Daiichi Sankyo/Astrazeneca PLC Sponsored ADR (AZN.US) heavyweight ADC therapy expected to receive EU approval again.

Recently, Daiichi Sankyo and Astrazeneca PLC Sponsored ADR (AZN.US) jointly announced that their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for approval in the European Union. It is approved as a monotherapy for the treatment of unresectable or metastatic hormone receptor (HR)-positive, HER2-low expression or HER2-very low expression breast cancer in adult patients who have received at least one endocrine therapy for metastatic cancer and are considered unsuitable for further endocrine therapy. Enhertu is an ADC therapy co-developed by Astrazeneca PLC Sponsored ADR and Daiichi Sankyo. It is designed using Daiichi Sankyo's proprietary DXd ADC technology platform, which consists of a humanized monoclonal antibody targeting HER2 linked to a tetrapeptide cleavable linker and a topoisomerase I inhibitor payload. Enhertu is the first HER2-targeted ADC therapy with indications across various types of cancer. The positive opinion from CHMP is based on the results of the phase 3 clinical trial DESTINY-Breast. The results of this trial 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 expression metastatic breast cancer patients who had not received chemotherapy, Enhertu reduced the risk of disease progression or death by 38% compared to chemotherapy (HR=0.62; 95% CI, 0.520.75; p<0.0001), with a median progression-free survival (PFS) of 13.2 months in the Enhertu group compared to 8.1 months in the chemotherapy group. The safety profile of Enhertu in the DESTINY-Breast06 trial was consistent with previous clinical trials in breast cancer, and no new safety issues were identified.