Nuvalent Announces Timing of Pivotal Data for TKI Pre-treated Patients with Advanced ROS1-positive NSCLC from ARROS-1 Clinical Trial of Zidesamtinib
Nuvalent (NASDAQ: NUVL) has announced it will host a webcast and conference call on June 24, 2025, at 8:00 AM ET to present pivotal data from their ARROS-1 Phase 1/2 clinical trial. The presentation will focus on zidesamtinib, their novel ROS1-selective inhibitor, specifically its performance in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer.
The event will be accessible via phone and live video webcast through the company's investor relations website, with presentation slides available. A replay will be archived for 30 days following the presentation.
Nuvalent (NASDAQ: NUVL) ha annunciato che terrà un webcast e una conference call il 24 giugno 2025 alle 8:00 AM ET per presentare i dati fondamentali del loro studio clinico di Fase 1/2 ARROS-1. La presentazione sarà incentrata su zidesamtinib, il loro nuovo inibitore selettivo di ROS1, con particolare attenzione alla sua efficacia nei pazienti trattati precedentemente con TKI affetti da carcinoma polmonare non a piccole cellule avanzato ROS1-positivo.
L’evento sarà accessibile tramite telefono e webcast video in diretta dal sito web delle relazioni con gli investitori dell’azienda, con le slide della presentazione disponibili. Una replica sarà archiviata per 30 giorni dopo la presentazione.
Nuvalent (NASDAQ: NUVL) ha anunciado que realizará una transmisión en vivo y una llamada de conferencia el 24 de junio de 2025 a las 8:00 AM ET para presentar datos clave de su ensayo clínico de Fase 1/2 ARROS-1. La presentación se centrará en zidesamtinib, su nuevo inhibidor selectivo de ROS1, específicamente su desempeño en pacientes con cáncer de pulmón no microcítico avanzado positivo para ROS1 que han sido tratados previamente con TKI.
El evento será accesible por teléfono y transmisión en vivo a través del sitio web de relaciones con inversores de la compañía, con las diapositivas de la presentación disponibles. Una repetición estará archivada durante 30 días después de la presentación.
Nuvalent (NASDAQ: NUVL)은 2025년 6월 24일 오전 8시(동부시간)에 ARROS-1 1/2상 임상시험의 중요한 데이터를 발표하는 웹캐스트 및 컨퍼런스 콜을 개최할 예정입니다. 발표는 그들의 새로운 ROS1 선택적 억제제인 지데삼티닙(zidesamtinib)에 초점을 맞추며, 특히 TKI 치료를 받은 진행성 ROS1 양성 비소세포폐암 환자에서의 성과에 대해 다룹니다.
행사는 회사 투자자 관계 웹사이트를 통해 전화 및 라이브 비디오 웹캐스트로 참여할 수 있으며, 발표 자료도 제공됩니다. 발표 후 30일간 재방송이 저장됩니다.
Nuvalent (NASDAQ : NUVL) a annoncé qu'il tiendra un webcast et une conférence téléphonique le 24 juin 2025 à 8h00 ET pour présenter des données clés de leur essai clinique de phase 1/2 ARROS-1. La présentation portera sur zidesamtinib, leur nouvel inhibiteur sélectif de ROS1, en particulier ses performances chez des patients traités auparavant par TKI atteints d'un cancer du poumon non à petites cellules avancé ROS1-positif.
L'événement sera accessible par téléphone et en webcast vidéo en direct via le site web des relations investisseurs de la société, avec les diapositives de la présentation disponibles. Une rediffusion sera archivée pendant 30 jours après la présentation.
Nuvalent (NASDAQ: NUVL) hat angekündigt, am 24. Juni 2025 um 8:00 Uhr ET ein Webcast und eine Telefonkonferenz abzuhalten, um entscheidende Daten aus ihrer ARROS-1 Phase 1/2 klinischen Studie vorzustellen. Die Präsentation wird sich auf zidesamtinib, ihren neuartigen ROS1-selektiven Inhibitor, konzentrieren, insbesondere auf dessen Wirksamkeit bei Patienten mit fortgeschrittenem ROS1-positivem nicht-kleinzelligem Lungenkrebs, die zuvor mit TKI behandelt wurden.
Die Veranstaltung ist telefonisch und per Live-Webcast über die Investor-Relations-Website des Unternehmens zugänglich, mit verfügbaren Präsentationsfolien. Eine Aufzeichnung wird 30 Tage nach der Präsentation archiviert.
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Company to host webcast and conference call on June 24, 2025 at 8:00am ET
Webcast and Conference Call Information
To access the call, please dial +1 (800) 836-8184 (domestic) or +1 (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined to the Nuvalent call.
Accompanying slides and a live video webcast will be available in the Investors section of the Nuvalent website at https://investors.nuvalent.com/events. A replay and accompanying slides will be archived on the Nuvalent website for 30 days.
About Zidesamtinib and the ARROS-1 Phase 1/2 Clinical Trial
Zidesamtinib is a novel 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. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.
Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who had been previously treated. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of zidesamtinib, with additional objectives including determination of the recommended Phase 2 dose, characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The ongoing global, single arm, open label Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with 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 program for zidesamtinib; the design and enrollment of Nuvalent's clinical trials, including for ARROS-1 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. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "aim," "goal," "intend," "believe," "expect," "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: risks that Nuvalent may not fully enroll its clinical trials or that enrollment will take longer than expected; unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies and clinical trials; the risk that preliminary results of clinical trials may not be predictive of future results from the same or other 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 zidesamtinib; 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, including the ARROS-1 trial; 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 Quarterly Report on Form 10-Q for the quarter ended March 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.
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SOURCE Nuvalent, Inc.
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