Zidesamtinib shows 93% response rate in ROS1-positive lung cancer trial

New data from the global phase 1/2 ARROS‑1 trial demonstrate clinically meaningful activity of zidesamtinib in patients with advanced or metastatic ROS1‑positive non‑small cell lung cancer (NSCLC) who had not previously received a tyrosine‑kinase inhibitor (TKI). The interim results were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC). In the study cohort, zidesamtinib produced objective responses and disease control in a substantial proportion of participants, underscoring its potential as a first‑line therapy for this molecular subgroup.

The ARROS‑1 trial enrolled patients across multiple centers worldwide, enrolling those with confirmed ROS1 rearrangements and no prior TKI exposure. Endpoints focused on safety, tolerability, and antitumor efficacy, with preliminary data showing an overall response rate exceeding 60% and a median progression‑free survival that surpassed historical controls for untreated ROS1‑positive disease. Adverse events were manageable and consistent with the drug’s known safety profile, reinforcing its suitability for early‑line use.

These findings suggest that zidesamtinib could become a new standard for patients with ROS1‑positive NSCLC who have not yet been treated with targeted therapy. Further phase 3 studies are planned to confirm these results and to evaluate long‑term outcomes, with the hope of expanding therapeutic options for this distinct patient population.