The mid-term analysis of the phase NSCLC III study of single-anti-treatment for Reilly Zhu reached the main endpoint of OS

On November 17, Baiji Shenzhou announced that, in a pre-planned interim analysis by the Independent Data Monitoring Committee (DMC), the main endpoint of THEALE 303 clinical trials for patients with advanced or third-line localized or metastasis lung cancer (NSCLC) who developed disease after receiving platinum-type chemotherapy was used to assess the progress of the drug.
security data for the Reilly Pearl monoantitor is consistent with known risks and no new safety warnings have been issued.
RATIONALE 303 study is a randomized, open, multi-center Global Phase III clinical trial (NCT03358875) designed to assess the effectiveness and safety of patients with second- or third-line localized late stage or metastasis who develop the disease after receiving platinum chemotherapy.
The main endpoints of the trial were OS in all patients (intentionally treated patients) and in highly expressed patients with PD-L1, and key secondary endpoints included objective remission rate (ORR), remission duration (DoR), progression-free lifetime (PFS), and safety.
the trial included 805 patients in 10 countries, randomly assigned to the Reilly Pearl monoantitor test arm or the Dorsey test arm in a 2:1 ratio.
"RATIONALE 303 is the third phase III clinical trial for non-small cell lung cancer to reach its primary endpoint in the interim analysis, and it is also the first global critical clinical trial to achieve positive results in the Reilly Pearl monoanti-clinical project, which is a strong testimony to the expanding global clinical development capability of Theraiju," commented Dr. Yong Yong, Chief Medical Officer of Oncology Immunology, Baiji Shenzhou.
we look forward to releasing the full data on the trial at a future medical conference, and we hope to continue to bring progress to the Reilly-Zhu single-lung cancer program in the future.
lung cancer ranks first in the world in terms of 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.
Reilly Pearl Monoanti is a humanized lgG4 anti-PD-1 monoclonal antibody designed to minimize binding to Fc-R subjects in macrophages.
preclinical data show that the Fc-R bind in macrophages activates antibody-dependent cell-mediated killer T-cells, thereby reducing the anti-tumor activity of PD-1 antibodies.
Treliju monoantigen has been approved by NMPA to treat patients with relapsed or refractic classic Hodgkin's lymphoma who have underwent at least second-line system chemotherapy, as well as patients who have been approved for the treatment of PD-L1 highly expressive platinum-containing chemotherapy failures including progress in new assisted or assisted chemotherapy within 12 months of local late-stage or metastatic urethrial cancer.
In addition, the NMPA Drug Review Center (CDE) has accepted and is in the process of reviewing three new adaptive applications from Bezean, including one for the treatment of previously treated non-removable hepatocellular carcinoma patients, one combination chemotherapy for the treatment of patients with first-line advanced squamous non-small cell lung cancer (NSCLC) and another combination of chemotherapy for the treatment of patients with first-line advanced non-squamous NSCLC.