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A new lung cancer drug is turning heads with near-perfect response rates. Updated data from the ARROS-1 trial show zidesamtinib achieved a 94% objective response rate in TKI-naïve patients with ROS1-positive NSCLC — among the highest ever seen in lung cancer. Impressively, all 10 patients with brain metastases responded, with 7 achieving a complete intracranial response.
Updated results from the phase 1/2 ARROS-1 trial, presented at the 2026 World Conference on Lung Cancer in Seoul, show that zidesamtinib (Jideytro) achieved a 94% objective response rate (ORR) in patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who had never received a tyrosine kinase inhibitor (TKI) — numbers that experts are calling some of the highest ever seen in lung cancer.
The drug, already FDA-approved in July 2026 for previously treated ROS1-positive NSCLC, is now being eyed for the frontline setting. GSK plans to file a supplemental new drug application to expand its use. Zidesamtinib was specifically designed to maximize ROS1 resistance mutation coverage and brain penetration while minimizing the neurological side effects that limit other agents.
By the Numbers:
Why it matters: Brain metastases are a major challenge in ROS1-positive NSCLC, and existing frontline TKIs have struggled with CNS penetration and tolerability. Zidesamtinib's combination of high efficacy, durable responses, and strong CNS activity could make it a meaningful advance for patients — potentially sparing them from whole-brain radiation and preserving quality of life.