A Phase I/II Clinical Study to Evaluate JS111 Capsules in Patients With Locally Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Mutations.

To evaluate the safety, tolerability, and preliminary efficacy of JS111 capsules in patients with locally advanced, metastatic, or recurrent NSCLC harboring EGFR mutations;to determine the recommended Phase II dose (RP2D).

开始日期2025-04-20

申办/合作机构

苏州君境生物医药科技有限公司

[+1]

NCT06945705

/ Recruiting临床2期IIT

A Prospective, Single-arm, Multi-center Clinical Trial of Furmonertinib Combined With Anlotinib as First-line Treatment for Advanced NSCLC With EGFR-sensitive Mutations and Brain Metastasis.

EGFR mutation-positive NSCLC patients have a higher risk of developing brain metastases. The prognosis is poor for patients presenting with brain or leptomeningeal metastases at any stage, particularly those with such metastases at initial diagnosis, who have the worst prognosis. Furmonertinib, as a novel EGFR-TKI, enhances its lipophilicity by incorporating a trifluoroethoxy pyridine group. Preclinical animal studies further confirm that both Furmonertinib (AST2818) and its metabolite (AST5902) exhibit excellent intracranial distribution. This provides strong theoretical support for the effective treatment of lung cancer brain metastasis patients with Furmonertinib.
EGFR TKI-based combination therapies, as a strategy to delay disease progression, have consistently been a focal point in medical research. Among these, antiangiogenic agents are increasingly recognized for their synergistic effects when combined with TKIs, jointly inhibiting tumor growth, proliferation, and metastasis.Such combinations have demonstrated clear efficacy and manageable safety profiles.
Based on this, the current study aims to explore the efficacy and safety of first-line treatment with 160 mg Furmonertinib combined with anlotinib for advanced NSCLC patients with EGFR-sensitive mutations and brain metastases.

开始日期2025-04-02

申办/合作机构

河南省肿瘤医院

NCT06861218

/ Not yet recruiting临床2期IIT

Cerebrospinal Fluid Cytology-guided Intrathecal Chemo-holiday Therapy for EGFR-positive NSCLC Meningeal Metastases: a One-arm, Phase II Clinical Study

With the rapid development of targeted drugs, the treatment of patients with leptomeningeal metastasis has become a very difficult problem in clinical work. High-dose targeted drugs and intrathecal chemotherapy are important treatment methods for meningeal metastasis. However, it is vital to note that safety is also of concern in previous studies of intrathecal chemotherapy. In this study, we aim to evaluate the safety and effectiveness of patient using chemo-holiday therapy based on the cerebrospinal fluid cytology, combined with double-dose EGFR-targeted drug in patients with leptomeningeal metastases from EGFR-positive NSCLC.

开始日期2025-04-01

申办/合作机构

浙江省肿瘤医院

100 项与 EGFR exon 20 相关的临床结果

登录后查看更多信息

100 项与 EGFR exon 20 相关的转化医学

登录后查看更多信息

0 项与 EGFR exon 20 相关的专利（医药）

登录后查看更多信息

234

项与 EGFR exon 20 相关的文献（医药）

2025-07-01·Revista Española de Patología

External quality assessment for EGFR exon 20 mutation testing in patients with non-small cell lung cancer in Spain

Article

作者: Enguita, Ana Belén ; Gómez, Lourdes ; Rodríguez Peralto, José Luis ; Ramón Y Cajal, Santiago ; Biscuola, Michele ; Martínez, Antonio ; Hernández-Iglesias, Teresa ; Ruano, Yolanda

INTRODUCTION AND AIMNon-small cell lung cancer (NSCLC) can arise from insertions in exon 20 of the EGFR gene, among other alterations. We carried out an external quality assessment (EQA) to evaluate the accuracy of laboratory methods and to highlight the importance of detecting and identifying genetic alterations, such as EGFR exon 20 insertion, in patients with NSCLC.MATERIALS AND METHODSThe 2021 EGRF exon 20 EQA program consisted of two rounds, in which four formalin-fixed paraffin-embedded specimens (round 1: two positive for EGFR exon 20 insertions/duplications, one positive for a common EGFR alteration, and one wild-type; round 2: three positive for EGFR exon 20 insertions/duplications and one wild-type) obtained from patients with NSCLC were tested.RESULTSApproximately 80% of the invited laboratories participated in each round. The most common DNA isolation techniques used were the cobas® DNA Sample Preparation Kit (46.7%) in round 1 and QIAamp (37.1%) in round 2. The most frequently used genotyping method in both rounds was the cobas® EGFR Mutation Test (round 1: 53.3%; round 2: 37.1%). In both rounds, 71.1% and 73.6% of the tests, respectively, reported the expected result. The lowest success rate was observed in the H773delinsRY Exon 20 determination (round 1: 17.8%; round 2: 31.4%). This alteration was correctly determined only by next-generation sequencing.CONCLUSIONSThe variability in the genotyping methods and the success rate obtained in our study highlight the importance of EQA in Spain to ensure high performance.

2025-05-01·Journal of Immunotherapy and Precision Oncology

PD-L1 Testing, Treatment Patterns, and Clinical Outcomes Among Patients with Metastatic NSCLC at an Academic Medical Center, 2017–2021

Article

作者: Simon, George R. ; Gibbons, Don L. ; Xu, Cai ; Malveaux, Donna ; Santorelli, Melissa L. ; Ponce, Darcy ; Rinsurongkawong, Waree ; Vaporciyan, Ara A. ; Heymach, John V. ; Sulihem, Saliha T. ; Burke, Thomas ; Sui, Dawen ; Williams, Loretta A. ; Rinsurongkawong, Vadeerat ; Altan, Mehmet ; Zhang, Jianjun ; Lee, J. Jack

ABSTRACTIntroductionTargeted therapies and immune checkpoint inhibitors (ICIs) have revolutionized the management of metastatic non–small cell lung cancer (NSCLC) over the past decade.MethodsThis single-center observational study was conducted to describe programmed death-ligand 1 (PD-L1) testing, choice of therapy, and outcomes for adult patients with stage IV NSCLC initiating first-line therapy from 2017 through 2020, with follow-up through June 2021. Patient characteristics and study assessments were described according to four histomolecular subtypes, defined by histologic characteristics and availability of standard-of-care therapies for molecular subgroups at the time of study conduct.ResultsOf 507 eligible patients with metastatic NSCLC, 85 (17%) had squamous NSCLC; 288 (57%) had nonsquamous NSCLC with no actionable genomic alteration; 44 (9%) had nonsquamous NSCLC with KRAS G12C mutation; and 90 (18%) had nonsquamous NSCLC with ROS1, BRAF V600E, EGFR exon 20 insertion, or RET or NTRK genomic alteration. Most tumors were PD-L1 tested. After excluding 40 patients whose PD-L1 testing status was unknown, all but 55 tumors (12%) were tested for PD-L1 expression, and the percentages tested rose from 86% in 2017 to 100% in 2020. From 27% of nonsquamous NSCLC with no actionable genomic alteration to 46% of KRAS G12C-mutated NSCLC had PD-L1 expression ≥ 50%. Use of chemotherapy decreased and use of ICI-chemotherapy combinations increased from 2017 to 2020. In the squamous NSCLC group, single or combination chemotherapy was administered most commonly (42%), whereas ICI-chemotherapy combinations were the most common first-line regimens in the three nonsquamous NSCLC histomolecular groups. For patients with NSCLC and no actionable genomic alterations, ICI-chemotherapy combinations were the most common regimens in 2018–2020 in all but the PD-L1 ≥ 50% category, for whom ICI monotherapy was most common every year except 2020. Median overall survival was 25.0 months (95% CI, 19.1–28.3) for all patients, and, by histomolecular cohort, 14.3 months for squamous NSCLC, 25.3 months for nonsquamous NSCLC with no actionable genomic alteration, not reached for KRAS G12C-mutated NSCLC, and 27.7 months for nonsquamous NSCLC with other genomic alterations.ConclusionStudy findings highlight the increased use of PD-L1 testing over the years from 2017 to 2020 and recent changes in therapy, with decreased use of chemotherapy and increased use of ICI-chemotherapy combinations during the study in each histomolecular group. Moreover, we observed improvements in survival for patients with metastatic NSCLC relative to historical real-world data.

2025-05-01·Lung Cancer

Real-world frontline treatments in patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor exon 20 insertions and adjusted comparisons versus amivantamab plus chemotherapy from the PAPILLON study

Article

作者: Galea, Francesca ; Chouaid, Christos ; Diels, Joris ; Li, Ziming ; Perualila, Nolen Joy ; Greystoke, Alastair ; Bosquet, Lise ; Caparros, Eduardo Quintero ; Schioppa, Claudio A ; Lin, Xiwu ; Schaeffer, Marcy ; Hultén, Annika ; Knott, Craig

INTRODUCTIONIn PAPILLON, frontline amivantamab + carboplatin + pemetrexed (ACP) demonstrated superior efficacy over carboplatin + pemetrexed in patients with advanced or metastatic non-small-cell lung cancer (aNSCLC) harboring mutations in epidermal growth factor receptor (EGFR) exon 20 insertions (exon20ins). Real-world (RW) treatment patterns and comparative effectiveness of ACP versus RW treatments are unknown.MATERIALS AND METHODSThe present study (NECTAR) retrospectively analyzed frontline treatments prescribed 2012-2023 for patients with aNSCLC and confirmed EGFR exon20ins from English (ENG-NCRD), French (FR-ESME), and US (US-COTA and US-ConcertAI) datasets. Overall survival (OS), time to next treatment (TTNT), and progression-free survival (PFS) were assessed in RW pooled and individual treatment classes and in indirect treatment comparisons (ITC) between ACP from PAPILLON and RW treatments using Cox proportional hazards model adjusted for prognostic factors.RESULTSNECTAR assessed 208 RW patients: ENG-NCRD, n = 23; FR-ESME, n = 91; US-COTA, n = 39, and US-ConcertAI, n = 55. Common frontline treatment classes were platinum-based chemotherapy (33.7 %), platinum + immunotherapy (23.1 %), EGFR tyrosine kinase inhibitors (TKIs) alone (15.4 %), platinum + VEGF inhibitors (VEGFi) (11.1 %), and immunotherapy alone (7.7 %). Compared with platinum-based chemotherapy, none of the evaluated treatment classes demonstrated improved OS, TTNT, and PFS. Exceptions were platinum + VEGFi in TTNT and PFS and platinum + immunotherapy in TTNT. In ITCs, ACP significantly improved OS over pooled RW treatments (HR = 0.48 [95 % CI, 0.32-0.71]; P < 0.001), platinum-based chemotherapy (HR = 0.48 [0.30-0.77]; P = 0.003), platinum + immunotherapy (HR = 0.41 [0.23-0.73]; P = 0.003), and EGFR TKI alone (HR = 0.48 [0.23-1.02]; P = 0.055). TTNT and PFS results were similar to OS.CONCLUSIONSIn patients with EGFR exon20ins aNSCLC, frontline ACP was superior to common RW treatments, highlighting the need for practice change.

352

项与 EGFR exon 20 相关的新闻（医药）

2025-04-30

·贝达药业

贝达药业四项研究成果亮相2025AACR年会

2025年第116届美国癌症研究协会（AACR）年会于2025年4月25-30日在美国芝加哥举行。贝达药业BPI-572270、BPI-585725、BK-001（VM-001）、MCLA-129等四项研究成果亮相2025AACR年会。△贝达同事参加AACR年会BPI-572270KRAS突变是导致多种癌症发生（如胰腺癌，非小细胞肺癌和结直肠癌）的致癌驱动因素，在所有癌症中的突变频率为20%-30%。目前已有靶向KRASG12C突变的药物获批并显示出临床获益。但尚未有靶向其他常见KRAS突变（如 KRASG12D/G12V/G12R等）以及另外两种RAS亚型（NRAS和HRAS）突变的药物获批上市，具有极大未满足临床需求。BPI-572270是一种强效泛RAS抑制剂，对携带KRAS、NRAS和HRAS不同突变的多种肿瘤细胞具有强效杀伤作用，显示出纳摩尔级IC50的细胞活性。BPI-572270在KRASG12V和KRASG12D的人胰腺癌异种移植小鼠模型中，低剂量每天口服给药一次可实现肿瘤消退。BPI-572270在小鼠、大鼠和比格犬中具有出色的药代动力学特性和良好的口服生物利用度。大鼠和比格犬进行的重复给药安全性评估数据初步显示BPI-572270安全性良好，进一步增强其在临床开发潜力。BPI-572270有望为携带不同RAS突变的广大实体瘤患者提供新的治疗方案。BPI-585725△杭州研发中心副主任周全博士作口头报告目前，尽管已有数款KRASG12C抑制剂上市，但是由于易出现耐药等原因，其疗效有限且应答持续时间较短。通过降解而非抑制KRAS蛋白有望实现持久的临床疗效。BPI-585725是一个新的多KRAS突变（KRASmulti）靶向蛋白降解嵌合体（PROTAC）分子。在细胞水平的KRAS降解实验中，BPI-585725通过泛素-蛋白酶体系统（UPS）依赖机制，对KRAS G12C、G12D、G12V、G13D及野生型扩增（WT-Amp）均能展现出显著的KRAS降解能力。该化合物对多种KRAS驱动型肿瘤细胞系（包括G12X、G13D和WT-Amp）均具有很好的增殖抑制作用，在多种细胞系中的IC50小于10 nM。生物化学水平靶点结合实验显示，BPI-585725对KRAS的亲和力比N/HRAS高300倍以上。在PK-59（KRASG12D）异源移植瘤模型中，单次静脉注射30 mg/kg BPI-585725可使药物在肿瘤组织中维持长达6天的有效浓度，并伴随持续的KRAS降解及下游DUSP6抑制效应。在该模型上每周一次给药，呈现出良好的剂量依赖性的肿瘤抑制能力。综上，BPI-585725是一款高效、高选择性KRASmulti降解剂，具有优良的药代动力学特性，且在临床前研究中展现出良好的安全性。BK-001（VM-001）目前的癌症治疗药物，如抗体、CAR-细胞，以及XDC等药物，主要是针对肿瘤相关抗原，而非肿瘤特异性抗原进行开发的。尽管这些治疗药物在一定程度上提高了靶向特异性并降低了毒性，但仍无法避免对正常信号通路的干扰和脱靶效应的发生。为了解决这些挑战，贝达药业徐汶新博士带领贝达药业和康万达的科学家们联合开发了一种创新的肿瘤治疗策略，即抗体与溶瘤病毒的协同疗法。该方法利用转基因溶瘤病毒（V113）在肿瘤细胞表面递呈人类不表达的靶抗原（TT3），随后，用CD3/TT3双特异性抗体（BK-001）靶向该抗原（TCE平台技术）。这一组合疗法不仅改变了肿瘤微环境，并具有精准靶向性和旁观者效应，显著提高了治疗效果，为癌症患者，特别是那些对现有治疗药物耐药或无药可医的患者，提供了全新的治疗选择。MCLA-129研究名称：《晚期非小细胞肺癌（NSCLC）中MET扩增/过度表达状态与MCLA-129响应的相关性：1期试验的生物标志物结果》背景：MCLA-129是一种靶向EGFR和c-MET的人源双特异性抗体，具有多种作用机制，包括抑制EGFR和c-MET信号传导、抗体依赖性细胞吞噬作用（ADCP）和增强抗体依赖性细胞毒性（ADCC）。在这项正在进行的针对晚期非小细胞肺癌患者的MET/EGFR双特异性抗体MCLA-129的1b期研究（NCT04930432）中，我们旨在更深入地探索MCLA-129与MET扩增（METamp）或蛋白质过表达（OE）人群疗效之间的关系。方法：符合条件的患者（≥18岁；ECOG PS 0-1；转移性或不可切除的非小细胞肺癌或其他实体瘤；EGFR或MET突变阳性）每两周接受一次静脉注射MCLA-129（1500 mg）。MET OE定义为IHC2+或IHC 3+（SP44抗体），METamp根据基因拷贝数（GCN）定义。我们使用不同的GCN截止值，旨在探索其与疗效结果的关系。结果：在数据截止日期（2024年3月31日），在24名NSCLC患者中，6名MET IHC 2+/3+患者和18名METamp患者的疗效可评估。6名MET IHC 2+/3+患者中有4名（中位既往治疗线数：1 [0-1]）达到了确认的部分缓解（PR）（总体缓解率[ORR]: 66.6% [95% CI 22.3-95.7]），所有这4名患者都存在共突变（3名METex14跳跃和1名EGFR exon20ins）。未达到中位反应持续时间（DOR）和无进展生存期（PFS）。18名METamp患者中有8名达到了确诊的PR（中位既往治疗线数：2 [1-7]）（ORR: 44.4% [95% CI 21.5-69.2]；DOR: NR [2.8-NR]；PFS: 4.8个月[2.7-9.6]）。在7名全身抗肿瘤治疗前检测到METamp的患者中，4名患者达到了确诊的PR，ORR为57.1%（95% CI 18.4-90.1），所有这4名患者都发生了共突变（2个EGFR exon20ins，1个METex14跳跃和1个L861Q）。在9名接受三代EGFR-TKI治疗的患者中，有3名患者达到了确诊的PR。不同MET临界值的患者表现出不同的ORR。结论：MCLA-129在携带MET OE或METamp的晚期非NSCLC患者中显示出具有临床意义的抗肿瘤活性，特别是在携带共突变的患者中。高GCN似乎与METamp的晚期NSCLC患者中更好的疗效呈现相关性，表明其预后特性。关于AACR年会AACR年会是世界上规模最大的癌症研究会议之一，每年都会吸引来自世界各地的近20000名专业人士出席会议。

AACR会议临床结果蛋白降解靶向嵌合体

2025-04-30

·药智网

抗癌药龙头业绩暴涨294%

随着两款创新药的上市并纳入医保，迪哲医药营收爆发式增长，亏损持续收窄，迈向盈利的曙光。2024年，迪哲医药实现营业总收入3.6亿元，同比增长294%。2025年第一季度，营业总收入突破1.6亿元，同比增长96%，主要得益于两款核心产品舒沃哲和高瑞哲的快速放量。同时，公司还在费用控制方面取得了显著成效。2024年销售费用率为124%，2025Q1为77%，明显下降。此外研发费用过去两年持平略微下降。在“降本增效”下，迪哲医药2024年全年净亏损同比减少24%；2025Q1净亏损进一步收窄，同比减少14%。12图1 迪哲业绩情况图片来源：迪哲医药1产品快速放量迪哲医药已有两款商业化产品，其全部营收均来源于这两款创新药的销售。目前，这两款产品都还处于放量早期阶段，后续还有显著增量空间，可为迪哲医药提供强劲而持续的现金流支持和市场竞争力，也为后续产品线的拓展和全球市场布局奠定了坚实基础。舒沃哲®（通用名：舒沃替尼片）：目前全球首个且唯一获批治疗表皮生长因子受体（EGFR）20号外显子插入突变（exon20ins）非小细胞肺癌（NSCLC）的口服小分子靶向药。该药于2023年8月通过优先审评在中国获批上市，成为中国EGFR exon20ins NSCLC患者二/后线治疗的唯一标准方案，是该领域唯一获批且可医保报销的药物，填补了近20年临床空白。2024年，舒沃替尼作为二/后线治疗EGFR exon20ins NSCLC的唯一I级推荐用药，被纳入《CSCO非小细胞肺癌诊疗指南（2024版）》，后陆续被列入中国各大非小细胞肺癌权威指南，并获得最高等级推荐。其市场独占性，为销量增长提供了有力支撑。此外，舒沃哲®一线治疗的全球III期注册临床研究也在快速推进，有望改变EGFR exon20ins突变NSCLC一线治疗格局。高瑞哲®（通用名：戈利昔替尼胶囊）：是高选择性的JAK1抑制剂，能够有效抑制JAK/STAT通路，单药治疗复发/难治外周T细胞淋巴瘤（r/r PTCL）中位总生存期（mOS）达24.3个月，是目前单药治疗r/r PTCL mOS最长的药物，首次突破2年以上。2024年6月，戈利昔替尼作为全球首个且唯一治疗PTCL的高选择性JAK1抑制剂，通过优先审评获批于中国首发上市，半年后成功纳入国家医保。今年4月，该药治疗PTCL获《CSCO淋巴瘤诊疗指南（2025版）》“全面推荐”：针对r/r PTCL获I级推荐，指南首次推荐其单药治疗复发/难治NK/T细胞淋巴瘤（r/r NKTCL），并提及高瑞哲®针对PTCL维持治疗的探索。权威指南高度认可，国内市场有望加速放量。舒沃哲®和高瑞哲®分别针对非小细胞肺癌EGFR TKI耐药和免疫治疗耐药的最新研究进展入选2025欧洲肺癌大会（ELCC），各自联合治疗临床应用的潜力初步显现。戈利昔替尼有望将适应症从血液瘤拓展到肺癌领域。由此可见，两款产品才刚进入高速增长期，还有更多适应症拓展潜力，商业回报空间未来可期。2夯实“肺癌+血液瘤”全球竞争力纵观迪哲医药的源头创新研管线，两款已上市FIC/BIC产品，海外市场蓄力待发，积极探索适应症拓展，还有多个潜力管线，以夯实其在“肺癌+血液瘤”领域的全球竞争力。图2 迪哲医药在研管线图片来源：迪哲医药两款已上市产品，均已获得FDA快速通道资格认定。舒沃哲®是迄今为止治疗EGFR Exon20ins NSCLC唯一全线拥有中美“突破性疗法认定”的大满贯药物，基于全球注册研究积极结果，其在该领域二/后线疗法的新药上市申请（NDA），已于今年1月获美国FDA受理并授予优先审评资格，预计年内获批。而高瑞哲®是下一款冲击全球市场的种子选手，拥有美国FDA授予的“快速通道认定”。DZD8586是一款全球首创、全新非共价LYN/BTK双靶点抑制剂，具备完全穿透血脑屏障能力，是全球开发进度最快针对B细胞非霍奇金淋巴瘤（B-NHL）双重耐药机制的双靶点药物。当前，尚无药物能同时应对BTK抑制剂的两种耐药机制（C481X BTK突变和非BTK依赖性BCR信号通路激活）。此外，虽然BTK降解剂在早期临床研究中显示了疗效,突变相关的耐药已有报道,且降解剂相关的毒副反应可能影响临床的长期应用。既往Ⅰ期临床研究数据显示，DZD8586具有良好的口服药代动力学特征及中枢神经系统渗透能力，能全面阻断BCR信号通路，安全性及耐受性良好，并在多种B-NHL亚型中显示了令人鼓舞的疗效。在即将召开的ASCO大会，DZD8586首次亮相并斩获了口头报告，这是迪哲研发成果连续第三年获得ASCO口头报告。本次大会迪哲将公布其针对共价或非共价BTK抑制剂以及BTK降解剂治疗失败慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者的最新临床数据。此前一项发表于第66届ASH大会的研究显示，在接受DZD8586治疗后,有94.4%的CLL/SLL患者出现肿瘤缩小。此外，在包括弥漫性大B细胞淋巴瘤（DLBCL）等多种类型的B-NHL患者中，均观察到显著的肿瘤缓解。DZD8586单药治疗复发/难治（r/r）DLBCL的一项Ⅱ期临床研究结果也将在此次ASCO大会展示。DZD6008是迪哲自主研发的新一代高选择性EGFR-TKI，可完全穿透血脑屏障，能有效抑制多种EGFR突变细胞及肿瘤动物模型的生长。目前，针对三代EGFR TKI耐药NSCLC的现有治疗手段的临床获益有限，同时，脑转移是导致疾病进展及患者死亡的主要原因之一，每年全球有超250万肿瘤脑转移患者，其中晚期肺癌患者脑转移发生率最高，DZD6008有望填补该领域未被满足的临床需求。DZD6008在已有的临床试验中，完全验证了该分子的设计理念，在三代EGFR TKI和多线治疗失败及脑转移的病人中显示优异的安全性和有效性。该产品也入选了ASCO 2025，迪哲将公布其针对接受过三代EGFR TKI等多线治疗的EGFR突变NSCLC的积极研究成果。此外，迪哲医药还在本次财报中披露一条已进入临床的管线GW5282，针对实体瘤和血液瘤。目前，迪哲医药已经形成了包括实体瘤、血液瘤和免疫治疗在内的7条差异化管线布局。3结语近日，作为科创板唯一获得定增许可的未盈利企业，迪哲医药已完成向特定对象发行股票募集资金约18亿元，募集资金将用于加速核心产品研发和布局自主研发生产基地。同时，伴随着核心产品的销售放量和运营效率的提升，迪哲医药的“自我造血”能力正在逐步增强。未来，叠加已上市产品的医保放量、海外市场的推进，以及新适应症、新管线的开发，迪哲医药有望加速盈利，不断突破增长天花板。声明：本内容仅用作医药行业信息传播，不代表药智网立场。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 小月石合作、投稿 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

优先审批CSCO会议上市批准临床3期财报

2025-04-28

·PRNewswire

2025 AACR | Abbisko Therapeutics Presents Late-Breaking Pre-clinical Research Results on ABSK112 (EGFR exon20ins), ABSK131 (PRMT5*MTA), and ABK-KRAS-1

SHANGHAI, April 27, 2025 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. (Abbisko Therapeutics 02256.HK) today announced that it has presented four late-breaking pre-clinical research posters at the 2025 AACR conference held in Chicago, Illinois (USA) from April 25 to April 30. Results were shared for ABSK112 (EGFR exon20ins inhibitor), ABSK131 (PRMT5*MTA inhibitor), and ABK-KRAS-1 (pan-KRAS inhibitor), as well as results from a study investigating potential resistance mechanisms to KRAS G12C inhibitors. Abbisko presented the following posters at the 2025 AACR: Title1: Preclinical Evaluation of ABSK112, a Selective and CNS-penetrant Compound with Strong HER2 Inhibitory Activity for Treating HER2-Driven Solid Tumors Session Category: Late-Breaking Research: Experimental and Molecular Therapeutics 2 Session Date and Time: April 28, 2025, 2:00 PM - 5:00 PM (CDT) Location: Poster Section 54 Poster Board Number: 14 Poster Number: LB240 Conclusion: Our findings establish ABSK112 as a potent, selective and CNS-penetrant HER2 inhibitor, warranting further clinical evaluation of it as a monotherapy or in combination with HER2-targeted ADCs for the treatment of HER2+ cancers with brain metastases. Title 2: Loss-of-Function (LoF) of KEAP1 promotes cell survival through multiple mechanisms, leading to resistance to KRAS G12C inhibitors Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 3 Session Date and Time: April 29, 2025 9: 00AM – 12: 00 PM (CDT) Location: Poster Section 52 Poster Board Number: 1 Poster Number: LB278 Conclusion: KEAP1 LoF mutant NSCLCs develop resistance to KRAS G12C inhibitors through reduced drug-induced ROS accumulation, metabolic adaptation, and sustained activation of MAPK and AKT signaling. Combination therapies targeting glutamine metabolism (e.g., GLS1 inhibitors), MAPK (e.g., MEK inhibitors), and PI3K-AKT-mTOR pathways (e.g., BEZ235) reverse resistance and improve therapeutic efficacy in KEAP1-mutant cell lines. These strategies may restore sensitivity to KRAS G12C inhibitors and enhance clinical outcomes. Title 3: The MTA-Cooperative PRMT5 Inhibitor ABSK131 Exhibits Potent Activity and Broad Synergistic Potential in MTAP-Deleted Cancer Models Session Category: Late-Breaking Research: Experimental and Molecular Therapeutics 4 Session Date and Time: April 30, 2025 9:00 AM - 12:00 PM (CDT) Location: Poster Section 51 Poster Board Number: 9 Poster Number: LB427 Conclusion: ABSK131 exhibits strong anti-tumor activity in MTAP-deleted lung and pancreatic cancer models and synergizes effectively with multiple therapeutic agents. These findings support the continued clinical development of ABSK131 as both a monotherapy and in combination regimens for MTAP-deleted cancers. Title 4: Discovery and characterization of a highly potent and orally available small-molecule inhibitor for diverse KRAS mutations Session Category: Late-Breaking Research: Experimental and Molecular Therapeutics 4 Session Date and Time: April 30, 2025 9:00 AM - 12:00 PM (CDT) Location: Poster Section 51 Poster Board Number: 13 Poster Number: LB431 Conclusion: Taken together, ABK-KRAS-1 exhibits broad in vitro activity against different KRAS mutations and induces dose-dependent tumor regression in KRAS mutated xenograft models. Moreover, ABK-KRAS-1 possesses favorable drug-like properties. Here, ABK-KRAS-1 is presented as a promising therapeutic candidate for the treatment of cancers harboring KRAS mutations. About Abbisko Therapeutics Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK), is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology. Please visit for more information. SOURCE Abbisko WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AACR会议