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Nuvalent Begins Study of ROS1 Inhibitor in Advanced NSCLC, Solid Tumors

NEW YORK – Nuvalent said on Friday that it has dosed its first ROS1-positive non-small cell lung cancer patient in a Phase I/II clinical trial of its ROS1 inhibitor NVL-520.

In the trial, dubbed ARROS-1, Nuvalent will evaluate the targeted agent as a treatment for patients with advanced NSCLC and other solid tumors. To enroll in the trial, patients must have a documented ROS1 rearrangement in their tumors.

In the dose escalation portion of the Phase I study, Nuvalent investigators will evaluate NVL-520's overall safety and tolerability as well as the recommended Phase II dose, the drug's pharmacokinetic profile, and preliminary anti-tumor activity.

Then, in the Phase II portion of the trial, investigators will evaluate the agent's activity in patients stratified into five expansion cohorts based on their prior treatments. One cohort will include patients who have not received any prior tyrosine kinase inhibitor therapy. For this portion, the trial's primary endpoint will be overall response rate.

The Phase II cohorts, Nuvalent hopes, will yield registrational data for NVL-520 as a treatment for ROS1-postive NSCLC patients who have and have not been treated with ROS1 inhibitors.

ROS1-positive NSCLC patients currently have access to several FDA-approved targeted drugs, including crizotinib (Pfizer's Xalkori) and entrectinib (Genentech's Rozlytrek).

Cambridge, Massachusetts-based Nuvalent, which launched roughly a year ago, designed NVL-520 as a potential treatment option for patients who have developed resistance to prior ROS1 inhibitors. The drug crosses the blood-brain barrier, which may make it active against tumors that have metastasized to the brain.

"We are encouraged by the preclinical data generated to date, which provide evidence that NVL-520 represents a differentiated ROS1-selective inhibitor with the potential to overcome the limitations of current tyrosine kinase inhibitor therapies and provide a new therapeutic option for patients in need," Christopher Turner, Nuvalent's chief medical officer, said in a statement.