AstraZeneta/13 ADC drug Enhertu is eligible for conditional approval in the European Union

According to statistics, 520,000 women in Europe are diagnosed with breast cancer each year and 137,000 die from breast cancer, of which about 20% are HER2 plus.
HER2, or human skin growth factor subject 2, is a tyrosine kinase protein that promotes cell growth, expressed on the surface of stomach cancer, breast cancer, lung cancer and other tumor cells, and its over-expression is related to a special HER2 gene change (HER2 amplification), often associated with invasive diseases and poor prognostication.
trastuzumab deruxtecan is an antibody coupled drug (ADC) for HER2, consisting of a humanized monoclonal antibody targeting HER2 Trastuzumab (curtobe monoantigen) and a new topological isomer 1 inhibitor Excan derivative (DX-8951 derivative, DX) consisting of 4 peptide links.
December 2019, the drug was approved by the FDA to treat adult patients with non-removable or metastasis HER2-positive breast cancer who had received at least two or more anti-HER2 therapies, known as Enhertu.
In March this year, the drug received conditional early approval in Japan for the treatment of HER2-positive, non-excisible or metastasis breast cancer patients who relapsed after prior chemotherapy (limited to patients who were ineffective or insatiable with standard treatment).
this time, Enhertu's conditional approval in the European Union is based on positive results from Phase II registered research ONY-Breast01, the first phase of which has been published in the New England Journal of Medicine and The Lancet Tumor.
, the latest results of the study were presented at the 2020 San Antonio Breast Cancer Symposium (SABCS), which showed that as of June 8, 2020, the medium follow-up duration of patients treated with trastuzumab deruxtecan (5.4 mg/kg) was 20.5 months, with an objective remission rate (ORR) of 61.4% and a medium duration of 20.8 months.
progressed survival (PFS) for the medium-level disease was 19.4 months.
in an exploratory milestone analysis of total lifetime (OS), maturity was assessed at 35 per cent, with an estimated 74 per cent of patients surviving at 18 months.
compared to the first phase of the study, Enhertu (trastuzumab deruxtecan) continues to exhibit impressive efficacy and continuous remission in patients who have received two or more anti-HER2 therapies that are not removable or metastasis HER2-positive breast cancer.
addition, trastuzumab deruxtecan has conducted a number of Phase III studies in patients with metastasis breast cancer expressed in HE2, whereESTINY-Breast02 is designed to evaluate its use for third-line treatment in HER2-positive metastasis breast cancer patients, DESTINY-Breast03 is designed to evaluate its use in second-line treatment in HER2-positive metastasis breast cancer patients, and DESTINY-Breast04 aims to explore its treatment for HER2 low-expression metastasis breast cancer.
In addition to breast cancer, trastuzumab deruxtecan has also been developed for the treatment of HER2 gastric and lung cancer, where the drug's treatment of HER2-positive non-removable advanced or relapsed gastrointestinal cancer has been approved in Japan in September this year, and its application for a supplementary biologics license for her2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma has been accepted by the FDA and granted priority review eligibility.
addition, the drug was awarded by the FDA for breakthrough drug eligibility for metastasis NSCLC with HER2 mutations during or after treatment with platinum-containing chemotherapy.
trastuzumab deruxtecan (research and development code DS-8201) is an ADC developed by The Third Communist Company.
In March 2019, AstraZeneta entered into a $6.9 billion cooperation agreement with First Third, under which AstraZeneta and First Third will jointly develop and commercialize the drug globally, while First Third Will retain exclusive market rights in Japan and be solely responsible for production and supply.
Given ADC's huge market potential, AstraZenecon reached a new global development and commercialization agreement in July for the latter's targeted human nourishing layer cell surface glycoprotein antigen 2 (TROP2) ADC drug DS-1062, in a deal estimated to be worth up to $6 billion.
DS-1062 is an ADC developed by the first three using proprietary DXd ADC technology, which is made up of monoclonal antibodies that target the Trop2 protein connected to DXd and has been developed to treat tumors such as NSCLC.
TROP2 is a trans-membrane glycoprotein that is highly expressed in a variety of solid tumors, including NSCLC.
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