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

The RATIONALE 303 study is a randomized, open, multi-center Global Phase III clinical trial (NCT03358875) designed to assess the effectiveness and safety of second- or third-line localized late-stage or metastasis patients who develop the disease after receiving platinum chemotherapy.
The main endpoints of the trial were OS in all patients (intentionally treated patients) and in patients with high expression in PD-L1, and key secondary endpoints included objective mitigation 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 Juju single lung cancer project 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.
Tyrelli pearl 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 with platinum-containing chemotherapy failures approved for the treatment of PD-L1 high expression, including progress in local late stage or metastatic urethroid cancer within 12 months of new assisted or complementary chemotherapy.
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 patients with non-excisive hepatocellular carcinoma who have been treated in the past, one for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in the first line, and another combination of chemotherapy for the treatment of patients with advanced non-squamous NSCLC.
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