Hengrui Medicine said a pre-specified interim analysis of the pivotal Phase III
trial of its HER2-targeting antibody–drug conjugate SHR-A1811 for first-line
HER2‑positive recurrent/metastatic breast cancer met the primary endpoint of
progression-free survival (PFS) in both randomized arms, showing statistically
significant and clinically meaningful improvement versus standard
docetaxel+trastuzumab+pertuzumab (THP). SHR-A1811, with or without pertuzumab,
significantly extended first-line PFS versus THP. The company will file a
pre-marketing communication application with the NMPA Center for Drug
Evaluation.
