Pipeline

Created for the Challenge

Nuvalent’s novel drug candidates solve for the dual challenges of kinase resistance and selectivity, with the goal of enabling durable responses for patients with cancer.

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Nuvalent Pipeline

Zidesamtinib (NVL-520)ROS1+ NSCLC
Arros-1 logo
phase 2
NELADALKIB (NVL-655)ALK+ NSCLC
Alkove-1 logo
phase 2
Alkazar logo
phase 3
NVL-330 HER2-altered NSCLC
HEROEX-1 logo
phase 1

Programs

ROS1 fusions are an oncogenic driver alteration found in up to 3% of patients with non-small cell lung cancer (NSCLC). The clinical utility of approved therapies for ROS1-driven NSCLC is limited by emergent resistance mutations as well as central nervous system (CNS) disease.

Zidesamtinib (NVL-520)

Zidesamtinib is a novel brain-penetrant ROS1-selective inhibitor created with the aim of addressing the combined medical needs of:

  • Treating tumors driven by ROS1 that have developed resistance to currently available ROS1 inhibitors, including tumors with the prevalent G2032R “solvent front” resistance mutation,
  • Avoiding inhibition of the structurally-related tropomyosin receptor kinase (TRK) family, and
  • Treating brain metastases.

ROS1-selectivity is emphasized to minimize CNS adverse events related to off-target inhibition of TRK and potentially drive durable responses for patients with ROS1-mutant variants. In addition, zidesamtinib has been optimized for brain penetrance to potentially improve treatment options for patients with brain metastases.

The Phase 2 portion of the ARROS-1 Phase 1/2 clinical trial of zidesamtinib for patients with advanced ROS1-positive NSCLC and other solid tumors is now enrolling. To learn more, please visit www.clinicaltrials.gov (NCT05118789).

Our Clinical Trials

Global Phase 2 investigating zidesamtinib for ROS1+ cancer

Have you or a loved one been diagnosed with ROS1-positive cancer?

Talk to your doctor today to find out whether you or a loved one may be eligible to receive zidesamtinib through the ARROS-1 clinical trial.

For more information, visit www.clinicaltrials.gov (NCT05118789).

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