AstraZeneca, Daiichi: 1st Phase 3 lung cancer results positive

 

• First phase 3 results for Daiichi Sankyo and AstraZeneca’s TROP2 directed ADC demonstrated statistically significant improvement in progression-free survival versus standard chemotherapy in previously treated locally advanced or metastatic disease
• Trial will continue to assess the dual primary endpoint of overall survival

Topline results from the TROPION-Lung01 phase 3 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.

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).

For the dual primary endpoint of overall survival (OS), the data were not mature and an early trend was observed in favor of datopotamab deruxtecan versus docetaxel that did not meet the pre-specified threshold for statistical significance at this interim analysis. The trial will continue as planned to assess OS with greater maturity. The investigators and participants will remain blinded to the results.

The safety profile of datopotamab deruxtecan was consistent with previous clinical trials with no new safety signals identified. All grade interstitial lung disease (ILD) was generally consistent with prior clinical trials, with the majority being low grade. Some grade 5 events were observed.

https://www.biospace.com/article/releases/datopotamab-deruxtecan-met-dual-primary-endpoint-of-progression-free-survival-in-patients-with-advanced-non-small-cell-lung-cancer-in-tropion-lung01-phase-3-trial/