▎WuXiEdited by Kant Content Team

AstraZeneca (AstraZeneca) andDaiichi SankyoRecently, AstraZeneca and Daiichi Sankyo jointly announced that their重磅 antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has been recommended for approval by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in the European Union. It is indicated as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low, or HER2-ultra-low breast cancer who have received at least one prior endocrine therapy for metastatic disease and are deemed unsuitable for further endocrine therapy as the next line of treatment.

The positive opinion of the CHMP is based on the results of the Phase 3 clinical trial DESTINY-Breast. The trial results were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. In the trial,For HR-positive, HER2-low metastatic breast cancer patients who have not received chemotherapy, Enhertu reduced the risk of disease progression or death by 38% compared to chemotherapy (HR=0.62; 95% CI, 0.52–0.75; p<0.0001). The median progression-free survival (PFS) was 13.2 months in the Enhertu group and 8.1 months in the chemotherapy group.

In the overall trial population (including patients with HER2-low or HER2-ultralow metastatic breast cancer), the median PFS was 13.2 months for patients randomly assigned to receive Enhertu and 8.1 months for those randomly assigned to receive chemotherapy (HR=0.64; 95% CI, 0.54–0.76; p<0.0001). In an exploratory analysis, the results were consistent between HER2-low and HER2-ultralow patients.

In the DESTINY-Breast06 trial, the safety of Enhertu was consistent with previous breast cancer clinical trials, and no new safety issues were identified.

Enhertu is an ADC therapy jointly developed by AstraZeneca and Daiichi Sankyo. It is designed using Daiichi Sankyo's proprietary DXd ADC technology platform and consists of a humanized monoclonal antibody targeting HER2, connected to a topoisomerase 1 inhibitor payload via a cleavable tetrapeptide linker.Enhertu was first approved by the U.S. FDA in 2019 for the treatment of patients with unresectable or metastatic HER2-positive breast cancer. In April 2024, the FDA approved this therapy for adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior treatment and lack satisfactory alternative treatment options. Previous press releases noted that Enhertu is the first HER2-targeted ADC therapy with a tumor-agnostic indication.

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