Domestic PD-1 therapy! Baiji Shenzhou Baizean ® first-line combination of chemotherapy treatment of non-squamous lung cancer (NSCLC) Phase III clinical success!

April 14, 2020 /
Biovalley BIOON/ -- BeiGene announced that the evaluation of anti-PD-1 therapy Beizean ® (tilelizumab, terrier-beadmono injection) combined with pemericeand and platinum first-line chemotherapy treatment of non-squamous non-small cell lung cancer (NSCLC) patients the main end of the clinical trial
phase III In a mid-term analysis of a plan, an independent evaluation committee (IRC) assessed a statistically significant increase in progression survival (PFS) in the Bacazean ® and Platinum Chemotherapy Treatment Group compared to the Pemequstere and Platinum Chemotherapy Treatment Group In the study, the safety data of bacsurean ® and the combination of pemecoande and platinum drugs were consistent with the known risks of each study drug, and no new safety signals were found "Following the announcement at the beginning of the year of positive results from the mid-term analysis of the first-line clinical trial of squamous non-small cell lung cancer phase III by Baize® an ®, we are pleased to announce that the clinical trial of Baize an first-line treatment of non-squamous non-small cell lung cancer patients in phase III has also achieved positive results in the medium-term analysis," said Dr Yu Yong, Chief Medical Officer of the Oncology
of the These results further confirm the efficacy and safety of bacherinate ® in the treatment of advanced cancer We will continue to evaluate the ® of Bacsa, including 15 potential registration trials, in 25 clinical trials "
Baiji Shenzhou has planned to discuss with the National Drug Administration (NMPA) Drug Review Center (CDE) about the submission of Baize's ® supplementary new drug application (NDA) for the first-line treatment of non-scale NSCLC new indications, and plans to publish detailed test data at a future medical conference The published Phase III trial is an open label, multicenter, randomized trial (NCT03663205, BGB-A317-304) without systematic treatment and does not carry EGFR mutation or ALK translocation phase IIIB or PHASE IV non-scale NS In CLC patients, the effectiveness and safety of bacillus ® (200mg dose every 3 weeks) and pemelic and platinum chemotherapy drugs selected by the researchers were evaluated, and compared with the combination of pemelic and platinum chemotherapy drugs The main endpoints of the study were the Progressless Lifetime (PFS) PFS assessed by the Independent Review Board (IRC), and the key secondary endpoints included total lifetime (OS) and security The trial began in July 2018 with 334 patients randomly assigned to a 2:1 ratio and received ® combination chemotherapy or single-use chemotherapy "Non-small cell lung cancer is a very malignant tumor , accounting for about 85% of the global lung cancer cases," said Professor Lu Wei, chief researcher of the trial and director of the oncology department at Shanghai Jiaotong University's affiliated thoracic hospital It is estimated that about 60 per cent of lung cancer patients are at advanced stages of the disease at the time of diagnosis and require more treatment options In this trial and in a mid-term analysis of other clinical trials , including first-line squamous non-small cell lung cancer, the positive results of the Bacazean ® show that the drug is a promising treatment option for patients with this advanced cancer "
contrast swords against the declining lung cancer mortality rate in most Western countries, and the incidence of lung cancer in China continues to rise In 2018, China added about 770,000 lung cancer cases and 690,500 deaths Lung cancer is the leading cause of cancer-related death in both men and women Non-small cell lung cancer (NSCLC) is the most common type of lung cancer in China Baczean ® (Treli-Jumono) is a human-derived lgG4 anti-procedural death receptor-1 (PD-1) monoclonal antibody designed to minimize binding to fc-R receptors in macrophages Preclinical data show that the binding of the Fc'r receptor in macrophages activates antibody-dependent cell-mediated killer T cells, thereby reducing the antitumor activity of PD-1 antibodies TreliZumais is the first drug candidate developed by Baiji Shenzhou's immuno-oncology bioplatform, and is currently conducting clinical trials for single-drug and combination therapy to develop a range of awide range of adaptations to solid tumor stoma and blood tumor Bazean ® has been approved by the State Drug Administration (NMPA) for the treatment of patients with recurrent or incurable classic Hodgkin's lymphoma with at least second-line system chemotherapy, as well as for patients with topical late or metastatic urinal skin cancer whose failure to treat PD-L1 high expression, including new or auxiliary chemotherapy, within 12 months of progress currently, there are 15 registered clinical trials in The ® in China and worldwide, including 11 Phase 3 clinical trials and four critical Phase 2 clinical trials (BiovalleyBioon.com) original origin: BeiGene Announce the phae 3 Trial of Tilelizumab Combined with With The Tyay In Patient with Firt-Line Non-Squamou Non-Small Cell Cancer The Primary of Progreion-Free Survival at Interimalyi