HER2-positive stomach cancer first ADC drug! First three co-antibody drug conjugate (ADC) Enhertu in Japan to submit a new indication sin application!

08 May 2020 / Biovalley BIOON / -- Daiichi Sankyo recently announced that it has submitted a new drug supplementary application (ND) to Japan's Ministry of Health, Labour and Welfare (MHLW) A), seek approval of HER2 targeted antibody drug Conjugate (ADC) Enhertu (tratuzumab deruxtecan, DS-8201) a new indication for the treatment of HER2-positive metastatic stomach cancer patients If approved, Enhertu will be the first ADC drug to treat HER2-positive stomach cancer, which will lead to meaningful therapeutic advances for such cancers , Enhertu has been granted SAKIGAKE (Innovative Drug) eligibility by MHLW for her2-positive metastatic stomach cancer, and the NDA will complete a rapid review within a six-month schedule At present, for the treatment of tratuzumab (a HER2 target monoantigen) after the progress of her2 positive metastatic gastric cancer patients, there is no approved HER2 targeting program Enhertu was the world's first in the U.S in December 2019: The FDA expedite the approval of Enhertu for HER2-positive metastatic breast cancer adult patients who have received 2 or more antiher2 drugs in metastatic diseases In Japan, Enhertu received conditional early approval from MHLW in March 2020 for the treatment of PATIENTs with BREAST cancer who are HER2-positive, non-resectionable or metastatic, and relapse after prior chemotherapy (limited to patients who are ineffective or intolerant of standard treatment) the NDA, based on data from the Key Phase II DESTINY-Gatric01 trial and the of Phase I clinical trials published in the Lancet Oncology The DESTINY-Gatric01 trial enrolled 189 patients from Japan and South Korea with HER2-positive advanced stomach cancer or gastroesophageal progressive cancer (defined as IHC3 plus or IHC2 plus/ISH plus) who had previously received 2 or more programs (including 5-FU, platinum chemotherapy, qutobeh monoantigen) but progress In the study, patients were randomly assigned at a 2:1 ratio and received either Enhertu (6.4 mg/kg) or chemotherapy (purple sequoia or Ilitocon monotherapy) selected by the study's investigators, once every three weeks results showed that the study reached the primary and critical secondary endpoints: the Enhertu treatment group achieved statistically significant and clinical improvements in objective remission (ORR) and total survival (OS) compared to the chemotherapy group In the study, Enhertu's overall safety and tolerance were consistent with previously published Phase I trials, with the most common adverse events (30%, any level) being hematology and gastrointestinal tract, including a decrease in neutrophil count, anemia , nausea, and decreased appetite Treatment of intersoletoid pulmonary disease (ILD) and pneumonia was reported in the study, with levels 1 and 2, and 2 cases each at levels 3 and 4 In the Phase I trial or destinY-Gatric01 trial, no death from PATIENTs with ILLD-related stomach cancer (level 5) occurred full results of the study will be presented at the 2020 annual meeting of the American Society of Clinical Oncology (ASCO) "This NDA submission brings us closer to bringing Enhertu to a group of patients whose medical needs are not met in Japan," said Dr Wataru Takaaki, Executive Director of First Three and Head of Research and Development in Japan If approved, Enhertu has the potential to meaningfully promote the treatment of HER2-positive metastatic gastric cancer patients "
stomach cancer is the fifth most common cancer in the world and the third leading cause of cancer death Globally, about 1 million new cases and 783,000 deaths were reported worldwide in 2018 Gastric cancer is usually at an advanced stage at the time of diagnosis, and even at an early stage, survival rates are still low About 20% of cases of stomach cancer are HER2-positive For HER2-positive or metastatic stomach cancer, the recommended first-line treatment options are chemotherapy and quto-bead monoantigen combined treatment Quto-behriat is a her2-targeted monoantigen, which has been shown to improve patient prognosis in combination with chemotherapy For patients with stomach cancer who received first-line treatment, qutozumab did not show any further efficacy, and there are currently no other approved HER2 targeted drugs HER2 is a tyrosine kinase receptor protein that promotes cell growth and is expressed on the surface of cells in a variety of tumors such as stomach cancer, breast cancer, and lung cancer HER2 overexpression is associated with a special HER2 gene modification (HER2 amplification), often associated with invasive diseases and poor prognosis Enhertu (tratuzumab deruxtecan, DS-8201) is a new generation of antibody drug conjugate (ADC) that targets HER2's humanized monoclonal monoclonal antibody trazumab (crankabe) through a 4 peptide link Anti) linked to a new type of topological isosome seroterase 1 inhibitor exatecan derivative (DX-8951 derivative, DXd) that can target the delivery of cytotoxic agents into cancer cells, reducing systemic exposure of cytotoxic agents compared to the usual chemotherapy March 2019, AstraZeneca and First Third reached a $6.9 billion immuno
oncology collaboration to develop Enhertu for the treatment of cancer patients with various HER2 expression levels or HER2 mutations, including stomach, colorectal and lung cancer, and HER2 low-expression breast cancer Under the agreement, the two sides will jointly develop and commercialize Enhertu on a global scale, with the First Three retaining exclusive rights to the Japanese market and solely solely responsible for manufacturing and supply Pharma Evaluate, a pharmaceutical market research firm, had forecast that Enhertu's sales were expected to reach $2 billion by 2024 (BioValleyBioon.com) original source: Daiichi Sankyo Supplemental New Drug app lication for Tratuzumab Deruxtecan in Japan for Treatment of Patient with HER2 Poitive Metatatic Gatatic Cancer