GSK plc announced positive results from its phase I/II ARROS-1 study for Jideytro (zidesamtinib), a ROS1 inhibitor for first-line treatment of advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). The study, which included 94 patients who had not received prior ROS1 tyrosine kinase inhibitors, reported a 94% objective response rate and 15% of patients achieving complete response after a median follow-up of 15.2 months.
Key findings also indicated that 90% of patients remained progression-free after 12 months, and approximately 70% of patients with measurable brain metastases achieved complete clearance of detectable brain tumors. GSK presented these findings at a medical conference in South Korea and plans to submit a supplemental new drug application to the FDA later this year.
The Nuvalent acquisition has further enhanced GSK’s oncology portfolio, which includes investigational therapies for genetically defined NSCLC. Year-to-date, GSK’s shares have declined by 1.9%, compared to a 5.2% increase in the industry.
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