Sacituzumab tirumotecan versus chemotherapy in previously treated locally recurrent or metastatic triple-negative breast cancer: final overall survival analysis of the Phase III OptiTROP-Breast01
Mené sur 263 patientes atteintes d'un cancer du sein triple négatif récidivant localement ou de stade métastatique (durée médiane de suivi : 29,4 mois), cet essai de phase III évalue l'efficacité, du point de vue de la survie globale, et la toxicité du sacituzumab tirumotécan par rapport à une chimiothérapie
Background: In the 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), with a statistically significant overall survival (OS) benefit observed at the prespecified interim OS analysis. Here we report the final OS analysis with extended follow-up.
Patients and methods: Overall, 263 patients with previously treated locally recurrent or metastatic TNBC were randomly assigned 1:1 to sac-TMT (n=130) or chemotherapy (n=133). OS was a key secondary endpoint.
Results: 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 (95% CI 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 observed at interim analysis was maintained at final analysis and generally consistent across all subgroups. Subsequent antibody-drug conjugate (ADC) therapy was received by 27.8% of patients in the chemotherapy group. After adjustment for subsequent ADC therapy using the rank-preserving structural failure time model, 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 (HR 0.59, 95% CI 0.43–0.82). The sac-TMT safety profile remained consistent with previous findings, with no new safety signals. The most common grade ≥3 treatment-related adverse events were decreased neutrophil count, decreased white blood cell count and anemia. 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, with the largest differences for fatigue and pain.
Conclusions: These final OS data after extended follow-up demonstrate a clinically meaningful and sustained OS benefit of sac-TMT versus chemotherapy and further reinforce its role as a treatment option for previously treated advanced TNBC. No new safety signals were identified.
Annals of Oncology , résumé, 2026