Multinational phase 3 trial of datopotamab deruxtecan versus docetaxel for previously treated advanced or metastatic NSCLC

Outcomes for patients with advanced or metastatic non-small cell lung cancer (A/M NSCLC) who receive standard docetaxel-based chemotherapy after disease progression remain suboptimal. The multinational phase 3 TROPION-Lung01 study evaluated datopotamab deruxtecan (Dato-DXd) versus docetaxel in patients with previously treated NSCLC. Dato-DXd demonstrated a statistically significant improvement in progression-free survival (median 4.4 versus 3.7 months; HR 0.75; p=0.004) and numerical improvement in overall survival (median 12.9 versus 11.8 months; HR 0.94; p=0.530) over docetaxel. Superior clinical benefits were observed in patients with nonsquamous histology. Grade 3 or higher treatment-related adverse events were less frequent with Dato-DXd than with docetaxel. The authors conclude that Dato-DXd significantly improved PFS versus docetaxel in patients with A/M NSCLC, driven by patients with nonsquamous histology.