WILMINGTON, DE — High-level results from the DESTINY-Breast09 Phase III trial revealed that ENHERTU® (fam-trastuzumab deruxtecan-nxki), in combination with pertuzumab, significantly improves progression-free survival (PFS) compared to the current 1st-line standard of care for patients with HER2-positive metastatic breast cancer.
The AstraZeneca and Daiichi Sankyo-developed therapy demonstrated a highly statistically significant, clinically meaningful improvement in PFS versus a regimen of taxane, trastuzumab, and pertuzumab (THP). Notably, these benefits were observed across all pre-specified patient subgroups.
Susan Galbraith, Executive Vice President of Oncology Hematology R&D at AstraZeneca, emphasized the importance of these findings, stating, “This is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic breast cancer patient population compared to the current 1st-line standard of care. This is a significant milestone for patients.”
HER2-positive metastatic breast cancer is a challenging and aggressive disease, affecting 15-20% of metastatic breast cancer patients. Despite advancements in 1st-line therapies, many patients experience disease progression within two years, and approximately one-third never proceed to subsequent treatments.
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, highlighted the therapy’s potential to reshape treatment approaches. “The results from DESTINY-Breast09 reinforce the importance of effectively targeting HER2 to achieve durable disease control early in the treatment of HER2-positive metastatic breast cancer,” Takeshita said.
While the trial’s key secondary endpoint, overall survival (OS), is not yet conclusive due to data immaturity, interim OS results show an encouraging trend favoring the ENHERTU combination. The arm of the trial analyzing ENHERTU monotherapy remains blinded and will proceed to a final PFS analysis.
Developed through a collaboration between AstraZeneca and Daiichi Sankyo, ENHERTU is an engineered HER2-directed DXd antibody-drug conjugate already approved in over 75 countries as a 2nd-line treatment following results from the DESTINY-Breast03 trial.
The latest trial results underline ENHERTU’s potential to establish itself as an important first-line therapy in HER2-positive metastatic breast cancer. Comprehensive data from the combination arm will be presented at an upcoming medical meeting and shared with regulatory bodies. Looking ahead, the findings set the stage for further regulatory and clinical developments aimed at enhancing outcomes for patients globally.
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