Nuvalent to Present New Data on Zidesamtinib at AACR 2026

Investigational ROS1-selective inhibitor to be featured in two poster presentations

Mar. 17, 2026 at 10:21pm

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Nuvalent, Inc., a clinical-stage biopharmaceutical company, announced it will present new data for zidesamtinib, an investigational ROS1-selective inhibitor, during two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026 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.

Why it matters

Zidesamtinib is designed to overcome limitations of currently available ROS1 inhibitors, including the ability to remain active in tumors that have developed resistance and to penetrate the central nervous system to treat brain metastases. These characteristics could lead to improved treatment options for patients with ROS1-positive non-small cell lung cancer (NSCLC).

The details

The two poster presentations will feature data on zidesamtinib's performance in TKI pre-treated patients with ROS1-positive NSCLC, as well as preclinical data on its brain penetrance and intracranial activity. Based on results from the ARROS-1 Phase 1/2 trial, Nuvalent has submitted a New Drug Application (NDA) to the FDA for zidesamtinib, which has been granted breakthrough therapy designation and orphan drug designation.

  • The AACR Annual Meeting 2026 will be held from April 17-22 in San Diego.
  • The two zidesamtinib poster presentations will take place on Tuesday, April 21, 2026 from 2:00-5:00 p.m. PT.

The players

Nuvalent, Inc.

A clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer.

Zidesamtinib

An investigational, brain-penetrant, ROS1-selective inhibitor designed to overcome limitations of currently available ROS1 inhibitors.

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

The presenting author for the poster on zidesamtinib in TKI pre-treated patients with ROS1-positive NSCLC.

Anupong Tangpeerachaikul, Ph.D.

The presenting author for the poster on preclinical data for zidesamtinib's brain penetrance and intracranial activity.

U.S. Food and Drug Administration (FDA)

The regulatory agency that has accepted Nuvalent's NDA submission for zidesamtinib and granted it breakthrough therapy designation and orphan drug designation.

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What’s next

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026 for Nuvalent's NDA submission for zidesamtinib.

The takeaway

Zidesamtinib's potential to overcome resistance, penetrate the central nervous system, and drive durable responses could make it an important new treatment option for patients with ROS1-positive NSCLC who have limited options after progressing on current therapies.