GSK Jideytro data showed a 94% objective response rate among 94 previously untreated patients with advanced or metastatic ROS1-positive non-small cell lung cancer. GSK (NYSE: GSK) presented the ARROS-1 Phase 1/2 findings at the World Conference on Lung Cancer.
The analysis included a 15% complete response rate after a median follow-up of 15.2 months. Among responding patients, 94% remained in response at nine months and 86% at 12 months, while 12-month progression-free survival was 90%.
GSK Jideytro Data Support Planned First-Line FDA Filing
All patients with measurable brain metastases at baseline responded to treatment, and 70% achieved complete clearance of detectable brain tumors. At 12 months, 78% maintained an intracranial response, according to the company.
GSK provides clinical disclosures through its official press release archive. Median duration of response and median progression-free survival had not been reached at the analysis cutoff, meaning longer follow-up will be important for evaluating durability.
GSK plans to use the GSK Jideytro data to support a supplemental New Drug Application seeking first-line use in the United States. The results are promising, but regulatory approval is not assured and the FDA will assess the full efficacy, safety and manufacturing package.
