An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations - TAS6417-201

开始日期2024-02-21

申办/合作机构

Taiho Oncology, Inc.

NCT05967689

/ Recruiting临床2期

An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations.

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and other mutations.

开始日期2023-07-31

申办/合作机构

Taiho Oncology, Inc.

CTIS2023-505085-28-00

/ Not yet recruiting临床1期

- TAS6417-102

开始日期2023-07-05

申办/合作机构

Taiho Oncology, Inc.

100 项与 Zipalertinib 相关的临床结果

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100 项与 Zipalertinib 相关的转化医学

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100 项与 Zipalertinib 相关的专利（医药）

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项与 Zipalertinib 相关的文献（医药）

2025-06-01·JOURNAL OF CLINICAL ONCOLOGY

Zipalertinib in Patients With EGFR Exon 20 Insertion-Positive NSCLC Previously Treated With Platinum-Based Chemotherapy With or Without Amivantamab.

Article

作者: Xu, Zhiying Cindy ; Yang, Zhihui Sunny ; Fernandez-Hinojal, Gonzalo ; Chih-Hsin Yang, James ; Nguyen, Danny ; Daga, Haruko ; Lee, Se-Hoon ; Spira, Alexander I ; Kim, Sang-We ; Keeton, Erika K ; Juan Vidal, Oscar J ; Umemura, Shigeki ; Piotrowska, Zofia ; Soo, Ross A ; Li, Shengting ; Passaro, Antonio ; Wrangle, John ; Shao-Weng Tan, Daniel ; Pulla, Mariano Provencio ; Velcheti, Vamsidhar ; Jones, Jeffrey A ; Yu, Helena Alexandra ; Kim, Se Hyun ; Ho-Fun Lee, Victor ; Ruiter, Gerrina

PURPOSE:

To evaluate the safety and efficacy of zipalertinib, an irreversible epidermal growth factor receptor (EGFR) inhibitor, in pretreated patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion (ex20ins) mutations.

METHODS:

REZILIENT1 (NCT04036682) is a phase I/II open-label trial enrolling patients with locally advanced or metastatic EGFR ex20ins-mutant NSCLC previously treated with platinum-based chemotherapy with/without ex20ins-targeted therapies. Asymptomatic, treated and untreated stable central nervous system (CNS) metastases are permitted. We report data from patients treated with zipalertinib 100 mg twice daily. The primary end points are objective response rate (ORR) and duration of response (DOR) by independent central review.

RESULTS:

At data cutoff (December 10, 2024), 244 patients had received treatment with zipalertinib 100 mg twice daily. The primary efficacy population (8 months' follow-up) comprised patients who had received prior platinum-based chemotherapy without ex20ins-targeted therapy (125 patients), with amivantamab only (30 patients), or with amivantamab and other ex20ins-targeted therapy (21 patients). The confirmed ORR was 35.2% (95% confidence interval [CI], 28.2 to 42.8); median DOR was 8.8 months (95% CI, 8.3 to 12.7). Among patients who received prior platinum-based chemotherapy without ex20ins-targeted therapy, amivantamab only, or amivantamab and other ex20ins-targeted therapy, the confirmed ORR was 40%, 30%, and 14.3%, and median DOR was 8.8, 14.7, and 4.2 months, respectively. Among 68 patients with CNS metastases, the ORR was 30.9%. The most common grade ≥3 treatment-related adverse events were anemia (7%), pneumonitis and rash (2.5% each), and diarrhea, alanine aminotransferase increased, and platelet count decreased (2% each).

CONCLUSION:

Zipalertinib demonstrated clinically meaningful efficacy with a manageable safety profile in patients with EGFR ex20ins-mutant NSCLC who received prior platinum-based chemotherapy with or without amivantamab.

2025-03-01·LUNG CANCER

Novel strategies for rare oncogenic drivers in non-small-cell lung cancer: An update from the 2024 Annual ESMO meeting

Review

作者: van der Wel, J W T ; de Langen, A J

Across the landscape of oncogene-addicted non-small-cell lung cancer (NSCLC), various tyrosine kinase inhibitors (TKIs) have been introduced in the last twenty years. During the 2024 Annual ESMO meeting new therapeutic options were presented for EGFR exon 20 insertion mutation, ALK fusion and ROS1 fusion positive advanced stage NSCLC. For EGFR exon 20 insertion mutation positive NSCLC, results from REZILIENT-1, a single arm phase II study with zipalertinib, were presented, showing an objective response rate (ORR) of 50% in patients that were pretreated with amivantamab, and 25% in patients pretreated with amivantamab and an EGFR exon 20 insertion-directed TKI. The vast majority of these patients also received platinum-doublet chemotherapy. For ALK, results from ALKOVE-1, a single arm phase I/II study with NVL-655, a next generation ALK TKI, were presented. The ORR was 35 % in patients pretreated with ≥ 2 ALK TKIs including lorlatinib and 57 % in patients pretreated with ≥ 1 ALK TKI, excluding lorlatinib. The median number of prior anticancer therapies was 3. Intracranial responses were seen in lorlatinib naïve- and lorlatinib pretreated patients and toxicity was manageable. In addition, results of the first-line randomized phase III INSPIRE study were presented, in which iruplinalkib, an ALK and ROS1 selective TKI, is being evaluated versus crizotinib. Iruplinalkib showed a superior median PFS (36.8 versus 14.55 months for crizotinib), but no difference in 36-month overall survival (OS) rate. Finally, results from ARROS-1, a single arm phase I/II study with zidesamtinib, a ROS1 selective and TRK-sparing TKI, were presented. An ORR of 73% was obtained in patients that were pretreated with crizotinib and an ORR of 38% in patients pretreated with repotrectinib. In this review, we will discuss the relevant study results presented at ESMO 2024 for these three genomic drivers and hypothesize on their respective place in the sequence of treatment options.

2025-02-19·Future Oncology

REZILIENT3: randomized phase III study of first-line zipalertinib plus chemotherapy in patients with EGFR exon 20 insertion-mutated NSCLC

Article

作者: Tan, Daniel SW. ; Heymach, John V. ; Cheng, Ying ; Besse, Benjamin ; Yu, Helena A. ; Wacheck, Volker ; Wei, Li ; Nishio, Makoto

There remains a significant unmet need for effective and tolerable treatments for patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations in the first-line setting. First and later generation EGFR tyrosine kinase inhibitors (TKIs) have shown efficacy for common EGFR mutations; however, their effectiveness against ex20ins mutations is limited, and platinum-based chemotherapy remains part of the standard of care. Data suggest that combining chemotherapy with EGFR inhibitors offers promise for EGFR ex20ins-mutated NSCLC. REZILIENT3 is an ongoing phase III study evaluating the efficacy and safety of zipalertinib (an orally available, irreversible EGFR-TKI) plus first-line standard-of-care platinum-based chemotherapy with chemotherapy alone in previously untreated patients with nonsquamous NSCLC harboring EGFR ex20ins mutations.Clinical Trial Registration: NCT05973773 (ClinicalTrials.gov).

项与 Zipalertinib 相关的新闻（医药）

2025-06-04

·医脉通

【2025 ASCO“彩风”】周彩存教授对话Thomas E. Stinchcombe教授，预见NSCLC精准治疗新蓝图

前言2025年美国临床肿瘤学会（ASCO）年会已于当地时间5月30日至6月3日在美国芝加哥圆满落幕。作为全球肿瘤学领域规模最大、最具影响力的学术盛会之一，ASCO年会汇聚了全球肿瘤学领域的众多专家学者，共同探讨癌症治疗的最新进展，分享前沿研究成果，共绘抗癌蓝图。在今年ASCO年会上，多项非小细胞肺癌（NSCLC）诊疗领域的重磅研究成果在本次ASCO年会集体亮相。值此之际，医脉通特邀上海市东方医院周彩存教授与杜克大学医学院Thomas E. Stinchcombe教授展开中外对话，深度解读本次NSCLC领域重磅研究新进展，共话NSCLC精准治疗的未来发展趋势。图1.周彩存教授（左）与Thomas E. Stinchcombe 教授（右）真实世界数据指导MET抑制剂治疗临床应用MET基因是NSCLC的重要驱动基因之一，其异常形式多样，包括METex14跳突、MET基因扩增以及MET蛋白过表达等。而目前针对METex14跳突人群的精准治疗探索最为成熟。其中，卡马替尼凭借其在关键临床研究GEOMETRY mono-1中展现出的优异的治疗疗效和良好的安全性，成功确立了其在METex14跳突晚期NSCLC中的治疗地位。与此前报告的II期临床研究GEOMETRY mono-1的疗效数据（ORR 68.3%，DCR 98.3%，mPFS 12.5个月，mOS 21.4个月）[1]相比，本次ASCO年会上公布的一项真实世界队列研究[2]再次验证了卡马替尼优异且稳定的临床疗效，在一线MET-TKI治疗（64.7%的患者使用卡马替尼治疗）不同剂量水平汇总的数据中，总体mPFS可达19.6个月，mOS更是长达33.3个月。同时，既往报告的II期注册研究同样提示卡马替尼具有优异的药物耐受性。但在MET抑制剂的临床应用中，仍有部分患者可能会因治疗不耐受而进行非常规的药物剂量给药方案。该真实世界研究提示，对于无法耐受标准剂量的患者，进行非常规药物剂量给药仍可维持稳定疗效获益，成为保障治疗连续性的有效策略，从而避免治疗终止。对此，Thomas E. Stinchcombe 教授首先肯定了卡马替尼在METex14跳突晚期NSCLC患者中的治疗地位和应用价值，并指出对于无法耐受MET-TKI标准剂量的患者进行非常规药物剂量给药，可能是平衡疾病控制与生活治疗的可行策略，但由于该真实世界研究仅为小样本回顾性分析，针对该方案尚需在更大样本量的前瞻性研究中进一步验证。结合本次ASCO年会公布的卡马替尼真实世界药物剂量处理经验的最新研究证据，我们可以看到，即使因治疗不耐受而进行非常规药物剂量给药，卡马替尼仍可保持优异且稳定的治疗疗效。而这一贯的优异疗效的保持离不开其在临床研究中扎实的数据支撑。此前报告的基于全球人群开展的GEOMETRY mono-1研究[1]和基于中国人群开展的GeoMETry-C研究[3]均提示，卡马替尼用于METex14跳突晚期NSCLC患者一线治疗疗效卓越。在安全性方面，卡马替尼同样表现良好，无论是在全球人群还是在中国人群，卡马替尼≥3级治疗相关不良事件（TRAE）发生率均较低，尤其在中国人群中安全性表现更佳，≥3级TRAE的发生率仅为20%[1,3]。且卡马替尼的外周水肿和肝毒性事件的发生率均较低，大多为1-2级[1,3]。卡马替尼良好的安全性表现更有助于患者实现“高质量长生存”，从临床试验到临床实践实现一致获益。NSCLC治疗版图再添新彩，多领域研究再结硕果除MET异常领域的治疗进展外，周彩存教授和Thomas E. Stinchcombe 教授对其他肺癌领域值得关注的多项新进展同样进行了广泛讨论。>>>EGFR-TKI耐药人群我国NSCLC人群EGFR突变高发，尤其在肺腺癌中占比可达50%[4]。尽管EGFR-TKI的出现显著提升了EGFR突变患者的生存获益，但患者在接受EGFR-TKI治疗后仍难以逃脱耐药困局。长期以来，针对EGFR-TKI耐药后的治疗探索一直是临床关注的重点。周彩存教授表示，近年来，ADC药物的快速发展为EGFR-TKI耐药人群带来了治疗新曙光。本次ASCO年会公布了两项针对EGFR突变经治耐药患者开展的ADC相关的随机对照研究结果。其中基于HER3 ADC开展的HERTHENA-Lung02研究并未达预期。在后续过程中，或许我们应该先确定一个生物标志物，再挑选合适的患者进行研究。但目前对于HER3表达是否能够作为潜在优势人群的筛选指标尚不明确。而另一款基于TROP2 ADC开展的OptiTROP-Lung03研究则取得了阳性结果，数据显示，TROP2 ADC较多西他赛用于EGFR突变经治耐药患者可显著提升ORR和PFS，甚至是OS[5]，结果令人鼓舞。Thomas E. Stinchcombe 教授同样表示，针对HER3 ADC的未来探索，由于当前III期临床研究筛选的人群并未达到理想的治疗效果，在后续可能需要进行广泛的生物标志物研究，以进一步筛选优势人群。而本次ASCO年会报告的TROP2 ADC在疗效方面表现出色，令人印象深刻，未来值得开展更多高质量研究进一步探索。周彩存教授进一步谈到，近年来，双特异性抗体在EGFR-TKI耐药人群中的应用同样备受瞩目。此前报告的III期HARMONi-A研究证实了依沃西单抗联合化疗在EGFR-TKI耐药人群中的显著疗效[6]，为该类人群带来了新的选择。Thomas E. Stinchcombe 教授表示，双特异性抗体依沃西单抗的PFS获益十分亮眼，我们期待其进一步的数据报告。此外，既往报告的基于免疫+抗血管+化疗四药联合方案开展的ORIENT-31研究、ATTLAS研究等也为EGFR-TKI耐药人群带来了更多选择。>>>KRAS G12C突变人群KRAS同样是NSCLC常见的致癌驱动基因之一，在KRAS突变NSCLC患者中，又以KRAS G12C突变亚型最为常见，占比约为30%[7]。近年来，KRAS G12C抑制剂的持续涌现助力KRAS G12C突变患者迈入了靶向治疗新时代。周彩存教授表示，在本次ASCO年会上，KRYSTAL-7研究提示，Adagrasib联合帕博利珠单坑一线治疗KRAS G12C突变晚期NSCLC临床疗效良好，该联合方案的肝毒性尚可耐受[8]。由于我们亚州人肝功能可能不太好，容易出现肝毒性，因此针对联合用药产生的肝毒性应给予关注。我们在中国开展的一项基于KRAS抑制剂与西妥昔单抗联合治疗的研究展现出良好的耐受性，肝毒性发生率较低。目前在KRAS G12C突变晚期NSCLC领域，联合治疗是探索热点，但哪种联合用药策略的治疗疗效更优，尚需进一步明确。Thomas E. Stinchcombe 教授表示，从目前的数据来看，KRAS G12C抑制剂单药的长期获益似乎有限，因此联合治疗是未来热门的发展方向。针对联合治疗的毒性作用，不同地区可能存在差异。比如，我所在的地区西妥昔单抗输注相关反应发生率非常高，约有25%为3级不良反应，这与当地蜱虫叮咬相关的α-gal综合征存在关联，患者既存的致敏抗体可触发药物特异性反应。因此，我们确实需要关注这些地区性毒性差异。>>>EGFR exon20ins突变/HER2突变周彩存教授表示，本次ASCO年会在EGFR exon20ins突变领域以及HER2突变领域同样有一些研究进展值得关注。评估Zipalertinib用于EGFR exon20ins突变患者[9]以及评估HER2 TKI BAY 2927088用于HER2突变患者的临床研究均成功入选口头报告[10]。两款新药均展现出令人鼓舞的治疗疗效。Thomas E. Stinchcombe 教授表示，Zipalertinib治疗的ORR、DoR、PFS均表现良好，且安全性也表现良好，支持其进一步探索。BAY 2927088同样展现出一定的治疗前景。但HER2突变类型存在多样性，针对HER2 TKI是否仅对酪氨酸激酶结构域的突变有效等问题尚需进一步明确。两个领域目前均有多款药物在布局中，对于哪款药物能够脱颖而出，尚待时间验证。小结纵览2025 ASCO年会NSCLC领域治疗新进展，我们可以发现，针对NSCLC的治疗正逐渐向更多元的模式发展。对于METex14跳突患者，真实世界数据证实卡马替尼可有效平衡患者的治疗有效性与耐受性；对于EGFR-TKI耐药人群，TROP2 ADC为患者带来了新的治疗选择；其他如KRAS G12C突变、EGFR exon20ins突变、HER2突变等靶点药物的研发也呈现出多元趋势。相信随着后续更多高质量研究的持续涌现，晚期NSCLC患者能够迎来更多更为有效的治疗策略和更长久的生存期。专家简介- 周彩存教授 -主任医师、教授、博士生导师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非小细胞肺癌专委会主任委员中国抗癌协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分会副主任委员- Thomas E. Stinchcombe 教授 -杜克大学医学院杜克癌症研究所胸部肿瘤学家赖恩伯格综合癌症中心副主任北卡罗来纳大学临床试验网络主任致力于非小细胞、小细胞肺癌、间皮细胞瘤等胸部恶性肿瘤研究在JCO、Journal of Thoracic Oncology、The Lancet 等国际顶级期刊杂志发表多篇论文参考文献：1. Wolf Jürgen, Hochmair Maximilian, Han Ji-Youn, et al. Capmatinib in MET exon 14-mutated non-small-cell lung cancer: final results from the open-label, phase 2 GEOMETRY mono-1 trial.[J] .Lancet Oncol, 2024, 25: 1357-1370.2. Rajaa Mohamed Salih, et al. Real world efficacy of dose-reduced capmatinib and tepotinib for advanced MET exon 14–skipping+ NSCLC. 2025 ASCO e20671.3. Yi-Long Wu, et al. Capmatinib in Chinese adults with EGFR wt, ALK rearrangement negative (ALK-R−), MET exon 14 skipping mutation (METex14), advanced NSCLC: Results from the phase II GEOMETRY-C study. 2022 ESMO AISA, 388P.4. 中国临床肿瘤学会(CSCO)非小细胞肺癌专家委员会等. "三代EGFR-TKI在EGFR突变N SCLC治疗中应用的专家共识(2022年版)." 中国肺癌杂志 009(2022):025.5. Li Zhang, et al. Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study. 2025 ASCO 8507.6. Wenfeng Fang, Yuanyuan Zhao, Yongzhong Luo, et al. Ivonescimab Plus Chemotherapy in Non-Small Cell Lung Cancer With EGFR Variant: A Randomized Clinical Trial.[J] .JAMA, 2024 Aug 20;332(7):561-570.7. Shen Mo, Qi Rongbin, Ren Justin, et al. Characterization With KRAS Mutant Is a Critical Determinant in Immunotherapy and Other Multiple Therapies for Non-Small Cell Lung Cancer.[J] .Front Oncol, 2021, 11: 780655.8. Pasi A. Jänne, et al. First-line adagrasib (ADA) with pembrolizumab (PEMBRO) in patients (pts) with advanced/metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) from the phase 2 portion of the KRYSTAL-7 study. 2025 ASCO 8500.9. Helena A. Yu, et al. Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab. 2025 ASCO 8503.10.Herbert H. Loong, et al. SOHO-01: Safety and efficacy of BAY 2927088 in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) who were pretreated but naïve to HER2-targeted therapy or had not received any treatment for advanced disease. 2025 ASCO 8504.审批码TAB0047753-101666，有效期为2025-06-04至2026-06-03，资料过期，视同作废撰写：Shirley审校：Shirley排版：Atai执行：Atai本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，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。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

ASCO会议临床结果临床1期

2025-06-03

·BiG生物创新社

2025ASCO研究集锦速报！

2025ASCO如约而至，再次迎来全球肿瘤研究领域的高光时刻，简要整理共飨同仁！本文导读：01 肺癌1.1 SACHI研究：赛沃替尼+奥希替尼对比化疗挑战EGFR-TKI耐药伴Met扩增肺癌成功1.2 HERTHEA-Lung02研究：HER3 ADC治疗TKI耐药EGFR突变NSCLC1.3 OptiTROP-Lung03研究：新款TROP2 ADC挑战TKI和铂类化疗耐药晚期肺癌成绩优异1.4 CAMPASS研究：PDL1单抗联合安罗替尼对比K药一线治疗PDL1阳性肺癌告捷！1.5 SOLO-1研究：sevabertinib BAY2927088治疗HER2突变NSCLC1.6 REZILIENT1研究：Zipalertinib治疗经治EGFR 20ins肺癌，ORR35%1.7 EGFR 20ins和HER2 肺癌药物进展盘点1.8 ALNEO研究：阿来替尼围手术期处理III期ALK阳性NSCLC，MPR42%1.9 InTRist研究：特瑞普利单抗加持大块型III期肺癌同步放化疗成绩斐然1.10 2SMALL研究：卢比替定联合T药二线治疗晚期SCLC，ORR 40.4%。1.11 DeLLphi-303研究：Tarlatamab联合PDL1单抗尝试SCLC维持治疗获初步成绩1.12 CD3/DLL3/DLL3三特异性抗体ZG006三线治疗SCLC，ORR 66.7%，DCR 92.6%1.13 靶向DLL3的BITE药物的进展汇总1.14 KRYSTAL-7研究：adagrasib联合K药治疗KRAS G12C突变肺癌，有效率44%1.15 Checkmate77T研究：O药围手术期治疗疗效更新1.16 EGFR/HER3双抗ADC新药BL-B01D1挑战EGFR非经典突变获佳绩!1.17 C-met ADC Tliso-V/MYTX-011治疗met过表达肺癌1.18 CHRYSALIS研究最终结果：埃万妥单抗治疗MET 14突变肺癌，PFS 5.3月，OS 15.8月。1.19 EGFR-TKI耐药后的处理方向1.20 小细胞肺癌的治疗路线1.21 EGFR突变肺癌的一线考虑（MARIPOSA/FLAURA2）02 乳腺癌2.1 OptiTROP-Breast05研究：新型TROP2 ADC Sac-TMT一线治疗晚期TNBC2.4 FINER研究：AKT抑制剂联合氟维司群二线治疗ER+HER2-乳癌2.5 VERITAC-2研究：首款雌激素受体蛋白降解剂挑战难治HR+HER2-乳癌获突破2.6 SERENA-6研究：雌激素受体降解剂camizestrant联合CDK4/6抑制剂2.7 乳癌内分泌耐药解决新方向：KAT6抑制剂2.8 内分泌+CDK4/6抑制剂进展后的处理总结2.9 HR阳性乳癌整体治疗策略2.10 新的HR+治疗策略2.11 HER2阳性乳癌的治疗策略2.12 CDK4/6抑制剂进军三阳乳癌一线获佳绩2.13 PD1+贝伐+铂治疗三阴乳癌脑转移，颅内有效率77%。2.14 口服紫杉醇对比静脉紫杉醇治疗乳腺癌，疗效不输03 消化道肿瘤3.1 BREAKWATER研究：康菲替尼+西妥昔单抗+mFOLFOX6对比标准治疗3.2 CheckMate 8HW研究：O+Y双免成就MSI-H/dMMR晚期肠癌新一线标准3.3 晚期结直肠癌的一线精准治疗更替3.4 ATOMIC研究：免疫T药+mFOLFOX6辅助治疗dMMR的III期肠癌，DFS提升3.5DESTINY-Gastric04研究：DS8201成功挑战HER2+胃癌二线3.6 Checkmate577研究：O药辅助治疗食管癌，OS有改善趋势3.7LEAP015研究：仑伐替尼+K药+化疗治疗初治晚期胃癌3.8 CodeBreak101研究：索托拉西布+帕尼单抗+FOLFIRI3.9 ANCHOR III期研究：安罗替尼+CapeOx对比贝伐单抗+CapeOx3.10 LOXO-RAS-20001研究：二代KRAS G12C抑制剂联合西妥昔单抗3.11 MATTERHORN研究：免疫Imfinzi（I药）围手术期处理无转移的II-Iva期胃癌，获阳。3.12 1801 Part3B研究：GSK-3β抑制剂联合化疗提升胰腺癌总生存3.13 PANOVA3研究：肿瘤电场疗法联合化疗提升总生存3.14 Claudin18.2 CART治疗晚期胃癌3.15 局晚期直肠癌：放化疗加上PD1单抗，pCR提升（59%：33%）3.16 肠癌治疗策略3.17 胆管癌治疗策略3.18ctDNA对肠癌治疗的预后指导意义3.19 结肠癌腹膜转移：围手术期化疗+细胞减灭术+腹腔热灌注化疗3.20 胃肠肿瘤的CAR-T和TC04 泌尿系统肿瘤4.1 SURE02研究：TROP2 ADC SG联合K药新辅助治疗肾癌，CR率44.4%4.2 肾癌新方向：HIF-2a抑制剂4.3 9MW2821研究：Nectin4 ADC联合PD1一线治疗尿路上皮癌，ORR 80%4.4 TALAPRO-2研究：恩杂鲁胺联合PARP抑制剂在非HRR前列腺癌人群的获益性4.5 膀胱癌的ADC药物疗效对比4.6 放射性配体疗法177LuPSMA联合双免治疗前列腺癌4.7 膀胱癌治疗路线4.8 前列腺癌治疗路线05 ADC5.1 TQB2102：双表位HER2 ADC疗效初现5.2 靶向HER3 ADC新药DB-13105.3 ADC总结06 其他癌肿6.1 SUPRAME研究：靶向PRAME的TCR-T细胞治疗免疫耐药黑色素瘤，ORR56%，可期。6.2 三项头颈鳞癌同步放化疗+免疫的研究对比6.3 NIVOPOSTOP研究：O药联合放化疗辅助治疗头颈鳞癌，DFS提升。6.4 PD-1和VEGF双靶点药物HB0025治疗子宫内膜癌，ORR 80% 01 肺癌 1.1 SACHI研究：赛沃替尼+奥希替尼对比化疗挑战EGFR-TKI耐药伴Met扩增肺癌成功MET扩增是EGFR-TKI耐药的原因之一，为此，MET抑制剂赛沃替尼一直在该领域探索，此次III期SACHI结果公布，对于EGFR突变一线TKI耐药后MET扩增（非T790突变）的晚期非小细胞肺癌患者，接受赛沃替尼+奥希替尼治疗，对比化疗，ORR：58%：34%，PFS 8.2：4.5月（HR 0.34），OS 未成熟，但HR0.84（40%事件数）。其中对于一代二代TKI耐药的患者PFS 9.9：5.4月，对于三代TKI耐药的患者PFS 6.8：3.0月（HR 0.32），脑转移患者亦有获益。1.2 HERTHEA-Lung02研究：HER3 ADC治疗TKI耐药EGFR突变NSCLC2023年12月，HER3 ADC药物Patritumab deruxtecan基于HERTHENA-Lung01结果，获得FDA加速获批，用于TKI和铂类治疗进展的EGFR突变NSCLC，ORR 29.8%，PFS 5.5月，OS 11.9月。此次ASCO公布了HERTHENA-Lung02研究的头对头对比结果，显示，对于既往使用过三代TKI耐药的EGFR突变晚期非鳞NSCLC患者，与铂类化疗相比，PFS 5.8：5.4月（HR 0.77，P=0.011），OS 16.0：15.9月（HR 0.98），无改善。1.3 OptiTROP-Lung03研究：新款TROP2 ADC挑战TKI和铂类化疗耐药晚期肺癌成绩优异Sac-TMT是一款新型TROP2抑制剂，借鉴前辈Patritumab deruxtecan的上市思路，以TKI和铂类化疗耐药的EGFR敏感突变晚期非鳞NSCLC患者为研究对象，与多西他赛进行头对头比较，ORR 45.1%：15.6%，PFS 6.9：2.8月，OS尚未达到，HR 0.49。完胜，且比Patritumab deruxtecan更优，TROP2界的黑马，该药此次在TNBC也有优秀数据披露，见乳癌章节。1.4 CAMPASS研究：PDL1单抗联合安罗替尼对比K药一线治疗PDL1阳性肺癌告捷！K药是目前PDL1≥1%的无驱动基因突变晚期NSCLC的标准治疗，是否会有更高的疗效方案，此次国内专家带来的CAMPASS研究给出了答案，采用PDL1单抗贝莫苏拜单抗联合抗血管小分子药物安罗替尼头对头与K药对比，PFS 11.0:7.1月，HR 0.70，在PDL1≥50%的高表达人群中，PFS 13.3:7.2，HR 0.60，为PDL1阳性NSCLC带来新的一线治疗标准，有望改变肺癌治疗格局。1.5 SOLO-1研究：sevabertinib BAY2927088治疗HER2突变NSCLCSevabertinib是一款HER2抑制剂，一线治疗HER2突变晚期NSCLC，ORR 59.0%，对于经治HER2突变，ORR 60.5%，基于如此优秀的结果，III期SOLO-2研究正在开展。1.6 REZILIENT1研究：Zipalertinib治疗经治EGFR 20ins肺癌，ORR35%对于既往只接受过化疗进展的EGFR20ins，ORR 40%，对于既往使用过埃万妥单抗或其他HER2 TKI药物进展的，ORR24%。1.7 EGFR 20ins和HER2 肺癌药物进展盘点1.8 ALNEO研究：阿来替尼围手术期处理III期ALK阳性NSCLC，MPR42%对于ALK阳性的初治局晚III期NSCLC，采用阿来替尼新辅助治疗2周期，序贯手术治疗+辅助治疗至24周期，主要病理缓解率（MPR）为42%，86% R0切除。III期开展中。1.9 InTRist研究：特瑞普利单抗加持大块型III期肺癌同步放化疗成绩斐然对于突变基因阴性的III期不可切除的NSCLC，同步放化疗+免疫治疗已经成为标准治疗。此次，特瑞普利单抗挑选了III期中大块型（肿瘤≥5cm或淋巴结≥2cm）的NSCLC，在同步放化疗之前增加了2周期的PD1+化疗治疗，对比单纯的化疗，PFS 85.8：54.5月，HR=0.26，ORR：77.8%：40.0%。1.10 2SMALL研究：卢比替定联合T药二线治疗晚期SCLC，ORR 40.4%。既往未接受免疫治疗的受试者ORR44.1%，既往接受过免疫治疗的受试者，ORR 37.3%，总体中位PFS 4.6月，OS 10.1月。1.11 DeLLphi-303研究：Tarlatamab联合PDL1单抗尝试SCLC维持治疗获初步成绩既往基于DeLLphi-301研究，靶向CD3/DLL3的双特异性抗体（BITE）Tarlatamab获批用于经治广泛期SCLC，ORR 40%。此次Tarlatamab公布了DeLLphi-303研究结果，探索一线化免治疗后，采用Tarlatamab联合PDL1作为维持治疗的疗效。DCR64.5%，DCR维持时间7.2个月或更长，初步疗效支撑III期DeLLphi-305研究的开展。1.12 CD3/DLL3/DLL3三特异性抗体ZG006三线治疗SCLC，ORR 66.7%，DCR 92.6%1.13 靶向DLL3的BITE药物的进展汇总1.14 KRYSTAL-7研究：adagrasib联合K药治疗KRAS G12C突变肺癌，有效率44%1.15 Checkmate77T研究：O药围手术期治疗疗效更新既往基于Checkmate77T研究，O药已获批II-IIIB期无EGFR/ALK突变的NSCLC围手术期治疗适应症（O+化疗新辅助4周期+手术+O药辅助至13个周期），此次公布了更新结果，EFS 46.6：16.9月，ctDNA/pCR与EFS相关，OS未达到，但有获益趋势（HR 0.85）。1.16 EGFR/HER3双抗ADC新药BL-B01D1挑战EGFR非经典突变获佳绩!多靶点ADC已成为ADC领域的新发展方向，此次国内一款EGFR/HER3 ADC新药（毒性载荷TOPi）BL-B01D1以肺癌非经典EGFR突变患者为切入点，获得亮眼成绩：治疗EGFR20ins肺癌，ORR 69.2%，中位PFS 10.5个月；治疗HER2突变肺癌，ORR 52.9%，DOR 5.7个月；治疗KRAS/BRAF/MET突变肺癌，ORR40%；整体ORR 46.2%，PFS 5.7个月。为非EGFR经典突变人群带来新的药物方向，尤其在EGFR 20ins领域值得进一步研究。该药在EGFR突变肺癌既往研究获得了63.2%的ORR。1.17 C-met ADC Tliso-V/MYTX-011治疗met过表达肺癌1.18 CHRYSALIS研究最终结果：埃万妥单抗治疗MET 14突变肺癌，PFS 5.3月，OS 15.8月。1.19 EGFR-TKI耐药后的处理方向1.20 小细胞肺癌的治疗路线1.21 EGFR突变肺癌的一线考虑（MARIPOSA/FLAURA2） 02 乳腺癌 2.1 OptiTROP-Breast05研究：新型TROP2 ADC Sac-TMT一线治疗晚期TNBC既往TROP2 ADC Sacituzumab打开了经治三阴乳癌的市场（ORR 35%，PFS 5.6月，OS 12.1月），此次新款TROP2 ADC Sac-TMT在初治三阴乳癌给出亮眼成绩，ORR 70%，PFS 13.4月。2项III期研究正在开展中，有望带来TNBC新的变革。2.2 ASCENT04研究：TROP2 ADC SG联合K药成就PDL1+三阴乳癌新一线标准对于PDL1+（CPS≥10）的三阴乳癌，免疫+化疗是目前标准一线方案，此次ASCO公布的ASCENT04研究，继续升级，采用免疫联合ADC（TROP2）的方案，结果显示，对比化疗联合免疫，PFS 11.2：7.8月，HR 0.65，P<0.001，有望成为新的三阴乳癌一线标准。OS 未成熟，但已见获益趋势（HR 0.89）。2.3 INAVO120研究：PIK3CA抑制剂inavolisib+帕博西利+氟维司群30%-40%的HR+/HER2-乳癌具有PI3K的突变，此次INAVO120研究首次将PI3K抑制剂提到一线，联合CDK4/6抑制剂及氟维司群治疗初治PIK3CA突变的HR+/HER2-乳癌，对比不联合，PFS 17.2：7.3月。催生出了新的靶向导引人群的新一线标准。2.4 FINER研究：AKT抑制剂联合氟维司群二线治疗ER+HER2-乳癌对于既往一线AI+CDK4/6抑制剂耐药的HER+HER2-乳癌患者，采用AKT抑制剂Ipatasertib联合氟维司群治疗，相比单纯的氟维司群，PFS 5，32：19.4月，HR 0.61，P=0.0007。在伴有AKT通路突变的乳癌患者中，获益更大，HR 0.47。2.5 VERITAC-2研究：首款雌激素受体蛋白降解剂挑战难治HR+HER2-乳癌获突破2.6 SERENA-6研究：雌激素受体降解剂camizestrant联合CDK4/6抑制剂另一款口服雌激素受体降解剂camizestrant在ESR1突变后使用，可下降56%的疾病进展风险，PFS 16：9.2个月。2.7 乳癌内分泌耐药解决新方向：KAT6抑制剂表观药物KAT6抑制剂，可以靶向抑制KAT6A/6B，后者在乳癌中的扩增表达率10%-15%，此次KAT6抑制剂联合氟维司群治疗既往CDK4/6抑制剂治疗进展的HR+/HER2-的晚期乳癌，43例患者，ORR 37%，PFS 10.7月。为内分泌耐药乳癌治疗提出新方向。2.8 内分泌+CDK4/6抑制剂进展后的处理总结提出三个方向：①多项新药如艾拉司群获批用于氟维司群无法处理的ESR1突变；②新的PI3K选择性突变抑制剂；③CDK2+CDK4/6；除此上节提及的KAT6抑制剂也是方向之一。2.9 HR阳性乳癌整体治疗策略伴随DS8201在HER2低表达人群获益性的确立及TROP2 ADC的获批，HR+乳癌的后线治疗日益丰富。2.10 新的HR+治疗策略2.11 HER2阳性乳癌的治疗策略2.12 CDK4/6抑制剂进军三阳乳癌一线获佳绩内分泌治疗+CDK4/6抑制剂+赫塞汀一线治疗90例HR+/HER2+晚期乳癌，有效率61%，PFS 30月。为三阳乳癌一线纳入CDK4/6抑制剂拉开序幕。2.13 PD1+贝伐+铂治疗三阴乳癌脑转移，颅内有效率77%。2.14 口服紫杉醇对比静脉紫杉醇治疗乳腺癌，疗效不输 03 消化道肿瘤 3.1 BREAKWATER研究：康菲替尼+西妥昔单抗+mFOLFOX6对比标准治疗BRAF抑制剂康菲替尼+西妥昔单抗+mFOLFOX6对比标准治疗一线治疗BRAF V600E突变的晚期结直肠癌，ORR 65%：37%，PFS 12.8：7.1月，OS：30.3：15.1月。催生了BRAF V600E突变晚期结直肠癌的一线标准治疗。3.2 CheckMate 8HW研究：O+Y双免成就MSI-H/dMMR晚期肠癌新一线标准对于MSI-H/dMMR的晚期结直肠癌，进行O+Y双免对比化疗对比O药单药疗效对比，结果显示，在所有线数O+Y与O药ORR 71%：58%，PFS NR：39.3月，O+Y与化疗PFS 54.1：5.9月。3.3 晚期结直肠癌的一线精准治疗更替随着BRAF突变肠癌一线研究（BREAKWATER）的成功及O+Y双免在MSI-H肠癌一线研究（CheckMate 8HW）的成功，肠癌一线精准治疗局面正在形成。3.4 ATOMIC研究：免疫T药+mFOLFOX6辅助治疗dMMR的III期肠癌，DFS提升3年DFS率86.4%：76.6%，HR0.53.5 DESTINY-Gastric04研究：DS8201成功挑战HER2+胃癌二线对于HER2+胃癌，以曲妥珠单抗为基础的联合治疗是胃癌的一线标准，但是这类人群耐药后，并没有抗HER2的二线方案推荐，雷莫卢单抗联合紫杉醇是目前标准二线，此次DS8201与标准二线进行头对头比较，获得了OS（14.7：11.4月，HR 0.70）、PFS（6.7：5.6月，HR 0.74）及ORR（44.3%：29.1%）的全面优效，为晚期胃癌二线带来新的标准方案。3.6 Checkmate577研究：O药辅助治疗食管癌，OS有改善趋势对于II/III期可切除食管癌，在新辅助放化疗+手术R0切除后，采用O药辅助治疗16周，对比安慰剂，OS提升， 51.7：35.3月，HR 0.85，在CSP≥1的受试者，HR 0.79，鳞癌 HR 0.72。3.7 LEAP015研究：仑伐替尼+K药+化疗治疗初治晚期胃癌3.8 CodeBreak101研究：索托拉西布+帕尼单抗+FOLFIRI采用KRAS抑制剂索托拉西布sotorasib+EGFR单抗帕尼单抗panitumumab+FOLFIRI治疗KRAS G12C突变经治晚期结直肠癌，ORR 58%，DOR 6.6月，OS 15.6月。3.9 ANCHOR III期研究：安罗替尼+CapeOx对比贝伐单抗+CapeOx安罗替尼+CapeOx对比贝伐单抗+CapeOx一线治疗晚期结直肠癌，疗效相近，ORR（均为61%），PFS（7：6.9月）。提供新的用药模式。3.10 LOXO-RAS-20001研究：二代KRAS G12C抑制剂联合西妥昔单抗二代KRAS G12C抑制剂Olomorasib联合西妥昔单抗治疗 KRAS G12C突变肠癌，ORR 43%，DCR 92%，PFS 7.4月。当然市场目前期待如何处理继发耐药问题。3.11 MATTERHORN研究：免疫Imfinzi（I药）围手术期处理无转移的II-Iva期胃癌，获阳。对于无转移的II-Iva期胃癌，采用I药+FLOT新辅助2周期，手术，术后2周期I药+FLOT+I药维持10周期，相比只是淡出FLOT，2年EFS 67%：59%，HR 0.71，2年OS率 76%：70%。3.12 1801 Part3B研究：GSK-3β抑制剂联合化疗提升胰腺癌总生存Elraglusib是一款GSK-3β抑制剂，GSK-3是CD8+T细胞中PD-1基因表达的上游调节因子，并证明GSK-3抑制剂在控制肿瘤生长方面与抗PD-1阻断剂一样有效。本次公布的研究结果显示，Elraglusib联合GnP方案相比单纯GnP，具有OS的提升（10.1：7.2月）。3.13 PANOVA3研究：肿瘤电场疗法联合化疗提升总生存3.14 Claudin18.2 CART治疗晚期胃癌3.15 局晚期直肠癌：放化疗加上PD1单抗，pCR提升（59%：33%）3.16 肠癌治疗策略3.17 胆管癌治疗策略3.18 ctDNA对肠癌治疗的预后指导意义ctDNA被证明是III期可切除肠癌的不良预后因素，但是DYNAMIC-III研究显示，对ctDNA阳性人群进行升级治疗，相比标准治疗，未见RFS的提升（29：36月）。3.19 结肠癌腹膜转移：围手术期化疗+细胞减灭术+腹腔热灌注化疗腹膜转移在结肠癌患者中常见，相比单纯手术，手术围手术期进行化疗+细胞减灭术+腹腔热灌注化疗，PFS翻倍（14：7月），但OS获益趋势小（44：39月）。3.20 胃肠肿瘤的CAR-T和TC 04 泌尿系统肿瘤 4.1 SURE02研究：TROP2 ADC SG联合K药新辅助治疗肾癌，CR率44.4%4.2 肾癌新方向：HIF-2a抑制剂4.3 9MW2821研究：Nectin4 ADC联合PD1一线治疗尿路上皮癌，ORR 80%4.4 TALAPRO-2研究：恩杂鲁胺联合PARP抑制剂在非HRR前列腺癌人群的获益性4.5 膀胱癌的ADC药物疗效对比4.6 放射性配体疗法177LuPSMA联合双免治疗前列腺癌对比单纯177LuPSMA，pPFS HR 0.53。4.7 膀胱癌治疗路线4.8 前列腺癌治疗路线 05 ADC 5.1 TQB2102：双表位HER2 ADC疗效初现TQB2102是一款双表位HER2 （曲妥+帕妥）ADC（毒性载荷TOPi，DAR=6），治疗实体瘤，在HER2阳性乳癌，ORR 52%；在HER2低表达乳癌，ORR 47%；在HER2 3+肠癌，ORR 44%；在HER2阳性胃癌/胃食管结合部癌，ORR 40%。疗效均可看，值得关注。5.2 靶向HER3 ADC新药DB-1310DB-1310，一款靶向HER3的ADC药物（毒性载荷TOPi，DAR=8）治疗123例晚期实体瘤，ORR为31%，中位PFS 5.5个月；其中46例EGFR突变肺癌患者，ORR 44%。安全性良好。5.3 ADC总结部分会场对ADC的发展进行了讨论，看到了一些振奋的疗效例如HER3 ADC DB-1310，一些新的ADC正在探索中，提出未来ADC的发展方向：新的靶点、更强的结合力、新的毒素载荷、更强的入脑性。以HER3靶点药物目前的不俗表现，HER3靶点成为另一个“HER2“吗？新三款ADC安全性比较。 06 其他癌肿 6.1 SUPRAME研究：靶向PRAME的TCR-T细胞治疗免疫耐药黑色素瘤，ORR56%，可期。6.2 三项头颈鳞癌同步放化疗+免疫的研究对比6.3 NIVOPOSTOP研究：O药联合放化疗辅助治疗头颈鳞癌，DFS提升。6.4 PD-1和VEGF双靶点药物HB0025治疗子宫内膜癌，ORR 80%共建Biomedical创新生态圈！如何加入BiG会员？

ASCO会议抗体药物偶联物临床结果临床3期

2025-06-01

·PRNewswire

Taiho Oncology and Cullinan Therapeutics Announce Pivotal REZILIENT1 Phase 1/2 Data Published in the Journal of Clinical Oncology

PRINCETON, N.J. and CAMBRIDGE, Mass., June 1, 2025 /PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced today the publication of positive results from the REZILIENT1 trial in the peer-reviewed Journal of Clinical Oncology (JCO). REZILIENT1 is a Phase 1/2, global, multicenter study of zipalertinib (development code: CLN-081/TAS6417) in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who have received prior therapy. Results from the REZILIENT1 trial will be presented in a simultaneous oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8503). Continue Reading Cullinan Therapeutics The full publication, titled Zipalertinib in Patients With Epidermal Growth Factor Receptor Exon 20 Insertion-Positive Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy With or Without Amivantamab, can be found here. Highlights of the REZILIENT1 Phase 1/2 trial in the authors' conclusions include: Zipalertinib demonstrated clinically meaningful efficacy in the primary efficacy population (n=176), including 51 patients who had received prior amivantamab. The confirmed objective response rate (ORR) was 35.2% overall, and median duration of response (mDOR) and progression-free survival were 8.8 months and 9.4 months, respectively. In patients treated after prior platinum-based chemotherapy only (n=125), ORR was 40% with mDOR of 8.8 months. The safety profile of zipalertinib was manageable and consistent with previously reported data.¹ In exploratory subgroup analyses: Patients who had received prior amivantamab without other ex20ins-targeted therapy showed a confirmed ORR of 30% and mDOR of 14.7 months. Patients with brain metastases showed a confirmed ORR of 30.9% and a mDOR of 8.3 months. "Despite recent treatment advances for patients with EGFR ex20ins-mutant NSCLC, there is a lack of oral targeted therapies for patients whose tumors harbor these mutations," said principal investigator Zofia Piotrowska, MD, Assistant Professor, Medicine, Harvard Medical School and a clinical researcher and lung cancer medical oncologist at the Massachusetts General Hospital Cancer Center. "Findings from the Phase 1/2 REZILIENT1 trial support our understanding of zipalertinib as a potential targeted therapy option for patients living with previously treated recurrent or metastatic NSCLC harboring EGFR ex20ins mutations." Taiho Oncology is actively recruiting patients in the Phase 3 REZILIENT3 trial (NCT05973773). About REZILIENT1 REZILIENT1 (Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors) is a Phase 1/2 clinical trial (NCT04036682) to evaluate efficacy and safety of zipalertinib in adult patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations who have received prior therapy. The primary endpoints were ORR and DOR as assessed by blinded independent central review (ICR) per RECIST v1.1. Adverse events were characterized and graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0). About Zipalertinib Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority. Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S. About EGFR Exon 20 Insertion Mutations NSCLC is a common form of lung cancer and up to 4% of all cases have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype.2 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,3 with insertions at exon 20 accounting for up to 12% of these mutations.2 About Taiho Oncology, Inc. The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company's European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada. For more information, visit , and follow us on LinkedIn and X. About Cullinan Therapeutics Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Cullinan's portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at , and follow us on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company's beliefs and expectations regarding our plans regarding future data presentations, the clinical development and regulatory filing plan and timeline of zipalertinib, the safety and efficacy profile of zipalertinib and its potential to address unmet medical need, and other statements that are not historical facts. The words "believe," "continue," "could," "estimate," "expect," "intends," "may," "plan," "potential," "project," "pursue," "will," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any NDA or other regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. References 1. Piotrowska Z, Tan DS, Smit EF, et al. Safety, tolerability, and antitumor activity of zipalertinib among patients with non-small-cell lung cancer harboring epidermal growth factor receptor exon 20 insertions. Journal of Clinical Oncology. Available at: . 2. Burnett H, Emich H, Carroll C, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. PLOS ONE. 2021;16(3):e0247620. Available at: . 3. Riess JW, Gandara DR, Frampton GM, et al. Diverse EGFR exon 20 insertions and co-occurring molecular alterations identified by comprehensive genomic profiling of NSCLC. Journal of Thoracic Oncology. 2018 Jul 5;13(10):1560–1568 . Available at: (18)30770-6/pdf. Contacts Taiho Oncology Leigh Labrie + 609.664.9878 [email protected] Cullinan Therapeutics Investors Nick Smith +1 401.241.3516 [email protected] Media Jessica Weinstein +1 508.254.3881 [email protected] SOURCE Taiho Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果ASCO会议突破性疗法临床3期

100 项与 Zipalertinib 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
EGFR突变的非小细胞肺癌	临床3期	美国	Taiho Oncology, Inc.	2023-06-30
EGFR突变的非小细胞肺癌	临床3期	日本	Taiho Oncology, Inc.	2023-06-30
EGFR突变的非小细胞肺癌	临床3期	比利时	Taiho Oncology, Inc.	2023-06-30
EGFR突变的非小细胞肺癌	临床3期	巴西	Taiho Oncology, Inc.	2023-06-30
EGFR突变的非小细胞肺癌	临床3期	保加利亚	Taiho Oncology, Inc.	2023-06-30
EGFR突变的非小细胞肺癌	临床3期	加拿大	Taiho Oncology, Inc.	2023-06-30
EGFR突变的非小细胞肺癌	临床3期	法国	Taiho Oncology, Inc.	2023-06-30
EGFR突变的非小细胞肺癌	临床3期	德国	Taiho Oncology, Inc.	2023-06-30
EGFR突变的非小细胞肺癌	临床3期	希腊	Taiho Oncology, Inc.	2023-06-30
EGFR突变的非小细胞肺癌	临床3期	以色列	Taiho Oncology, Inc.	2023-06-30

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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


NCT04036682 (REZILIENT1, ASCO2025)	临床2期	EGFR exon 20 insertion mutations	176	Zipalertinib 100 mg BID	鏇衊餘憲窪觸鹹壓簾選(醖鹹壓糧鹽鹽夢餘膚淵) = 壓齋觸蓋鹽鬱壓鏇網窪遞膚積醖襯窪築積餘製 (襯獵蓋願製衊鹽餘築製 ) 更多	积极	2025-05-30
NCT04036682 (REZILIENT1, ASCO2025)	临床2期	EGFR exon 20 insertion mutations	176	Prior platinum-based chemotherapy	鏇衊餘憲窪觸鹹壓簾選(醖鹹壓糧鹽鹽夢餘膚淵) = 壓遞簾蓋構範淵窪夢鹽遞膚積醖襯窪築積餘製 (襯獵蓋願製衊鹽餘築製 )	积极	2025-05-30
NCT04036682 (REZILIENT1, PRNewswire) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌二线 EGFR Exon 20 Insertion	-	Zipalertinib	膚蓋鹽構鏇糧糧築襯範(醖範鹽衊鬱艱窪製糧鑰) = met its primary endpoint of overall response rate 願餘壓鑰繭鏇鏇鹹憲蓋 (築築壓夢願艱夢積齋膚 ) 达到	积极	2025-01-28
NCT05973773 (REZILIENT3, ESMO_ASIA2024) 人工标引	临床3期	EGFR 20号外显子插入突变非小细胞肺癌一线 EGFR exon 20 insertion	6	Zipalertinib 100 mg PO BID + Chemotherapy	鏇鹹衊衊觸膚淵窪簾觸(築淵廠夢顧醖襯艱繭夢) = 窪簾積壓繭窪獵蓋築襯構築鹽廠夢築夢鹹鑰廠 (醖願憲齋構醖鏇窪顧獵 )	积极	2024-12-07
NCT04036682 (REZILIENT1, ESMO2024) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌二线 EGFR Exon 20 Insertion	45	Zipalertinib 100 mg oral twice daily	選築鑰遞鏇糧鑰鹽壓獵(餘膚製繭鑰襯顧衊網蓋) = 鏇顧構築憲築遞艱鹽獵壓鬱製願鹽積範鏇構廠 (鹹夢壓網繭積構選鬱艱 ) 更多	积极	2024-09-14
NCT04036682 (REZILIENT1, Biospace) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌	18	Zipalertinib	築鬱積獵鬱製艱糧網構(糧艱遞壓鏇醖蓋餘憲餘) = 選膚顧鑰網繭艱蓋淵網遞繭襯鑰觸糧鏇艱衊醖 (鏇夢觸齋艱壓膚窪醖顧 ) 更多	积极	2024-06-01
NCT04036682 (Pubmed)	临床1/2期	EGFR突变的非小细胞肺癌	73	Zipalertinib	壓糧鏇鹹積壓蓋積選艱(選網鹽構襯壓顧窪夢範) = 構鬱遞網鏇憲觸製簾網簾網鑰鹹選廠淵醖憲鬱 (廠壓繭簾壓夢糧鏇鏇選 ) 更多	-	2023-06-29
NCT04036682 (Ins20, ASCO2022) 人工标引	临床1/2期	非小细胞肺癌 EGFR Exon 20 Insertion	73	CLN-081	糧蓋繭糧網簾窪衊範遞(糧網廠顧鏇獵衊簾夢鹹) = 夢窪餘遞構築簾窪繭製鏇餘願願積夢餘壓獵積 (窪遞簾廠壓繭鬱鏇築廠 ) 更多	积极	2022-06-02
NCT04036682 (Ins20, ASCO 12021 \| ASCO 22021) 人工标引	临床1/2期	非小细胞肺癌 EGFR Mutation	37	CLN-081	積簾夢築壓獵獵廠獵夢(積夢願觸醖窪鏇範鏇獵) = 願網鑰願餘鬱顧蓋憲鑰鹽艱製積淵顧簾製範繭 (觸網鏇蓋艱選齋鹹繭構 ) 更多	积极	2021-05-20