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    Home > Medical News > Latest Medical News > The paper holds the clinical research data of four domestic PD-1 lung cancers.

    The paper holds the clinical research data of four domestic PD-1 lung cancers.

    • Last Update: 2020-09-23
    • Source: Internet
    • Author: User
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    Lung cancer is the most morbid and mortality malignant tumor in China, non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancer (non-scale cancer accounted for 55%, squamous about 30%), a large patient population makes NSCLC the largest in PD-1 mono-resistance.
    have laid out clinical studies on lung cancer, especially the first-line treatment of late NSCLC.
    incomplete statistics, at least 10 domestic PD-1 inhibitors have entered clinical trials or are about to enter clinical trials.
    so the efficacy of domestic PD-1 inhibitors in lung cancer? Today, the author for you to summarize the current four domestic PD-1 clinical research data in lung cancer.
    Karelli pearl monoantigen resistance 1, Camel research: chemical-free first-line treatment of advanced non-squamous non-small cell lung cancer, PFS/OS double benefit domestic PD-1 inhibitors in non-scale NSCLC research and development is the fastest progress of Kari Lizhu monoanti, June 19, 2020, has been officially approved for non-scale NSCLC first-line treatment, the approval of this adaptation certificate is based on a Karelli pearl monoantigen PHASE III clinical study - CameL study. the
    CameL study aims to explore the effectiveness and safety of carelli's single-anti-combination platinum-containing double-drug chemotherapy (carptonin-pemetroser) as a first-line treatment in patients with late-stage/metastasis non-scale NSCLC who drive gene-negative.
    in this Phase III study, a total of 412 NSCLC patients were recruited in China and randomly assigned to a combination or chemotherapy group of Karelliju monoantigen and chemotherapy on a 1:1 scale.
    study ends with no progression lifetime (PFS), with secondary endpoints including objective mitigation rate (ORR), disease control rate (DCR), mitigation duration (DoR), and total lifetime (OS).
    similar clinical studies abroad, the CameL data are from China, so the study is of greater significance to Chinese patients.
    results showed that kariliju monotherapy significantly extended the patient's mid-level PFS (11.3 months vs. 8.3 months) and the combined treatment group's ORR (60.0% vs. 39.3) compared to pure chemotherapy. 1%), DCR (87.3% vs. 74.4%), DoR (17.6 months vs. 9.9 months) and OS (less than 20.9 months) were significantly better than patients in the chemotherapy group alone.
    these positive results have established the position of Karelli pearl monoantigen in driving gene-negative non-scale NSCLC patients with first-line treatment.
    CameL study explores the effectiveness and safety of kariliju monotherapy for non-scale NSCLC, and in the field of lung scale cancer, there are several studies that have confirmed the good performance of karelli pearl monoantigen.
    the future, Carelli's monoantigen resistance has a long-awaited prospect in the fields of new auxiliary treatment of local late-stage non-small cell lung cancer, as well as postoperative ancillary treatment and small cell lung cancer.
    2, single drug for second-line treatment, the medium total survival of up to 19.4 months 2019 WCLC, Guangdong Provincial People's Hospital Professor Wu Yilong reported the Karelli Zhu single-drug second-line treatment of late NSCLC Phase II clinical research results.
    as of August 1, 2018, a total of 146 patients had been treated with Carelli's single-drug drug.
    results showed that the ORR (objective mitigation rate) of the ITT (intentional therapy) population was 18.5%, the medium PFS (no progression lifetime) was 3.2 months, and the medium OS was 19.4 months.
    subgroup analysis showed that PD-L1 expression was positively related to efficacy, and no disease relief was observed in patients who were positive for EGFR mutations.
    , the patient had long-term, sustained remission, with a half-DoR (remission duration) of 15.1 months.
    in patients with late/metastasis NSCLC who had been treated in the past, Karelli's monoantigen resistance was improved on ORR, PFS, and OS compared to previous studies of second-line chemotherapy.
    3, combined chemotherapy remission rate of up to 60%, is expected to become a new treatment for advanced/metastasis non-small cell lung cancer treatment program between May 12, 2017 and June 6, 2018, a total of 412 cases of EGFR and ALK-driven gene-negative patients with advanced non-squamous non-small cell lung cancer received treatment, of which 205 patients received Carilizhu monotherapy, 207 patients received simple chemotherapy.
    results showed that carelli-pearl monoantigen chemotherapy significantly extended the patient's medium PFS to 11.3 months.
    , the ORR was as high as 60% in patients in the Karelliju single anti-combination chemotherapy group, significantly better than in patients in the chemotherapy group alone.
    studies have shown that the treatment of Karelliju single anti-combination chemotherapy has significantly improved the overall survival benefits of lung cancer patients.
    Sindili monoantiant ORIENT-11: is a randomized, double-blind, Phase III study designed to compare the efficacy of Pythyridoxe and platinum-type combined Cindili monoanti/placebo therapy for local late stage or metastasis non-scale NSCLC Chinese patients.
    included 397 untreated patients with localized late stage or metastasis non-scaly NSCLC, who were not suitable for surgery or topical treatment without EGFR or ALC gene changes.
    were randomly assigned to the Syndicate monoanti (n-266) or placebo (n-131) group at 2:1.
    study ends with PFS.
    secondary endpoints include OS, ORR, DCR, TTR, DoR, and security.
    as of November 15, 2019, the mid-range follow-up time is 8.9 months (interval: 0.6-14.8).
    227 cases (85.3%) and 105 (80.2%) in the placebo group completed four cycles of induction therapy and received maintenance therapy, the main reasons for the induced suspension of the drug were disease progression, 21 cases (7.9%) in the Syndicate monoantigroup and 13 cases (9.9%) in the placebo group.
    PFS was significantly longer than that of the placebo group (8.9 months vs 5.0 months; HR, 0.482, 95% CI, 0.362-0.643; p.lt;0.00001).
    68.3 per cent (95 per cent CI, 62.0-73.8) and 42.0 per cent (95 per cent CI, 32.8-50.9) in the placebo group.
    HR in patients with brain transfer was 0.578 (95%CI, 0.283-1.180) and HR in patients without brain transfer was 0.468 (95% CI, 0.342-0.641).
    orR in the Syndicate monoantigroup was 51.9% (95% CI, 45.7-58.0) significantly higher than the placebo group 29.8% (95% CI, 22.1-33.4) (P-0.0. 00003), DCR was 86.8% (95% CI, 82.1-99.7) and 75.6% (95% CI, 67.3-82.7) in the Syndicate monoantigroup.
    DoR in the Syndicate monoantigroup has not yet reached (95% CI, 8.0-NR), while the placebo group has 5.5 months (95% CI, 4.1-10.9).
    TTR was 1.5 months (interval, 1.2-7.0) and the placebo group was 2.6 months (interval, 1.2-5.1).
    Three Reilly Pearl Monoantigen RATIONALE-206:RATIONALE-206 is a Phase II multi-queue clinical study designed to observe the clinical efficacy and safety of the first-line treatment of patients with advanced lung cancer in China in the first-line treatment of the Reilly Pearl Monoantigen-Platinum Chemotherapy Program, divided into two stages of safe importation and dose expansion.
    four queues are targeted at different pathological types or treatment options.
    : As of June 30, 2019, all 54 patients included were analyzed.
    non-squamous cancer queue ORR is 44%, the medium PFS 9 months, the medium OS has not yet reached, the scale cancer-A queue ORR is 80%, the medium PFS 7 months, the medium OS has not yet reached, the SQ-B queue ORR is 67%, the medium PFS and OS have not yet reached, the SCLC queue ORR is 77%, the medium PFS 6.9 months, the middle OS is 15.6 months.
    RATIONALE 307:307 study is an open, multicenter randomized Phase III clinical trial designed to assess the effectiveness and safety of first-line therapy in patients with styrobacterium monoantigen (200mg given every 3 weeks) combined with yew alcohol plus platinum or albumin-yew alcohol plus platinum with yew alcohol plus platinum for phase II or IV scaly NSCLC patients.
    the clinical design of the study is unique in that it is a three-arm trial, with chemotherapy (yew alcohol and carptonin) as a control group, and two other test groups were set up, namely, Terelli pearl monoantigen and sequoia plus carptonin, and tyrelli pearl monoanti and albumin yew alcohol and carptonin.
    study included 360 Chinese patients, who were asseded to a 1:1:1 ratio.
    results showed that in the PFS, the mPFS of the reilly-pearl monoantigen-albumin-carptonin group was 7.6 months, the risk of disease progressity was reduced by 52%, the mPFS of the reilly-pearl monoantigen-sequoia-carpul was reduced by 7.6 months, and the risk of disease progress was reduced by 48%, and the chemotherapy control group mPFS was 5.5 months.
    In orR, the ORR of the reilly bead monoantigen and albumin yew alcohol and carptonin group reached 74.8%, the orR of the reilly pearl monoantigen and the carpulol group reached 72.5%, and the chemotherapy control group was 49.6%.
    In the DoR, mDoR in the reilly bead monoantigen-albumin-carptonin group was 8.6 months, mDoR in the reilly-pearl monoantigen-sequoia-carptonin group was 8.2 months, and in the chemotherapy control group it was 4.2 months.
    Ripley single-resistance CT18: This is a Phase II, multi-center, open-label, one-arm study.
    study included 40 patients who had previously failed to receive EGFR TKI treatment without T790M mutation or EGFR activation mutation with failure to receive oghithinib treatment, receiving 240 mg or 360 mg Fixed doses of Terripri monoantigen (Q3W) combined with carpton and pyrethroids 4 to 6 cycles, followed by tripri monoantigen pyrethroids maintenance therapy until the disease progresses (PD) or is not resistant to toxicity.
    study ends with ORR.
    results: Data as of July 25, 2019, 40 patients in the group were assessed, with 50% orR confirmed (95% CI: 33.8% to 66.2%), 20 partial remission (PR), 15 patients stable (SD; including 1 unrefirmed PR) ), the disease control rate (DCR) was 87.5% (95% CI: 73.2% to 95.8%), the medium DoR: 7.0 months, and the middle PFS for the overall population was 7.0 months (95% CI: 4.8 months to 10.3 months).
    four major domestic PD-1 each show the gods, in the field of lung cancer treatment efficacy does not lose imports, cheer for the national medicine, look forward to the rise of more domestic new drugs.
    source: 1.CT083 - Camrelizumab plus apatinib in large-stage small-cell cancer (PASSION): A multicenter, two-stage, phase 2 trial. 2020 AACR. 2.Zhijie Wang, et al. A Phase 2 Study of Tislelizumab in Group With Platinum-Based Knowy as First-line Treatment for Advanced Lung Cancer in Chinese Patients. Lung Cancer, In press. 3.Dahan R, Sega E, Engelhardt J, Selby M, Korman AJ, Ravetch JV. Cancer Cell. 2015;28(3):285-295. 4.Desai J, Deva S, Lee S, et al. J Immunother Cancer. In press. 5. Wang Z, Zhao J, Ma Z, et al. Lung Cancer. Under review.
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