The first three announced the latest positive data of DS-8201 treatment of gastric cancer
January 19, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On January 18th, the First Sankyo Pharmaceutical announced the latest clinical phase 1 safety and efficacy of the company's HER2 targeting antibody-conjugated drug (ADC) DS-8201 in patients with previous gastric cancer subgroups who received the drug trastuzumab and chemotherapy. Sexual data, the results were published in the 2018 American Society of Clinical Oncology (ASCO) gastrointestinal cancer symposium.
The latest subgroup preliminary analysis results were obtained from 44 patients with HER2-expressing gastric cancer or gastroesophageal junction adenocarcinoma who had previously received trastuzumab therapy and chemotherapy. The analysis showed that DS-8201 achieved a confirmed overall response rate of 45.5% (20/44) and 81.8% disease control rate (36/44) with a median duration of 7.0 months (95% CI: NR), survival analysis The median progression-free survival under Kaplan-Meier was 5.8 months (95% CI: 3.0, 8.3). At the time of data cut-off, a total of 17 of the 44 patients continued to receive treatment.
Dr. Toshihiko Doi, Department of Experimental Therapy, National Cancer Center Hospital East, Japan, said: "Stomach cancer is difficult to treat due to its molecular complexity. There are no targeted therapies or ADC drugs for patients with HER2-positive gastric cancer after trastuzumab treatment. The clinical phase 1 result is Encouraging and demonstrating the importance of continuing to study the potential of DS-8201 in the treatment of HER 2 positive gastric cancer. A critical clinical phase 2 study is currently underway."
Analysis of 23 subgroups of patients who had previously received CPT-11 (irinotecan) showed that DS-8201 achieved a total response rate of 43.5% (10/23) and a disease control rate of 82.6% (19/23). The median duration of response was 6.9 months (95% CI: NR), and the median progression-free survival of survival analysis under Kaplan-Meier was 4.1 months (95% CI: 2.5, 8.3).
Dr. Antoine Yver, executive vice president and global leader of the first three in oncology research and development, said: "These data from HER2-positive gastric cancer patients who have previously received HER2 targeted therapy combined with chemotherapy and some irinotecan system chemotherapy failures show that The ADC drug DS-8201 appears to be able to achieve its therapeutic goal of specialization and innovation: it is a chemotherapy method that can treat HER2 receptor-expressing tumors, regardless of the previous use of topoisomerase I inhibitors. We plan and conduct a comprehensive transformational study to further understand the biological basis of observed activity, including tumor heterogeneity and the role of HER2 expression, which may lead to resistance mechanisms for previous treatment failure, and DS-8201 unique pharmacological characteristics related factors."
This time, we also reported the latest safety data for patients with gastric cancer subgroup treated with trastuzumab. The most common adverse reactions (>30%, any level) included nausea (71.1%), decreased appetite (64.4%), and decreased platelet count. (33.3%), white blood cell count decreased (33.3%) and constipation (31.1%). Grade 3 adverse events in >10% of patients included anemia (24.4%), decreased neutrophil count (15.6%), decreased platelet count (13.3%), and decreased white blood cell count (11.1%). Grade 4 adverse events included a decrease in platelet count (4.4%), a decrease in white blood cell count (4.4%), and a decrease in neutrophil count (4.4%). Three patients discontinued treatment for treatment-related emergency adverse events (pneumonia, loss of appetite). The investigators reported two patients with potential interstitial lung disease (ILD) in the gastric cancer subgroup (1 grade, 1 grade 3), and both patients, along with all suspected ILD patients, are currently receiving independent ILD review committees. The assessment included two potential patients with grade 5 pneumonia who were previously reported in the breast cancer cohort.
Based on these clinical Phase 1 data, the company is recruiting patients with a critical clinical phase 2 study of DESTINY-Gastric01 to investigate the safety of DS-8201 in the treatment of HER2-positive advanced gastric cancer or gastroesophageal junctional adenocarcinoma (IHC3+ or IHC2+/ISH+). Efficacy, in which these patients have received 2-line therapy (fluoropyrimidine drugs, platinum drugs and trastuzumab) and have progressed. (Sina Pharmaceutical Compilation / David)
Article Reference Source: Daiichi Sankyo Presents Updated Data for DS-8201 in Patients With HER2-Expressing Gastric Cancer at ASCO 2018 Gastrointestinal Cancers Symposium
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