Trastuzumab Botidotin Outperforms T-DM1 in HER2-Positive Breast Cancer Trial

This phase III, open-label, randomized trial (NCT06968585) compared the novel HER2-directed antibody-drug conjugate trastuzumab botidotin with trastuzumab emtansine in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane. The trial reported that trastuzumab botidotin produced significantly longer progression-free survival than trastuzumab emtansine (median 11.1 vs 4.4 months; HR 0.39) and a higher objective response rate (76.9% vs 53.0%), while overall survival data remained immature. The authors noted that trastuzumab botidotin had a distinct safety profile, including a high incidence of ocular treatment-related adverse events that generally resolved, alongside lower rates of pulmonary, hematologic, hepatic, and GI toxicities compared with trastuzumab emtansine.

Most relevant for: Patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane.

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