Overview

• In the phase 2 IDeate-Lung01 primary analysis (n=137), I-DXd 12 mg/kg produced a confirmed objective response rate of 48.2% and a disease control rate of 87.6%.
• Median progression-free survival reached 4.9 months and median overall survival was 10.3 months, with a median time to response of 1.4 months and a median duration of response of 5.3 months.
• Second-line patients achieved a 56.3% response rate with longer progression-free and overall survival than the overall cohort.
• Safety monitoring identified treatment-related adverse events in 89.8% of patients, grade ≥3 events in 36.5%, adjudicated ILD/pneumonitis in 12.4%, and fatal treatment-related events in 4.4%.
• A randomized phase 3 study (IDeate-Lung02; NCT06203210) is underway comparing I-DXd 12 mg/kg with topotecan, amrubicin, or lurbinectedin in relapsed disease.