AstraZeneca's TROP2 ADC Dato-DXd Misses OS Endpoint in Phase III NSCLC Trial

▎Armstrong

On September 9, 2024, AstraZeneca announced the latest Phase III clinical data for Trop2 ADC Dato-DXd in treating locally recurrent or metastatic non-small cell lung cancer at the WCLC conference. The data was simultaneously published in the JCO journal.

AstraZeneca has a wide range of layouts in the lung cancer field, and the PFS endpoint of the dual primary endpoints in the TROPION-Lung01 study for 2-3 line treatment of NSCLC with Dato-DXd has been previously achieved.

The updated OS data show that the mOS for the Dato-DXd treatment group and the docetaxel chemotherapy group were 12.9 months and 11.8 months, respectively, with an HR of 0.94 and a p-value of 0.53, which did not reach statistical significance.

A clinically meaningful improvement in OS was observed in the non-squamous NSCLC subgroup, but not in squamous NSCLC.

AstraZeneca further conducted Biomarker analysis.

For patients who are QCS-NMR positive, Dato-DXd can bring more significant ORR and PFS benefits.

AstraZeneca believes that QCS-NMR can serve as a biomarker for efficacy prediction, and also provides valuable experience for the selection of biomarkers in the clinical development of more ADC drugs.

Summary

Dato-DXd is advancing in multiple combination therapy clinical trials, expanding to front-line treatment for non-small cell lung cancer. Its good tolerability lays the foundation for combination therapies with IO and chemotherapy.