Anbenitamab (KN026) is an investigational HER2-targeted bispecific antibody developed by Alphamab Oncology and co-developed with JMT-Bio Technology. The therapy is being developed across multiple HER2-positive malignancies, including breast cancer and gastric/gastroesophageal junction cancer (GC/GEJ).

In May 2026, Anbenitamab received approval in China in combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive GC/GEJ who had previously received at least one trastuzumab-containing regimen. In breast cancer, the clinical development program has advanced into several registrational Phase III studies. In H1 2026, the company expects a BLA submission based on Phase III data from the neoadjuvant HER2-positive breast cancer study evaluating Anbenitamab plus albumin-bound docetaxel. The agent is also being investigated in a late-stage trial as a first-line treatment for HER2-positive metastatic breast cancer.

Key Efficacy Highlights:

• The experimental regimen significantly improved BIRC-assessed tpCR vs. control (62.4% vs. 51.2%; p=0.0036)

• Investigator-assessed tpCR also favored the experimental arm (63.9% vs. 51.2%; p=0.0011)

• tpCR benefits were consistent irrespective of carboplatin use and across key prespecified subgroups

• Higher bpCR rates were observed with the experimental regimen by both BIRC (64.6% vs. 55.0%; p=0.0099) and investigator assessment (65.8% vs. 55.4%; p=0.0057)

Key Safety Highlights:

• Overall TEAE incidence: 98.5% vs. 98.8%

• Grade ≥3 TEAEs: 29.3% vs. 28.3%

• Rates of treatment interruption: 5.7% vs. 7.4% 

• Treatment discontinuation: 4.9% vs. 3.5% due to TEAEs were low

• The most common severe TEAEs were neutropenia (11.4% vs. 10.9%) and leukopenia (7.6% vs. 8.5%)

• No new safety signals or significant additive toxicities were reported

KOL insights

“Anbenitamab plus nab-docetaxel, with or without carboplatin, demonstrated compelling efficacy with manageable safety, supporting its potential as a future neoadjuvant standard of care for HER2-positive early or locally advanced breast cancer.” – Expert Opinion

“With only about half of patients achieving a total pathological complete response with the current trastuzumab-, pertuzumab-, and chemotherapy-based standard of care, the significant tpCR improvement observed with Anbenitamab plus HB1801, with or without carboplatin, represents a meaningful advance. If confirmed with longer-term outcomes, this regimen could offer a more effective neoadjuvant treatment option and potentially redefine the standard of care for HER2-positive early or locally advanced breast cancer.”– Expert Opinion

Conclusion-

Breast cancer is the most common cancer in women in the United States, accounting for ~306,800 cases in 2025. HER2-positive breast cancer accounts for approximately 15-20% of all breast cancer cases, and over the years, it has witnessed significant advancements in treatment options. 

The treatment landscape in HER2-positive breast cancer is rapidly evolving, with agents such as trastuzumab deruxtecan (ENHERTU) increasingly moving into early-stage settings.The emergence of HER2-targeted therapies has greatly improved the survival and prognosis of patients with HER2-positive breast cancer. However 20-30% of patients with HER2 positive breast cancer still develop recurrence and metastasis after adjuvant therapy. In the Phase III anbenitamab + HB1801, ± carboplatin, achieved a tpCR rate of 62.4%, compared with trastuzumab- and pertuzumab-based regimens. While ENHERTU has demonstrated pCR rate 67.3% in select neoadjuvant studies, cross-trial comparisons remain limited. Overall, Neo-Healer positions anbenitamab as a promising emerging option to improve neoadjuvant outcomes in HER2-positive early breast cancer.