Domestic anti PD-1 therapy! The primary end point of the first-line treatment of squamous non-small cell lung cancer in Baiji, Shenzhou, was reached ahead of time!

January 22, 2020 / BIOON / -- beigene is a biomedical company in the commercial stage, focusing on the development and commercialization of innovative molecular targeting and tumor immune drugs for cancer treatment Recently, the company announced that its anti-PD-1 antibody baizean ® (tirelizumab) combined with two chemotherapy regimens was used in the critical phase 3 clinical trials for the first-line treatment of patients with squamous non-small cell lung cancer (NSCLC) In the planned interim analysis, the Independent Review Committee (IRC) assessed that it reached the main end point of improving the progression free survival (PFS) In this trial, patients with advanced squamous NSCLC who had not been treated before were randomly treated with paclitaxel plus carboplatin, paclitaxel plus albumin paclitaxel (Abraxane ®) plus carboplatin, or paclitaxel plus carboplatin The results of the interim analysis conducted according to the protocol plan showed that compared with the control group only using chemotherapy, the experimental groups of two groups of baizean ® reached the preset effectiveness limit The safety data of the two groups were consistent with the known risks of each group, and there was no new safety warning Benyong, MD, chief medical officer of tumor immunology of Baiji Shenzhou, said: "baizean ® was recently approved in China for the treatment of relapsed or refractory classic Hodgkin's lymphoma patients We have carried out a wide range of development projects for bazaar ® and have now enrolled more than 5000 patients in more than 25 trials, including 15 potential registered trials We are very excited to see that bazaar ® has made great achievements in this phase 3 clinical trial, demonstrating its potential of first-line treatment for patients with advanced squamous NSCLC in China We are also looking forward to the continuation of the development project for lung cancer, including three additional phase 3 clinical trials, and the publication of more data " The company plans to communicate with the drug review center (CDE) of the National Drug Administration (nmpa) on the submission of SNDA for the treatment of first-line squamous NSCLC patients, and publish the data in the next medical conference This randomized, open, multicenter phase 3 clinical trial (bgb-a317-307; clinical trials.gov registration number: nct03594747; drug clinical trial Registration No.: ctr20181746) was used to evaluate the efficacy of combination of paclitaxel and carboplatin, or combination of albumin paclitaxel and carboplatin (Abraxane; Baiji Shenzhou has its commercial right in China) Compared with paclitaxel and carboplatin only, paclitaxel and carboplatin were used to treat patients with stage 3B or stage 4 squamous NSCLC in mainland China who had not received treatment before, regardless of PD-L1 expression The primary end point of the trial was PFS assessed by the IRC; the key secondary end point included total survival and safety The trial started in July 2018 360 patients were randomly treated with bezoar (once every three weeks, at a dose of 200mg each time) combined with any chemotherapy program or only chemotherapy until the disease progressed, or intolerable toxicity occurred, or the doctor decided to stop the treatment, or the patient withdrew informed consent Patients in the trial control group who were only treated with chemotherapy will be eligible to receive bazaar ® treatment after independent review and verification after disease progression Wang Jie, MD, chief physician of the Cancer Hospital of the Chinese Academy of Medical Sciences and the main researcher of the trial, commented: "in China, squamous NSCLC accounts for about 30% of all NSCLC, with highly unmet medical needs The prognosis of patients with squamous NSCLC is often not ideal This 3-phase clinical trial is used to evaluate the efficacy of bazaar ® combined with chemotherapy in patients with advanced squamous NSCLC, and the results also show that we may bring a new treatment option and new hope for patients " About non-small cell lung cancer: compared with the decreasing lung cancer mortality rate in most western countries, the incidence rate of lung cancer in China has increased by [1], [2] In 2018, there were about 770000 new lung cancer cases in China Lung cancer is the main cause of cancer-related deaths in both male and female cancer patients, with 690500 deaths in China in 2018 [3] Non small cell lung cancer (NSCLC) accounts for the majority of lung cancer in China [4] About baizean ® (tirelizumab): baizean ® (tirelizumab) is a humanized monoclonal antibody against programmed death receptor 1 (PD-1) of lgg4, designed to minimize the binding with FC γ r receptor in macrophages Preclinical data show that the binding of FC γ r receptor in macrophages can activate antibody dependent cell mediated killing T cells, thus reducing the anti-tumor activity of PD-1 antibody Tirelizumab is the first candidate drug developed by the platform of immune tumor biology in Baiji At present, a series of single drug and combined therapy clinical trials are being carried out to develop a series of broad indications for solid tumors and blood tumors Baizean ® has been approved by the National Drug Administration of China (nmpa) for the treatment of relapsed or refractory classic Hodgkin's lymphoma patients undergoing at least second-line chemotherapy Another new indication listing application of bazaar ® for patients with locally advanced or metastatic urothelial cancer who have been previously treated has been included in the priority review by the drug review center (CDE) of the State Drug Administration, and is currently under review As a single drug and combined therapy, baze'an ® is developing a series of indications for solid tumor and blood tumor treatment At present, there are 15 potential registered clinical trials in China and around the world, including 11 3-phase clinical trials and 4 key 2-phase clinical trials Baizean ® has not been approved outside China Original source: Baiji Shenzhou