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    Home > Medical News > Latest Medical News > The latest data of HER2 double anti DDoS in cooperation with Baiji and Shenzhou

    The latest data of HER2 double anti DDoS in cooperation with Baiji and Shenzhou

    • Last Update: 2019-11-25
    • Source: Internet
    • Author: User
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    Baiji Shenzhou (NASDAQ: bgne; Hong Kong stock exchange code: 06160) Co., Ltd announced in a poster display today at the 2019 esmoasia conference of European Society of oncology in Singapore that it is developing anti-PD-1 antibody tirelizumab combined with chemotherapy for the treatment of adenocarcinoma patients in the g / GEJ and ESCC patients Preliminary data from a phase 2 clinical trial of "The combination of tirelizumab and chemotherapy showed long-lasting remission and overall tolerance in this trial for g / GEJ adenocarcinoma and ESCC patients," said Ben Yong, MD, chief medical officer of cancer immunology in Baiji Gastric cancer and esophageal cancer are among the most common types of cancer in the world [i], with a high unmet demand for treatment, especially in China [II], which is more prominent We are very pleased to be able to continue the development of tirelizumab in these and other high-risk cancers in Asia " Updated results poster 128p of tirelizumab combined with chemotherapy for g / GEJ adenocarcinoma or ESCC patients This open, multicenter, phase 2 clinical trial of tirelizumab combined with standard chemotherapy as a potential first-line treatment in China (clinical trials Gov Registration No.: nct03469557) includes two patient cohorts, g / GEJ adenocarcinoma and ESCC As of March 31, 2019, 30 patients were enrolled in the trial, including 15 patients with g / GEJ adenocarcinoma and 15 patients with ESCC G / GEJ adenocarcinoma patients received 200 mg of tirelizumab and oxaliplatin on the first day of each three week cycle, and capecitabine twice a day on the first to 15th days; ESCC patients received 200 mg of tirelizumab and cisplatin on the first day of each three week cycle, and fluxuria on the first to fifth days Treatment with pyridine As of the data cut-off point, 8 patients were still receiving tirelizumab treatment, including 4 patients with g / GEJ adenocarcinoma and 4 patients with ESCC The results were as follows: up to the data cut-off point, 7 cases of g / GEJ adenocarcinoma (46.7%) achieved confirmed partial remission (PR), the objective remission rate (ORR; the sum of complete remission and partial remission) of the cohort was 46.7%, 7 cases of ESCC (46.7%) achieved confirmed PR, and the orr of the cohort was 46.7%; In the g / GEJ adenocarcinoma cohort, the median duration of remission (DOR) was immature; in the ESCC cohort, the median dor was estimated to be 12.8 months; in the g / GEJ adenocarcinoma cohort, the median progression free survival (PFS) was 6.1 months; in the ESCC cohort, the median PFS was 10.4 months; Although the median follow-up time was longer in the g / GEJ adenocarcinoma cohort (15.4 months) and ESCC cohort (13 months), the median overall survival time (OS) was not reached; in the g / GEJ adenocarcinoma cohort, the OS rate was 85% at 6 months and 62% at 12 months; in the ESCC cohort, the OS rate was 71% at 6 months and 50% at 12 months; Tirelizumab combined with standard first-line chemotherapy is generally tolerated in patients with g / GEJ adenocarcinoma and ESCC Adverse events (AE) were consistent with the tolerance of known PD-1 inhibitors combined with chemotherapy; all patients experienced adverse events (teaes) during treatment, most of which were mild or moderate in severity; The most common teaes at any level (incidence ≥ 40%) were anemia (60%), anorexia (56.7%), nausea (53.3%), weakness (50%), leukopenia (43.3%), vomiting (43.3%), neutropenia (40%) and thrombocytopenia (40%); 11 patients (g / GEJ adenocarcinoma, n = 6; ESCC, N = 5) experienced three to four levels of teae, the most common of which were vomiting (16.7%), hyponatremia (13.3%), aspartate aminotransferase (AST) rise, weight loss, anorexia, hypokalemia, anemia, leukopenia, neutropenia and thrombocytopenia (one case each); 13 patients (g / GEJ adenocarcinoma, n = 5; ESCC, N = 8) experienced serious adverse events (SAE); serious teaes in at least 2 patients (regardless of cohort) included hyperbilirubinemia (g / GEJ adenocarcinoma, n = 2), dysphagia (ESCC, n = 3) and asthenia (ESCC, n = 2); one ESCC patient died due to AE (liver dysfunction), mainly due to disease progression, may also be related to trial treatment or potential hepatitis B infection About tirelizumab tirelizumab (bgb-a317) is a monoclonal antibody against programmed death receptor-1 (PD-1) of human lgg4, which is under research The design purpose is to minimize the binding with Fc receptor in macrophage Preclinical data show that Fc receptor binding in macrophages can activate antibody dependent cell mediated killing of T cells, thus reducing the anti-tumor activity of PD-1 antibody Tirelizumab is the first candidate drug developed by Baiji's immune tumor platform It is currently being developed as a single drug therapy and combination therapy for a series of solid tumor and blood tumor treatment indications The current clinical studies of tirelizumab include a phase 3 clinical study for patients with second-line or third-line non-small cell lung cancer (NSCLC); a phase 3 clinical study for patients with first-line liver cancer (HCC); a phase 3 clinical study for patients with second-line esophageal squamous cell carcinoma (ESCC); a phase 1 clinical study for patients with first-line gastric / gastroesophageal junction (g / GEJ) cancer Three phase clinical study for first-line ESCC patients and two-phase clinical study for second-line to third-line HCC patients These clinical trials are recruiting patients in many countries and regions, including the United States, Europe and China In addition to a critical phase 2 clinical study in patients with relapsed / refractory (R / R) classic Hodgkin's lymphoma (CHL) and a critical phase 2 clinical study in patients with locally advanced or metastatic urothelial carcinoma (UC), Baiji Shenzhou is also carrying out a phase 3 clinical study in patients with first-line non squamous NSCLC and a phase 3 clinical study in patients with first-line squamous NSCLC Research: a phase 3 clinical study for NPC patients, a phase 3 clinical study for UC patients, a phase 3 clinical study for early ESCC patients, and a phase 2 clinical study for solid tumors with high microsatellite instability (MSI-H) or mismatch repair defect (dmmr) These clinical studies are mainly in the process of patient enrollment in China The drug review center (CDE) of China National Drug Administration (nmpa, formerly CFDA) is reviewing the application for new drug marketing (NDA) of tirelizumab for the treatment of R / rchl patients and for the treatment of patients with locally advanced or metastatic UC who have previously received treatment, both of which are included in the priority review Baiji Shenzhou has the global development and commercialization authorization for leilizumab About Baiji Shenzhou, a global, commercial stage, R & D-based biotechnology company, focusing on the research and development of molecular targeting and immunotherapy for tumor At present, Baiji Shenzhou has more than 3000 employees in mainland China, the United States, Australia and Switzerland, and its research product line includes new oral small molecule and monoclonal antibody anti-cancer drugs At present, Baiji Shenzhou is also building a drug combination program for anti-cancer treatment, aiming to bring lasting and far-reaching impact on the life of cancer patients Baichi sells brukinsa in the United States Gamma (zebudinib); under the authorization of Xinji company, Baiji Shenzhou sells in China Abraxane ® paclitaxel for injection (nano albumin particle binding type), rifumee ® (lenalidomide capsule) and vidasha ® (azacytidine for injection) [III] Reference: [i] Bray F, ferry J, soerjamataram I, Siegel RL, Torre La, Jemal A global cancer statistics 2018: global estimates of identity and vitality worldwide for 36 cancers in 185 countries CA cancer J Clin 2018; 68 (6): 394-424 [II] GLOBOCAN Cancer incidence and mortality worldwide in 2019 Http://globocan.iarc.fr / Accessed July 2019 [III] Abraxane ®, rife and vidasha are registered trademarks of new base pharmaceutical company 37
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