Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) on Monday reported positive registrational Phase I/II ARROS-1 data for Jideytro (zidesamtinib) in previously untreated ROS1-positive non-small cell lung cancer (NSCLC), supporting a planned US regulatory submission in 2026 to expand its indication to first-line treatment.

Among 94 TKI-naïve patients, Jideytro achieved a 94% objective response rate after median follow-up of 15.2 months, including a 15% complete response rate. Progression-free survival was 90% at 12 months, while median PFS and duration of response had not been reached.

All 10 patients with measurable brain metastases responded, with 70% achieving complete clearance of detectable brain tumours. Treatment discontinuation due to treatment-related adverse events was 1%, while 11% of patients required dose reductions.

Jideytro was approved by the US FDA in July 2026 for adults with locally advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 TKI.