2026-06-23 メモリアル・スローン・ケタリングがんセンター（MSKCC）
＜関連情報＞
- https://www.mskcc.org/news/fda-approves-new-treatment-for-triple-negative-breast
- https://www.annalsofoncology.org/article/S0923-7534(26)00130-4/fulltext
未治療の進行トリプルネガティブ乳がん患者におけるダトポタマブ・デルクステカン（TROPION-Breast02）：無作為化、非盲検、国際共同第III相試験 Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial
R. Dent S ∙ Z. Shao ∙ P. Schmid ∙ … ∙ M.J. Maxwell ∙ T. Traina on behalf of the TROPION-Breast02 investigators
Annals of Oncology Published:April 3, 2026
DOI:https://doi.org/10.1016/j.annonc.2026.03.008
Highlights
- In TROPION-Breast02, Dato-DXd demonstrated statistically significantly improved PFS by BICR and OS versus chemotherapy.
- Confirmed ORR was higher and median DoR was longer with Dato-DXd than with chemotherapy.
- The safety profile of Dato-DXd was consistent with that reported in previous studies.
- Rates of serious and grade ≥3 TRAEs were similar, and discontinuation due to TRAEs was lower with Dato-DXd versus chemotherapy.
Abstract
Background
Prognosis is poor, and treatment options are limited for patients with previously untreated, advanced triple-negative breast cancer (TNBC), especially for those who are not candidates for immunotherapy.
Patients and methods
In the randomised, open-label, phase III TROPION-Breast02 trial, patients with previously untreated, locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option were randomly assigned 1:1 to datopotamab deruxtecan (Dato-DXd; 6 mg/kg intravenously every 3 weeks) or investigator’s choice of chemotherapy. Randomisation was stratified by geographic location, disease-free interval, and programmed cell death ligand-1 status. Dual primary endpoints were progression-free survival (PFS; blinded independent central review per RECIST version 1.1) and overall survival (OS). Efficacy analyses were performed in the intention-to-treat population. Safety analyses included all patients who received ≥1 dose of study treatment.
Results
Between 16 May 2022 and 11 June 2024, 644 patients were randomly assigned to receive Dato-DXd (n = 323) or chemotherapy (n = 321). Median PFS was 10.8 months [95% confidence interval (CI) 8.6-13.0] with Dato-DXd and 5.6 months (95% CI 5.0-7.0) with chemotherapy [hazard ratio 0.57 (99% CI 0.44-0.73); P < 0.0001]. Median OS was 23.7 months (95% CI 19.8-25.6) and 18.7 months (95% CI 16.0-21.8) with Dato-DXd and chemotherapy, respectively [hazard ratio 0.79 (95.01% CI 0.64-0.98); P = 0.029]. Treatment-related adverse events (TRAEs) of grade ≥3 were reported in 105 (33%) and 89 (29%) patients who received Dato-DXd and chemotherapy, respectively, and TRAEs led to treatment discontinuation in 14 (4%) and 23 (7%) patients. There were no treatment-related deaths in either arm.
Conclusions
Dato-DXd demonstrated significantly improved PFS and OS versus chemotherapy in patients with previously untreated, locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. Safety was consistent with the known profile for Dato-DXd.
