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Nuvalent to Present Pivotal Data from ARROS-1

On August 13, 2025, Nuvalent, Inc. (Nasdaq: NUVL), a biopharmaceutical company focused on targeted cancer therapies, announced significant findings from the ARROS-1 clinical trial of zidesamtinib. This trial specifically concerns TKI (tyrosine kinase inhibitor) pre-treated patients suffering from advanced ROS1-positive non-small cell lung cancer (NSCLC). The pivotal data will be shared during the Presidential Symposium of the IASLC 2025 World Conference on Lung Cancer (WCLC 2025), which occurs from September 6-9, 2025, in Barcelona, Spain.

Dr. Christopher Turner, the Chief Medical Officer of Nuvalent, emphasized the importance of collaboration with physician-scientists, noting that it underpins the development of zidesamtinib. This innovative therapy aims to enhance treatment options for patients with ROS1-positive NSCLC, allowing them to make informed decisions about their care without sacrificing efficacy for tolerability. The encouraging results from the trial herald a step towards improving outcomes for these patients.

Presentation Details

The presentation is scheduled for September 7, 2025, from 8:15 a.m. to 10:30 a.m. CEST. Dr. Alexander Drilon of Memorial Sloan Kettering Cancer Center in New York will lead this session, where pivotal efficacy and safety data will be revealed.

Key Aspects of Zidesamtinib

Zidesamtinib represents a novel, brain-penetrant ROS1-selective inhibitor, designed to effectively target tumors that have developed resistance to existing therapies. This includes tumors with treatment-emergent mutations such as G2032R. Furthermore, the drug aims for central nervous system (CNS) penetrance, which enhances treatment efficacy for patients with brain metastases, making it distinct from other dual TRK/ROS1 inhibitors that have been associated with adverse CNS events.

Despite the ongoing development challenges in the pharmaceutical world, zidesamtinib has already received FDA breakthrough therapy designation, reflecting its potential in treating ROS1-positive metastatic NSCLC.

Regulatory Pathway

Nuvalent has initiated a rolling New Drug Application (NDA) submission for zidesamtinib targeting TKI pre-treated patients. The FDA has accepted the NDA for participation in the Real-Time Oncology Review (RTOR) pilot program, allowing provisions for earlier submission of preliminary efficacy data. Nuvalent aims to complete the NDA submission by the third quarter of 2025 and continues to engage with the FDA on expansion opportunities.

Current Status of the ARROS-1 Trial

The ARROS-1 trial (NCT05118789) encompasses a Phase 1/2 clinical study testing zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors. The Phase 1 portion aimed to establish safety and tolerability while evaluating the recommended Phase 2 dose and preliminary anti-tumor activity. Currently, the global Phase 2 portion is intent on registration for both TKI-naïve and TKI pre-treated patients.

About Nuvalent

Founded and based out of Cambridge, Massachusetts, Nuvalent operates with the mission of crafting precisely targeted cancer therapies. Their innovative approach encompasses significant investments in chemistry and drug design to address the unique challenges faced by cancer patients today. With an ambitious pipeline, they are working on various candidates for ROS1-positive, ALK-positive, and HER2-altered NSCLC, alongside ongoing discovery-stage research programs.

As we look forward to the presentation at WCLC 2025, the advancements showcased will not only highlight Nuvalent’s commitment to cancer treatment but also represent a significant potential shift in the therapeutic landscape for patients grappling with advanced ROS1-positive NSCLC.