Phase III MONARCH 2 study of abemaciclib meets primary endpoint of PFS

Enhertu (fam-trastuzumab deruxtecan-nxki) demonstrated a highly statistically significant and clinically meaningful improvement in invasive disease-free survival in patients with a high risk of disease recurrence, according to results from DESTINY-Breast05 phase III trial. 

Positive results from the DESTINY-Breast11 phase III trial showed Enhertu (fam-trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab, and pertuzumab in the neoadjuvant setting demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response rate. 

Two years of adjuvant Verzenio (abemaciclib) plus endocrine therapy reduced the risk of death by 15.8% versus ET alone and resulted in sustained long-term improvements in invasive disease-free survival and distant relapse-free survival, in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer, according to the primary overall survival analysis of the phase III monarchE trial.

The phase III HER2CLIMB-05 trial of first-line combination therapy with the tyrosine kinase inhibitor Tukysa in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer has met its primary endpoint. 

Positive high-level results showed Enhertu (fam-trastuzumab deruxtecan-nxki) demonstrated a highly statistically significant and clinically meaningful improvement in invasive disease-free survival versus trastuzumab emtansine in patients with HER2-positive early breast cancer with residual invasive disease in the breast or axillary lymph nodes after neoadjuvant treatment and a high-risk of disease recurrence, according to a planned interim analysis of the DESTINY-Breast05 phase III trial.