First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option: Additional efficacy endpoints from the TROPION-Breast02 study.

作者：David W. Cescon, Tiffany A. Traina, P Schmid, J Cortes, Z M Shao, Shigehira Saji, Kyung Hae Jung, Thomas Bachelot, Shouman Wang, Emilio Murillo Ramírez, Gul Basaran, Yee Soo Chae, Agostina Stradella, Rofhiwa Mathiba, S C Chen, Nicola Battelli, Naoki Niikura, Kechen Zhao, Micah J. Maxwell, Rebecca Dent · 发表于：Journal of Clinical Oncology · 年份：2026 · DOI：10.1200/jco.2026.44.16_suppl.1002 · 被引用次数：2 · 研究领域：Cancer Treatment and Pharmacology、Advanced Breast Cancer Therapies、Breast Cancer Treatment Studies

1002 Background: In the primary analysis of the phase 3 TROPION-Breast02 study (NCT05374512), first-line Dato-DXd demonstrated statistically significant and clinically meaningful improvements in overall survival (OS; hazard ratio [HR]: 0.79 [95% confidence interval [CI]: 0.64–0.98]; p = 0.0291) and progression-free survival (PFS; HR: 0.57 [95% CI: 0.47–0.69]; p < 0.0001) compared with investigator’s choice of chemotherapy (ICC) in patients with locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. Both median OS and PFS by blinded independent central review (BICR) were ≥5 months longer with Dato-DXd compared with ICC. Moreover, with Dato-DXd vs ICC, the confirmed objective response rate was more than double and median duration of response was > 5 months longer. The Dato-DXd safety profile was manageable and generally consistent with the known profile. Here we report additional efficacy endpoints. Methods: Adult patients with previously untreated locally recurrent inoperable or metastatic TNBC, for whom immunotherapy was not an option, were randomized 1:1 to Dato-DXd (6 mg/kg IV every 3 weeks) or ICC ([nab]-paclitaxel/capecitabine/eribulin mesylate/carboplatin). Dual primary endpoints were OS and PFS by BICR per RECIST 1.1; secondary endpoints included time to second progression or death (PFS2), time to first subsequent therapy or death (TFST), and time to second subsequent therapy or death (TSST). The planned sample size was approxima...