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Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca Receive Grant for ENHERTU® (fam-trastuzumab deruxtecan-nxki) Breakthrough Therapy Designation in the U.S

10/04/2021 | 03:52am EST

The U.S. Food and Drug Administration (FDA) has granted ENHERTU® (fam-trastuzumab deruxtecan-nxki) Breakthrough Therapy Designation (BTD) in the U.S. 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. ENHERTU is a HER2 directed antibody drug conjugate (ADC) jointly developed by Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca. The U.S. FDA's BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines. The FDA granted BTD based on data from the DESTINY-Breast03 pivotal trial presented during the 2021 European Society for Medical Oncology (ESMO) Congress. In the trial, ENHERTU demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1 (hazard ratio [HR] = 0.28; 95% CI: 0.22-0.37; p=7.8x10-22) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. The safety profile of the most common adverse events with ENHERTU in DESTINY-Breast03 was consistent with previous clinical trials with no new safety concerns identified. The most common grade 3 or higher drug-related treatment emergent adverse events in the ENHERTU arm were neutropenia (19.1%), thrombocytopenia (7.0%), leukopenia (6.6%), nausea (6.6%), anemia (5.8%), fatigue (5.1%), vomiting (1.6%), increase in ALT (1.6%), decreased appetite (1.2%), increase in AST (0.8%), diarrhea (0.4%) and alopecia (0.4%). Overall, 10.5% of patients had interstitial lung disease (ILD) or pneumonitis related to treatment as determined by an independent adjudication committee. The majority of ILD events (9.7%) were low grade (grade 1 (2.7%) or grade 2 (7.0%)) with two grade 3 (0.8%) events reported. No grade 4 or grade 5 ILD or pneumonitis events occurred. About HER2 Positive Breast Cancer: Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide. 1 More than two million cases of breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally. Approximately one in five cases of breast cancer are considered HER2 positive. HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancers. 6 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer. Despite initial treatment with trastuzumab and a taxane, patients with HER2 positive metastatic breast cancer will often experience disease progression. 3 More effective options are needed to further delay progression and extend survival. About DESTINY-Breast03: DESTINY-Breast03 is a global, head-to-head, randomized, open-label, pivotal phase 3 trial evaluating the safety and efficacy of ENHERTU (5.4 mg/kg) versus T-DM1 in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. The primary efficacy endpoint of DESTINY-Breast03 is progression-free survival (PFS) based on blinded independent central review. Secondary efficacy endpoints include overall survival, objective response rate, duration of response, progression-free survival based on investigator assessment and safety. About ENHERTU ENHERTU® (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca's ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker. ENHERTU (5.4 mg/kg) is approved in Canada, EU, Israel, Japan, UK and U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting based on the results from the DESTINY-Breast01 trial. ENHERTU (6.4 mg/kg) is also approved in Israel, Japan and U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial. ENHERTU is approved in the U.S. with Boxed WARNINGS for Interstitial Lung Disease and Embryo-Fetal Toxicity.

© S&P Capital IQ 2021
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Sales 2022 1 021 B 9 053 M 9 053 M
Net income 2022 64 911 M 576 M 576 M
Net cash 2022 625 B 5 541 M 5 541 M
P/E ratio 2022 84,7x
Yield 2022 0,94%
Capitalization 5 456 B 48 251 M 48 378 M
EV / Sales 2022 4,73x
EV / Sales 2023 4,45x
Nbr of Employees 16 033
Free-Float 97,6%
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Sunao Manabe President, CEO & Representative Director
Hiroyuki Okuzawa CFO, Director, Executive Officer & Head-Management
Ken Takeshita Global Director-Research & Development
Noritaka Uji Independent Outside Director
Tsuguya Fukui Independent Outside Director
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