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European Union

ENHERTU Receives EU Approval for HER2 Positive Metastatic Breast Cancer

Strategic Insights

— 1 min read

The European Commission (EC) has approved Daiichi Sankyo and AstraZeneca's ENHERTU (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens. This approval follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the results of the DESTINY-Breast03 phase 3 trial, which showed that ENHERTU reduced the risk of disease progression or death by 72% compared to trastuzumab emtansine (T-DM1).

Key Takeaways:

  • ENHERTU has been approved in the EU as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens.
  • The approval is based on the results of the DESTINY-Breast03 phase 3 trial, which showed that ENHERTU reduced the risk of disease progression or death by 72% compared to T-DM1.
  • Additional results from the DESTINY-Breast03 trial showed that in the secondary endpoint of overall survival, there was a strong trend towards improved OS with ENHERTU, however this analysis is not yet mature and further follow-up is ongoing.
  • Nearly all patients treated with ENHERTU were alive at nine months (96.1%) compared to 91.3% of patients treated with T-DM1.
  • The confirmed objective response rate (ORR) was more than doubled in the ENHERTU arm versus the T-DM1 arm, with 79.7% of patients treated with ENHERTU achieving an ORR compared to 34.2% of patients treated with T-DM1.
  • The median duration of treatment with ENHERTU was 11.3 months, with the most common adverse reactions including nausea, fatigue, vomiting, and neutropenia.
  • Cases of interstitial lung disease (ILD) or pneumonitis were reported in 12.0% of patients, with most cases being grade 1 or 2 and no grade 4 cases occurring.
  • AstraZeneca is due to pay Daiichi Sankyo a second-line milestone payment of $75 M in HER2 positive metastatic breast cancer.

Statistics:

  • Hazard ratio (HR) for disease progression or death with ENHERTU vs. T-DM1: 0.28 (95% CI: 0.22-0.37; p
  • Daiichi Sankyo Co Ltd. (2022). DESTINY-Breast03 Phase 3 Trial Results: ENHERTU (Trastuzumab Deruxtecan) Reduces the Risk of Disease Progression or Death by 72% Compared to T-DM1 in Patients with HER2 Positive Unresectable and/or Metastatic Breast Cancer. Retrieved from

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