AstraZeneca and Daiichi Sankyo’s TROP2 ADC Demonstrates Clinically Meaningful Survival Improvement in Phase 3 Lung Cancer Subgroup

1. Datopotamab Deruxtecan (Dato-DXd): An investigational TROP2-directed ADC developed by Daiichi Sankyo and jointly developed by AstraZeneca and Daiichi Sankyo.
2. Phase 3 TROPION-Lung01 Trial: Enrolled approximately 600 patients globally, assessing the efficacy and safety of datopotamab deruxtecan versus chemotherapy with docetaxel in advanced nonsquamous non-small cell lung cancer (NSCLC).
3. Survival Improvement: Datopotamab deruxtecan showed a clinically meaningful improvement in overall survival (OS) compared to docetaxel in the prespecified subgroup of patients with nonsquamous NSCLC.
4. Primary Endpoints: The trial met its dual primary endpoints of progression-free survival (PFS) and OS, with PFS previously reported to be statistically significant.
5. Safety Profile: Datopotamab deruxtecan demonstrated a favorable safety profile with fewer dose reductions or discontinuations due to adverse events compared to docetaxel.
6. Regulatory Applications: The trial data will support regulatory applications currently under review globally, including in the US and EU, for the treatment of advanced NSCLC.
7. Potential Impact: Datopotamab deruxtecan could potentially replace conventional chemotherapy in the late-line setting and has ongoing trials evaluating its use in first-line lung cancer.