Chemotherapy-based regimens remain the standard-of-care first-line treatment for the large proportion of patients with advanced-stage triple-negative breast cancer (TNBC) who are not eligible for anti-PD-(L)1 antibodies. Now, results from the phase III TROPION-Breast02 trial demonstrate that the TROP2-targeted antibody–drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) improves overall survival (OS) in this setting.
A total of 644 patients were randomly allocated (1:1) to receive Dato-DXd versus investigator’s choice of chemotherapy. Patients either had previously untreated TNBC that was PD-L1-low (combined positive score (CPS) <10) or PD-L1-high (CPS ≥10) relapsed after anti-PD-(L)1 antibodies for early-stage disease, or could not receive such agents owing to comorbidities or lack of regulatory access. Progression-free survival (PFS) and OS were the dual primary end points.
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