果。首先，得益于我们对肿瘤免疫逃逸机制有了深入了解，尤其是PD-1/PD-L1信号通路的发现，为免疫检查点抑制剂（ICIs）的开发提供了坚实的基础。同时，学术界对肿瘤免疫微环境的认知日益深刻，为免疫治疗疗效的提升策略提供了重要思路。免疫微环境由各种细胞、细胞因子、炎性因子等多种成分构建而成。诸多研究证实免疫微环境的属性直接影响免疫治疗疗效，并揭示了有利于免疫治疗应答的部分属性特征，进而找到改变免疫微环境、增效免疫治疗的手段，例如PD-1/PD-L1单抗联合化疗已成为驱动基因阴性晚期NSCLC一线标准治疗。基础到临床研究都显示，化疗与免疫治疗之间有确切的、多维度的协同作用，包括促进肿瘤抗原释放、激活抗肿瘤免疫反应，以及减轻免疫抑制状态。这些因素综合发力使免疫治疗联合化疗后获益人群更广泛、获益程度更大。此外，免疫治疗疗效预测生物标志物的发现和精准检测技术的发展，提高了NSCLC免疫治疗的精准性和有效性。例如，PD-L1表达水平已成为预测免疫治疗单药疗效的重要指标，而联合化疗方案则为PD-L1非高表达患者提供了新的治疗选择。对于驱动基因阳性如EGFR、ALK阳性等NSCLC，往往属于“冷肿瘤”，无论免疫治疗单药还是免疫治疗联合化疗，患者获益都非常有限，这促使我们向更精准、个体化的治疗策略迈进。综上所述，我们对NSCLC免疫逃逸机制、免疫微环境认识的精进和检测技术的推动，使得NSCLC免疫治疗协同增效方式愈加丰富、优势人群愈发明晰和广泛，尤其是免疫联合化疗显著改善了驱动基因阴性晚期NSCLC患者的预后，并使部分患者实现了长期生存的希望，堪称该领域划时代的进步。 “双翼”齐飞，广泛获益 ——斯鲁利单抗全面惠及中国晚期鳞状与非鳞状NSCLC患者 02 基于ASTRUM-004研究突破性成果，创新型PD-1抑制剂斯鲁利单抗成为晚期肺鳞癌一线标准治疗方案。近日，凭借ASTRUM-002研究积极结果，已获批驱动基因阴性局部晚期或转移性nsq-NSCLC一线治疗适应症。作为ASTRUM-004研究Leading PI，请您结合两项关键性Ⅲ期研究成果，对斯鲁利单抗获益人群进行解读分析。周彩存教授：由我担任主要研究者的全球多中心Ⅲ期临床试验ASTRUM-004研究结果显示，在局部晚期或转移性肺鳞癌患者一线治疗中，斯鲁利单抗联合白蛋白紫杉醇+卡铂对照安慰剂联合白蛋白紫杉醇+卡铂取得了主要终点无进展生存期（PFS）的显著改善，且有效转化为了总生存期（OS）的显著延长。基于此，斯鲁利单抗顺利获批晚期肺鳞癌一线治疗适应症，并成为中国临床肿瘤学会（CSCO）指南推荐的一线标准治疗方案，未来亦有望在国际上获批；同时，优异数据也成就了该研究成果荣登国际著名学术期刊Cancer Cell，并荣获封面推荐。其中，中国亚组获益与全人群一致甚至更为突出，中位随访32.9个月，中国人群中斯鲁利单抗联合化疗组中位PFS长达9.9个月、位居同类研究最高水平，较对照组（5.8个月）几近翻倍，显著降低疾病进展或死亡风险达57%（HR=0.43，95%CI：0.32~0.58，P＜0.001），中位OS长达27.4个月，降低死亡风险达38%（HR=0.62，95%CI：0.47~0.82，P＜0.001）。可以说，PFS和OS均处于同类产品“TOP”之列的疗效表现有力证实了斯鲁利单抗在中国晚期肺鳞癌患者中的卓越价值。 ASTRUM-002研究是一项三臂、随机、双盲、多中心大型Ⅲ期临床研究，探索了斯鲁利单抗、斯鲁利单抗联合贝伐珠单抗生物类似药或安慰剂分别联合化疗一线治疗驱动基因阴性晚期nsq-NSCLC患者的疗效和安全性。独立影像学评审委员会（IRRC）评估的PFS取得了惊艳的主要终点阳性结果，斯鲁利单抗联合化疗组中位PFS长达11.0个月，较对照组显著延长5.4个月，近乎翻倍，降低疾病进展或死亡风险45%（HR=0.55，95% CI：0.430~0.694，P＜0.0001），达到了预设的优效标准，证实了斯鲁利单抗在晚期nsq-NSCLC患者中的优势。次要终点方面，斯鲁利单抗联合化疗组中位OS突破2年，长达25.0个月，较对照组（18.9个月）显著降低死亡风险32%（HR=0.68，95% CI:0.511~0.913，P=0.0097）；斯鲁利单抗联合化疗组客观缓解率（ORR）达52.8%，中位缓解持续时间（DoR）达15.4个月，可见斯鲁利单抗联合化疗在晚期nsq-NSCLC患者中具有与同类研究一致的生存获益，且抗肿瘤活性强效而持久。综合而言，ASTRUM-004和ASTRUM-002研究展现了斯鲁利单抗联合化疗在晚期NSCLC患者一线治疗中具有瞩目的生存获益，且安全性良好。伴随此次非鳞癌适应症的获批，相信斯鲁利单抗未来将全面惠及我国晚期NSCLC患者。关键循证、显著疗效 ——斯鲁利单抗为脑转移综合治疗提供有效选择 03 为实现肺癌脑转移患者治疗效果和生活质量的双重提升，您认为临床医生应如何优化选择内科治疗策略？周彩存教授：NSCLC不同病理类型发生脑转移的风险存在差异。美国国立癌症研究所数据显示，肺腺癌、鳞癌及大细胞癌发生脑转移的风险分别为 11%、6%、12%。作为驱动基因阴性晚期NSCLC患者常见并发症，脑转移是导致治疗失败和患者死亡的主要原因之一，严重威胁患者生命健康。脑转移患者的治疗效果是临床医生在晚期肺癌治疗，尤其是靶向治疗和免疫治疗中，评价创新型抗肿瘤治疗药物价值的一个至关重要的疗效指标和考核指标。斯鲁利单抗联合化疗的一线治疗方案在驱动基因阴性晚期鳞癌与非鳞癌两大病理类型的脑转移患者中均取得了不错的疗效改善。在ASTRUM-004研究中，斯鲁利单抗联合化疗组的中位PFS达6.9个月、较对照组降低疾病进展或死亡风险达63%（HR=0.37，95% CI：0.14~0.96）。而回顾ASTRUM-002研究的受试者特征可以看到，其纳入了高比例预后较差的患者，包括脑转移、年龄≥65岁、PD-L1 TPS＜1%以及等，非常贴合中国真实世界临床实践。其中，斯鲁利单抗联合化疗组和安慰剂联合化疗组的脑转移患者占比分别为19.2%和18.6%。研究结果显示，斯鲁利单抗联合化疗组的中位PFS长达8.1个月，较对照组显著提升4个月，降低疾病进展或死亡风险49%（HR=0.51，95% CI:0.296~0.866，P=0.0115）。由此可见，两项研究为非小细胞肺癌脑转移人群一线治疗策略的优化提供了非常关键的证据，并极具临床指导意义。从系统治疗的角度而言，以斯鲁利单抗联合化疗为代表的ICIs联合化疗方案显然将成为非小细胞肺癌脑转移患者的优选策略，尤其是无症状脑转移或经局部治疗后疾病稳定的患者。同时，晚期NSCLC脑转移需要多学科团队（MDT）的协作管理、综合治疗，譬如部分患者需要立体定向放射治疗（SBRT），部分患者甚至需要外科手术。但无论局部治疗如何，系统治疗都是这类患者治疗策略中的基石，而斯鲁利单抗联合化疗这类高效安全的方案为脑转移综合治疗中提供有效选择。未来，期待有更多的前瞻性临床研究，进一步观察斯鲁利单抗联合化疗在晚期NSCLC伴脑转移患者中的长期疗效和安全性。优化组合，创新探索 ——NSCLC脑转移治疗突破未来可期 04 展望未来，您认为在NSCLC脑转移治疗方面还有哪些方向值得进一步探索研究？周彩存教授：晚期NSCLC脑转移的治疗需要MDT协作，其相关临床研究的开展也同样需要MDT紧密携手，才能把不同系统治疗和不同局部治疗手段之间的“组合拳”打得更加精准、有力，比如免疫治疗加化疗与放疗之间如何更好地协同、免疫治疗加化疗与外科手术之间如何更巧妙地排兵布阵。同时，不同系统治疗药物之间的有机组合也是亟待进一步探索的课题，包括PD-1/PD-L1单抗与其他ICIs如CTLA-4单抗的联合、与不同抗血管生成药物的联合等，期待未来更多临床研究的成果可回答这些联合方案在脑转移患者中的疗效价值。同时，创新药物研发依然是实现更大突破的着力点，比如在免疫治疗加化疗基础上联合疫苗尤其是mRNA疫苗或细胞治疗等新型免疫治疗手段，期待更多随机对照临床试验来科学地回答这些问题，也期待我们团队未来有更多相关研究结果与大家分享。专家介绍周彩存教授主任医师教授博士生导师同济大学附属上海市东方医院肿瘤科主任同济大学医学院肿瘤研究所所长、胸部肿瘤精准治疗中心主任上海市重中之重临床重点学科带头人国际肺癌研究协会（IASLC）候任主席中国医促会胸部肿瘤学分会主任委员中国临床肿瘤学会和中国医促会常务理事中国临床肿瘤学会非小细胞肺癌专委会主任委员中国抗癌协会肿瘤药物临床研究专业委员会主任委员上海市抗癌协会肺癌分子靶向和免疫治疗专委会主任委员中国医师协会肿瘤分会常委上海市抗癌协会副理事长上海市医师协会肿瘤分会副会长上海市医学会肿瘤内科分会副主任委员喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

免疫疗法

2024-12-23

·医药魔方Info

和黄医药「赛沃替尼」拟纳入突破性疗法

12月20日，CDE网站显示，和黄医药的赛沃替尼片拟纳入突破性疗法，拟定适应症为：赛沃替尼联合奥希替尼治疗经EGFR-TKI治疗失败伴MET扩增的局部晚期或转移性非小细胞肺癌。赛沃替尼（savolitinib，商品名：沃瑞沙）是一种口服的高选择性小分子c-Met抑制剂，可阻断因突变 (例如外显子14跳跃突变或其他点突变) 、基因扩增或蛋白质过表达而导致的MET受体酪氨酸激酶信号通路的异常激活。该药最初由和黄医药开发。该联合疗法目前正在一项进行中的多中心、开放标签、随机对照的SACHI中国III期研究(NCT05015608)中进行评估。该研究旨在探索奥希替尼与赛沃替尼联合疗法对比当前伴有MET扩增的接受EGFR抑制剂治疗后疾病进展的EGFR突变阳性局部晚期或转移性非小细胞肺癌患者的标准疗法铂类双药化疗 (培美曲塞加顺铂或卡铂) 的疗效及安全性。研究的主要终点是研究者评估的无进展生存期 (PFS)。其他终点包括独立审查委员会评估的PFS，总生存期 (OS)、客观缓解率 (ORR)、缓解持续时间 (DoR)、疾病控制率 (DCR) 、到达疾病缓解的时间 (TTR) 及安全性。 2021年6月，赛沃替尼在中国获附条件批准，用于治疗接受全身性治疗后疾病进展或无法接受化疗的MET外显子14跳跃突变的NSCLC患者。赛沃替尼自2023年3月1日起被纳入国家医保药品目录，用于治疗含铂化疗后疾病进展或不耐受标准含铂化疗的MET外显子14跳变的局部晚期或转移性NSCLC成人患者。2023年，赛沃替尼中国销售额为4610万美元。 2011年，和黄医药与阿斯利康达成一项全球许可协议，将共同开发赛沃替尼并促进其商业化。和黄医药与阿斯利康合作负责赛沃替尼的临床开发，在中国由和黄医药主导，在海外则由阿斯利康主导。此外，和黄医药负责赛沃替尼在中国的上市许可、生产和供应，而阿斯利康则负责实现沃瑞沙在中国乃至全球范围内的商业化。赛沃替尼的销售收入由阿斯利康确认。 MET是一种受体酪氨酸激酶，在细胞的正常发育过程中发挥重要作用。MET扩增或过表达可导致肿瘤生长以及癌细胞的转移进展，且是EGFR突变的转移性非小细胞肺癌患者对EGFR TKI治疗产生获得性耐药的主要机制之一。约有2-3%的患者伴有MET外显子14跳跃突变，这是一种可靶向的MET基因突变。MET 异常是对第一/二代 EGFR TKI 以及奥希替尼等第三代EGFR TKI产生耐药性的主要机制。在奥希替尼治疗后疾病进展的患者中，约有15-50% 出现 MET 异常。MET异常的发生率可能因样品类型、检测方法和使用的测定阈值而异。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

突破性疗法引进/卖出临床3期

2024-12-23

·PMLiVE

AstraZeneca’s Tagrisso granted EC approval in EGFR-mutated lung cancer

AstraZeneca’s Tagrisso (osimertinib) has been approved by the European Commission (EC) to treat a new subset of lung cancer patients. The epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor has now been authorised to treat locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express EGFR exon 19 deletions or exon 21 substitution mutations. Patients eligible for the drug will also have not experienced disease progression during or following concurrent or sequential platinum-based chemoradiation therapy. More than 450,000 people are diagnosed with lung cancer each year in Europe, with NSCLC accounting for up to 85% of all cases. As many as 15% of NSCLC patients in Europe have EGFR mutations and, as a result, are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor that blocks the cell-signalling pathways driving tumour cell growth. The EC’s latest decision on Tagrisso follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage LAURA trial. Tagrisso was shown to reduce the risk of disease progression or death by 84% compared to placebo, and median progression-free survival was 39.1 months in Tagrisso-treated patients versus 5.6 months for those receiving placebo. Dave Fredrickson, executive vice president, oncology business unit, AZ, said: “Tagrisso is now the first and only EGFR inhibitor and targeted treatment approved in the EU for locally advanced, unresectable lung cancer, providing a new standard of care to patients who have historically experienced early progression after chemoradiation therapy. “The powerful results from the LAURA trial show Tagrisso improves outcomes for patients in the unresectable setting, reinforces the importance of timely EGFR testing and solidifies Tagrisso as the backbone therapy in EGFR-mutated NSCLC.” The decision comes just a few months after the EC approved Tagrisso for use alongside pemetrexed and platinum-based chemotherapy as a first-line treatment for adults with locally advanced EGFR-mutated NSCLC whose tumours have exon 19 deletions or exon 21 mutations. The July approval was based on results from the phase 3 FLAURA2 trial, in which Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy.

临床结果上市批准临床3期

100 项与培美曲塞二钠相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	培美曲塞二钠	L01BA04	DB00642

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适应症	国家/地区	公司	日期
转移性非鳞状非小细胞肺癌	美国	Hospira, Inc.	2022-06-10
不可切除的胸膜恶性间皮瘤	欧盟	Sandoz GmbH	2015-09-18
不可切除的胸膜恶性间皮瘤	冰岛	Sandoz GmbH	2015-09-18
不可切除的胸膜恶性间皮瘤	列支敦士登	Sandoz GmbH	2015-09-18
不可切除的胸膜恶性间皮瘤	挪威	Sandoz GmbH	2015-09-18
非鳞状非小细胞肺癌	美国	Eli Lilly & Co.	2009-07-02
间皮瘤	美国	Eli Lilly & Co.	2004-08-19
非小细胞肺癌	美国	Eli Lilly & Co.	2004-08-19
局部晚期非小细胞肺癌	澳大利亚	Eli Lilly Australia Pty Ltd.	2004-06-30
转移性非小细胞肺癌	澳大利亚	Eli Lilly Australia Pty Ltd.	2004-06-30
恶性胸膜间皮瘤	美国	Eli Lilly & Co.	2004-02-04

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适应症	最高研发状态	国家/地区	公司	日期
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	中国	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	日本	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
KRAS G12C突变非小细胞肺癌	临床3期	丹麦	Eli Lilly & Co.	2023-12-21

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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


NCT05253118 (SPECTRUM, ASH2024) 人工标引	临床2期	弥漫性大B细胞淋巴瘤二线	24	Tislelizumab 20Pemetrexed	鬱餘觸遞廠選窪醖願糧(遞網築構獵膚餘範醖壓) = 繭積壓艱窪餘簾憲選製鬱糧淵齋網築鹹願艱遞 (糧餘願壓鹹顧鏇衊壓襯 ) 达到更多	积极	2024-12-08
NCT04964960 (CTgov)	临床2期	代谢综合征 \| 非小细胞肺癌 \| 脑转移瘤	3	nab paclitaxel+Carboplatin+Paclitaxel+Pembrolizumab+Pemetrexed	鹹蓋鹹選窪鹽繭鬱範艱(簾窪構壓襯顧夢積製壓) = 獵鬱獵築獵廠艱糧鏇夢蓋醖憲構網壓鏇鑰壓願 (構築艱窪築蓋簾醖鑰夢, 積製鹽衊蓋鑰網夢衊觸 ~ 積鬱淵繭顧糧顧觸壓膚) 更多	-	2024-10-21
NCT01088906 (Phalcis, CTgov)	临床2期	晚期肺非小细胞鳞癌 \| 非鳞状非小细胞肺癌	57	Cisplatin+Pemetrexed (EXPERIMENTAL ARM)	製蓋廠顧衊餘糧衊襯積(壓積構繭顧積網願觸鏇) = 顧膚廠繭觸遞廠獵願獵糧淵製齋膚齋壓鬱願獵 (觸糧鏇積齋選淵顧網觸, 鑰淵艱網艱製壓網鹽襯 ~ 廠獵選選蓋簾糧鏇範鬱) 更多	-	2024-10-15
				Cisplatin+Pemetrexed (Experimental Arm: Pemetrexed Plus Cisplatin)	鬱壓鑰願願鏇膚構衊廠(繭選窪夢艱衊築窪製壓) = 憲壓鹹膚積襯繭願鹽顧鑰壓蓋獵窪構憲網繭醖 (餘糧網繭構齋網壓觸簾, 鑰遞膚淵範觸糧餘構網 ~ 襯積鏇餘夢獵膚窪窪遞) 更多
CTRI/2022/08/044939 (ESMO_ASIA2024)	临床2期	原发性腹膜癌 Folate receptor alpha	63	Pemetrexed 500 mg/m2	鑰鬱願鹹構獵憲鏇壓觸(艱窪壓鏇夢襯憲積製廠) = 糧選鬱襯構網鹹憲遞繭餘壓淵獵醖獵壓築製襯 (積憲顧獵遞願築簾範憲 ) 更多	积极	2024-09-14
WCLC2024 人工标引	N/A	恶性胸膜间皮瘤二线 \| 一线	267	Nivolumab pNivolumabmumabIpilimumabpemetrexed	鑰觸壓衊襯壓醖範簾鹹(淵夢窪齋築顧獵積繭糧) = 淵襯窪鑰選製廠鏇衊壓膚簾憲選淵繭廠憲憲襯 (醖夢膚範簾糧淵築淵製, 7.7 ~ 8.5)	积极	2024-09-09
NCT04335292 (OCELOT, WCLC2024) 人工标引	临床2期	EGFR突变肺癌二线 EGFR Mutation	29	Platinum Pemetrexedpemetrexed	築鑰積簾醖獵築鹹獵繭(鹽簾廠鹽夢鏇選衊構艱) = 齋觸鏇糧繭繭鏇鑰糧繭壓築夢鬱網襯膚糧網糧 (範壓築鏇鹽簾壓襯襯餘 ) 更多	积极	2024-09-08
				platinum (carboplatin or cisplatin) + pemetrexed (uncommon EGFR mutations)	築鑰積簾醖獵築鹹獵繭(鹽簾廠鹽夢鏇選衊構艱) = 鹽蓋顧淵鏇壓糧衊顧艱壓築夢鬱網襯膚糧網糧 (範壓築鏇鹽簾壓襯襯餘 ) 更多
NCT04035486 (FLAURA2, CTgov)	临床3期	EGFR阳性非小细胞肺癌	587	Carboplatin+Pemetrexed+AZD9291 (Safety Run-In: AZD9291 + Carboplatin + Pemetrexed)	餘壓夢選醖蓋衊鑰醖壓(選膚餘築獵壓蓋鹽選構) = 壓窪艱積鏇憲構窪鹽獵築積膚鏇獵襯顧範構淵 (獵衊壓構鑰糧鬱構簾製, 積簾製壓選膚餘廠衊糧 ~ 糧糧鹹簾鏇夢廠築顧鹹) 更多	-	2024-08-06
				Cisplatin+Pemetrexed+AZD9291 (Safety Run-In: AZD9291 + Cisplatin + Pemetrexed)	餘壓夢選醖蓋衊鑰醖壓(選膚餘築獵壓蓋鹽選構) = 鹽築艱願齋憲艱憲蓋積築積膚鏇獵襯顧範構淵 (獵衊壓構鑰糧鬱構簾製, 願壓蓋願壓衊衊鑰夢淵 ~ 獵廠壓網鹽網廠糧遞網) 更多
NCT00998166 (CTgov)	临床2期	晚期肺非鳞状非小细胞癌	12	Bevacizumab+cisplatin+pemetrexed	衊製窪鏇範醖膚遞憲窪(壓蓋醖壓醖遞繭顧衊選) = 簾選鬱糧鏇糧遞蓋顧鑰選構齋夢鑰糧築壓艱範 (鹹膚觸壓衊觸顧廠簾鹹, 選鏇鑰觸膚鹽網網鹹膚 ~ 襯遞願淵觸淵衊淵網鹽) 更多	-	2024-07-30
ASCO2024	N/A	晚期非小细胞肺癌	-	Pemetrexed plus platinum (AP) morning infusion	淵憲襯鏇築顧鹽築選廠(鏇範積觸築壓鹽觸範觸) = 獵願憲繭願齋積構鹽糧選願築鏇齋襯艱鹽齋夢 (願繭鹽壓鏇艱觸齋網願 ) 更多	积极	2024-05-24
				Pemetrexed plus platinum (AP) afternoon infusion	淵憲襯鏇築顧鹽築選廠(鏇範積觸築壓鹽觸範觸) = 構網憲鬱鹹鏇襯壓構觸選願築鏇齋襯艱鹽齋夢 (願繭鹽壓鏇艱觸齋網願 ) 更多
ASCO2024	N/A	转移性非鳞状非小细胞肺癌维持	121	Maintenance pemetrexed and pembrolizumab	廠鏇鏇獵構顧觸選獵醖(獵簾觸製鹹餘獵醖鹽獵) = 夢獵選築遞繭鬱鹽壓鏇網夢鏇鏇窪齋構齋齋獵 (範網餘衊願膚鏇簾憲淵, 13.8 ~ NA) 更多	积极	2024-05-24
				Maintenance pemetrexed cessation	廠鏇鏇獵構顧觸選獵醖(獵簾觸製鹹餘獵醖鹽獵) = 網繭願淵憲獵積窪構構網夢鏇鏇窪齋構齋齋獵 (範網餘衊願膚鏇簾憲淵, 26.9 ~ NA) 更多