First-line treatment NSCLC! Junshi biological PD-1 antibody new drug Phase 3 research reached the main endpoint

According to the press release, the CHOICE-01 study was a randomized, double-blind, multi-center Phase 3 clinical study of anti-PD-1 monoantial combination chemotherapy as a first-line treatment in patients with two histological subtypes of late-stage scaly and non-squamous non-small cell lung cancer.
study endpoints were assessed by researchers based on the RECIST 1.1 standard for progress-free survival (PFS).
secondary study endpoints include total lifetime (OS), BIRC PFS based on RECIST 1.1 assessment, objective mitigation rate (ORR), security, and so on.
the study, led by Professor Wang Jie of the Oncology Hospital of the Chinese Academy of Medical Sciences, included 465 NSCLC patients in 63 centers in China, including 220 patients with squamous cancer and 245 patients with non-squamous cancer, according to 2: 1 randomized group, squamous cancer subjects received Tripri monoanti/placebo combined albumin binding yew alcohol and carpentry therapy, non-scale cancer patients received Tripri monoanti/placebo combined pyrithione and cisplatin/carpentry therapy.
progression of the disease, subjects in the eligible control group were treated with the cross-treatment of Ripley monoantigen. The results of phase
analysis showed that IDMC determined that the main study endpoint PFS reached the optimal effect boundary value of the program, and the results showed that the first-line treatment of advanced non-small cell lung cancer with Terripri monoanti-anti-combination chemotherapy compared to chemotherapy, which significantly extended the patient's progress-free survival.
's single-resistance security data matches known risks and no new security signals are found.
lung cancer has the highest incidence and mortality rate of malignant tumors in the world.
NSCLC is the main subsype of lung cancer, accounting for about 85% of all cases.
, about 70% of NSCLC patients were diagnosed with local advanced or metastasis diseases that could not be surgically removed, and 30% to 60% of NSCLC patients undergoing genomic surgery eventually relapsed or metas later metasized.
current studies suggest that PD-(L)1 single-drug or combination chemotherapy is expected to become a new standard treatment for first-line non-small cell lung cancer.
Ripley monoantigen injection is the first Chinese-made PD-1 monoantigen to be approved for sale, and its first adaptive disorder is the treatment of non-excisive or metastasis melanoma that has failed to receive systemic treatment in the past.
The product is used to treat relapse/metastatic nasopharyngeal cancer that has failed to receive second-line and above system treatment in the past, and new adaptive applications for the treatment of local progress or metastatic urethra cancer that have been treated systematically in the past have been accepted by NMPA and included in the priority review process.
addition, Ripley monotherapy for nasopharyngeal cancer has been recognized by the FDA as a breakthrough therapy.
: The first-line treatment of non-small cell lung cancer Phase III clinical studies reached the end® of the main study. Retrieved Dec 13, 2020, from Source: Medical Mission Hills