Anbenitamab Plus HB1801 Improves PFS vs THP in HER2-Positive Advanced Breast Cancer

A regimen of anbenitamab plus albumin-bound docetaxel (HB1801) improved progression-free survival (PFS) compared with docetaxel, trastuzumab, and pertuzumab (THP) in patients with human epidermal growth factor receptor 2 (HER2)–positive advanced breast cancer. The results come from the phase 3 HEALER trial, published in NEJM.

The investigators noted that THP is an established first-line treatment for HER2-positive advanced breast cancer. The efficacy and safety of anbenitamab, a HER2-targeted bispecific antibody, plus HB1801 in this setting were unknown. 

The multicenter, open-label HEALER trial, conducted in China, randomly assigned 885 patients 1:1 to anbenitamab plus HB1801 (n=445) or THP (n=440). The primary end point was PFS assessed by blinded independent central review. A prespecified interim analysis was done after 401 progression or death events, at a median follow-up of 21.0 months. At that analysis, estimated 24-month PFS was 58.5% with anbenitamab plus HB1801 and 34.4% with THP (hazard ratio for progression or death, 0.46; 95% CI, 0.37-0.56).

Objective response, a secondary end point, occurred in 87.6% of patients in the anbenitamab group and 73.4% in the THP group. Grade 3 or higher adverse events occurred in 45.9% and 34.4% of patients, respectively. Neutropenia was the most common such event in both groups (13.1% and 8.4%). Adverse events led to death in 2 patients in each group.

The investigators concluded that anbenitamab plus HB1801 led to significantly higher PFS than THP among patients with HER2-positive advanced breast cancer. 

Source: Wang J, Li H, Xu F, et al. Anbenitamab plus HB1801 for HER2-positive advanced breast cancer. N Engl J Med. Published online October 23, 2026. doi:10.1056/NEJMoa2610345