GSK plans expanded US submission for Jideytro after positive results

(Alliance News) - GSK PLC on Monday reported positive findings from a phase I/II trial evaluating zidesamtinib in patients with non-small cell lung cancer who have not received previous treatment.

The London-based pharmaceutical company said the results were presented at the 2026 World Conference on Lung Cancer in Seoul and will support a planned supplemental new drug application to the US Food & Drug Administration this year to expand the indication for zidesamtinib to include first-line treatment.

Zidesamtinib, sold under the brand name Jideytro, was acquired by GSK as part of the USD10.6 billion acquisition of Boston, Massachusetts-based clinical-stage biopharmaceutical company Nuvalent Inc. The deal was completed in July.

The drug is designed as a ROS1 tyrosine kinase inhibitor. In July, GSK said the US FDA had approved Jideytro for previously treated ROS1-positive non-small cell lung cancer. It is not approved anywhere in the world for use as first-line therapy.

ROS1 refers to a specific genetic change that can drive the development of certain cancers, such as NSCLC.

On Monday, GSK said results from the registrational phase I/II Arros-1 trial showed zidesamtinib achieved a clinically meaningful 94% objective response rate in the 94 TKI-naive patients included in the analysis, including a 15% complete response rate, after a median follow-up of 15.2 months.

Responses were durable, with 94% of patients continuing to respond to treatment at nine months and 86% at 12 months. Progression-free survival was 90% at 12 months.

In the trial, 100% of patients with measurable brain metastases at baseline responded to zidesamtinib and 70% achieved a complete clearance of detectable brain tumours.

Hesham Abdullah, senior vice president, Global Head of Oncology, R&D, GSK said the results "show a combination of high response rates and a tolerability profile that helped most patients stay on treatment."

Shares in GSK were up 3.5% to 1,832.00 pence each in London on Monday morning.

On Sunday, GSK and Lianyungang, China-headquartered licensor Hansoh Pharmaceutical Group Co Ltd, reported results from the Artemis-008 phase three trial evaluating the B7-H3-targeted antibody-drug conjugate risvutatug rezetecan, also known as Ris-Rez.

GSK said Ris-Rez cut the risk of death by 54% versus topotecan in patients with relapsed small cell lung cancer in China. The patients who received Ris-Rez lived a median of 18.5 months, while those receiving topotecan lived for 10.3 months.

By Jeremy Cutler, Alliance News reporter

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