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19/05/2025A new phase 3 trial demonstrated clinically meaningful improvements in progression-free survival compared to chemotherapy, with a manageable safety profile
A randomized phase 3 trial recently published on Nature Medicine supports the use of the anti-TROP2 antibody–drug conjugate sacituzumab tirumotecan (sac-TMT) as an additional effective treatment option for pretreated metastatic triple-negative breast cancer, thanks to a statistically significant improvement in progression-free survival.
For the OptiTROP-Breast01 phase 3 trial a total of 263 patients with locally advanced, recurrent or metastatic triple-negative breast cancer who had received two or more prior therapies, including at least one for metastatic disease, were enrolled and randomly assigned to receive either sac-TMT or chemotherapy of the physician’s choice. The median progression-free survival by blinded independent central review was 6.7 months with sac-TMT and 2.5 months with chemotherapy; the percentage of patients with an objective response was 45.4% with sac-TMT and 12% with chemotherapy, the median duration of response was 7.1 months and 3 months respectively. Adverse events reported with sac-TMT were generally consistent with those reported previously, and no unexpected safety signals were observed: the most common treatment-related adverse event with sac-TMT was hematologic toxicity. As authors conclude, «Because the population was drawn from a broad range of patients with previously treated metastatic triple-negative breast cancer, the study findings support sac-TMT as an effective treatment option for this patient population that has limited treatment options».





