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Tuesday, September 15, 2026

Positive Jideytro ARROS-1 trial data for first-line ROS1+ NSCLC drives GSK premarket surge

 


  • GSK reported 94% objective response rate (15% complete) in TKI-naive patients from phase I/II ARROS-1 trial at WCLC 2026.
  • Strong durability shown with 90% progression-free survival at 12 months; median PFS not yet reached after 15.2 months follow-up.
  • Excellent intracranial efficacy: 100% response rate and 70% complete clearance in patients with measurable brain metastases.
  • Data supports planned supplemental NDA to FDA this year to expand Jideytro (zidesamtinib) from second-line to first-line use.
  • Concurrent positive OS data from Ris-Rez phase 3 (ARTEMIS-008) in relapsed SCLC: 54% death risk reduction, median OS 18.5 vs 10.3 months.
  • London shares rose ~3.6% on announcement; NYSE ADR mirrored with ~3.7% premarket gain on Sept 14, 2026.
  • Results from recent Nuvalent acquisition and Hansoh licensing bolster GSK oncology pipeline momentum.

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