GSK reported a 94% objective response rate for Jideytro (zidesamtinib) in a predefined cohort of TKI-naive patients with ROS1-positive advanced non-small-cell lung cancer (NSCLC) from its registrational phase I/II Arros-1 trial. The dataset supports GSK’s plan for a supplemental NDA filing with the FDA. The response rate is drawn from a dedicated subset, and the company framed the results as another clinical confirmation for a ROS1-first-line positioning narrative where time-to-response and durability can shape regulatory strategy. GSK is effectively translating WCLC-reported activity into near-term U.S. submission planning. For competing targeted therapies, the takeaway is intensified bar-setting in ROS1 untreated populations. With the FDA-facing filing pathway already in motion, the near-term watch items are label scope, confirmatory design, and integration with biomarker testing for ROS1 status and patient selection criteria.