The pivotal DESTINY-Breast04 Phase III trial of Enhertu shows efficacy in HER2-low breast cancer.- AstraZeneca and Daiichi Sankyo
Detailed positive results from the pivotal DESTINY-Breast04 Phase III trial showed that Enhertu (trastuzumab deruxtecan), from AstraZeneca and Daiichi Sankyo, demonstrated superior and clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients with HER2-low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridisation (ISH)-negative) unresectable and/or metastatic breast cancer with hormone receptor (HR) positive or HR-negative disease versus standard of care physician’s choice of chemotherapy.
Results will be presented during the Plenary Session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, and have been simultaneously published in The New England Journal of Medicine.
In the primary endpoint analysis for DESTINY-Breast04, Enhertu demonstrated a 49% reduction in the risk of disease progression or death versus physician’s choice of chemotherapy in patients with HER2-low metastatic breast cancer with HR-positive disease (PFS hazard ratio [HR] 0.51; 95% confidence interval [CI]: 0.40-0.64; p<0.001). a median pfs of 10.1 months was seen in patients treated with enhertu compared to 5.4 months with chemotherapy, as assessed by blinded independent central review (bicr). results also showed a 36% reduction in the risk of death with enhertu compared to chemotherapy in patients with hr-positive disease (os hr 0.64; 95% ci: 0.48-0.86; p="0.003)" with a median os of 23.9 months with enhertu versus 17.5 months with chemotherapy, meeting a key secondary endpoint of the trial.
Additionally, data showed consistent efficacy for Enhertu in the overall trial population of patients with HER2-low metastatic breast cancer with HR-positive or HR-negative disease and across levels of HER2 expression (IHC 1+ and IHC 2+/ISH-). In the key secondary endpoint analysis of PFS by BICR in all patients, a similar 50% reduction in the risk of disease progression or death was observed between Enhertu and chemotherapy (PFS HR 0.50; 95% CI: 0.40-0.63; p<0.001). results also showed a 36% reduction in the risk of death with enhertu compared to chemotherapy (os hr 0.64; 95% ci: 0.49-0.84; p="0.001)" with a median os of 23.4 months for enhertu versus 16.8 months with chemotherapy.
See- "Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer"-Shanu Modi, M.D., William Jacot, M.D., Ph.D., Toshinari Yamashita, M.D., Ph.D., et al. June 5, 2022,DOI: 10.1056/NEJMoa2203690.
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