#Dato dxd trial#

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#Dato dxd trial#

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.” 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. Some Grade 5 events were observed.ĭatopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. All grade interstitial lung disease was generally consistent with prior clinical trials, with the majority being low grade. The safety profile of datopotamab deruxtecan was consistent with previous clinical trials with no new safety signals identified. The investigators and participants will remain blinded to the results. The trial will continue as planned to assess OS with greater maturity.

Positive high-level results from the TROPION-Lung01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior therapy.įor the dual primary endpoint of overall survival (OS), 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. Trial will continue to assess the dual primary endpoint of overall survival In previously treated locally advanced or metastatic disease

Improvement in progression-free survival vs. Non-small cell lung cancer in TROPION-Lung01 Phase III trialįirst Phase III results for AstraZeneca and Daiichi Sankyo’s TROP2-directed antibody drug conjugate demonstrated statistically significant

Progression-free survival in patients with advanced Datopotamab deruxtecan met dual primary endpoint of