AstraZeneca reports results from DESTINY-Breast11 trial

Topline results from the DESTINY-Breast11 phase 3 trial showed Enhertu followed by paclitaxel, trastuzumab and pertuzumab demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response rate versus standard of care when used in the neoadjuvant setting in patients with high-risk, locally advanced HER2 positive early-stage breast cancer. Pathologic complete response is defined as no evidence of invasive cancer cells in the removed breast tissue and lymph nodes following treatment. The secondary endpoint of event-free survival was not mature at the time of this analysis; however, EFS data showed an early positive trend favoring Enhertu followed by THP compared to standard of care. The trial will continue to follow EFS. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (AZN). Enhertu followed by THP showed an improved safety profile compared to ddAC-THP. The safety profiles of Enhertu and THP were consistent with the known profiles of each individual medicine with no new safety concerns identified. Rates of interstitial lung disease were similar across the Enhertu followed by THP and the ddAC-THP arms as determined by an independent adjudication committee. Following a recommendation by the Independent Data Monitoring Committee, patient enrollment in a third arm of the study evaluating Enhertu alone was closed based on a previous interim efficacy assessment of the study arms.