LONDON (dpa-AFX) - A pooled analysis of the TROPION-Lung05 phase 2 and the TROPION-Lung01 phase 3 trials showed that Daiichi Sankyo (DSKYF.PK) and AstraZeneca's (AZN, AZN.L) datopotamab deruxtecan (Dato-DXd) demonstrated clinically meaningful tumor response in patients with previously treated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), the companies said in a statement.
Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.
According to the companies, Datopotamab deruxtecan demonstrated a confirmed objective response rate (ORR) of 42.7% in a pooled analysis of 117 patients with EGFR-mutated NSCLC from the TROPION-Lung05 and TROPION-Lung01 trials, as assessed by blinded independent central review (BICR). 4.3% complete responses, 38.5% partial responses and 41.0% cases of stable disease were observed.
The median duration of response was 7.0 months and the disease control rate (DCR) was 86.3%. Median progression-free survival was 5.8 months and median overall survival was 15.6 months.
The safety profile of datopotamab deruxtecan was consistent with previous reports from the TROPION-Lung05 and TROPION-Lung01 trials, with no new safety concerns identified. No grade 4 or 5 stomatitis, ocular surface events or adjudicated drug-related ILD events occurred.
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