British drug major AstraZeneca plc (AZN,AZN.L) announced Monday positive high-level results from the TROPION-Lung01 Phase III trial of datopotamab deruxtecan (Dato-DXd) in patients with advanced non-small cell lung cancer.
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate or ADC being jointly developed by AstraZeneca and Daiichi Sankyo. It is designed using Daiichi Sankyo’s proprietary DXd ADC technology.
In the trial, Datopotamab deruxtecan met dual primary endpoint of statistically significant improvement in progression-free survival in previously treated locally advanced or metastatic disease. This was compared to docetaxel, the current standard of care chemotherapy.
The company said the trial will continue to assess the dual primary endpoint of overall survival. For this, the data were not mature and an early trend was observed in favour of datopotamab deruxtecan versus docetaxel that did not meet the prespecified threshold for statistical significance at this interim analysis.
In the trial, datopotamab deruxtecan’s safety profile was consistent with previous clinical trials with no new safety signals identified.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, “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 III 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.”
The data will be presented at a forthcoming medical meeting and shared with health authorities.
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