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    Home > Active Ingredient News > Drugs Articles > "Li" creates extraordinary, "Da" has a promising future│Taboshu® is launched in the new indication, rewriting the first-line treatment pattern of non-squamous NSCLC in China

    "Li" creates extraordinary, "Da" has a promising future│Taboshu® is launched in the new indication, rewriting the first-line treatment pattern of non-squamous NSCLC in China

    • Last Update: 2021-04-21
    • Source: Internet
    • Author: User
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    Lung cancer is currently the number one malignant tumor in China in terms of morbidity and mortality [1] .
    There are in all type of lung cancer, 80% to 85% [2] is a non-small cell lung cancer (NSCLC), and in NSCLC patients, about 60% of China [3] non-squamous NSCLC, of which more than 50% [4] of Patients have no EGFR sensitive mutations or ALK gene rearrangements.
    These patients with advanced lung cancer cannot benefit from targeted therapy, and the treatment options are relatively limited, and there are huge unmet medical needs.

    [1] [2] [3] [4]



    Dabo Shu ® (letter Dealey monoclonal antibody injection) is Eli Lilly and Cinda innovative PD-1 inhibitor drugs of international quality in China together biopharmaceutical research and development.
    The phase III clinical study ORIENT-11 confirmed the efficacy and safety of sintilimab combined with pemetrexed and platinum-based chemotherapy for the first-line treatment of non-squamous NSCLC.
    In February 2021, Sintilimab was approved by the National Medical Products Administration (NMPA), and its indication is combined with pemetrexed and platinum-based chemotherapy for non-squamous NSCLC without EGFR sensitive mutations or ALK gene rearrangement First-line treatment.

    ®

    March 21, 2021, China Health Promotion Foundation, 2021 of lung cancer immune Forum and Dabo Shu ® (natalizumab injection Dealey letter) first-line treatment of non-squamous NSCLC new indications listed will be held in Shanghai.
    A number of top domestic lung cancer experts visited the site to witness Sintilimab's opening of a new chapter in the first-line treatment of non-squamous NSCLC in China.

    ®



    After the meeting, doctors Naomaitong honor to interview the leading PI ORIENT-11 research professors tension , "Dabo Shu it ® clinical significance and application prospects indications listed (letter Dealey monoclonal antibody injection) first-line non-squamous NSCLC.
    " Make a wonderful interpretation.

    Professor Zhang Li®

    Professor Zhang Li

     Professor Zhang LiProfessor Zhang Li 

    Director of the Department of Internal Medicine, Sun Yat-sen University Cancer Hospital, PhD supervisor, chief expert on lung cancer

    Director of the Department of Internal Medicine, Sun Yat-sen University Cancer Hospital, PhD supervisor, chief expert on lung cancer

    Director-designate of the Professional Committee of Oncology Rehabilitation and Palliative Care of the Chinese Anti-Cancer Association

    Director-designate of the Professional Committee of Oncology Rehabilitation and Palliative Care of the Chinese Anti-Cancer Association

    Vice Chairman of the Clinical Trial Committee of the Chinese Anti-Cancer Association

    Vice Chairman of the Clinical Trial Committee of the Chinese Anti-Cancer Association

    Executive Director of Chinese Society of Clinical Oncology (CSCO)

    Executive Director of Chinese Society of Clinical Oncology (CSCO)

    CSCO-Immuno Therapy Expert Committee Designated Chairperson

    CSCO-Immuno Therapy Expert Committee Designated Chairperson

    Chairman of the Cancer Chemotherapy Professional Committee of Guangdong Anti-Cancer Association

    Chairman of the Cancer Chemotherapy Professional Committee of Guangdong Anti-Cancer Association

    Deputy Chairman of the Lung Cancer Professional Committee of Guangdong Anti-Cancer Association

    Deputy Chairman of the Lung Cancer Professional Committee of Guangdong Anti-Cancer Association

    Leading Medical Talents of Guangdong Province, Outstanding Talents of "Special Support Plan" (Southern Guangdong Baijie)

    Leading Medical Talents of Guangdong Province, Outstanding Talents of "Special Support Plan" (Southern Guangdong Baijie)

    The project leader of the precision research project on the diagnosis and treatment of lung cancer and the application plan of the national key research and development program "Precision Medicine Research"

    The project leader of the precision research project on the diagnosis and treatment of lung cancer and the application plan of the national key research and development program "Precision Medicine Research"



    ORIENT-11 study: Sintilizumab combined with chemotherapy significantly improves PFS in non-squamous NSCLC in China

    ORIENT-11 study: Sintilizumab combined with chemotherapy significantly improved PFS in China's non-squamous NSCLC ORIENT-11 study: Sintilizumab combined with chemotherapy significantly improved PFS in China's non-squamous NSCLC



    The emergence of immunotherapy has brought new hope for the treatment of patients with advanced non-squamous NSCLC.
    However, data on imported drugs for Asian patients, including the Chinese population, are very limited.
    The KEYNOTE-189 study only included about 3% 3333px;">[5 ] Of Asian patients.
    In order to explore whether Asians can benefit from immunization combined with chemotherapy, the researchers conducted the ORIENT-11 study in China.

    3333px;">[5]3333px;"> [5]



    The ORIENT-11 study [6] is the first randomized controlled, double-blind phase III clinical study in China for PD-1 inhibitors combined with chemotherapy for the first-line treatment of non-squamous NSCLC.
    Taking into account the interests of patients, the ORIENT-11 study was designed with a randomization ratio of 2:1.
    A total of 397 patients were enrolled in the study, and they were randomly assigned to the sintilimab combined chemotherapy group (experimental group, n=266) and placebo combined chemotherapy group (control group, n=131).
    The main study endpoint is progression-free survival (PFS).

    The ORIENT-11 study [6] is the first randomized controlled, double-blind phase III clinical study in China for PD-1 inhibitors combined with chemotherapy for the first-line treatment of non-squamous NSCLC.
    [6]


    The results showed that the median PFS of the sintilimab combined chemotherapy group was significantly longer than that of the placebo combined chemotherapy group (8.


    9 months vs.
    5.
    0 months; HR, 0.


    The results showed that the median PFS of the Sintilimab combined chemotherapy group was significantly longer than that of the placebo combined chemotherapy group.



    Sintilizumab combined with chemotherapy as first-line treatment significantly prolongs PFS in patients with non-squamous NSCLC

    Sintilizumab combined with chemotherapy as first-line treatment significantly prolongs PFS in patients with non-squamous NSCLC



    "The final results of the ORIENT-11 study showed that the median PFS of the experimental group was 8.
    9 months, and that of the control group was 5.
    0 months.
    The experimental group achieved nearly 4 months of improvement in PFS; the risk of disease progression was reduced by 52%.
    The HR is 0.
    48.
    " Professor Zhang Li said, "The results of this study are actually similar to those of the K drug, so in February this year, Sintilimab was approved by the National Food and Drug Administration for the indication of non-squamous NSCLC.
    "

    Professor Zhang Li



    Sintilimab: Improve the availability of immunotherapy drugs and rewrite the first-line treatment pattern of non-squamous NSCLC in China

    Sintilimab: Improve the availability of immunotherapy drugs and rewrite the first-line treatment pattern for non-squamous NSCLC in China Sintilimab: Improve the availability of immunotherapeutic drugs and rewrite the first-line treatment pattern for non-squamous NSCLC in China


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