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TOKYO & MUNICH - Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: NASDAQ:AZN) have announced that their drug ENHERTU (trastuzumab deruxtecan) has been recommended for approval in the European Union for a specific type of breast cancer treatment. This recommendation follows the positive results from the DESTINY-Breast06 phase 3 trial which demonstrated ENHERTU’s superiority over chemotherapy in terms of progression-free survival (PFS).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its recommendation on the DESTINY-Breast06 trial data, which was presented at the 2024 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine. The European Commission will review the CHMP’s recommendation, holding the authority to grant marketing authorizations within the EU. This development could further boost Daiichi Sankyo’s robust revenue growth, which InvestingPro data shows reached 19.46% in the last twelve months.
ENHERTU is designed as a monotherapy for adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low or HER2 ultralow breast cancer who have previously undergone at least one endocrine therapy in the metastatic setting and are unsuitable for further endocrine therapy.
In the trial, ENHERTU reduced the risk of disease progression or death by 38% compared to chemotherapy in patients with chemotherapy-naïve HR positive, HER2 low metastatic breast cancer. The median PFS for patients treated with ENHERTU was 13.2 months, versus 8.1 months for those receiving chemotherapy. The confirmed objective response rate (ORR) was also higher in the ENHERTU arm at 56.5%, compared to 32.2% in the chemotherapy arm.
Safety data from the DESTINY-Breast06 trial indicated that ENHERTU’s profile was consistent with previous studies, with no new safety concerns identified. The most common severe treatment-emergent adverse events included neutropenia, leukopenia, and anemia. Interstitial lung disease or pneumonitis was reported in 11.3% of patients treated with ENHERTU, with most cases being low grade.
Currently, ENHERTU is approved in over 75 countries for patients with HER2 low metastatic breast cancer who have received prior systemic therapy or who have relapsed during or within six months of completing adjuvant chemotherapy. This follows the results from the DESTINY-Breast04 trial. According to InvestingPro analysis, Daiichi Sankyo appears undervalued based on its Fair Value metrics, with multiple positive indicators including consistent dividend payments and strong market position in the pharmaceuticals industry. Subscribers can access 8 additional ProTips and comprehensive financial analysis.
The DESTINY-Breast06 trial involved 866 patients across Asia, Europe, North America, Oceania, and South America, assessing the efficacy and safety of ENHERTU versus chemotherapy.
This news is based on a press release statement from Daiichi Sankyo and AstraZeneca.
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