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Zidesamtinib Shows 93% Response Rate in Advanced ROS1-Positive NSCLC

New results from the global Phase I/II ARROS-1 trial demonstrate the clinical efficacy of zidesamtinib. The drug achieved a 93% response rate in patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who had not previously received tyrosine kinase inhibitors.

14 September 2026
Zidesamtinib Shows 93% Response Rate in Advanced ROS1-Positive NSCLC

New results from the global Phase I/II ARROS-1 trial highlight the clinical efficacy of zidesamtinib in treating non-small cell lung cancer (NSCLC). The study observed a 93% overall response rate among patients with advanced ROS1-positive NSCLC who had not previously received treatment with tyrosine kinase inhibitors (TKIs).

The data also indicated significant systemic and intracranial activity. The intracranial response rate was 100%, with a complete intracranial response rate of 70%. These findings suggest zidesamtinib's potential to offer substantial benefits for TKI-naive patients with advanced ROS1-positive NSCLC, including those with brain metastases.

The ARROS-1 trial is a Phase I/II, multicenter study evaluating the safety, tolerability, and efficacy of zidesamtinib in patients with advanced solid tumors. The study is gathering data on zidesamtinib's effects in ROS1-positive NSCLC, a rare cancer subtype accounting for approximately 1-2% of all NSCLC cases.

In preparation for potential future regulatory submissions, the company continues to collect further data on zidesamtinib's long-term outcomes and effectiveness across various patient populations. These results are expected to provide a deeper understanding of the drug's role in targeted cancer therapy.

Original source: prnewswire.com