1.主要目的：以山东朗诺制药有限公司生产的达可替尼片为受试制剂（T），以Pfizer Europe MA EEIG持证，Pfizer Manufacturing Deutschland GmbH生产的达可替尼片（商品名：VIZIMPRO®）为参比制剂（R），评估健康受试者在空腹和餐后状态下单次给药受试制剂和参比制剂的药代动力学特征。 2. 次要目的：考察健康受试者给药受试制剂和参比制剂后的安全性。

开始日期2023-12-30

申办/合作机构

山东朗诺制药有限公司

CTR20231341 / CompletedN/A

中国健康成年受试者在空腹/餐后状态下单次口服达可替尼片（45 mg）受试制剂和达可替尼片（45 mg）参比制剂（VIZIMPRO®）的生物等效性试验

主要研究目的：本研究以昆山龙灯瑞迪制药有限公司研制的达可替尼片（规格：45 mg）为受试制剂，按生物等效性研究的有关规定，以Pfizer Europe MA EEIG持证的欧盟上市的未进口原研药品达可替尼片（规格：45 mg，商品名：VIZIMPRO®）为参比制剂，评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。次要目的：观察受试制剂达可替尼片和参比制剂达可替尼片（VIZIMPRO®）在健康受试者中的安全性。

开始日期2023-05-30

申办/合作机构

昆山龙灯瑞迪制药有限公司

CTR20230688 / CompletedN/A

达可替尼片在健康受试者中的单剂量、空腹和餐后、随机、开放、两周期、两交叉生物等效性研究

主要目的：评价中国健康成人受试者空腹/餐后状态下口服重庆药友制药有限责任公司生产的达可替尼片（15mg）与参比制剂达可替尼片（15mg，商品名：Vizimpro®）是否具有生物等效性。次要目的：评价受试制剂与参比制剂在健康受试者中的安全性。

开始日期2023-03-24

申办/合作机构

重庆药友制药有限责任公司

100 项与 EGFR 外显子 19 缺失突变型非小细胞肺癌相关的临床结果

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100 项与 EGFR 外显子 19 缺失突变型非小细胞肺癌相关的转化医学

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0 项与 EGFR 外显子 19 缺失突变型非小细胞肺癌相关的专利（医药）

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项与 EGFR 外显子 19 缺失突变型非小细胞肺癌相关的文献（医药）

2024-02-21·ACS Applied Materials & Interfaces

Nanoplasmonic Detection of EGFR Mutations Based on Extracellular Vesicle-Derived EGFR–Drug Interaction

Article

作者: Jung, Jik-Han ; Han, Junhee ; Park, Ji-Ho ; Lee, Sung Yong

Analysis of membrane proteins from extracellular vesicles (EVs) has emerged as an important strategy for molecular cancer diagnosis. The epidermal growth factor receptor (EGFR) is one of the most well-known oncogenic membrane proteins, particularly in non-small cell lung cancer (NSCLC), where targeted therapies using tyrosine kinase inhibitors (TKIs) are often addressed based on EGFR mutation status. Consequently, several studies aimed at analyzing oncogenic membrane proteins have been proposed for cancer diagnosis. However, conventional protein analysis still faces limitations due to the requirement for large sample quantities and extensive post-labeling processes. Here, we develop a nanoplasmonic detection method for EGFR mutations in the diagnosis of NSCLC based on interactions between EGFR loaded in EVs and TKI. Gefitinib is selected as a model TKI due to its strong signals in the surface-enhanced Raman spectroscopy (SERS) and mutation-dependent binding affinity to EGFR. We demonstrate an SERS signal attributed to gefitinib at a higher value in the EGFR exon 19 deletion, both in cells and EVs, compared to wild-type and exon 19 deletion/T790M variants. Furthermore, we observe a significantly higher gefitinib SERS signal in EGFR obtained from exon 19 deletion NSCLC patient plasma-derived EVs compared with those from wild-type and exon 19 deletion/T790M EVs. Since our approach utilizes an analysis of the SERS signal generated by the interaction between oncogenic membrane proteins within EVs and targeted drugs, its diagnostic applicability could potentially extend to other liquid biopsy methods based on EVs.

2023-09-15·Maedica - A Journal of Clinical Medicine

EGFR Mutated Non-Small Cell Lung Cancer Complicated by Cancer Associated Ischemic Stroke

作者: Satoh, Hiroaki ; Okauchi, Shinichiro ; Ohara, Gen ; Hasegawa, Sachie ; Hizawa, Nubuyuki ; Taguchi, Manato ; Kawakami, Takeshi

We describe herein two patients with epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC) who developed cancer-associated ischemic stroke (CAIS), infarction caused by thromboembolism in the central nervous system. Case 1 was a 63-year-old man with Exon 19 deletion type EGFR mutated lung adenocarcinoma presenting with CAIS. Case 2 was a 71-year-old woman with Exon 21 L858R type EGFR mutated lung adenocarcinoma who developed CAIS during chemotherapy after EGFR-tyrosine kinase inhibitor (TKI) resistance. Although there was no recurrence of CAIS in these patients, anticancer therapy could be hampered by the comorbidity of CAIS. This can develop anytime from before clinical manifestations of NSCLC to the next treatment after EGFR-TKI resistance. The development of CAIS should be noted in patients with EGFR mutated NSCLC, who have a promising long-term prognosis. Anticancer and anticoagulant therapies as well as rehabilitation are important for patients who develop CAIS. Establishment of measurement tests to detect CAIS before onset is desired.

2023-08-25·Medicine

Efficacy of 3rd generation TKI in patients with EGFR mutation lung adenocarcinoma with bone metastases: A review of 3 case reports and literature

Review

作者: Zhang, Deyuan ; Wei, Yiping ; Feng, Weiqiang ; Hu, Sheng ; Su, Lang ; Wang, Silin ; Zhang, Wenxiong ; Xu, Jianjun ; Ye, Jiayue ; Zhang, Yang ; Guo, Qiang

Rationale:With the advancement of targeted therapies, epidermal growth factor receptor tyrosine kinase inhibitors have become the preferred initial treatment for patients with advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer. Osimertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor, is effective against exon 19 and 21 mutations as well as the T790M mutation. It has been approved by both the food and drug administration and European Medicines Agency for the treatment of non-small cell lung cancer patients with locally advanced or metastatic EGFR-mutated tumors, including those who have acquired T790M mutations.Patient concerns:To evaluate the effectiveness of osimertinib in treating patients with EGFR-mutated advanced lung adenocarcinoma and bone metastases, we present the treatment outcomes of 3 patients with EGFR 19 deletion-mutated advanced lung adenocarcinoma and bone metastases who received osimertinib treatment in recent years. All 3 cases involved elderly female patients, aged 62, 62, and 54, respectively.Diagnoses:All 3 cases exhibited a diagnosis of pulmonary adenocarcinoma accompanied by osseous metastases, with genetic testing revealing the presence of an EGFR 19del mutation.Interventions:In the first case, following 17 months of gefitinib therapy, disease progression prompted a switch to osimertinib treatment. In the second case, bone metastases were detected after 20 months of pemetrexed-carboplatin chemotherapy, leading to a transition to osimertinib therapy. In the third case, after 11 months of erlotinib treatment, bone metastases were identified. Subsequent interventions, including radiation therapy, pemetrexed-carboplatin chemotherapy, pemetrexed-bevacizumab maintenance therapy, and docetaxel chemotherapy, failed to arrest the progression of bone metastases. As a result, a combination of osimertinib and anlotinib targeted therapy was administered.Outcomes:All 3 patients experienced relatively good and favorable survival outcomes, with a progression-free survival of 22.7 months, 12 months, and 17.7 months, respectively.Lessons:These cases suggest that osimertinib is a promising treatment option for patients with EGFR 19 deletion-mutated lung adenocarcinoma and bone metastases, although further clinical studies are needed to confirm its efficacy.

项与 EGFR 外显子 19 缺失突变型非小细胞肺癌相关的新闻（医药）

2024-10-08

·Pharma CMC

信达生物与奥赛康药业达成战略合作

10月8日，信达生物宣布与奥赛康药业签署合作协议，双方就第三代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）靶向药物利厄替尼片（奥壹新®）达成独家商业化合作。奥赛康药业将作为合作产品的上市许可持有人，负责合作产品的商业化生产及供货，并根据合作协议向信达生物支付销售推广服务费。信达生物取得合作产品在中国大陆地区的独家推广销售权，将按合作协议约定向奥赛康药业支付首付款、注册里程碑和销售里程碑款项。利厄替尼是具有自主知识产权、全新分子实体、活性显著的口服的第三代EGFR-TKI。目前，利厄替尼片（奥壹新®）的两项适应症的新药上市申请（NDA）在国家药品监督管理局（NMPA）审评审批中，分别为：既往经EGFR酪氨酸激酶抑制剂（TKI）治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M突变阳性，或原发性EGFR T790M突变阳性的局部晚期或转移性非小细胞肺癌成人患者的治疗；具有表皮生长因子受体（EGFR）外显子 19 缺失（19DEL）或外显子 21置换突变（L858R）的局部晚期或转移性非小细胞肺癌成人患者的一线治疗。在一项多中心、随机、双盲、阳性对照III期临床试验中，利厄替尼头对头吉非替尼一线治疗EGFR敏感突变的局部晚期或转移性非小细胞肺癌患者，达到主要研究终点。该III期临床研究的相关数据及分析计划在未来学术大会或学术期刊上发表。早先，利厄替尼在2022年美国临床肿瘤学会（ASCO）年会上以壁报的形式展示了其2b期临床研究结果。

临床3期ASCO会议引进/卖出申请上市

2024-08-21

·药明康德

不用化疗一线治疗肺癌，双特异性抗体联合疗法获FDA批准

强生（Johnson & Johnson）今天宣布，美国FDA批准其双特异性抗体Rybrevant（amivantamab）联合第三代表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）口服药物Lazcluze（lazertinib）用于一线治疗经美国FDA批准检测证实带有EGFR外显子19缺失或外显子21中L858R替代突变的局部晚期或转移性非小细胞肺癌（NSCLC）成年患者。之前试验结果显示，与活性对照药物相比，Rybrevant与Lazcluze联合疗法可降低患者疾病进展或死亡风险达30%。这次美国FDA的批准主要是基于MARIPOSA临床3期研究的积极结果，该研究检视Rybrevant与Lazcluze联合疗法与活性对照TKI药物Tagrisso相比，用以一线治疗EGFR外显子19缺失或外显子21中L858R替代突变的局部晚期或转移性NSCLC患者的疗效与安全性。分析显示，Rybrevant与Lazcluze与活性对照药物相比，可将疾病进展或死亡风险降低30%，联合疗法与活性对照药物组患者的中位无进展生存期（PFS）分别为23.7个月与16.6个月。此外，联合疗法组的中位DOR比活性对照药物长9个月（25.8个月vs 16.7个月），这是该研究的次要终点。联合疗法的安全性与各个组分的已知安全性一致。 Rybrevant是一款人源化EGFR/MET双特异性抗体。它具有多重抗癌的作用机制，不但能够阻断EGFR和MET介导的信号传导，还可以引导免疫细胞靶向携带激活性和耐药性EGFR/MET突变和扩增的肿瘤。Rybrevant于2021年5月获得美国FDA的加速批准，用于治疗经FDA批准的检测发现EGFR外显子20插入突变、接受铂类化疗过程中或化疗后病情进展的局部晚期或转移性NSCLC成年患者。Lazcluze则是一种具高选择性、可穿透血脑屏障的第三代口服EGFR TKI。参考资料： [1] RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer. Retrieved August 20, 2024 from https://www.jnj.com/media-center/press-releases/rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-approved-in-the-u-s-as-a-first-line-chemotherapy-free-treatment-for-patients-with-egfr-mutated-advanced-lung-cancer 内容来源于网络，如有侵权，请联系删除。