Anbenitamab plus HB1801 for HER2-Positive Advanced Breast Cancer
Mené sur 885 patientes atteintes d'un cancer du sein HER2+ de stade avancé (durée médiane de suivi : 21 mois), cet essai de phase III évalue l'efficacité, du point de vue de la survie sans progression, et la toxicité d'un traitement de première ligne combinant anbénitamab (un anticorps bispécifique ciblant HER2) et HB1801 (formulation de docétaxel lié à l'albumine) par rapport au traitement standard (docétaxel, trastuzumab et pertuzumab)
Background: The combination of docetaxel, trastuzumab, and pertuzumab (THP) is an established first-line treatment for human epidermal growth factor receptor 2 (HER2)–positive advanced breast cancer. The efficacy and safety of anbenitamab, a HER2-targeted bispecific antibody, plus albumin-bound docetaxel (HB1801) in this context are unknown.
Methods: In this phase 3, multicenter, open-label, randomized trial conducted in China, we randomly assigned patients with HER2-positive advanced breast cancer in a 1:1 ratio to receive either anbenitamab plus HB1801 or THP. The primary end point was progression-free survival, as assessed by blinded independent central review. Objective response was a secondary end point.
Results: A total of 885 patients were enrolled (445 were assigned to receive anbenitamab plus HB1801 and 440 to receive THP). At this prespecified interim analysis (with 401 events [disease progression or death] and a median follow-up of 21.0 months), the estimated 24-month progression-free survival was significantly higher with anbenitamab plus HB1801 than with THP (58.5% vs. 34.4%; hazard ratio for progression or death, 0.46; 95% confidence interval, 0.37 to 0.56; P<0.001). The percentage of patients with an objective response was 87.6% in the anbenitamab group and 73.4% in the THP group. Adverse events of grade 3 or higher occurred in 204 of 444 patients (45.9%) in the anbenitamab group and in 151 of 439 patients (34.4%) in the THP group. Neutropenia was the most common adverse event of grade 3 or higher in both groups (13.1% in the anbenitamab group and 8.4% in the THP group). Adverse events leading to death occurred in 2 patients in each group.
Conclusions: Anbenitamab plus HB1801 led to significantly higher progression-free survival than THP among patients with HER2-positive advanced breast cancer.
New England Journal of Medicine , résumé, 2026