Datopotamab deruxtecan shows improved overall and progression‑free survival versus chemotherapy in first‑line advanced TNBC

The European Society for Medical Oncology (ESMO) reported results from the phase III TROPION‑Breast02 study showing that first‑line treatment with datopotamab deruxtecan significantly improved clinical outcomes compared with investigator’s choice of chemotherapy in patients with previously untreated, locally recurrent inoperable or metastatic triple‑negative breast cancer (TNBC) who were not eligible for immunotherapy.

TROPION‑Breast02 is an international, open‑label, randomised phase III trial comparing datopotamab deruxtecan monotherapy with standard chemotherapy. The study met both dual primary endpoints, demonstrating statistically significant improvements in progression‑free survival (PFS) and overall survival (OS). Median PFS was 10.8 months with datopotamab deruxtecan compared with 5.6 months with chemotherapy, while median OS was 23.7 months versus 18.7 months, respectively. Objective response rate and duration of response were also higher in the datopotamab deruxtecan arm.

Datopotamab deruxtecan is a TROP2‑directed antibody‑drug conjugate. According to ESMO, the safety profile observed in TROPION‑Breast02 was manageable and consistent with previous studies, with no treatment‑related deaths reported. Patient‑reported outcomes supported the efficacy and safety findings.

The results were published in Annals of Oncology on 3 April 2026 and support datopotamab deruxtecan as a potential first‑line treatment option for patients with advanced TNBC for whom immunotherapy is not an option.
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