Overview

• The primary analysis of the phase 2 IDeate-Lung01 trial presented at WCLC 2025 evaluated 137 patients treated with I-DXd 12 mg/kg every three weeks, with a March 3, 2025 data cutoff and 12.8 months median follow-up.
• Confirmed objective response rate was 48.2% with a disease control rate of 87.6%, a median time to response of 1.4 months, and a median duration of response of 5.3 months.
• Median progression-free survival reached 4.9 months and median overall survival was 10.3 months, with the second-line subgroup showing a 56.3% response rate and numerically longer PFS and OS.
• Safety signals included treatment-related adverse events in 89.8% of patients, grade 3 or higher events in 36.5%, discontinuations in 9.5%, and treatment-related deaths in 4.4%.
• Adjudicated interstitial lung disease or pneumonitis occurred in 12.4% (17 patients), including grade 3–5 cases, and a phase 3 trial (IDeate-Lung02) is comparing I-DXd 12 mg/kg with physician’s choice of topotecan, amrubicin, or lurbinectedin after one prior therapy.