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    Home > Active Ingredient News > Antitumor Therapy > FDA: Approves second-line treatment of navulyo monoantine approved esophageal squamous cancer

    FDA: Approves second-line treatment of navulyo monoantine approved esophageal squamous cancer

    • Last Update: 2020-06-16
    • Source: Internet
    • Author: User
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    Esophageal cancer is a common digestive tumor, compared with Europe and the United States, the incidence of esophageal cancer in China is higher, and has a certain degree of regional differencesEurope and the United States are mainly esophageal adenocarcinoma (accounting for 70% to 80% of all esophageal cancer), while China is mainly esophageal squamous cancer (more than 90%)The treatment of esophageal squamous cancer in the past is mainly chemotherapy, and there is no very standard treatment plan, the patient's treatment options are very limited, metastatic esophageal cancer prognosis is poorThe relative survival rate of 5 years is 8%In recent years, the emergence of immunotherapy has broken the existing treatment bottleneck, so that patients have more and better choices, treatment efficiency has been significantly improvedNavuliu monotonica, also known as Opdivo, is a PD-1 immunosuppressant and the first immunotherapy drug to be taken part in the countryThe FDA approved Navuliu monotophobic approved esophageal squamous cancer, the first immunotherapy approved for treatment in people with this type of patient, regardless of PD-L1 statusThis approval is based on the findings of Issue III ATTRACTION-3The ATTRACTION-3 study was a multicenter, random, open-label, global Phase III study that included 419 patients with non-recitability late or recurrent ESCC who had previously received combination of fluorine and platinum-containing drugs that were difficult to treat or not tolerated, and evaluated the efficacy and safety of Navuriu monoantithed chemotherapy (docel or yew) of comparative chemotherapy (dosiel alcohol or yew)The in-group patients (regardless of PD-L1 expression) received vulyo monotophosis or chemotherapy at random 1:1, with the main study endpoint being OS
    Figure: Experimental design 01 Both PD-L1 expression, both benefit from the OS extension of the Navuliu mono-resistant group than the chemotherapy group, including different PD-L1 expression subgroupsAbout half of the PD-L1 positive and negative patients in ATT-3 were: - In the PD-L1 positive population (-1%) reduced the risk of death (HR-0.69, 95% CI: 0.51-0.94); - In The PD-L1 negative (1%) population: the advantage is still present (HR.84, 95% CI: 12.14)Based on this result, Navuliu monotophobic is the first immunocheckpoint inhibitor in the world to be shown to improve The OS of PD-L1 non-selected population in the second-line treatment of non-removable late-stage or recurrent esophageal squamous cell carcinoma
    02, one-year survival rate, data bright-eyed Navuliu mono-resistgroup median survival (mOS) for 10.9 months (95% CI: 9.2-13.3), chemotherapy group for 8.4 months (95% CI: 7.2-9.9)Across the study group, the Navuliu mono-anti-mono-anti-group mOS was increased by 2.5 months and the risk of death was reduced by 23%The one-year OS rate was 47% vs34% in the Navuu mono-anti-group and chemotherapy group, and the OS rate was 31% vs 21% for 18 months This means that at 12 and 18 months, there were more survivors in the Navuliu monotom group, and one in two patients survived one year after treatment
    Figure: Total survival data 03, once effective, the objective mitigation rate (ORR) of the two groups of sustainable mitigation is 19% and 22%, respectively, although the two groups of ORRs are close, but the Navuliu monotoreactor brings more lasting relief The median duration of the neuresauta (mDoR) reached 6.9 months, a "staggering" three-month extension compared to 3.9 months in the chemotherapy group, nearly doubling At the time of the statistical data, seven patients in the Navuliu monotomatogens group were still in constant remission, while only 2 in the chemotherapy group, and the "tailing effect" of significant immunotherapy survival benefits was again apparent
    Figure: Median remission duration 04, significantly reduced serious adverse reactions The safety of navulyo-u-seinresistance in this trial is consistent with previous clinical trials of esophageal cancer and other solid tumors Compared to chemotherapy, Navuliu monotherapy-related adverse events (TRAEs) were less, with a total incidence of 66%, compared with 95% in the chemotherapy group, while the majority of TraEs of Navuliu sepsis were 1 and 2, and the incidence of TRAEs at 3-4 levels was 3 times lower than that of the chemotherapy group (18% vs 63%), and the overall controlled reversibility was reversed
    05 An exploratory analysis of patient report outcomes (PRO) showed an overall significant improvement in the health-related quality of life (HRQoL) in the Navuliu monoto-resaton group compared to chemotherapy
    Figure: The PRO Exploratory Analysis ATTRACTION-3 study is the world's first Phase III clinical study of esophageal scale cancer, designed not only in size but also in the Asian population Therefore, the results of this research for China's esophageal scale cancer treatment has "ice-breaking" significance, and may even change the recommendation of authoritative guidelines at home and abroad It is very much hoped that the immuno-tumor treatment represented by Navuli Yusaanti will benefit more patients with esophageal cancer in China as soon as possible References: 1.U.S Food and Drug Administration Approves Opdivo ® (nivolumab) for The Treatment of the Patients with Advanced Beacheal Squamous Cell Carcinoma (ESCC) After Prior Fluoropyrimidine-and Platinum-Grid Published June 10, 2020 AccessEd June 10, 2020 2.Cho BC, Kato K, Takahashi M, et al Nivolumab versusy in the gesilleal squamous cell carcinoma (ESCC): the phase 3 ATTRACTION-3 study Presented at ESMO 2019; September 27-October 1, 2019; Barcelona, Spain Abstract LBA 11 Author: MedSci Source: MedSci
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