Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of zidesamtinib (NVL-520), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors.
Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of zidesamtinib in patients with advanced ROS1-positive solid tumors.
Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of zidesamtinib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors.

开始日期2022-01-04

申办/合作机构

Nuvalent, Inc.

NCT06797362

/ AvailableN/A

Expanded Access Treatment of Zidesamtinib (NVL-520) in Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors

The Expanded Access Program will provide an alternate mechanism for these patients, who lack satisfactory therapeutic alternatives and cannot participate in a zidesamtinib clinical trial, to access investigational zidesamtinib.

开始日期-

申办/合作机构

Nuvalent, Inc.

100 项与齐德替尼相关的临床结果

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100 项与齐德替尼相关的转化医学

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100 项与齐德替尼相关的专利（医药）

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项与齐德替尼相关的文献（医药）

2025-06-01·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.

2024-05-01·Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

Comprehensive Review of ROS1 Tyrosine Kinase Inhibitors-Classified by Structural Designs and Mutation Spectrum (Solvent Front Mutation [G2032R] and Central β-Sheet 6 [Cβ6] Mutation [L2086F])

Review

作者: Nagasaka, Misako ; Zhang, Shannon S ; Ou, Sai-Hong Ignatius ; Hagopian, Garo G

Despite ROS1 fusion-positive NSCLC accounting for approximately 1% to 2% of NSCLC, there is a long list of ROS1 tyrosine kinase inhibitors (TKIs) being developed in addition to three approved ROS1 TKIs, crizotinib, entrectinib and repotrectinib. Here, we categorized ROS1 TKIs by their structures (cyclic versus noncyclic) and inhibitory abilities (active against solvent front mutation G2032R or central β-sheet #6 [Cβ6] mutation L2086F) and summarized their reported clinical activity in order to provide a dashboard on how to use these ROS1 TKIs in various clinical situations. In addition, the less known Cβ6 mutation ROS1 L2086F confer resistances to next-generation ROS1 TKIs (repotrectinib, taletrectinib, and potentially NVL-520) that can be overcome by cabozantinib as documented in published patient reports and potentially by certain L-shaped type I ROS1 TKIs including ceritinib and gilteritinib, which is approved as a FLT3 inhibitor for relapsed refractory FLT3+ acute myeloid leukemia but have published preclinical activites against ROS1 (and ALK). Future clinical trials should investigate cabozantinib and gilteritinib to repurpose them as ROS1 TKIs that can target ROS1 L2086F Cβ6 mutation.

2023-01-09·Cancer discovery

TKIs for ROS1+ Cancers Get High Marks

Article

Abstract:

Next-generation tyrosine kinase inhibitor candidates are continuing to emerge for patients with tumor types harboring ROS1 fusions. Phase I findings from two trials, TRIDENT-1 and ARROS-1, indicate high response rates with repotrectinib and NVL-520, respectively. The latter may be a potential best-in-class agent, with potent ROS1 selectivity that avoids off-target toxicity.

110

项与齐德替尼相关的新闻（医药）

2026-04-21

·动脉网

Nuvalent将在2026年美国临床肿瘤学会年会上展示来自 ALKOVE-1试验的关于 Neladalkib在 TKI预处理的晚期 ALK阳性非小细胞肺癌中的关键数据

Company to also present preliminary data for zidesamtinib in advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 trial 公司还将从全球ARROS-1试验中展示zidesamtinib在非小细胞肺癌以外的晚期ROS1阳性实体瘤中的初步数据。CAMBRIDGE, Mass. 马萨诸塞州剑桥市, ，April 21, 2026 2026年4月21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 that pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global ALKOVE-1 Phase 1/2 clinical trial, in addition to preliminary data for TKI-naïve patients, will be presented during an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago. . 针对癌症中临床验证的激酶靶点的靶向疗法，今日宣布了一项关键数据，涉及neladalkib（一种在研的ALK选择性抑制剂），用于经TKI预治疗的晚期ALK阳性非小细胞肺癌（NSCLC）患者。该数据来自全球ALKOVE-1 I/II期临床试验，同时还将展示TKI初治患者的初步数据。这些数据将在2026年5月29日至6月2日于芝加哥举行的2026年美国临床肿瘤学会（ASCO）年会上进行口头报告。Additionally, preliminary data in patients with advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 Phase 1/2 clinical trial of zidesamtinib, an investigational ROS1-selective inhibitor, will be presented during a poster session. 此外，来自全球 ARROS-1 一期/二期临床试验的初步数据，涉及非小细胞肺癌以外的晚期 ROS1 阳性实体瘤患者，该试验的研究药物是 ROS1 选择性抑制剂 zidesamtinib，这些数据将在海报展示环节中呈现。Details of the presentations are as follows: 演示的详细信息如下：Title: 标题：ALKOVE-1: Efficacy and safety of neladalkib in patients with advanced ALK+ NSCLC ALKOVE-1：尼拉达克利布在晚期ALK+非小细胞肺癌患者中的疗效与安全性Presenting Author 报告作者: Jessica J. Lin, M.D. ：Jessica J. Lin，医学博士1 1Abstract Number: 摘要编号：8503 8503Oral Session Title: 口头报告标题： Lung Cancer—Non-Small Cell Metastatic 肺癌——非小细胞转移性Presentation Date and Time: 演示日期和时间： May 29, 2026, 1:00 PM-4:00 PM CDT 2026年5月29日，下午1:00-4:00（中部夏令时间）Location: 位置：Hall D2 D2厅Title: 标题：Zidesamtinib efficacy and safety in patients with advanced ROS1-positive solid tumors other than NSCLC in the ARROS-1 study ARROS-1研究中Zidesamtinib在晚期ROS1阳性非NSCLC实体瘤患者中的疗效与安全性Presenting Author: 报告作者：Benjamin Solomon, M.D., Ph.D. 本杰明·所罗门，医学博士，哲学博士2 2Abstract Number: 摘要编号：3108 3108Poster Session Title: 海报会议标题： Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology 发展治疗学——分子靶向药物与肿瘤生物学Session Date and Time: 会话日期和时间： May 30, 2026, 1:30 PM-4:30 PM CDT 2026年5月30日，下午1:30-4:30（中部夏令时间）Location: 位置：Hall A 大厅 APoster Board Number: 海报板编号：245 2451 1Mass General Brigham Cancer Institute, Boston, MA, USA; 马萨诸塞州波士顿麻总百瀚癌症研究所，美国；2 2Peter MacCallum Cancer Centre, Melbourne, Australia 彼得·麦考伦癌症中心，墨尔本，澳大利亚 About Neladalkib 关于NeladalkibNeladalkib is an investigational, brain-penetrant, ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. Neladalkib 是一种研究性、可穿透大脑、选择性 ALK 抑制剂，旨在克服目前可用的 ALK 抑制剂所观察到的局限性。Neladalkib 的设计目标是在对第一、第二和第三代 ALK 抑制剂产生耐药性的肿瘤中仍然保持活性，包括具有单个或复合治疗相关 ALK 突变（如 G1202R）的肿瘤。In addition, neladalkib 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/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. 此外，neladalkib 旨在穿透中枢神经系统 (CNS)，以改善脑转移患者治疗选择，并避免抑制结构相关的原肌球蛋白受体激酶 (TRK) 家族。这些特性共同有可能避免与双重 TRK/ALK 抑制剂相关的 TRK 相关 CNS 不良事件，并为所有治疗阶段的患者带来深度且持久的反应。Neladalkib has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.. Neladalkib 已获得美国食品药品监督管理局 (FDA) 的突破性疗法认定，用于治疗先前接受过两种或更多种 ALK 酪氨酸激酶抑制剂治疗的局部晚期或转移性 ALK 阳性非小细胞肺癌 (NSCLC) 患者，并获得了 ALK 阳性 NSCLC 的孤儿药认定。About Zidesamtinib 关于ZidesamtinibZidesamtinib 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，包括携带治疗后出现的 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，齐德萨替尼设计为可穿透中枢神经系统 (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，并为所有治疗线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NuvalentNuvalent, 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证实的激酶靶点的局限性。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，这些小分子有潜力克服耐药性、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阳性和HER2变异的非小细胞肺癌的候选研究药物，以及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 programs for zidesamtinib and neladalkib; 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 and neladalkib; 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；齐德萨替尼(zidesamtinib)和内拉达基布(neladalkib)的临床开发计划；Nuvalent产品开发候选药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，包括齐德萨替尼和内拉达基布；Nuvalent针对癌症治疗的研发计划；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语。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成功实现产品的商业化。您不应过分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，并受到多种风险、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 zidesamtinib 产品候选药物注册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的潜在产品，甚至根本不批准的风险；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；公共卫生紧急事件或全球地缘政治局势对 Nuvalent 临床试验、战略及未来运营的时机和预期结果产生的直接或间接影响；Nuvalent 计划与监管机构互动的时机和结果；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 Form 10-K 年度报告中“风险因素”部分有更详细的描述，同时也包含在任何先前及后续的文件中。SOURCE Nuvalent, Inc. 来源：Nuvalent, Inc.21 21% %more press release views with 更多新闻发布观点 Request a Demo 请求演示

2026-04-21

·PRNewswire

Nuvalent to Present Pivotal Data from ALKOVE-1 Trial of Neladalkib in TKI Pre-treated Advanced ALK-positive NSCLC at the 2026 American Society of Clinical Oncology Annual Meeting

Company to also present preliminary data for zidesamtinib in advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 trial CAMBRIDGE, Mass., April 21, 2026 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global ALKOVE-1 Phase 1/2 clinical trial, in addition to preliminary data for TKI-naïve patients, will be presented during an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago. Additionally, preliminary data in patients with advanced ROS1-positive solid tumors outside of NSCLC from the global ARROS-1 Phase 1/2 clinical trial of zidesamtinib, an investigational ROS1-selective inhibitor, will be presented during a poster session. Details of the presentations are as follows: Title: ALKOVE-1: Efficacy and safety of neladalkib in patients with advanced ALK+ NSCLC Presenting Author: Jessica J. Lin, M.D.1 Abstract Number: 8503 Oral Session Title: Lung Cancer—Non-Small Cell Metastatic Presentation Date and Time: May 29, 2026, 1:00 PM-4:00 PM CDT Location: Hall D2 Title: Zidesamtinib efficacy and safety in patients with advanced ROS1-positive solid tumors other than NSCLC in the ARROS-1 study Presenting Author: Benjamin Solomon, M.D., Ph.D.2 Abstract Number: 3108 Poster Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Session Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT Location: Hall A Poster Board Number: 245 1 Mass General Brigham Cancer Institute, Boston, MA, USA; 2 Peter MacCallum Cancer Centre, Melbourne, Australia About Neladalkib Neladalkib is an investigational, brain-penetrant, ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib 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/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC. About 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. 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. 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. 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. About Nuvalent Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely 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. 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. Forward-Looking Statements 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 programs for zidesamtinib and neladalkib; 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 and neladalkib; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development. 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. 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. 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. 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 filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent's views only as of today and should not be relied upon as representing its views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements. SOURCE Nuvalent, Inc. 21% more press release views with Request a Demo

孤儿药突破性疗法ASCO会议快速通道

2026-04-20

·BioPharmaDive

AACR 2026: Revolution’s next prospect, Merck’s reveal and a lung cancer battle

The annual meeting of the American Association for Cancer Research is a chance for drug companies to showcase new and emerging ways to attack tumors. The gathering typically focuses on early research and clinical work, the studies developers use to build confidence in the larger and longer trials to come.This years meeting was no different. Over the weekend, trial investigators revealed new data for the kind of immunotherapies and targeted medicines that have captured the attention of investors and drugmakers in recent years.Read on for a look at three of the more notable datasets at this years meeting:Revolutions second actOver the last year or so, Revolution Medicines joined the ranks of the biopharmaceutical industrys most valuable companies. The recent success of its lead drug in testing against a tough-to-treat pancreatic tumor has positioned the company to unlock whats believed to be a more than $10 billion market opportunity.AACR is buzzing with excitement following the study results, and more data on that therapy are coming this week, wrote Stifel analyst Laura Prendergast. But the meeting also featured a second Revolution drug that may be underappreciated, she wrote.That treatment is known as zoldonrasib. Like Revolutions other therapies, zoldonrasib is aimed at a kind of RAS protein implicated in cancer growth. But whereas the companys pancreatic cancer medicine aims at multiple RAS proteins, zoldonrasib blocks a specific variant, G12D, that occurs in about 4% of people with non-small cell lung cancer. This variant is different than the one targeted by marketed medicines from Bristol Myers Squibb and Amgen.Zoldonrasib is being evaluated in an early-stage trial of people whose solid tumors harbor this G12D variant. Among a subset of 27 patients who have non-small cell lung cancer and were previously given immunotherapy and chemotherapy, the drug held tumors in check for a median of 11.1 months. Some 52% responded to treatment, and around 73% were still alive after a year, Revolution said Sunday.The findings represent a clear improvement over chemotherapy, which historically delivers around a 4-month benefit on tumor progression, wrote Leonid Timashev, an analyst at RBC Capital Markets. Timashev added that despite the studys small size and different patient populations, the results also compare favorably with other targeted therapies being tested in the second-line setting and appear definitively better than whats been seen with G12C-targeting agents.The benefits on progression-free survival also surpass a 10-month threshold some experts believe could support an accelerated approval, according to Stifels Prendergast. A Phase 3 study is expected to begin shortly.Mercks PD-1/VEGF revealMerck & Co. is a relative latecomer in the push to see whether drugs that simultaneously block the proteins PD-1 and VEGF, two well-known cancer targets, will prove a meaningful step forward in cancer care.The pharmaceutical giant is well behind the fields leaders, Akeso and Summit Therapeutics, as well as others like BioNTech that have prospects in advanced testing. But early data presented at AACR this weekend suggest Mercks entrant in the PD-1/VEGF race a drug it acquired from China-based biotech LaNova Medicines in 2024 are sufficient to warrant further development, wrote RBC Capital Markets analyst Trung Huynh.The results come from a first-in-human study of Mercks drug, MK-2010, in China. The study enrolled patients whose non-small cell lung cancers are positive for a protein, PD-L1, associated with an immunotherapy response. According to Huynhs Friday note, study data show that 6 of 11 previously untreated patients, or 55%, who received the lower of two tested doses responded to treatment.The response rate was slightly lower, at 44%, among those who received a higher dose.The most common side effects associated with treatment were those often associated with VEGF inhibitors, among them hypertension and excess protein in the urine. Adverse events judged by investigators as severe or worse occurred in 17% of those on the lower dose and 27% of patients on the higher.Though cross-trial comparisons can be misleading, these response rates are in line with competitors, among them Akeso and Summits ivonescimab and BioNTechs pumitamig, wrote Huynh. The update puts Merck back in contention in the PD-1/VEGF pace, albeit with data that lacks a distinctive edge, the analyst added.A battle of next-gen lung cancer drugsAbout 2% of people with non-small cell lung cancer have alterations in a gene known as ROS1. Multiple drugs are available for these cancers, among them Pfizers Xalkori, Roches Rozlytrek and Bristol Myers Squibbs Augtyro. But theyve largely struggled commercially, leading to skepticism from Wall Street analysts about their sales potential.Two biotech companies, Nuvation Bio and Nuvalent, are hoping for better luck. Both are touting newer treatments designed to improve upon earlier drugs in one way or another, hoping these enhanced properties will lead to better sales uptake. The Food and Drug Administration approved Nuvations drug, Ibtrozi, last year; Nuvalents zidesamtinib could follow by mid-September. The companies are both presenting fresh results at AACR.Nuvalent provided updates from a study testing zidesamtinib in advanced, ROS-1 positive non-small cell lung cancer. Some of the findings pertained to people whod previously received Augtyro or Ibtrozi. In those patients, Nuvalents drug was associated with response rates of 41% and 47%, respectively. The responses lasted a median of 15.7 months in those whod gotten Augtyro; that figure hasnt yet been reached in those whod received Ibtrozi before.To Jefferies Roger Song, Nuvalent's data strengthens confidence in zidesamtinibs ability to deliver durable, CNS-active disease control and tolerability suitable for chronic use, overcoming a key issue with other therapies. Response rates of 44% and 71% were observed, respectively, in people with brain metastases, a leading cause of disease progression, he noted.Nuvation, meanwhile, is providing a new look at durability data from two studies in patients who hadnt yet received these kinds of tyrosine kinase inhibitor drugs. The findings show the median response to Ibtrozi has now increased to 50 months in duration. But Nuvation and Nuvalents drugs look similar, wrote RBCs Timashev. Treatment preferences will ultimately come down to individual decisions between patients and physicians on the drugs relative side effect profiles and the weight they place on length of efficacy follow-up. '

临床结果AACR会议免疫疗法上市批准临床3期

100 项与齐德替尼相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
ROS1阳性非小细胞肺癌	申请上市	美国	Nuvalent, Inc.	2025-11-21
ROS1阳性实体瘤	临床2期	美国	Nuvalent, Inc.	2022-01-04
ROS1阳性实体瘤	临床2期	日本	Nuvalent, Inc.	2022-01-04
ROS1阳性实体瘤	临床2期	澳大利亚	Nuvalent, Inc.	2022-01-04
ROS1阳性实体瘤	临床2期	比利时	Nuvalent, Inc.	2022-01-04
ROS1阳性实体瘤	临床2期	加拿大	Nuvalent, Inc.	2022-01-04
ROS1阳性实体瘤	临床2期	法国	Nuvalent, Inc.	2022-01-04
ROS1阳性实体瘤	临床2期	德国	Nuvalent, Inc.	2022-01-04
ROS1阳性实体瘤	临床2期	意大利	Nuvalent, Inc.	2022-01-04
ROS1阳性实体瘤	临床2期	荷兰	Nuvalent, Inc.	2022-01-04

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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


NCT05118789 (ARROS-1, WCLC2025) 人工标引	临床1/2期	ROS1阳性非小细胞肺癌 ROS1 Positive	432	Zidesamtinib 100 mg QZidesamtinib 100 mg Q (ALL TKI pre-treated ±chemo)	淵醖願鏇廠襯廠廠遞鑰(糧糧襯繭憲艱憲積範襯) = 範顧鑰窪窪憲範窪齋鑰醖鏇鏇網簾鑰鏇鏇製蓋 (簾築憲構觸觸夢範襯鹽, 34 ~ 53) 更多	积极	2025-09-07
				Zidesamtinib 100 mgQD (1 prior ROS1 TKI(crizotinib or entrectinib) ±chemo)	淵醖願鏇廠襯廠廠遞鑰(糧糧襯繭憲艱憲積範襯) = 鹹糧簾廠觸壓積築憲艱醖鏇鏇網簾鑰鏇鏇製蓋 (簾築憲構觸觸夢範襯鹽, 37 ~ 65) 更多
NCT05118789 (ARROS-1, ESMO2024) 人工标引	临床1/2期	ROS1阳性实体瘤 \| ROS1阳性非小细胞肺癌 ROS1 Positive	104	Zidesamtinib 100 mg QD	繭獵範醖衊鑰糧廠憲衊(糧網繭夢憲鹽淵簾範襯) = 網齋鬱憲艱獵糧壓夢衊顧積選憲蓋糧簾醖齋製 (膚襯簾網餘襯襯獵顧襯, 45 ~ 84) 更多	积极	2024-09-14
				Zidesamtinib 100 mg QD (ROS1+ NSCLC + Prior ROS1 TKIs ± chemo Any (range: 1-4))	窪廠淵衊艱鹹糧觸築衊(願顧積製構簾範選願蓋) = 選獵蓋鑰築廠襯積選齋鹹構鹽廠顧窪製顧淵遞 (廠艱遞淵願鹽積鏇鑰廠 ) 更多