GSK's Jideytro Shows 94% Response Rate in First-Line ROS1-Positive NSCLC, FDA Filing Planned for 2026
GSK sits 27% above its 52-week low of $39.29.
Summary
GSK announced positive registrational data for Jideytro in first-line ROS1-positive NSCLC, with a 94% response rate and plans to file for FDA approval this year.
Key Events · Product Development and Regulatory · GSK
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94% Objective Response Rate in First-Line Setting
In 94 TKI-naïve patients, Jideytro achieved a 94% ORR (88/94; 95% CI: 87-98), including a 15% complete response rate, after a median follow-up of 15.2 months.
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Durable Responses and Brain Metastasis Clearance
90% of patients were progression-free at 12 months, and 70% of patients with measurable brain metastases achieved complete clearance of detectable brain tumours.
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FDA Submission Planned for 2026
GSK plans to submit a supplemental New Drug Application to the US FDA this year to expand Jideytro's indication to first-line ROS1-positive NSCLC.
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Expansion of Recently Acquired Nuvalent Asset
Jideytro came to GSK through the completed acquisition of Nuvalent in July 2026; first-line approval would significantly broaden its market opportunity beyond the previously treated setting.
Analysis · GSK · Life Sciences
Registrational data from the ARROS-1 trial show Jideytro (zidesamtinib) achieved a 94% objective response rate in TKI-naïve patients with ROS1-positive NSCLC, with 90% progression-free survival at 12 months and 70% complete clearance of brain metastases. These results support a planned supplemental New Drug Application to the FDA this year to expand the drug's label to first-line use. This is a meaningful expansion opportunity for a recently acquired asset (Nuvalent) and could significantly broaden the addressable patient population beyond the previously treated setting approved in July 2026.
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At the time of this filing, GSK was trading at $49.83 on NYSE in the Life Sciences sector, with a market capitalization of approximately $95.9B. The 52-week trading range was $39.29 to $61.70. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.