AstraZeneca and Daiichi Sankyo’s cancer drug has delivered a 92.4% three-year invasive disease-free survival rate in high-risk patients, marking its first EU approval in the curative-intent early breast cancer setting.

 

The nod for Enhertu (trastuzumab deruxtecan) for patients with HER2-positive early breast cancer who have residual invasive disease after treatment before surgery opens a new treatment option for patients at heightened risk of recurrence.

 

The approval is based on results from the Phase III DESTINY-Breast05 trial, which showed that Enhertu reduced the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine (T-DM1), the study’s comparator.

 

The decision marks Enhertu’s first approval in the European Union for early breast cancer in a curative-intent setting, extending the drug’s role into treatment aimed at preventing the disease from returning after surgery.

 

In DESTINY-Breast05, 92.4% of patients treated with Enhertu remained alive without invasive disease at three years, compared with 83.7% of those receiving T-DM1.

 

The trial enrolled 1,635 patients with HER2-positive early breast cancer who had residual invasive disease in the breast or lymph nodes after neoadjuvant therapy and were at high risk of recurrence.

 

The findings point to a significant reduction in the risk of the disease returning or death among patients who continue to face substantial risks despite treatment before surgery.

 

Sibylle Loibl, of the German Breast Group and Goethe University Medicine Frankfurt, and lead investigator of DESTINY-Breast05, said: “For patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant therapy, reducing the risk of disease recurrence is critical for sustained long-term outcomes. The EU approval of trastuzumab deruxtecan, which demonstrated a more than 50 per cent reduction in risk of recurrence compared to standard of care in DESTINY-Breast05, has the potential to change how we treat eligible patients in this setting.”

 

HER2-positive breast cancer accounts for approximately one in five breast cancer cases and is associated with more aggressive disease in some patients.

 

Treatment typically begins before surgery, using chemotherapy and HER2-targeted medicines to shrink the tumour. Patients who still have invasive cancer in the breast or lymph nodes after this treatment face a greater risk of recurrence, making post-surgical treatment a critical opportunity to improve long-term outcomes.

 

Despite advances in care, recurrence remains a major concern. Once breast cancer becomes metastatic, five-year survival falls from around 90% to approximately 30%, according to the company’s cited data.

 

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “The goal of treatment in early breast cancer is to help as many patients as possible achieve cure. Unfortunately, despite treatment advances, some patients still face recurrence in the long term. The approval of Enhertu in the adjuvant setting for patients with residual disease after neoadjuvant treatment has the potential to establish a new benchmark in this curative-intent setting, with more than 92 per cent of patients alive and free of invasive disease at three years.”

 

Ken Keller, Global Head of Oncology Business and President and CEO of Daiichi Sankyo, Inc., said: “By bringing Enhertu into the adjuvant setting, we are advancing this treatment option earlier in the course of disease for patients with HER2-positive early breast cancer. This first approval of Enhertu in early breast cancer in the EU reflects our continued commitment to bringing innovative medicines into earlier treatment settings, where there is significant potential to improve long-term outcomes for patients.”