GSK announced positive registrational data from Nuvalent’s ARROS-1 trial for Jideytro (zidesamtinib), supporting a planned supplemental U.S. filing to expand use into first-line treatment for ROS1-positive non-small cell lung cancer (NSCLC).
In the TKI-naïve cohort, zidesamtinib showed a 94% objective response rate after a median 15.2 months of follow-up, with 90% of patients progression-free at 12 months.
The trial also showed strong activity in the brain:
all patients with measurable brain metastases responded, and 70% achieved complete clearance of detectable brain tumors.
Safety remained favorable, with low discontinuation rates; the most common treatment-related side effects were edema, weight gain, creatine phosphokinase increase, taste changes, and AST increase.
This comes after GSK completed its acquisition of Nuvalent and earlier won U.S. approval for zidesamtinib in previously treated ROS1-positive NSCLC, reinforcing its push to build a lung-cancer franchise.
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