CAMBRIDGE, Mass.

马萨诸塞州剑桥市

,

，

March 17, 2026

2026年3月17日

/PRNewswire/ --

/PRNewswire/ --

Nuvalent, Inc.

努瓦莱特公司

(Nasdaq:

（纳斯达克：

NUVL

NUVL

), a clinical-stage biopharmaceutical company focused on creating

），一家专注于创造的临床阶段生物制药公司

precisely

准确地

targeted therapies for clinically proven kinase targets in cancer, today announced the presentation of new data for zidesamtinib, an investigational ROS1-selective inhibitor, during two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026, being held April 17-22 in San Diego.

针对癌症中经过临床验证的激酶靶点的靶向疗法，今日宣布在2026年美国癌症研究协会（AACR）年会上，通过两场海报展示发布其实验性ROS1选择性抑制剂Zidesamtinib的新数据，该会议将于4月17日至22日在圣地亚哥举行。

The posters will highlight clinical data from a subset of TKI pre-treated patients with ROS1-positive NSCLC treated in the ARROS-1 Phase 1/2 clinical trial and preclinical data further characterizing zidesamtinib's brain penetrance and intracranial activity..

这些海报将重点展示来自ARROS-1一期/二期临床试验中一部分经TKI预处理的ROS1阳性非小细胞肺癌患者的临床数据，以及进一步表征齐德萨替尼脑渗透和颅内活性的临床前数据。

Details of the poster presentations are as follows:

海报展示的详细信息如下：

Title:

标题：

Zidesamtinib in Patients with ROS1+ NSCLC Previously Treated with Repotrectinib or Taletrectinib

齐德萨替尼治疗先前接受过雷波曲替尼或塔勒曲替尼的ROS1阳性非小细胞肺癌患者

Presenting Author:

报告作者：

Geoffrey Liu, M.Sc., M.D.

刘杰弗里，理学硕士，医学博士

1

1

Abstract Number:

摘要编号：

CT248

CT248

Session Title:

会议标题：

Phase II Clinical Trials

II期临床试验

Session Date and Time

会议日期和时间

: Tuesday, April 21, 2026, 2:00-5:00 p.m. PT

：2026年4月21日星期二，下午2:00-5:00（太平洋时间）

Location:

位置：

Poster Section 50

海报第50节

Poster Board Number:

海报板编号：

13

13

Title:

标题：

Zidesamtinib Has Differentiated Preclinical Brain Penetrance and Intracranial Activity Compared to Other ROS1 Inhibitors

Zidesamtinib在临床前研究中显示出与其他ROS1抑制剂相比具有不同的脑穿透能力和颅内活性。

Presenting Author:

报告作者：

Anupong Tangpeerachaikul, Ph.D.

唐培亚库尔·阿努蓬，博士

2

2

Abstract Number:

摘要编号：

LB366

LB366

Session Title:

会议标题：

Late-Breaking Research: Experimental and Molecular Therapeutics 3

最新突破性研究：实验与分子治疗学 3

Session Date and Time:

会话日期和时间：

Tuesday, April 21, 2026, 2:00-5:00 p.m. PT

2026年4月21日星期二，下午2:00-5:00（太平洋时间）

Location:

位置：

Poster Section 53

海报部分 53

Poster Board Number:

海报板编号：

23

23

1

1

Princess Margaret Hospital, Toronto, Ontario, Canada;

加拿大安大略省多伦多玛格丽特公主医院；

2

2

Nuvalent, Inc., Cambridge, MA, USA

努瓦莱特公司，美国马萨诸塞州剑桥市

About Zidesamtinib

关于Zidesamtinib

Zidesamtinib is an investigational, brain-penetrant, ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R.

Zidesamtinib 是一种研究性、可穿透大脑、选择性 ROS1 抑制剂，旨在克服目前可用的 ROS1 抑制剂所观察到的局限性。Zidesamtinib 的设计目标是在对现有 ROS1 抑制剂产生耐药性的肿瘤中仍然保持活性，包括具有治疗后出现的 ROS1 突变（如 G2032R）的肿瘤。

In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy..

此外，齐德萨替尼设计用于穿透中枢神经系统 (CNS)，以改善脑转移患者的治疗选择，并避免抑制结构相关的原肌球蛋白受体激酶 (TRK) 家族。这些特性共同有望避免使用双重 TRK/ROS1 抑制剂时出现的 TRK 相关 CNS 不良事件，并为各线治疗的患者带来深度且持久的反应。

Based on results for tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial, the U.S. Food and Drug Administration (FDA) has accepted for filing Nuvalent's NDA submission for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI.

基于全球注册性ARROS-1一期/二期临床试验中，预先接受过酪氨酸激酶抑制剂（TKI）治疗的晚期ROS1阳性非小细胞肺癌（NSCLC）患者的结果，美国食品药品监督管理局（FDA）已受理Nuvalent公司提交的关于zidesamtinib的新药申请（NDA），用于治疗曾接受至少一种ROS1 TKI治疗的局部晚期或转移性ROS1阳性NSCLC成年患者。

The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with 2 or more ROS1 TKIs and orphan drug designation for ROS1-positive NSCLC. .

该申请已被分配至2026年9月18日的《处方药使用者费用法案》（PDUFA）目标行动日期。Zidesamtinib已获得突破性疗法认定，用于治疗先前接受过两种或更多种ROS1酪氨酸激酶抑制剂（TKI）治疗的ROS1阳性转移性非小细胞肺癌（NSCLC）患者，并获得了针对ROS1阳性非小细胞肺癌的孤儿药认定。

About Nuvalent

关于Nuvalent

Nuvalent, Inc. (Nasdaq:

努瓦莱特公司（纳斯达克：

NUVL

NUVL

) is a clinical-stage biopharmaceutical company focused on creating

）是一家处于临床阶段的生物制药公司，专注于创造

precisely

准确地

targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses.

针对癌症患者的靶向治疗，旨在克服现有疗法在临床上已验证的激酶靶点上的局限性。凭借在化学和基于结构的药物设计方面的深厚专业知识，我们开发创新的小分子，有望克服耐药性、减少不良反应、应对脑转移并实现更持久的疗效。

Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs..

Nuvalent 正在推进一条强大的研发管线，其中包括针对 ROS1 阳性、ALK 阳性以及 HER2 改变的非小细胞肺癌的研究候选药物，还有多个处于探索阶段的研究项目。

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, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; the expected timing of data announcements; the clinical development program for zidesamtinib; the potential benefits and effects of Nuvalent's product development candidates; the design of Nuvalent's clinical trials, including for the ARROS-1 trial its intended pivotal registration-directed design; the potential of Nuvalent's pipeline programs, including zidesamtinib; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development.

本新闻稿包含1995年《私人证券诉讼改革法案》（经修订）所指的前瞻性声明，包括但不限于关于Nuvalent的战略、业务计划和重点的明示或暗示声明；数据发布的预期时间；zidesamtinib的临床开发计划；Nuvalent产品开发候选物的潜在益处和效果；Nuvalent临床试验的设计，包括ARROS-1试验的预期关键注册导向设计；Nuvalent管线项目的潜力，包括zidesamtinib；Nuvalent针对癌症治疗的研发项目；以及与药物开发相关的风险和不确定性。

The words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'aim,' 'goal,' 'intend,' 'believe,' 'estimate,' 'seek,' 'predict,' 'future,' 'project,' 'potential,' 'continue,' 'target' or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

“可能”、“也许”、“将”、“可以”、“会”、“应该”、“预期”、“计划”、“预期”、“目标”、“目的”、“打算”、“相信”、“估计”、“寻求”、“预测”、“未来”、“项目”、“潜力”、“继续”、“目标”这些词语或其否定形式以及类似的词语或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。

Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented..

药物开发和商业化涉及高度风险，只有少数研发项目能够成功实现产品的商业化。您不应过度依赖这些声明或所提供的科学数据。

Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies and clinical trials; the risk that results of earlier clinical trials may not be predictive of the results of later-stage clinical trials; the risk that data from our clinical trials may not be sufficient to support registration and that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of our zidesamtinib product candidate; the occurrence of adverse safety events; risks that the FDA may not approve our potential products on the timelines we expect, or at all; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property.

本新闻稿中的任何前瞻性陈述均基于管理层的当前预期和信念，并受多种风险、不确定性和重要因素的影响，这些因素可能导致实际事件或结果与本新闻稿中包含的任何前瞻性陈述所表达或暗示的内容存在重大差异，包括但不限于：在临床前研究和临床试验期间从额外数据、分析或结果中可能出现的意外问题；早期临床试验结果可能无法预测后期临床试验结果的风险；我们临床试验的数据可能不足以支持注册，Nuvalent 可能需要在寻求注册我们的候选产品 zidesamtinib 之前进行一项或多项额外研究或试验的风险；发生不良安全事件的风险；FDA 可能不会按照我们预期的时间表批准我们潜在产品的风险，或者根本不会批准；出现意外成本、延迟或其他意外障碍的风险；Nuvalent 可能无法从其发现计划中提名候选药物的风险；公共卫生紧急情况或全球地缘政治局势对 Nuvalent 临床试验、战略及未来运营的时间安排和预期结果的直接或间接影响；Nuvalent 计划与监管机构互动的时间和结果；以及与获取、维护和保护 Nuvalent 知识产权相关的风险。

These and other risks and uncertainties are described in greater detail in the section entitled 'Risk Factors' in Nuvalent's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as well as any prior and subsequent filing.

这些以及其他风险和不确定性在 Nuvalent 公司截至 2025 年 12 月 31 日的财政年度的 Form 10-K 年度报告中“风险因素”部分有更详细的描述，以及任何先前和后续的文件中也有提及。

SOURCE Nuvalent, Inc.

来源：Nuvalent, Inc.

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