Multicenter phase 3 trial of sacituzumab tirumotecan versus chemotherapy for advanced TNBC: final OS analysis of OptiTROP-Breast01

In the multicenter phase 3 OptiTROP-Breast01 trial, sacituzumab tirumotecan (sac-TMT) significantly improved progression-free survival versus chemotherapy in patients with previously treated advanced triple-negative breast cancer (TNBC). The final overall survival (OS) analysis of the trial has now been reported. Overall, 263 patients with previously treated locally recurrent or metastatic TNBC were randomized 1:1 to receive sac-TMT (n=130) of chemotherapy (n=133). At a median follow-up of 29.4 months, median OS was 14.7 months (95% CI 12.1-20.1) with sac-TMT and 9.9 months (8.6-11.8) with chemotherapy (HR 0.60; 95% CI 0.45-0.80); 30-month OS rates were 26.8% and 13.2%. The OS benefit was generally consistent across all subgroups. Subsequent antibody-drug conjugate (ADC) therapy was received by 27.8% in the chemotherapy group. After adjustment for subsequent ADC therapy using the rank-preserving structural failure time mode, median OS was 14.7 months with sac-TMT and an estimated 9.4 months with chemotherapy (HR 0.55; 95% CI 0.39-0.73); censoring analysis yielded consistent results. The sac-TMT safety profile remained consistent with previous findings, with no new safety signals. Exploratory patient-reported outcome analyses showed numerically longer median time to deterioration with sac-TMT than with chemotherapy across all five evaluated health-related quality of life domains. The authors conclude that these final data after extended follow-up demonstrate a clinically meaningful and sustained OS benefit of sac-TMT versus chemotherapy in previously treated advanced TNBC.