GSK presents Jideytro data supporting a potential first-line lung-cancer filing

GSK ($GSK) reported a 94% response rate for Jideytro in 94 evaluable patients with ROS1-positive advanced lung cancer who had not previously received a ROS1 tyrosine kinase inhibitor. In the single-arm Phase 1/2 ARROS-1 study, 90% were progression-free at twelve months. Seven of ten patients with measurable brain metastases achieved complete clearance of detectable brain tumors.

Treatment-related adverse events led to dose reductions in 11% of patients and discontinuation in 1%. GSK plans a US supplemental application to expand the drug’s indication. Jideytro is already approved for previously TKI-treated patients, but not for first-line use. These results do not provide a randomized comparison with competing treatments, and the small brain-metastasis subgroup should not be generalized to all patients.

Sources:

• GSK — ARROS-1 data and filing plans