Activity of patritumab deruxtecan (U3-1402; HER3-DXd) has been shown in a phase I/II study in patients with HER3 expressing breast cancer as well as in a phase I study in patients with EGFR TKI refractory EGFR mutation positive NSCLC with a preliminary ORR of 25%. HER3 expression can be seen in multiple tumor types and is therefore an attractive target for antibody drug conjugate (ADC) treatment. However, intra- and intertumor heterogeneity of HER3 expression might be substantial, as is seen for HER2, and might contribute to treatment failure or heterogeneous responses. In addition, HER3 expression is dynamic and has been shown to change over time.
In order to identify patients that may benefit most from treatment with patritumab deruxtecan, better knowledge of the in vivo behaviour of the drug is warranted. One way to visualize this behaviour is positron emission tomography (PET) imaging with radiolabelled antibodies (immune-PET). 89Zr-Patritumab deruxtecan PET/CT can assess HER3 expression non-invasively at a whole body level, including sites that may be difficult to biopsy. It also visualizes and quantifies biodistribution of patritumab deruxtecan, thereby obtaining valuable information for safety and toxicity analyses.

开始日期2024-05-01

申办/合作机构

Netherlands Cancer Insitute

[+1]

NCT06037733 / RecruitingN/AIIT

Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy

The aim of this randomized study is to investigate pneumonitis, local tumor control, and survival outcomes of primary tumor radiotherapy omitting CTV for patients with advanced NSCLC responded to immunotherapy and chemotherapy

开始日期2024-03-13

申办/合作机构

湖北省肿瘤医院

NCT05865990 / Active, not recruiting临床2期

Multicenter, Single-arm, 3 Cohort, Phase II Trial of HER3-DXd in Patients With Active Brain Metastases From Metastatic Breast Cancer and Non-small Cell Lung Cancer, and in Patients With Leptomeningeal Disease From Advanced Solid Tumors

The goal of this phase II clinical trial] is to analyze the efficacy of patritumab deruxtecan (HER3-DXd) in patients with metastatic breast cancer (MBC) or advanced non-small cell lung cancer (aNSCLC) with active brain metastases (BM) who have received at least one line of systemic therapy in the advanced setting, or patients with active leptomeningeal carcinomatosis/disease (LMD) after radiotherapy from an advanced solid tumor who do not need immediate local treatment, and have not received prior treatment with an anti-HER3 targeted drug].
The main questions it aims to answer are:
* The intracranial objective response rate (ORR-IC) per local investigator as judged by best central nervous system (CNS) response according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria of HER3-DXd in patients with active BM from MBC (Cohort 1) and aNSCLC (Cohort 2).
* The overall survival (OS) rate at 3 months of HER3-DXd in patients with advanced solid tumors with untreated LMD (Cohort 3).
Participants will receive HER3-DXd on day (D1) of each 21-day cycle until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason.
Researchers will compare historical groups to see if HER3-DXd positively impacts patient outcomes.

开始日期2023-11-24

申办/合作机构

Medica Scientia Innovation Research SL

[+1]

100 项与晚期肺非小细胞鳞癌相关的临床结果

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100 项与晚期肺非小细胞鳞癌相关的转化医学

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0 项与晚期肺非小细胞鳞癌相关的专利（医药）

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项与晚期肺非小细胞鳞癌相关的文献（医药）

2024-09-23·Japanese journal of clinical oncology

Phase II study of carboplatin plus weekly paclitaxel with bevacizumab for non-squamous, non-small cell lung cancer with idiopathic interstitial pneumonia (Hanshin Cancer Group IP002).

Article

作者: Morita, Satoshi ; Nakakura, Akiyoshi ; Amano, Yoshihiro ; Tamiya, Motohiro ; Watanabe, Kana ; Kaneda, Toshihiko ; Okamoto, Tadashi ; Oki, Masahide ; Nagata, Kazuma ; Katakami, Nobuyuki ; Hatachi, Yukimasa ; Tokito, Takaaki

BACKGROUNDThere is an increased risk of acute exacerbation of idiopathic interstitial pneumonia when treating patients with advanced non-small cell lung cancer with idiopathic interstitial pneumonia. There is no standard optimal treatment regimen for patients with lung cancer complicated with idiopathic interstitial pneumonia. We aimed to evaluate the efficacy and safety of carboplatin (CBDCA), bevacizumab (Bmab) and weekly paclitaxel (PXT) in patients with idiopathic interstitial pneumonia.METHODSThis phase 2 study involved chemotherapy-naïve patients with advanced non-small cell lung cancer with idiopathic interstitial pneumonia. Patients received CBDCA (area under the curve: 5 on day 1), PXT (70 mg/m2 on days 1, 8 and 15) and Bmab (15 mg/kg on day 1) every 4 weeks. The primary endpoint was the overall response rate.RESULTSTwenty-one patients were enrolled between January 2013 and October 2018 and received at least one course of the protocol treatment. The study was terminated before enrolling the planned number of patients because of poor accrual. The median patient age was 69 (range: 62-79) years, and 19 (90.5%) patients were men. The overall response rate was 61.9% (95% confidence interval [CI], 38.4-81.9), meeting the primary endpoint. The median progression-free survival, time to treatment failure, and overall survival were 9.69 (95% CI, 5.78-11.63), 8.21 (95% CI, 3.75-11.63) and 20.93 (95% CI, 13.17-29.83) months, respectively. There was no acute exacerbation or treatment-related death during protocol treatment.CONCLUSIONThe results indicate that patients with advanced non-squamous, non-small cell lung cancer with idiopathic interstitial pneumonia could be effectively and safely treated using a combination of CBDCA, PXT and Bmab.

2024-09-13·Expert Review of Pharmacoeconomics & Outcomes Research

Cost-effectiveness analysis of first-line serplulimab plus chemotherapy for advanced squamous non-small-cell lung cancer in China: based on the ASTRUM-004 trial

Article

作者: Wu, Meiyu ; Tan, Chongqing ; Meng, Kehui ; Xiang, Heng

OBJECTIVEIn the ASTRUM-004 trial, serplulimab plus chemotherapy demonstrated significantly improved survival and controllable safety. This study assessed the cost-effectiveness of serplulimab plus chemotherapy in advanced squamous non-small cell lung cancer (sqNSCLC), considering the perspective of the Chinese healthcare system.METHODSA decision tree and a Markov model were constructed to simulate the treatment. The interesting results included total cost, life-years (LYs), quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). Scenario, one-way and probabilistic sensitivity analyses were used to examine model instability.RESULTSCompared with placebo plus chemotherapy, serplulimab plus chemotherapy had an ICER of $55,539.46/QALY ($47,278.84/LY). The ICERs were estimated to be $58,706.03/QALY, $48,978.34/QALY and $59,709.54/QALY inpatients with programmed death-ligand 1 expression level of tumor proportion score (TPS) < 1%, 1% ≤ TPS < 50%, and TPS ≥ 50%. The cost-effective prices of serplulimab were $168.276/100 mg, $349.157/100 mg, and $530.039/100 mg at the willingness-to-pay threshold of $12,574.30/QALY, $25,148.60/QALY, and $37,722.90/QALY. Patient weight and price of serplulimab created the most significant impact. Presently, the probability of serplulimab plus chemotherapy being cost-effective was 14.15%.CONCLUSIONCompared with placebo plus chemotherapy, serplulimab plus chemotherapy might not be cost-effective in the first-line treatment for advanced sqNSCLC.

2024-08-01·European Journal of Cancer

Letter Re: Real-world outcomes of Italian patients with advanced non-squamous lung cancer treated with first-line pembrolizumab plus platinum-pemetrexed

Letter

作者: Wang, Fa-Lin ; Zhu, Hao ; Liu, Jia-Ren

项与晚期肺非小细胞鳞癌相关的新闻（医药）

2024-10-08

·思路迪医药 3D Medicines

2024 WCLC｜恩维达®治疗鳞状非小细胞肺癌II期临床试验于WCLC大会展示最新临床数据

2024年世界肺癌大会（WCLC）于9月初美国圣地亚哥隆重召开。大会汇聚了全球顶尖专家学者，以"探索肺癌的洞见与创新"为主题。在本次大会上，山东大学齐鲁医院刘联教授以壁报形式发表一项关于恩维达®（恩沃利单抗注射液，ENWEIDA®）联合重组人血管内皮抑素和化疗在晚期鳞状非小细胞肺癌（sq-NSCLC）一线治疗的II期研究（NCT05243355）临床数据，各项数据表现良好。本次研究，是一项单臂、多中心、前瞻性II期研究，评估了恩维达®联合重组人血管内皮抑素和化疗在晚期鳞状非小细胞肺癌（sq-NSCLC）一线治疗中的疗效和安全性，数据显示, 客观缓解率（ORR）为81%，疾病控制率（DCR）达100%。虽然生存数据尚未成熟，但初步结果表明，该联合疗法在晚期sq-NSCLC患者中疗效显著，且安全性方面表现良好。有数据统计，肺癌是全球癌症死亡的重要原因。非小细胞肺癌产生于较大的细胞，如呼吸道上皮细胞或粘液产生细胞，约占这些病例的85%。大约30%的非小细胞肺癌患者会在早期被诊断出来，五年复发率在45%（IB期）到76%（III期）之间。大约70%的患者会在晚期被诊断出来，局部晚期的存活率为35%，转移性病例的存活率为7%。在患病率方面，全球大约有240万个记录在案的肺癌病例，其中估计有210万个病例为非小细胞肺癌。在亚太地区的发病率较高，其次是欧洲、北美和世界其他地区。各国的患病率有所不同，其中中国、美国、日本、印度、德国、英国和法国的病例数较高。思路迪医药始终以临床需求为导向，在肺癌及肺癌新辅助治疗上积极探索更优临床治疗选择，以求在未来可以帮助到更多的患者获益。关于恩维达®（恩沃利单抗注射液）恩维达®（恩沃利单抗注射液）由康宁杰瑞自主研发，2016年起与思路迪医药共同开发，2020年3月30日，康宁杰瑞、思路迪医药、先声药业三方达成战略合作，康宁杰瑞作为原研方负责生产和质量，思路迪医药负责肿瘤领域的临床开发，先声药业负责产品在中国大陆的独家商业推广。基于其独特设计，恩维达®在有效性、安全性、便利性、依从性方面具有优势，患者无需进行静脉滴注，同时有望降低医疗成本。目前在中国、美国和日本针对多个肿瘤适应症同步开展临床试验，多个适应症已进入注册/Ⅲ期临床。恩维达®已被美国FDA授予晚期胆道癌孤儿药资格、软组织肉瘤孤儿药资格。2021年11月，恩维达®正式在中国率先获批上市，适用于不可切除或转移性微卫星高度不稳定(MSI-H)或错配修复基因缺陷型(dMMR)的成人晚期实体瘤患者的治疗，包括既往经过氟尿嘧啶类、奥沙利铂和伊立替康治疗后出现疾病进展的晚期结直肠癌患者以及既往治疗后出现疾病进展且无满意替代治疗方案的其他晚期实体瘤患者。关于思路迪医药（3D Medicines Inc.）思路迪医药是一家进入商业化阶段专注肿瘤慢病化治疗领域的创新药公司，秉承“帮助肿瘤患者活得更久更好”的愿景，研发新一代抗肿瘤药物。公司产品线包括12款具有差异化临床价值或全球领先的创新药，其中8款已进入临床开发或商业化阶段，包括全球首个皮下注射PD-L1单域抗体新药恩维达®已获国家药品监督管理局批准上市销售；依托公司自有mRNA研发平台和肿瘤基因组大数据AI分析平台，研发系列mRNA产品；公司自主研发的多靶点激酶抑制剂3D011也进入了临床开发阶段，临床前品种包括国际领先的CD3xPD-L1双特异性抗体。公司建立了从药物发现、临床前研究、临床开发、申报上市及商业化能力。思路迪医药坚持以患者为中心，开发具有差异化临床价值的创新药。更多信息请访问： http://www.3d-medicines.com 思路迪医药前瞻性声明本文所作出的前瞻性陈述仅与本文作出该陈述当日的事件或资料有关。除法律规定外，于作出前瞻性陈述当日之后，无论是否出现新资料、未来事件或其他情况，我们并无责任更新或公开修改任何前瞻性陈述及预料之外的事件。请细阅本文，并理解我们的实际未来业绩或表现可能与预期有重大差异。本文内所有关于或引用的本公司及董事的陈述、观点或意愿乃本文章刊发日期作出，可能因未来发展而出现变动。

孤儿药临床结果临床2期上市批准

2024-09-12

·复星医药

2024 CSCO | 复宏汉霖H药汉斯状多项研究入选

2024年9月25日至29日，第27届全国临床肿瘤学大会暨2024年CSCO学术年会将在厦门举办。复宏汉霖抗PD-1单抗H药汉斯状®（斯鲁利单抗）多项最新研究结果将在本次大会上发布，广泛覆盖肺癌、消化道肿瘤领域的治疗进展与前沿探索。其中，H药一线治疗鳞状非小细胞肺癌（sqNSCLC）III期临床研究（ASTRUM-004）的中国亚组数据、H药一线治疗广泛期小细胞肺癌（ES-SCLC）III期临床研究（ASTRUM-005）的亚洲人群数据以及H药联合贝伐珠单抗和化疗一线治疗转移性结直肠癌（mCRC）II期/III期临床研究（ASTRUM-015）的II期数据将以口头报告形式在本次大会上发布。 H药为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液，也是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。目前，H药已在中国获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、sqNSCLC、ES-SCLC和食管鳞状细胞癌（ESCC），惠及患者约8万人。以临床需求为导向，公司就H药进行了差异化、多维度布局，广泛覆盖肺癌、消化道肿瘤等高发大癌种，在全球范围内累计入组逾4000名受试者。肺癌领域 ASTRUM-004：斯鲁利单抗联合化疗一线治疗晚期鳞状非小细胞肺癌的III期研究中国亚组数据牵头主要研究者：周彩存上海市东方医院汇报人：熊安稳上海市东方医院报告场次：非小细胞肺癌免疫治疗专场口头报告报告时间：2024年9月26日下午17:05-17:10 ASTRUM-005：斯鲁利单抗或安慰剂联合化疗一线治疗广泛期小细胞肺癌的国际多中心、随机、双盲III期研究亚洲人群数据牵头主要研究者：程颖，吉林省肿瘤医院汇报人：张爽吉林省肿瘤医院报告场次：小细胞肺癌专场2 口头报告报告时间：2024年9月28日上午11:10-11:20 消化道肿瘤领域斯鲁利单抗联合HLX04和XELOX对比安慰剂联合贝伐珠单抗和XELOX一线治疗转移性结直肠癌：一项II/III期研究牵头主要研究者&汇报人：徐瑞华中山大学肿瘤防治中心报告场次：结直肠癌专场2 口头报告报告时间：2024年9月28日下午15:31-15:39 斯鲁利单抗联合瑞戈非尼和肝动脉灌注碳酸氢盐三线治疗晚期肠癌肝转移患者: 一项单中心、单臂II期临床研究方案牵头主要研究者：袁瑛浙江大学医学院附属第二医院展示形式：壁报交流关于H药汉斯状® H药汉斯状®为重组人源化抗PD-1单抗注射液（通用名：斯鲁利单抗注射液），是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国和印度尼西亚获批上市。截至目前，H药已有4项适应症获批上市，2项适应症上市申请分别在中国和欧盟获受理，10余项临床试验同步在全球开展。 2022年3月，H药正式于中国获批上市，目前可用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）及食管鳞状细胞癌（ESCC）。H药联合化疗一线治疗非鳞状非小细胞肺癌（nsNSCLC）和一线治疗广泛期小细胞肺癌（ES-SCLC）的上市申请也分别获得中国NMPA和欧盟EMA受理。聚焦肺癌和消化道肿瘤，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，在全球同步开展10余项肿瘤免疫联合疗法临床试验，于中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超4000人。H药的4项关键性临床研究结果分别发表于知名期刊《美国医学会杂志》（JAMA）、《自然-医学》（Nature Medicine）、Cancer Cell和British Journal of Cancer。此外，H药还荣获《CSCO 小细胞肺癌诊疗指南》、《CSCO非小细胞肺癌诊疗指南》、《CSCO 食管癌诊疗指南》、《CSCO结直肠癌诊疗指南》、《CSCO免疫检查点抑制剂临床应用指南》和《中国食管癌放射治疗指南》等多部权威指南推荐，为肿瘤临床诊疗提供重要参考。海外方面，H药治疗SCLC也已获得美国FDA和欧盟EC的孤儿药资格认定，并在美国启动了一项H药对比一线标准治疗阿替利珠单抗的头对头桥接试验。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，3款产品在国际获批上市，24项适应症获批，3个上市申请分别获中国药监局和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖50多个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

CSCO会议临床3期上市批准临床2期临床结果

2024-08-15

·Business Wire

Bicara Therapeutics Expands Board of Directors with Appointments of Mike Powell, Ph.D., and Christopher Bowden, M.D.

BOSTON--( BUSINESS WIRE )--Bicara Therapeutics, a clinical-stage biotechnology company developing transformative bifunctional therapies for patients with solid tumors, today announced the appointments of Mike Powell, Ph.D., and Christopher Bowden, M.D., to the company’s board of directors. Dr. Powell currently serves as executive partner of Omega Funds and will serve as Bicara’s chairman of the board. Dr. Bowden is the former chief medical officer of Agios Pharmaceuticals and current chief medical officer of Remix Therapeutics and will serve as an independent director. “ Mike and Chris are distinguished biopharma industry leaders that have contributed to the approvals of multiple innovative oncology medicines. We are thrilled to welcome them to our board of directors,” said Claire Mazumdar, Ph.D., MBA, chief executive officer of Bicara Therapeutics. “ The combination of Mike’s four decades of pharmaceutical clinical development experience and Chris’ strategic medical and corporate expertise will be critical as we continue to advance ficerafusp alfa (BCA101) into late-stage development for recurrent/metastatic head and neck squamous cell carcinoma as well as other indications.” About Mike Powell, Ph.D. Dr. Mike Powell joined Omega Funds as executive partner in 2021 from Sofinnova Investments, where he served as managing general partner since 1997. Previously, Dr. Powell was Group Leader at Genentech from 1990 to 1997, where his focus was on drug delivery, CMC, and formulation of both small molecule and protein drug entities. Before this, he served as the director of product development for Cytel Corp, an immunology biotech company. Prior to this, he was senior scientist and project team leader at Syntex Research (Roche). Dr. Powell was the first person in the biotech industry to become a fellow of the American Association of Pharmaceutical Scientists (AAPS). He was previously board president of the AIDS Vaccine Advocacy Coalition, an advisor to the Institute for One World Health, IAVI, and the Bill and Melinda Gates Foundation, and an adjunct associate professor in the Department of Pharmaceutical Chemistry at the University of Kansas. Dr. Powell holds a Ph.D. in physical chemistry from the University of Toronto, and a postdoc in bio-organic chemistry at the University of California. About Christopher Bowden, M.D. Dr. Chris Bowden currently serves as the chief medical officer of Remix Therapeutics. Prior to Remix, Dr. Bowden served as a strategic advisor and chief medical officer of Agios Pharmaceuticals from 2014-2022. As chief medical officer at Agios, he oversaw clinical development that led to U.S. approvals for the IDH inhibitors IDHIFA™ and TIBSOVO™ in acute myeloid leukemia (AML), for TIBSOVO™ in cholangiocarcinoma and for PYRUKYND™ for adults with pyruvate kinase deficiency. Prior to joining Agios, Dr. Bowden was vice president of product development in oncology, franchise lead (signaling group) at Genentech, Inc. where he was responsible for the successful development of several novel targeted oncology medicines, including Zelboraf™ and Tarceva™. Dr. Bowden received his M.D. from Hahnemann University School of Medicine in Philadelphia after which he completed his internal medicine training at Roger Williams Medical Center and the Providence VA Medical Center, Rhode Island. He conducted his medical oncology fellowship at the National Cancer Institute Medicine Branch. Dr. Bowden is board certified in internal medicine and medical oncology. About Ficerafusp Alfa (BCA101) Ficerafusp alfa is a bifunctional antibody designed to inhibit the epidermal growth factor receptor (EGFR) and disable transforming growth factor beta (TGF-β) directly at the tumor site. This approach is designed with the intent to allow ficerafusp alfa to inhibit tumor proliferation, while restoring the cytolytic activity of the local immune cells. Ficerafusp alfa is currently being evaluated in a dose expansion phase of an open-label Phase 1/1b study in combination with pembrolizumab in HPV-negative patients with R/M HNSCC, advanced squamous non-small cell lung cancer (SqNSCLC), or squamous cancer of the anal canal (SCAC) and as a monotherapy for cutaneous squamous cell carcinoma (cSCC). About Bicara Therapeutics Bicara Therapeutics is a clinical-stage biotechnology company developing bifunctional therapies engineered to combine the precision of well validated, tumor-targeting antibodies with the power of tumor microenvironment modulators. The Company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, offering the potential for synergistic therapeutic impact at the site of the tumor. Bicara’s lead product candidate, ficerafusp alfa, is a EGFR/TGF-β-trap bifunctional antibody in clinical development for multiple tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X.

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