Neoadjuvant Anbenitamab Plus Docetaxel Elicits Responses in HER2+ Early Breast Cancer

The neoadjuvant combination of anbenitamab injection (KN026) and albumin-bound docetaxel (HB1801) generated a statistically significant improvement in total pathologic complete response (tpCR) rate as assessed by blinded independent review committee assessment (BIRC) vs standard treatment in patients with HER2-positive early or locally advanced breast cancer, meeting the prespecified primary end point of the phase 3 Neo-Healer trial (KN026-004; NCT06747338).¹

Detailed findings from this study are planned to be presented at an upcoming international academic meeting.

What is the regulatory history of anbenitamab across cancer types?

In September 2025, China’s National Medical Products Administration (NMPA) accepted a new drug application seeking the approval of the HER2-directed bispecific antibody anbenitamab for the second- and later-line treatment of patients with HER2-positive advanced gastric cancer. The NMPA also granted this agent breakthrough therapy designation for the treatment of patients with HER2-positive gastric cancer, including gastroesophageal junction (GEJ) cancer, who have progressed on first-line standard therapy.

Furthermore, the FDA granted anbenitamab orphan drug designation for the treatment of patients with HER2-positive or HER2-low gastric cancer.

In addition to the Neo-Healer trial investigating neoadjuvant anbenitamab plus albumin-bound docetaxel in patients with HER2-positive early or locally advanced breast cancer, several clinical trials are investigating anbenitamab across multiple indications, including first-line HER2-positive gastric/GEJ cancer, first-line HER2-positive breast cancer, and adjuvant HER2-positive breast cancer.

What is the design of the Neo-Healer trial?

This ongoing, randomized, controlled, open-label, multicenter trial has a planned enrollment target of 520 patients, who need to be at least 18 years of age with histologically and cytologically confirmed early or locally advanced HER2-positive breast cancer.^1,2 Patients are required to have an ECOG performance status of 0 or 1, as well as adequate organ and bone marrow function.²

Patients will be excluded if study investigators identify contraindications for breast cancer surgery, or if patients have:

• Inflammatory or bilateral breast cancer
• A history of non-breast malignancies within 3 years prior to study enrollment (except for carcinoma in situ of the breast or cervix, as well as basal cell carcinomas)
• Undergone primary axillary lymph node dissection biopsy and/or lumpectomy before random assignment (excluding diagnostic biopsy for primary breast cancer or surgery for benign breast tumors)
• Previously received any chemotherapy, HER2-directed biological therapy, local radiotherapy, or endocrine therapy for breast cancer
• Sensitivity to any of the study drugs or any ingredients or excipients of these drugs
• Known contraindications and/or allergies to glucocorticoids
• An acquired or congenital immune deficiency, such as HIV infection
• A serious cardiovascular or cardiac disease or condition
• Serious active or chronic infections requiring therapy with intravenous antifungal, antiviral, or antimicrobial therapy that are present within 14 days prior to random assignment
• Undergone major organ surgery (excluding biopsy) within 28 days before random assignment and have not fully recovered
• Used potent CYP3A4 inhibitors or inducers within 14 days before random assignment or require continued use of these agents

Patients are being randomly assigned 1:1 to receive anbenitamab plus albumin-bound docetaxel with or without carboplatin, or trastuzumab (Herceptin) plus pertuzumab (Perjeta) and docetaxel with or without carboplatin.

The primary end point is tpCR rate per BIRC. Secondary end points include investigator-assessed event-free survival, tpCR rate, breast pCR (bpCR) rate, overall response rate, and invasive disease–free survival; BIRC-assessed bpCR rate; the frequency and severity of treatment-emergent adverse effects (AEs) and serious AEs; serum concentrations of anbenitamab and albumin-bound docetaxel; and the incidence of anbenitamab anti-drug antibodies and neutralizing antibodies.

References

1. Phase III clinical study of anbenitamab (KN026) in combination with docetaxel (albumin-bound) (HB1801) for neoadjuvant treatment of HER2+ breast cancer meets primary endpoint. News release. CSPC Pharmaceutical Group Limited. March 31, 2026. Accessed March 31, 2026. https://doc.irasia.com/listco/hk/cspc/announcement/a260331.pdf
2. A phase III study of KN026 in combination with HB1801 ± carboplatin as neoadjuvant treatment for early or locally advanced HER2-positive breast cancer (Neo-Healer). ClinicalTrials.gov. Updated April 24, 2025. Accessed March 31, 2026. https://clinicaltrials.gov/study/NCT06747338