Home-made PD-1 therapy! Baiji Shenzhou Baizean ® (for Reilly zhu single resistance) treatment of non-small cell lung cancer Phase 3 clinical success!

November 18, 2020 // -- BeiGene recently announced the evaluation of the anti-PD-1 antibody drug Bazean ® (Tislelizumab, Terelli Phase 3 RATIONALE 303 study (NCT03358875) for the treatment of non-small cell lung cancer (NSCLC) reached the primary endpoint of total lifetime (OS) during the medium-term analysis.
RATIONALE 303 is a randomized, open-label, multi-center, global Phase 3 clinical trial conducted in patients with second- or third-line localized late-stage or metastasis NSCLC who progressed after receiving platinum-containing chemotherapy to assess the efficacy and safety of Bezean® compared to dosital chemotherapy.
the study included 805 patients in 10 countries around the world who were randomly assigned to the Bizean®therapy group or the dorsey treatment group in a 2:1 ratio.
the main endpoints of the study were OS in the entire study patient population (intentional treatment (ITT) patient population) and in patients with high expression of PD-L1;
in a pre-designated interim analysis, the main endpoint of OS was reached in the population of intentional therapy (ITT) patients, based on the judgment of the Independent Data Monitoring Board (DMC).
the study, the security data of ® was consistent with the known risks and no new security signals appeared.
the study will be presented at a future medical conference.
It is worth mentioning that RATIONALE 303 is the third Phase 3 clinical trial for Bazean®3, which reached the primary endpoint of non-small cell lung cancer in the medium-term analysis, and the first global critical clinical trial to achieve positive results in the Bazean ® clinical project, which is a strong testimony to The State's expanding global clinical development capabilities.
lung cancer ranks first in the world in cancer morbidity and related mortality.
non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancers and is usually advanced at the time of diagnosis.
five-year survival rates were 5% and 2%, respectively, for patients with IIIB and phase IV NSCLC.
Bezean® is a humanized lgG4 program-resistant death-1 (PD-1) monoclonal antibody specifically designed to minimize binding to the Fc-R subject in macrophages.
preclinical data show that the Fc-R subject in macrophages binds to activate antibodies that rely on cell-mediated killer T-cells, thereby reducing the anti-tumor activity of PD-1 antibodies.
® is the first drug candidate developed by baiji Shenzhou's bio-platform for immuno-oncology, and is currently conducting clinical trials of single-drug and combination therapies worldwide to develop a range of broad-based adaptations to solid and blood tumors.
Bzean® has been approved by China's State Drug Administration (NMPA) for the treatment of patients with relapsed or refractic classic Hodgkin's lymphoma (cHL) who have underwent at least second-line system chemotherapy, as well as patients with platinum-containing chemotherapy that has been approved for the treatment of high expression of PD-L1, including localized advanced or metastatic urethra cancer (mUC) that progresses within 12 months of new assisted or assisted chemotherapy.
In addition, the NMPA Drug Review Center (CDE) has accepted and is in the process of reviewing three new adaptive applications from Perseus ®, including one for the treatment of patients with non-removable hepatocellular carcinoma (HCC) who have been treated in the past, one combination of chemotherapy for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) and another combination of chemotherapy for the treatment of patients with advanced non-squamous NCLC.
currently has 16 registered clinical trials in China and around the world®, including 12 Phase 3 clinical trials and 4 critical Phase 2 clinical trials.
() original source: BeiGene's tislezumab meets OS endpoint interim analysis of lung cancer