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    Home > Medical News > Medical World News > The results of stage III of The first-line treatment of non-squamous non-small cell lung cancer by Dabsch joint chemotherapy were published.

    The results of stage III of The first-line treatment of non-squamous non-small cell lung cancer by Dabsch joint chemotherapy were published.

    • Last Update: 2020-08-23
    • Source: Internet
    • Author: User
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    On August 8, Syntech Biopharmaceuticals and Lilly Pharmaceuticals jointly announced that the results of the ORIENT-11 study were published in oral presentations at the 21st World Lung Cancer Congress (IASLC WCLC) Online Theme Forum in 2020.
    , the results were selected by Journal of Journal of Thoracic Oncology, a leading international journal in the field of lung cancer, and published online on the same day.
    The purpose of this study was to evaluate the efficacy of the innovative PD-1 inhibitor Dabershu ® (Sedili mono-injection) combined with Pythre ® (injected with pemethase glycosate) and platinum chemotherapy for first-line treatment of non-squamous non-small cell lung cancer (NSCLC).
    ORIENT-11 is a randomized, double-blind, Phase III controlled clinical study of first-line treatment for late-stage or recurrent non-squamous non-small cell lung cancer in the form of Daberschu ® (Sedili monoanti-injection) or placebo-combined pyrethromycin ® (injected with phosphate®
    Based on an in-period analysis conducted by the Independent Data Monitoring Committee (IDMC), the Dabershu ® (Sindilli mono-injection) combined force bithal ® (injection-based pyrethromysterone) and the platinum-based comparative placebo combined pyrethroid® (injected permeate glycosate) and platinum significantly extended the pre-progress survival (PFS) to achieve pre-set quality-of-life standards.
    The mid-term analysis data cut-off period was 8.9 months, while the trial and control groups were assessed by the Independent Imaging Review Board (IRRC) with a mid-progress non-progressable survival period (PFS) of 8.9 months and 5.0 months, respectively, and HR (95% CI) of 0.482 (0.362), 0.643), P 0.00001.
    the two groups of medium total survival (OS) had not yet been achieved, and the Creditili monoantigen combined chemotherapy group had an increase in OS compared to the placebo combined chemotherapy group OS (HR?0.609, 95% CI: 0.400-0.926).
    The confirmed objective remission rate (ORR) assessed by the IRRC increased from 29.8% to 51.9%, and Sedili monoantigen combined chemotherapy obtained objective remission earlier than placebo combined chemotherapy (up to 1.51 months vs. 2.63 months).
    safety characteristics are consistent with previously reported findings of ® (Sidili monoindration injections) and there are no new safety signals.
    The National Drug Administration (NMPA) has formally accepted the new adaptation application (sNDA).
    about non-squamous non-small cell lung cancer is the number one malignant tumor in China in both morbidity and mortality.
    small cell lung cancer (NSCLC) accounts for about 80 to 85 percent of all lung cancers, and about 70 percent of NSCLC patients are diagnosed with local advanced or metastatic tumors that are not suitable for root surgery.
    same time, a significant proportion of early NSCLC patients undergoing surgery have relapses or distant metastasis and later die as a result of the progression of the disease.
    About 70% of NSCLC patients in China are non-scaly NSCLCs, of which nearly 50% of NSCLC patients do not have EGFR sensitive mutations or ALK gene rearration, this part of advanced lung cancer patients are not suitable for targeted treatment, treatment methods are limited, there are huge unsatisfied medical needs.
    Orient-11 Study ORIENT-11 Study is a randomized, double-blind, Phase III controlled clinical study evaluating the effectiveness and safety of the first-line treatment of advanced or recurrent non-squamous non-small cell lung cancer (ClinicalTrials.gov) by evaluating the effectiveness and safety of The Daberschu ® (Xindily monoanti injection) or placebo-combined Pythretone ® (injected with Pemexate) and platinum for advanced or recurrent non-squamous non-small cell lung cancer NCT03607539).
    study endpoint was progressless survival (PFS) assessed by the Independent Imaging Review Board on the basis of the RECIST v1.1 criteria.
    secondary study endpoints include total lifetime (OS), safety, and so on.
    The study included 397 subjects who were randomly grouped at 2:1 and received 200mg of Daberschu ® (Sedili monoanti injections) or a placebo combined pyrethroid® (injectable pyrethromycosin) and platinum therapy, respectively. , given once every 3 weeks, after completing 4 cycles of treatment, enter the D'Aberschu ® (Sedili monoanti injection) or placebo combined pyrethromycin ® (injection of pyrethromycin) maintenance phase, treatment until the progression of the disease, toxic intolerance or other conditions requiring termination of treatment.
    the progression of the disease in the control group can be conditionally crossed to ® (Sudili mono-injection) single-drug treatment.
    original title: The results of the phase III study of the first-line treatment of non-squamous non-small cell lung cancer in combination with chemotherapy were published in the form of an oral report at the WCLC Online Theme Forum 2020.
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