Neoadjuvant treatment with the ERBB2-biparatopic antibody anbenitamab plus a solvent-free albumin-bound docetaxel formulation (HB1801) significantly improved total pathologic complete response vs conventional therapy with trastuzumab plus pertuzumab and a taxane (THP) in patients with early or locally advanced ERBB2-positive breast cancer, according to results from the multicenter phase III Neo-Healer trial published by Li et al in JAMA Oncology.
“These findings, together with the manageable safety profile, suggest that this regimen may offer a promising treatment option for these patients,” the investigators wrote.
Of note, anbenitamab is not currently approved for the treatment of breast cancer. In May 2026, the agent was approved in China in combination with chemotherapy for patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who previously received at least one trastuzumab-containing therapy.
Study Details
Systemic therapy–naive patients with stage II or III ERBB2-positive breast cancer from 61 centers in China (median age = 52 years) were randomly assigned in a 1:1 ratio to receive neoadjuvant anbenitamab plus HB1801 (n = 263) or THP with docetaxel as the taxane (n = 258), each with or without carboplatin, every 3 weeks for six cycles.
The primary endpoint was blinded independent review committee–assessed total pathologic complete response.
Key Findings
The total pathologic complete response rate was found to be significantly higher with anbenitamab plus HB1801 vs THP (62.4% vs 51.2%; absolute difference = 11.4 percentage points, 95% confidence interval = 3.2–19.6 percentage points; P = .004).
According to the investigators, the improvement in total pathologic complete response with anbenitamab plus HB1801 was consistent across subgroups, including patients with hormone receptor–positive disease (51.7% vs 44.4%), hormone receptor–negative disease (76.3% vs 59.5%), early-stage disease (63.8% vs 51.8%), locally advanced disease (59.6% vs 50.0%), and those treated with (66.7% vs 54.5%) and without (59.2% vs 48.6%) carboplatin.
Treatment-related adverse events of grade 3 or 4 occurred in 29.3% and 28.3% of patients treated with anbenitamab plus HB1801 and THP, respectively. No treatment-related deaths were reported.
“This randomized clinical trial found that neoadjuvant anbenitamab and HB1801 in patients with breast cancer significantly improved the total pathologic complete response rate compared with standard therapy, with a highly manageable safety profile,” the investigators concluded.
They added, “This new combination may offer an improved treatment option, although long-term survival follow-up analyses are warranted.”
Zhi-Ming Shao, MD, and Lei Fan, MD, of Fudan University Shanghai Cancer Center, China, are the corresponding authors of the article in JAMA Oncology.
DISCLOSURE: The work was supported by Shanghai JMT-Bio Technology (CSPC Pharmaceutical Group). The study authors reported no conflicts of interest.
