太和肿瘤学与库利南治疗公司宣布关键的REZILIENT1一期/二期数据发表在《临床肿瘤学杂志》上-动脉网

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

CISION 等信源发布 2025-06-01 20:21

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可切换为仅中文

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PRINCETON, N.J.

普林斯顿，新泽西州

and

和

CAMBRIDGE, Mass.

马萨诸塞州剑桥市

，

June 1, 2025

2025年6月1日

/PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced today the publication of positive results from the REZILIENT1 trial in the peer-reviewed

/PRNewswire/ -- 大鹏制药公司（Taiho Oncology, Inc.）和库利南治疗公司（Cullinan Therapeutics, Inc.）今天宣布，REZILIENT1 试验的积极结果已在同行评审的期刊上发表。

Journal of Clinical Oncology (JCO)

临床肿瘤学杂志 (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

REZILIENT1 是一项全球多中心的 1/2 期临床研究，评估 zipalertinib（研发代号：CLN-081/TAS6417）用于治疗携带表皮生长因子受体（EGFR）外显子 20 插入突变（ex20ins）并曾接受过既往治疗的非小细胞肺癌（NSCLC）患者。

。

Results from the REZILIENT1 trial will be

REZILIENT1 试验的结果将会是

presented

呈现

in a simultaneous oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8503).

在2025年美国临床肿瘤学会（ASCO）年会的同步口头报告中（摘要编号#8503）。

继续阅读

Cullinan Therapeutics

库利南制药公司

The full publication, titled

完整出版物，标题为

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,

Zipalertinib用于治疗先前接受过铂类化疗联合或不联合Amivantamab的表皮生长因子受体外显子20插入阳性非小细胞肺癌患者，

can be found

可以找到

here

这里

。

Highlights of the REZILIENT1 Phase 1/2 trial in the authors' conclusions include:

REZILIENT1 1/2期试验在作者结论中的亮点包括：

Zipalertinib demonstrated clinically meaningful efficacy in the primary efficacy population (n=176), including 51 patients who had received prior amivantamab.

Zipalertinib在主要疗效人群（n=176）中表现出具有临床意义的疗效，其中包括51名之前接受过amivantamab治疗的患者。

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.

确认的总体客观缓解率（ORR）为35.2%，中位缓解持续时间（mDOR）和无进展生存期分别为8.8个月和9.4个月。

In patients treated after prior platinum-based chemotherapy only (n=125), ORR was 40% with mDOR of 8.8 months.

在既往接受过铂类化疗后治疗的患者中（n=125），ORR为40%，mDOR为8.8个月。

The safety profile of zipalertinib was manageable and consistent with previously reported data.¹

齐帕勒替尼的安全性特征是可管理的，并且与之前报告的数据一致。¹

In exploratory subgroup analyses:

在探索性亚组分析中：

Patients who had received prior amivantamab without other ex20ins-targeted therapy showed a confirmed ORR of 30% and mDOR of 14.7 months.

既往接受过阿米万他单抗治疗但未接受其他ex20ins靶向治疗的患者，确认的客观缓解率（ORR）为30%，中位缓解持续时间（mDOR）为14.7个月。

Patients with brain metastases showed a confirmed ORR of 30.9% and a mDOR of 8.3 months.

脑转移患者的确认客观缓解率（ORR）为30.9%，中位缓解持续时间（mDOR）为8.3个月。

'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

“尽管EGFR ex20ins突变型非小细胞肺癌患者的近期治疗取得了进展，但目前尚无针对这些肿瘤突变的口服靶向疗法，”主要研究者表示。

Zofia Piotrowska

索菲亚·皮奥特罗夫斯卡

, MD, Assistant Professor, Medicine,

医学博士，助理教授，内科，

Harvard Medical School

哈佛医学院

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.'.

麻萨诸塞州总医院癌症中心的临床研究员和肺癌内科肿瘤学家表示：“1/2期REZILIENT1试验的结果支持我们对齐帕替尼作为携带EGFR ex20ins突变的既往治疗过的复发性或转移性非小细胞肺癌患者的潜在靶向治疗选择的理解。”

Taiho Oncology is actively recruiting patients in the Phase 3 REZILIENT3 trial (

太和肿瘤学正在积极招募第三阶段REZILIENT3试验的患者（

NCT05973773

）。

About REZILIENT1

关于REZILIENT1

REZILIENT1 (Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors) is a Phase 1/2 clinical trial (

REZILIENT1（研究Zipalertinib在EGFR非小细胞肺癌肿瘤中的应用）是一项1/2期临床试验（

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)..

）评估zipalertinib在携带EGFR外显子20插入突变的晚期或转移性非小细胞肺癌（NSCLC）成人患者中的疗效和安全性，这些患者曾接受过先前治疗。主要终点是由盲态独立中心审查（ICR）根据RECIST v1.1评估的客观缓解率（ORR）和缓解持续时间（DOR）。不良事件根据常见不良事件术语标准（CTCAE v5.0）进行特征描述和分级。

About Zipalertinib

关于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（开发代号：CLN-081/TAS6417）是一种口服小分子，旨在靶向EGFR的激活突变。该分子因其能够抑制带有20号外显子插入突变的EGFR变体，同时保留野生型EGFR而被选中。Zipalertinib被设计为新一代不可逆的EGFR抑制剂，用于治疗具有特定基因特征的非小细胞肺癌患者亚群。

Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority..

Zipalertinib 已获得 FDA 的突破性疗法认定。Zipalertinib 尚在研究中，尚未获得任何卫生部门的批准。

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.

Zipalertinib 正由大鹏制药有限公司及其母公司 Taiho Oncology, Inc. 与美国的 Cullinan Therapeutics, Inc. 合作开发。

About EGFR Exon 20 Insertion Mutations

关于EGFR外显子20插入突变

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.

非小细胞肺癌是一种常见的肺癌类型，高达4%的病例存在EGFR第20外显子插入突变，这使其成为第三常见的EGFR突变亚型。

在

the United States

美国

, approximately 16% of patients with NSCLC harbor EGFR mutations,

大约16%的非小细胞肺癌患者携带EGFR突变，

with insertions at exon 20 accounting for up to 12% of these mutations.

其中第20号外显子插入占这些突变的12%。

About Taiho Oncology, Inc.

关于大鹏制药公司

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, Inc. 的使命是改善癌症患者、他们的家人及护理人员的生活。公司专注于开发和商业化用于各种肿瘤类型的口服抗癌药物。Taiho Oncology 拥有针对实体瘤和血液恶性肿瘤的众多小分子临床候选药物的强大研发管线，同时还有其他处于临床前开发阶段的候选药物。

Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in .

大鹏制药是隶属于大冢控股有限公司的大鹏制药有限公司的子公司。大鹏制药总部位于。

Princeton, New Jersey

新泽西州普林斯顿

and oversees its parent company's European and Canadian operations, which are located in Baar,

并监督其母公司位于巴尔的欧洲和加拿大业务，

Switzerland

瑞士

and

和

Oakville, Ontario, Canada

加拿大安大略省奥克维尔

。

For more information, visit

欲了解更多信息，请访问

https://www.taihooncology.com/

, and follow us on

，并关注我们

领英

and

和

。

About Cullinan Therapeutics

关于库利南治疗公司

Cullinan Therapeutics, Inc.

库利南治疗公司

(Nasdaq:

（纳斯达克：

CGEM

中国地面环境监测（China Ground Environment Monitoring）

) 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.

）是一家致力于为患者创造新护理标准的生物制药公司。Cullinan战略性地构建了多样化的临床阶段资产组合，这些资产能够抑制疾病的关键驱动因素，或利用免疫系统消除自身免疫疾病和癌症中的病变细胞。

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.

库里南的产品组合涵盖了多种治疗模式，每种模式都有成为同类最佳或首创的潜力。基于对肿瘤学、免疫学和转化医学的深刻理解，我们提出差异化理念，确定最合适的目标，并选择最佳的治疗模式，以开发针对各种自身免疫疾病和癌症适应症的变革性疗法。

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.

我们突破传统界限，从候选药物筛选到差异化治疗，我们在研发的每个阶段都应用严格的行/不行标准，以快速推进最有希望的分子进入临床，并最终实现商业化。凭借深厚的科学专业知识，我们的团队发挥创造力和紧迫感，履行我们为患者带来全新治疗方案的承诺。

Learn more about Cullinan at .

请访问以下链接以了解更多关于Cullinan的信息：。

https://cullinantherapeutics.com/

, and follow us on

，关注我们

领英

and

和

。

Forward Looking Statements

前瞻性声明

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..

本新闻稿包含《1995年私人证券诉讼改革法案》所指的前瞻性陈述。这些前瞻性陈述包括但不限于关于公司对我们未来数据发布计划、齐帕勒替尼的临床开发和监管申报计划及时间表、齐帕勒替尼的安全性和有效性特征及其满足未满足医疗需求的潜力的信念和预期的明示或暗示陈述，以及其他非历史事实的陈述。“相信”、“继续”、“可能”、“估计”、“预期”、“意图”、“或许”、“计划”、“潜力”、“预计”、“追求”、“将”以及类似的表达旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

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.

本新闻稿中的任何前瞻性陈述均基于管理层对当前事件的预期和对未来事件的信念，并受到已知和未知风险及不确定性的影响，这些风险和不确定性可能导致我们的实际结果、业绩或成就与前瞻性陈述中明示或暗示的任何未来结果、业绩或成就存在重大差异。这些风险包括但不限于以下内容：关于监管提交的时间和结果的不确定性；我们向美国食品药品监督管理局或其他全球监管机构提交的新药申请（NDA）或其他监管文件可能无法按我们预期的时间表获批，甚至完全不获批的风险；我们临床试验和临床前研究的成功与否；与我们保护和维持知识产权地位能力相关的风险；与我们候选产品制造、供应和分销相关的风险；我们的一个或多个候选产品（包括合作开发的产品）可能无法成功开发和商业化的风险；临床前研究或临床研究的结果可能无法预测未来研究相关结果的风险；以及任何合作、伙伴关系、许可或类似协议的成功与否。这些以及其他重要的风险和不确定性在我们向证券交易委员会提交的文件中有讨论，包括我们最近的年度报告Form 10-K中的“风险因素”部分以及随后向SEC提交的文件，可能导致实际结果与本新闻稿中所做的前瞻性陈述所表明的结果存在重大差异。

While we may elect to update such forward-looking statements at some point .

虽然我们可能会选择在某个时候更新这些前瞻性声明。

References

参考文献

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.

1. Piotrowska Z, Tan DS, Smit EF, 等。Zipalertinib 在携带表皮生长因子受体第 20 外显子插入的非小细胞肺癌患者中的安全性、耐受性和抗肿瘤活性。

Journal of Clinical Oncology

临床肿瘤学杂志

. Available at:

。可于以下位置获取：

https://ascopubs.org/doi/full/10.1200/JCO.23.00152

。

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.

2. Burnett H, Emich H, Carroll C, 等。EGFR第20外显子插入在晚期非小细胞肺癌中的流行病学和临床负担：一项系统性文献综述。

PLOS ONE

. 2021;16(3):e0247620. Available at:

. 2021;16(3):e0247620. 可在以下网址获取：

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0247620

。

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.

3. Riess JW，Gandara DR，Frampton GM，等。通过NSCLC的全面基因组分析鉴定出多样的EGFR第20外显子插入和共存的分子改变。

Journal of Thoracic Oncology

胸部肿瘤学杂志

. 2018

Jul 5

7月5日

;13(10):1560–1568

。

Available at:

可从以下地址获取：

https://www.jto.org/article/S1556-0864(18)30770-6/pdf

。