Patients with non-small cell lung cancer could be administered an alternative to chemotherapy after results from a Phase III trial of datopotamab deruxtecan (Dato-DXd) have shown a better rate of progression-free survival.

Topline results from Daiichi Sankyo and AstraZeneca’s Phase III trial of TROPION-Lung01 (NCT04656652) show Dato-DXd has a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one previous therapy.

Dato-DXd is a specifically engineered TROP2-directed DXd antibody-drug conjugate while TROP2 is a protein highly expressed in a large majority of lung cancers.

Meeting endpoints

For the primary endpoint of overall survival (OS), the data did not meet the pre-specified threshold for statistical significance in this interim analysis despite an early trend. Sankyo has said the trial will continue as planned to assess OS. The trial is due to continue until 27 June 2024.

AstraZeneca oncology R&D executive vice-president Dr Susan Galbraith clarifies: “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 program provide compelling evidence for the potential role this TROP2 directed antibody-drug conjugate can play in treating patients with lung cancer.”

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Treatment testing in various cancers

Daiichi Sankyo and AstraZeneca are also testing Dato-DXd in cancers of the breast, ovary, oesophagus, and cervix.

The 590 participants in the global, randomised, multicentre, open-label phase III trial were recruited with and without actionable genomic alterations such as EGFR and ALK.

Patients with actionable genomic alterations were previously treated with platinum-based chemotherapy and an approved targeted therapy. Patients without actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. The latest data shows no new safety signals were identified.

All-grade interstitial lung disease (ILD) was generally consistent with prior clinical trials, with the majority being low-grade.

More than one million people worldwide are diagnosed with advanced NSCLC each year. For decades, chemotherapy has been the last treatment available for patients in the absence of other treatment options despite limited effectiveness and known side effects.