• SHR-A1811, a novel anti-HER2 ADC, shows promising anti-tumor activity and acceptable safety in HR-positive/HER2-low breast cancer in a phase 2 trial.
• In HR-positive/HER2-low breast cancer, SHR-A1811 achieved an objective response rate of 74.3% in the first stage of a phase 2 trial.
• The FASCINATE-N trial showed SHR-A1811 monotherapy had similar pathological complete response rates compared to standard chemotherapy in HER2-positive breast cancer.
• Common treatment-related adverse events with SHR-A1811 include neutropenia, leukopenia, anemia, nausea, asthenia, and vomiting, with manageable safety profiles.