The US Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have received a prior ROS1 kinase inhibitor.
ROS1-positive NSCLC is a rare and aggressive lung cancer that typically occurs in patients aged 50 years and older and who have never smoked. Brain metastases are common in patients with this condition.
Zidesamtinib is a ROS1 selective inhibitor designed to combine high target-selectivity, broad coverage of ROS1 resistance mutations and blood-brain barrier penetration. The approval is based on results from 117 patients in the ongoing global single-arm ARROS-1 phase 1/2 clinical trial (NCT05118789) in patients with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor.
The study demonstrated meaningful and durable responses, including in patients with brain metastases and ROS1 resistance mutations. In the overall population, the objective response rate was 44% and duration of response rates at 6 and 12 months were 82% and 69%, respectively.
The most common adverse reactions in the pooled safety population of 446 patients included oedema, peripheral neuropathy, constipation, fatigue and dyspnoea.
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