KEY TAKEAWAYS
- The TROPION-Breast01 phase III trial aimed to evaluate the efficacy and safety of Dato-DXd versus chemotherapy in HR+/HER2- BC.
- The primary endpoints were PFS and OS.
- The study significantly improved PFS compared to chemotherapy in patients with HR+/HER2- breast cancer and had a favorable safety profile, making it a promising new treatment option for this patient population.
Dato-DXd, a treatment targeting TROP2, showed promising results in patients with advanced HR+/HER2- breast cancer(BC) in a previous study. Researchers aimed to evaluate the efficacy and safety of Dato-DXd versus chemotherapy in HR+/HER2- BC. The study randomized 1:1 adult patients with inoperable or metastatic hormone receptor-positive/human epidermal growth factor receptor 2-negative BC.
Patients having experienced progression on endocrine therapy(ET) with unsuitability for further ET and having undergone 1-2 prior lines of systemic chemotherapy(CT) were chosen to receive Dato-DXd (6 mg/kg Q3W) or the investigator’s choice of chemotherapy (ICC; eribulin, vinorelbine, capecitabine, or gemcitabine) until progression or unacceptable toxicity. The dual primary endpoints were progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST 1.1 and overall survival (OS).
About 732 patients were randomized (Dato-DXd: 365; ICC: 367), with median ages of 56 (29–86) years in the Dato-DXd group and 54 (28–86) years in the ICC group. As of the data cut-off on July 17, 2023, 93 patients in the Dato-DXd group and 39 in the ICC group were still undergoing treatment.
The results demonstrated that patients receiving Dato-DXd exhibited significantly improved progression-free survival (PFS) compared to those receiving ICC (HR 0.63 [95% CI 0.52–0.76]; P<0.0001). Overall survival (OS) data were not mature, but a favorable trend for improvement with Dato-DXd was observed.
Patients on Dato-DXd experienced lower rates of grade ≥3 treatment-related adverse events (TRAEs) and dose reductions than those on ICC.
The study significantly improved PFS compared to chemotherapy in HR+/HER2- BC patients and had a favorable safety profile, making it a promising new treatment option for this patient population.
Clinical Trial: https://www.clinicaltrials.gov/study/NCT05104866
Bardia A, Jhaveri K, Im S, Pernas Simon S, De Laurentiis M, Wang S, Martinez N, Santos Borges G, Cescon DW, Hattori M, Lu Y, Hamilton EP, Zhang QY, Tsurutani J, Kalinsky K, Xu L, Denduluri N, Rugo HS, Xu B, Pistilli B. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Primary results from the randomised phase III TROPION-Breast01 trial. Annals of Oncology (2023) 34 (suppl_2): S1254-S1335. 10.1016/S0923-7534(23)04149-2
