GSK Jideytro Hits 94% Response Rate, Aiming for First-Line FDA Approval

GSK reported positive results from its ARROS-1 trial for the lung cancer drug Jideytro (zidesamtinib). The data, presented at the 2026 World Conference on Lung Cancer, showed a 94% objective response rate in 94 patients with ROS1-positive non-small cell lung cancer (NSCLC). These participants had not previously received a similar therapy.

After a median follow-up of 15.2 months, 90% of patients remained progression-free at 12 months. The drug also demonstrated a 100% response rate in all 10 patients with measurable brain tumors.

GSK plans to submit a supplemental New Drug Application to the U.S. FDA in 2026 to expand Jideytro’s approval to first-line treatment. The company acquired the drug through its purchase of Nuvalent. The FDA initially approved Jideytro in July 2026 for patients previously treated with another tyrosine kinase inhibitor.