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Daiichi Sankyo, AstraZeneca Begin Phase II Datopotamab Deruxtecan Trial in NSCLC

NEW YORK – Daiichi Sankyo and AstraZeneca have begun a Phase II clinical trial of datopotamab deruxtecan in non-small cell lung cancer with actionable genomic alterations.

The global, single-arm trial, called TROPION-Lung05, is evaluating the treatment in NSCLC patients with a variety of activating alterations in genes, such as EGFR, ALK, ROS1, NTRK, BRAF, MET, or RET. Participants must have cancer that has progressed despite treatment with a tyrosine kinase inhibitor and platinum-based chemotherapy with or without other systemic therapies.

TROPION-Lung05 will enroll about 150 patients. The primary endpoint is objective response rate and secondary endpoints include duration of response, progression-free survival, overall survival, adverse events, and pharmacokinetics.

In July, AstraZeneca paid $1 billion upfront to Daiichi Sankyo for rights to datopotamab deruxtecan and the two companies have agreed to jointly develop and commercialize the drug worldwide. Datopotamab deruxtecan is an antibody drug conjugate that targets TROP2 expression. Previous research has found TROP2 expression occurs in up to 64 percent of non-small cell lung adenocarcinomas and up to 75 percent of squamous cell carcinomas.

In a Phase I trial of datopotamab deruxtecan, researchers observed durable responses in NSCLC patients. Based on the results of that trial, Daiichi Sankyo and AstraZeneca decided to explore the activity of the drug in previously treated, advanced NSCLC patients with actionable genomic markers, Gilles Gallant, global head of oncology development and oncology R&D at Daiichi Sankyo, said in a statement.