On March 17, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the presentation of new data for zidesamtinib, an investigational ROS1-selective inhibitor, during two poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, being held April 17-22 in San Diego. 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.
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Details of the poster presentations are as follows:
Title: Zidesamtinib in Patients with ROS1+ NSCLC Previously Treated with Repotrectinib or Taletrectinib
Presenting Author: Geoffrey Liu, M.Sc., M.D.1
Abstract Number: CT248
Session Title: Phase II Clinical Trials
Session Date and Time: Tuesday, April 21, 2026, 2:00-5:00 p.m. PT
Location: Poster Section 50
Poster Board Number: 13
Title: Zidesamtinib Has Differentiated Preclinical Brain Penetrance and Intracranial Activity Compared to Other ROS1 Inhibitors
Presenting Author: Anupong Tangpeerachaikul, Ph.D.2
Abstract Number: LB366
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Session Date and Time: Tuesday, April 21, 2026, 2:00-5:00 p.m. PT
Location: Poster Section 53
Poster Board Number: 23
1 Princess Margaret Hospital, Toronto, Ontario, Canada; 2 Nuvalent, Inc., Cambridge, MA, USA
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.
(Press release, Nuvalent, MAR 17, 2026, View Source [SID1234663637])