New Indication: Datopotamab Deruxtecan in NSCLC with Actionable Mutations

Phase II, single-arm, open-label study (TROPION-Lung05)

Advanced/metastatic NSCLC with actionable genomic alterations

Datopotamab deruxtecan 6mg/kg Q3W

ORR: 35.8% (95% CI, [27.8-44.4])

ORR in EGFR-mutated: 43.6% (95% CI, [32.4-55.3])

ORR in ALK-rearranged: 23.5% (95% CI, [10.7-41.2])

mDOR: 7.0 mos (95% CI, [4.2-9.8])

mPFS: 5.4 mos (95% CI, [4.7-7.0])

mOS: 13.6 mos (95% CI, [9.9-NE])

Grade ≥3 TRAEs: 28.5%

Most common TRAE: Stomatitis (56.2%, Grade ≥3: 9.5%)

ILD/Pneumonitis: 3.6% (Grade 5: 0.7%)

Sands J,Ahn MJ,Lisberg A Datopotamab Deruxtecan in Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study

Reviewed by Ulas D. Bayraktar, MD on Mar 31, 2025