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    Home > Medical News > Latest Medical News > Several clinical data of tirelizumab published by Baiji Shenzhou

    Several clinical data of tirelizumab published by Baiji Shenzhou

    • Last Update: 2019-09-23
    • Source: Internet
    • Author: User
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    Baiji Shenzhou is a biomedical company in the commercial stage, focusing on the development and commercialization of innovative molecular targeting and immune tumor drugs for cancer treatment The company today announced the results of three clinical trials of its anti-PD-1 antibody tirelizumab in China A total of seven oral reports of tirelizumab data were published at the 22nd annual meeting of the Chinese society of Clinical Oncology (CSCO), five of which were new or updated data; in addition, the clinical data of tirelizumab, zebutinib and pamiparib were displayed in four posters CSCO annual meeting will be held in Xiamen on September 18-22, 2019 "These data together show the potential of tirelizumab to benefit patients in a number of indications that also represent unmet treatment needs in China and around the world," commented Ben Yong, MD, chief medical officer of tumor immunology in Baiji While we are waiting for tirelizumab to be approved in China for the treatment of classic Hodgkin's lymphoma and urothelial cancer, phase I project of our world leading biopharmaceutical production base is about to be completed, and we are looking forward to opening high-quality biopharmaceutical production in line with global standards as soon as possible " Results of a phase 2 clinical trial of tirelizumab combined with chemotherapy in the treatment of lung cancer This open, multi group phase 2 clinical trial of tirelizumab combined with chemotherapy as a first-line treatment for patients with advanced lung cancer (clinical trials.gov Registration No.: nct03432598) is being carried out in China Patients with non squamous non-small cell lung cancer (NSCLC) received 200 mg tirelizumab and dual chemotherapy every three weeks as the first day of a cycle; chemotherapy was administered for up to four cycles, while pemetrexed and tirelizumab were administered continuously under the clinical permission Patients with squamous NSCLC (two groups) and small cell lung cancer (SCLC) were treated once every three weeks with 200 mg tirelizumab and dual chemotherapy for 4-6 cycles, while tirelizumab was given continuously with clinical permission As of February 25, 2019, 54 patients received tirelizumab, with a median treatment time of 38.4 weeks (3-79) 14 patients were still receiving treatment as of the data cut-off point Results: the total response rate (ORR) was 66.7% (n = 36) in all groups, 43.8% (7 / 16) in patients with non squamous NSCLC, 80% (12 / 15) in patients with squamous NSCLC, 66.7% (4 / 6) in patients with squamous NSCLC, 76.5% (13 / 17) in patients with SCLC; Median progression free survival (PFS) was measured at the following cut-off points as of June 30, 2019; 9 months in patients with non squamous NSCLC; 7 months in patients with squamous NSCLC (group A); 6.9 months in patients with SCLC; not yet achieved in patients with squamous NSCLC (group B); When the median follow-up time was 15.3 months, the total survival time (OS) was 15.6 months in patients with SCLC; Adverse events (teaes) occurred in all 54 patients during the treatment, and those related to tirelizumab occurred in 46 patients (85.2%) Seven patients (13%) interrupted the treatment of tirelizumab due to Ae; Among 43 patients with tertiary teae, the most common were neutropenia (48.1%), anemia (18.5%), leucopenia (13%), thrombocytopenia (13%), thrombocytopenia (11.1%), neutropenia (7.4%), and elevation of ALT (5.6%); A total of 14 patients (25.9%) experienced at least one immune related adverse event (Irae), the most common being thyroid disease (16.7%), immune-mediated pneumonia (7.4%) and immune-mediated hepatitis (3.7%); The most common teaes associated with tirelizumab were weakness (18.5%), hypothyroidism (13%), elevated ALT (11.1%), and elevated ast (11.1%); and 14 patients (25.9%) experienced at least one serious teae; one patient with squamous NSCLC (group A) experienced immune-mediated myolysis / rhabdomyolysis / cardiomyopathy death after receiving one dose of tirelizumab Results of a phase 2 clinical trial of tirelizumab combined with chemotherapy for ESCC patients This open, multi group clinical trial of tirelizumab combined with chemotherapy for advanced esophageal, gastric or esophageal gastric junction cancer patients (clinical trials Gov Registration No.: nct03469557) is being carried out in China The updated results of the ESCC group were published in an oral report at the CSCO annual meeting On the first day of the three week cycle, patients received 200 mg of tirelizumab and cisplatin, and fluorouracil on the first to fifth days As of March 31, 2019, 15 ESCC patients received tirelizumab, and four of them are still receiving treatment The results were as follows: as of the data cut-off point, seven patients achieved confirmed partial remission (PR), Orr was 46.7%; median duration of remission (DOR) was 12.8 months; median PFS was 10.4 months (5.6-15.1); although median follow-up time was 13 months, median OS was not achieved; AES reported in this short were consistent with the safety profile of tiselizumab observed in previous studies with other tumor types and were generally of low severity; AEs reported in this cohort were consistent with the known tolerability profile of PD-1 inhibitors in combination with chemotherapy; In this group, the reported safety data were generally consistent with that of tirelizumab in other previous tumor types, to a lesser extent; in this group, the reported AE was consistent with the tolerance of known PD-1 inhibitors combined with chemotherapy; the most common teaes were anemia (n = 12) and anorexia (n = 11); Five patients, including pneumonia, tracheal fistula, AST rise, pulmonary infection and autoimmune dermatitis (one case each), were interrupted by teae; Twenty three cases of Irae were reported in 12 patients (80%) The most common cases were rash (20%), pruritus (20%), AST (13.3%), ALT (13.3%), pulmonary infection (13.3%) and autoimmune dermatitis (13.3%) Most of the iraes were mild or moderate; five three or more iraes were reported in four patients (26.7%), pulmonary infection was one of three or more iraes in more than one patient, and two patients (13.3%) The most common AE associated with tirelizumab were anorexia (66.7%), anemia (60%), nausea (40%), leukopenia (40%), neutropenia (40%), vomiting (33.3%), weight loss (33.3%), leucopenia (33.3%), weakness (33.3%), albumin reduction (33.3%) and hyponatremia (33.3%); The AE related to tirelizumab were vomiting (20%), hyponatremia (20%), anemia (13.3%) and leukopenia (13.3%); Any attributable serious teae in more than one patient was dysphagia (n = 3) and asthenia (n = 2); one case in each item may be related to tirelizumab; and one patient died of AE (liver dysfunction), mainly due to the progress of the disease, may also be related to trial treatment or potential hepatitis B Tirelizumab in the treatment of advanced solid tumor This multicenter, open-ended tirelizumab phase 1 / 2 clinical trial (clinical trial registration number: ctr20160872) for the treatment of advanced solid tumor patients is being carried out in China, including the phase 1 component of dose validation and pharmacokinetics, and the phase 2 component of indication expansion in specific disease groups, including non-small cell lung cancer (NSCLC) Melanoma, UC, RCC, ESCC, GC, HCC and MSI-H / dmmr solid tumors As of December 1, 2018, 300 patients in all indication groups were treated with tirelizumab at a dose of 200 mg once every three weeks Safety data in all indications (n = 300): tirelizumab is generally tolerated in patients with advanced solid tumors; Most of the treatment-related adverse events (trae) were first or second grade, the most common were anemia (23%), AST (22%), ALT (20%), proteinuria (14%), bilirubin (13%), hypothyroidism (11%), leucopenia (11%), conjugated bilirubin (11%) and fever (10%); The most common traes of grade 3 and above were elevated γ - glutamyltranspeptidase (4%), anemia (3%) and AST (3%); a GC patient experienced brain edema leading to death, which may be related to tirelizumab treatment according to the judgment of researchers; most iraes were grade 1 or grade 2, the most common were AST / ALT (24%) and hyperbilirubinemia (15%); and The most common Irae of grade 3 and above were elevated γ - glutamyltranspeptidase (4%) and AST / ALT (3%) Validity data: tirelizumab (bgb-a317) is a monoclonal antibody against programmed death receptor-1 (PD-1) of human lgg4, which is under development 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 At present, the ongoing clinical research of tirelizumab includes 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 3 clinical study for patients with first-line gastric cancer (GC); A phase 3 clinical study for first-line ESCC patients and a phase 2 clinical study for second 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 mainly focus on
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