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Zidesamtinib Shows 94% Response Rate in ROS1-Positive Lung Cancer Trial

A 94% objective response rate in TKI-naive patients with advanced ROS1-positive non-small cell lung cancer has emerged from the Phase I/II ARROS-1 clinical trial. Presented at the 2026 World Conference on Lung Cancer, the data highlight the drug's potent systemic and intracranial performance in previously untreated individuals.

Zidesamtinib Shows 94% Response Rate in ROS1-Positive Lung Cancer Trial
Photo: Bio & News

Among 94 efficacy-evaluable patients who had not previously received tyrosine kinase inhibitor therapy, the objective response rate reached 94% via blinded independent central review. Durability remained high, with a 12-month duration-of-response rate of 86%. These results suggest a potential shift in standard care for advanced or metastatic cases, according to findings discussed by Alexander Drilon of Memorial Sloan Kettering Cancer Center.

The drug also displayed significant intracranial activity. In a subset of 10 patients with central nervous system metastases, the intracranial objective response rate hit 100%, with a 70% complete response rate. Safety data across the broader population of 532 participants showed manageable side effects; peripheral edema was the most frequent, appearing in 34% of patients. Only 1% of the cohort discontinued treatment due to adverse events, supporting the therapy's viability for earlier intervention.

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