AstraZeneca says Dato-DXd showed clinically meaningful trend toward improving OS

Detailed results from the TROPION-Lung01 Phase 3 trial showed a clinically meaningful trend toward improving overall survival, or OS, with datopotamab deruxtecan, or Dato-DXd, compared to docetaxel, the current standard of care chemotherapy, in adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer, or NSCLC, treated with at least one prior line of therapy, AstraZeneca (AZN) announced. These results will be presented during an oral presentation at the IASLC 2024 World Conference on Lung Cancer, or WCLC, hosted by the International Association for the Study of Lung Cancer. Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo (DSNKY). In the overall trial population, OS results numerically favored datopotamab deruxtecan compared to docetaxel, but did not reach statistical significance, the company stated. In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a 2.3-month improvement in OS compared to docetaxel. In patients with nonsquamous NSCLC, OS improvement was observed regardless of the presence of actionable genomic alterations. In patients with squamous NSCLC, consistent with the previous analysis, datopotamab deruxtecan did not show an OS improvement. Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “TROPION-Lung01 showed a clinically meaningful trend towards improving the survival of patients with advanced or metastatic nonsquamous non-small cell lung cancer, building on the previously reported progression-free survival data. Together with the data we have presented for the potential TROP2-QCS biomarker and from NeoCOAST-2 in early-stage disease, these results underscore our confidence in the important role datopotamab deruxtecan can play across segments and settings of non-small cell lung cancer.”