Pyrotinib

Hengrui Pharma showcased 15 innovative drugs across 72 research outcomes at the 2025 ASCO Annual Meeting, including 4 oral presentations and 5 rapid oral presentations.

Fam-trastuzumab deruxtecan-nxki (T-DXd) is currently the only FDA-approved therapy for HER2-mutated NSCLC post-chemotherapy, making platinum-based chemotherapy the preferred first-line treatment.

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.

• Analysis of circulating tumor DNA (ctDNA) in HER2-low metastatic breast cancer (MBC) identifies frequent mutations in TP53, PIK3CA, and ESR1. • HER2-low MBC exhibits distinct mutation profiles compared to HER2-0 and HER2-positive MBC, with differences in genes like ERBB2, AKT1, and ESR1. • HER2-low MBC patients with ERBB2 mutations may benefit from HER2-TKI treatment, while those with metabolic pathway-related gene mutations show improved outcomes with chemotherapy and endocrine therapy. • Molecular clustering of HER2-low MBC reveals distinct subgroups with varying mutation frequencies in RTK–RAS, PI3K, ERBB2, and metabolic pathways, suggesting potential for tailored therapies.

• Disitamab vedotin (RC48) demonstrates an objective response rate of 34.4% in HER2-expressing metastatic breast cancer patients with abnormal PAM pathway activation. • The disease control rate with disitamab vedotin was 81.97% across all HER2-expressing metastatic breast cancer patients in the phase 2 trial. • Median progression-free survival was 3.5 months in all patients, with no significant difference between HER2-positive and HER2-low subgroups. • The safety profile of disitamab vedotin was manageable, with most adverse events being grade 1 or 2, and no treatment-related deaths reported.