- ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab shows significant improvement in progression-free survival (PFS) over THP in HER2+ metastatic breast cancer treatment.
- The DESTINY-Breast09 Phase III trial is the first in over a decade to demonstrate this level of efficacy across all patient subgroups.
- 15-20% of metastatic breast cancer patients are affected by HER2-positive disease, with a poor prognosis under current treatments.
Positive interim results from the DESTINY-Breast09 Phase III trial reveal that ENHERTU® (fam-trastuzumab deruxtecan-nxki) combined with pertuzumab significantly improves progression-free survival (PFS) compared to the current first-line standard treatment of taxane, trastuzumab, and pertuzumab (THP) for patients with HER2-positive metastatic breast cancer. This trial marks the first significant advancement in over a decade, showcasing superior efficacy across all pre-specified patient subgroups.
HER2-positive metastatic breast cancer, which affects 15-20% of metastatic breast cancer patients, often leads to disease progression within two years under existing THP treatment. Approximately one-third of these patients do not receive second-line therapy due to disease progression or death. The early trends in overall survival from the trial favor the ENHERTU combination, although comprehensive overall survival data are still maturing.
This breakthrough underscores the potential of ENHERTU to disrupt the longstanding standard of care in first-line treatment settings and provides a promising new therapy option for patients. The safety profile of ENHERTU in combination with pertuzumab remains consistent with that of its individual components, which supports future regulatory considerations.
With ENHERTU already approved in over 75 countries as a second-line treatment based on previous findings, AstraZeneca (AZN, Financial) and Daiichi Sankyo are well-positioned to progress towards regulatory submissions for first-line treatment approval. The data from the trial's second arm, which explores ENHERTU monotherapy, is pending final analysis and remains under observation.
