Clinical Trials

The dual primary endpoint of overall survival (OS) did not have sufficient supporting evidence, as the data was not mature and an early trend was observed in favour of the drug, which did not appear to meet the prespecified threshold for statistical significance at this interim analysis. The trial is expected to continue to assess OS with greater maturity.

The drug’s safety profile remained consistent with previous clinical trials, and no new safety signals were identified.

Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, commented: “With TROPION-Lung01, we met the dual primary endpoint of progression-free survival, challenging the entrenched standard of care in a previously treated and unselected patient population that has long deserved an alternative to chemotherapy. These first phase 3 trial results from the datopotamab deruxtecan clinical programme provide compelling evidence for the potential role this TROP2-directed antibody drug conjugate can play in treating patients with lung cancer.”

Ken Takeshita, MD and global head of Oncology R&D at Daiichi Sankyo, added: “We are encouraged by the statistically significant results of the dual primary endpoint of progression-free survival seen with datopotamab deruxtecan and look forward to the final overall survival analysis. We plan to share these data with regulatory authorities to discuss next steps.”