WEDNESDAY, April 22, 2026 (HealthDay News) -- For patients with previously untreated, locally recurrent inoperable or metastatic, advanced triple-negative breast cancer (TNBC), first-line datopotamab deruxtecan (Dato-DXd) is associated with improvements in progression-free survival (PFS) and overall survival (OS), according to a study published online April 3 in the Annals of Oncology.
Rebecca Dent, M.D., from the National Cancer Centre Singapore, and colleagues conducted a randomized, phase 3 trial involving patients with previously untreated, locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. Participants were randomly assigned to receive Dato-DXd (6 mg/kg intravenously every three weeks) or the investigator's choice of chemotherapy (323 and 321 participants, respectively). PFS and OS were dual primary end points.
The researchers found that the median PFS was 10.8 months with Dato-DXd and 5.6 months with chemotherapy (hazard ratio [HR], 0.57). The corresponding median OS was 23.7 and 18.7 months, respectively (HR, 0.79). Overall, 33 percent of patients who received Dato-DXd and 29 percent who received chemotherapy had treatment-related adverse events (TRAEs) of grade ≥3; TRAEs led to treatment discontinuation in 4 and 7 percent, respectively. No treatment-related deaths occurred.
"First-line Dato-DXd demonstrated clinically meaningful and significant improvements in PFS and OS for these TNBC patients," Dent said in a statement.
Several authors report ties to the biopharmaceutical industry.