More than 92% of patients treated with AstraZeneca and Daiichi Sankyo\u2019s ENHERTU were free of invasive disease at three years<\/b><\/i><\/p>\n
DESTINY-Breast05 presented in ESMO Presidential Symposium alongside DESTINY-Breast11 reinforce potential for ENHERTU to become a foundational treatment in curative-intent early breast cancer setting<\/i><\/b><\/p>\n
WILMINGTON, Del.–(BUSINESS WIRE<\/a>)– \nResults showed ENHERTU significantly reduced the risk of invasive disease recurrence or death by 53% compared with T-DM1 as a post-neoadjuvant treatment (based on an IDFS hazard ratio [HR] of 0.47, 95% confidence interval [CI] 0.34-0.66, p<0.0001). At three years, 92.4% of patients in the ENHERTUarmwere alive and free of invasive disease, compared with 83.7% of those in the T-DM1 arm. The IDFS results were consistent across all prespecified subgroups.<\/p>\n \nENHERTU also significantly reduced the risk of disease recurrence or death (disease-free survival [DFS]), a key secondary endpoint, by 53% (HR 0.47; 95% CI 0.34-0.66; p<0.0001). Further, ENHERTU lowered the risk of distant disease recurrence (distant recurrence-free interval [DRFI]) by 51% and the risk of brain metastases (brain metastasis-free interval [BMFI]) by 36% versus T-DM1.<\/p>\n \nOverall survival (OS) was not mature at the time of this planned interim analysis (2.9% maturity at data cut-off) and will be assessed in future analyses (HR 0.61; 95% CI 0.34-1.10).<\/p>\n \nCharles Geyer, MD, Chief Scientific Officer of the National Surgical Adjuvant Breast and Bowel Project Foundation (NSABP) Foundation, Professor of Medicine at the UPMC Hillman Cancer Center and principal investigator for the trial, said: “For patients with residual disease after neoadjuvant treatment, the post\u2011neoadjuvant setting represents a critical second opportunity to reduce recurrence risk, and in DESTINY\u2011Breast05 Enhertu<\/i> reduced the risk of early recurrence or death by 53 percent compared to the current standard of T\u2011DM1. These results, coupled with the safety data from the trial, are likely to transform clinical practice in the post-neoadjuvant setting for patients with high-risk disease, with the potential for Enhertu<\/i> to set a new standard of care.”<\/p>\n \nSusan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “Progress in treating HER2-positive early breast cancer has been significant, yet managing patients at a higher-risk of recurrence remains challenging. These landmark data, alongside those from DESTINY-Breast11, underscore the potential of Enhertu<\/i> to become a foundational treatment in early-stage breast cancer, increasing the likelihood that more patients could be cured in this setting.\u201d<\/p>\n \nKen Takeshita, Global Head, R&D, Daiichi Sankyo, said: “The results of DESTINY-Breast05 demonstrate a clear benefit of Enhertu<\/i> over the current standard of care in patients with high-risk HER2-positive early breast cancer following surgery, improving their chance for sustained long-term outcomes. These results, coupled with the results of DESTINY-Breast11, illustrate the continued promise of Enhertu<\/i> to move earlier in the breast cancer treatment paradigm where it can have the greatest impact on the lives of patients.”<\/p>\n Summary of Results: DESTINY-Breast05i<\/sup><\/b><\/p>\n
\nPositive results from the DESTINY-Breast05 Phase III trial showed ENHERTU\u00ae<\/sup> (fam-trastuzumab deruxtecan-nxki) demonstrated a highly statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) in patients with a high risk of disease recurrence. The trial compared ENHERTU with trastuzumab emtansine (T-DM1) as a post-neoadjuvant treatment (after surgery) in patients with HER2-positive early breast cancer with residual invasive disease in the breast and\/or axillary lymph nodes after neoadjuvant treatment.<\/p>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20251018027927\/en\/2613593\/3\/Logo.jpg\"){kind=logo}
<\/td>\n<\/tr>\n