The company reported trial data supporting an FDA submission later this year.
GSK announced positive data on 14 September 2026 from the phase I/II ARROS-1 trial testing Jideytro in advanced or metastatic ROS1-positive non-small cell lung cancer. The drug was evaluated as a first-line treatment in 94 patients who had not received a previous ROS1 tyrosine kinase inhibitor. GSK added the therapy through its acquisition of Nuvalent.
In the trial, Jideytro showed a 94% objective response rate, with 15% of patients reaching a complete response after a median follow-up of 15.2 months. At 12 months, 90% of patients remained progression-free, while median progression-free survival was not yet reached. Among patients with measurable brain metastases, roughly 70% had complete clearance of detectable brain tumors.
GSK presented the findings at a medical conference in South Korea. The company plans to submit a supplemental new drug application to the FDA later this year to expand Jideytro into first-line care. The Nuvalent acquisition also brought neladalkib, an ALK inhibitor with an FDA decision date set for 27 November 2026, and NVL-330 in phase I testing.
Year to date, GSK shares have dropped 1.9%, compared with a 5.2% gain for the broader industry.
Share prices can rise and fall. Past performance does not guarantee future results. This article is news, not investment advice.
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