Nuvalent to Present New Data on Zidesamtinib at AACR 2026

Investigational ROS1-selective inhibitor shows promise in ROS1-positive NSCLC

Mar. 17, 2026 at 9:48pm

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Nuvalent, Inc., a clinical-stage biopharmaceutical company, announced that it will present new preclinical and clinical data for zidesamtinib, an investigational ROS1-selective inhibitor, at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego. The data will highlight zidesamtinib's potential to overcome limitations of current ROS1 inhibitors and improve treatment options for patients with ROS1-positive non-small cell lung cancer (NSCLC), including those with brain metastases.

Why it matters

Zidesamtinib is designed to address the challenges faced by current ROS1 inhibitors, such as the development of resistance mutations and limited central nervous system (CNS) penetration. If successful, zidesamtinib could provide a more effective and durable treatment option for patients with ROS1-positive NSCLC, including those with brain metastases, a common and difficult-to-treat complication of the disease.

The details

The data to be presented at AACR 2026 will include clinical results from a subset of TKI pre-treated patients with ROS1-positive NSCLC enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial, as well as preclinical data further characterizing zidesamtinib's brain penetrance and intracranial activity. Based on the ARROS-1 trial results, Nuvalent has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zidesamtinib, which has been accepted for filing and assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Zidesamtinib has also 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, as well as orphan drug designation for ROS1-positive NSCLC.

  • The AACR Annual Meeting 2026 will be held from April 17-22 in San Diego.
  • The posters will be presented 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, designed to overcome the limitations of existing therapies for clinically proven kinase targets.

Zidesamtinib

An investigational, brain-penetrant, ROS1-selective inhibitor created by Nuvalent to overcome limitations observed with currently available ROS1 inhibitors.

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

The presenting author for the poster titled "Zidesamtinib in Patients with ROS1+ NSCLC Previously Treated with Repotrectinib or Taletrectinib".

Anupong Tangpeerachaikul, Ph.D.

The presenting author for the poster titled "Preclinical Data Characterizing the Brain Penetrance and Intracranial Activity of Zidesamtinib".

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What they’re saying

“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.”

— Nuvalent, Inc.

What’s next

The U.S. Food and Drug Administration (FDA) has accepted 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.

The takeaway

Zidesamtinib, Nuvalent's investigational ROS1-selective inhibitor, has the potential to address the limitations of current ROS1 inhibitors and provide a more effective and durable treatment option for patients with ROS1-positive NSCLC, including those with brain metastases. The upcoming data presentations at AACR 2026 will further showcase the drug's promise in this patient population.