AstraZeneca says Dato-DXd showed meaningful OS improvement in trial

High-level overall survival, or OS, results from the TROPION-Lung01 Phase III trial, which previously met the dual primary endpoint of progression-free survival, or PFS, numerically favoured datopotamab deruxtecan, or Dato-DXd, compared to docetaxel in the overall trial population of patients with locally advanced or metastatic non-small cell lung cancer, or NSCLC, treated with at least one prior line of therapy, AstraZeneca announced. Survival results did not reach statistical significance in the overall trial population. In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy. The final analysis of OS builds on the positive progression-free survival results presented at the 2023 European Society for Medical Oncology Congress which showed datopotamab deruxtecan demonstrated a statistically significant improvement in PFS in the overall trial population and a clinically meaningful PFS benefit in patients with nonsquamous NSCLC. In TROPION-Lung01, patient enrolment by tumour histology was balanced across treatment arms and consistent with real-world incidence with approximately 75% of patients having nonsquamous NSCLC. The safety profile of datopotamab deruxtecan in TROPION-Lung01 was consistent with the previous analysis including fewer dose reductions or discontinuations due to adverse events compared to docetaxel, and no new safety concerns identified. No new interstitial lung disease events of any grade were adjudicated as drug-related, the company stated.