Artigo

Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor–Positive Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer: Primary Results From TROPION-Breast01

Autor(es): Aditya Bardia, MD, MPH1,2 ; Komal Jhaveri, MD, FACP3,4 ; Seock-Ah Im, MD, PhD5 ; Sonia Pernas, MD, PhD6 ; Michelino De Laurentiis, MD7 ; Shusen Wang, MD8 ; Noelia Mart´ınez Jañez, MD, PhD9; Giuliano Borges, MD10; David W. Cescon, MD, PhD11 ; Masaya Hattori, MD12 ; Yen-Shen Lu, MD, PhD13 ; Erika Hamilton, MD14 ; Qingyuan Zhang, MD, PhD15; Junji Tsurutani, MD, PhD16 ; Kevin Kalinsky, MD, MS17 ; Pedro Emanuel Rubini Liedke, MD18,19,20 ; Lu Xu, PhD21; Rick M. Fairhurst, MD, PhD21; Sabrina Khan, MD, MPH21 ; Neelima Denduluri, MD21 ; Hope S. Rugo, MD22 ; Binghe Xu, MD, PhD23 ; and Barbara Pistilli, MD24 ; for the TROPION-Breast01 Investigators

ABSTRACT

PURPOSE: The global, phase 3, open-label, randomized TROPION-Breast01 study assessed the trophoblast cell surface antigen 2–directed antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) versus investigator’s choice of chemotherapy (ICC) in hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR1/HER2–) breast cancer.

METHODS: Adult patients with inoperable/metastatic HR1/HER2‒ breast cancer, who had disease progression on endocrine therapy, for whom endocrine therapy was unsuitable, and had received one to two previous lines of chemotherapy in the inoperable/metastatic setting, were randomly assigned 1:1 to Dato-DXd (6 mg/kg once every 3 weeks) or ICC (eribulin/vinorelbine/capecitabine/gemcitabine). Dual primary end points were progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS).

RESULTS: Patients were randomly assigned to Dato-DXd (n 5 365) or ICC (n 5 367). Dato-DXd significantly reduced the risk of progression or death versus ICC (PFS by BICR hazard ratio [HR], 0.63 [95% CI, 0.52 to 0.76]; P < .0001). Consistent PFS benefit was observed across subgroups. Although OS data were notmature, a trend favoring Dato-DXd was observed (HR, 0.84 [95%CI, 0.62 to 1.14]). The rate of grade ≥3 treatment-related adverse events (TRAEs) with Dato-DXd was lower than ICC (20.8% v 44.7%). The most common TRAEs (any grade; grade ≥3) were nausea (51.1%; 1.4%) and stomatitis (50%; 6.4%) with Dato-DXd and neutropenia (grouped term, 42.5%; 30.8%) with ICC.

CONCLUSION: Patients receiving Dato-DXd had statistically significant and clinically meaningful improvement in PFS and a favorable and manageable safety profile, compared with ICC. Results support Dato-DXd as a novel treatment option for patients with inoperable/metastatic HR1/HER2‒ breast cancer who have received one to two previous lines of chemotherapy in this setting.

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12/09/2024

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