Anbenitamab plus HB1801 for HER2-Positive Advanced Breast Cancer
In brief
Anbenitamab combination raises 24-month progression-free survival to 58.5%
In a phase 3 trial of 885 patients in China, 58.5% of those receiving anbenitamab plus albumin-bound docetaxel were alive without disease progression at 24 months, compared with 34.4% receiving trastuzumab, pertuzumab, and docetaxel. Tumor response was also more frequent, but serious adverse events were more common; longer follow-up will clarify how durable the benefit is.
- Journal
- The New England journal of medicine (Q1)
- Published
- 24 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Jiayu Wang, Huiping Li, Fei Xu, Tao Wu, Zhongsheng Tong, Jiuwei Cui, et al.
- PMID
- 42929681
- DOI
- 10.1056/NEJMoa2610345
Why clinicians should know about it
- Picked for Oncology and Radiation Oncology (top studies of the week, 1 November 2026): Phase III randomized HER2-targeted regimen comparison in advanced breast cancer
Abstract
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. (Funded by Shanghai JMT-Bio Technology and others; HEALER ClinicalTrials.gov number, NCT05838066.).
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.