The Phase 3 Neo-Healer trial has met its main goal, showing that a new treatment combination can improve outcomes for patients with HER2-positive breast cancer. The study found that anbenitamab (KN026) combined with albumin-bound docetaxel led to a significantly higher rate of total pathologic complete response compared with the current standard treatment using trastuzumab, pertuzumab, and docetaxel.
The trial included 520 patients in a randomized, open-label design. It compared the new regimen with the widely used dual-HER2 targeted approach. In addition to the main outcome, researchers are also tracking long-term results such as survival without disease events, invasive disease-free survival, and overall safety.
Anbenitamab is a bispecific antibody that targets HER2 and is being studied in several cancer settings, including early and advanced breast cancer. It is also under review in China for gastric cancer and has received special designation in the United States for certain HER2-related cancers. The trial focused on patients with confirmed HER2-positive disease and good overall health, excluding those who had prior HER2 treatments or significant heart conditions. Full results from the study are expected to be presented at an upcoming international medical meeting.