Datopotamab deruxtecan extends overall survival in first-line metastatic TNBC when immunotherapy is not an option: 23.7 versus 18.7 months (TROPION-Breast02)

In the phase 3 TROPION-Breast02 trial, datopotamab deruxtecan — a TROP2-directed antibody-drug conjugate — extended median overall survival to 23.7 months versus 18.7 months with the investigator's choice of chemotherapy (HR 0.79; 95% CI 0.64-0.98; p=0.0291), with median progression-free survival of 10.8 versus 5.6 months (HR 0.57; 95% CI 0.47-0.69; p<0.0001). The trial enrolled first-line locally recurrent inoperable or metastatic triple-negative breast cancer in patients for whom IMMUNOTHERAPY WAS NOT AN OPTION — the result therefore does not apply to patients eligible for checkpoint inhibition, for whom chemoimmunotherapy remains the standard first-line approach. Both dual primary endpoints were met; the five-month gain in median survival is the endpoint that matters most to patients, and it was achieved in a setting with few options.