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    Home > Active Ingredient News > Antitumor Therapy > The FDA has approved Odivo® (Navuliyu monotherapy) as the first and currently the only approved immunotherapy for patients with previously untreated, non-removable malignant thoracic mesothelioma.

    The FDA has approved Odivo® (Navuliyu monotherapy) as the first and currently the only approved immunotherapy for patients with previously untreated, non-removable malignant thoracic mesothelioma.

    • Last Update: 2020-10-20
    • Source: Internet
    • Author: User
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    The U.S. Food and Drug Administration (FDA) has approved Odivo (360mg, once every 3 weeks) for the first-line treatment of adult patients with non-removable malignant thoracic mesothelioma (MPM).
    1 This approval is based on an in-preset mid-period analysis of Phase III clinical study CheckMate -743.
    study showed that after at least 22.1 months of follow-up, the total lifetime (OS) of patients in the Odivo combined ipymu monoantigroup (n-303) was better than that of the platinum-containing standard chemotherapy group (n-302) (risk ratio: 0.74( 95% confidence interval: 0.61), 0.89) ;p-0.002), the medium total survival (mOS) of the double immunotherapy group was 18.1 months (95% confidence interval: 16.8, 21.5), and the chemotherapy group was 14.1 months (95% confidence interval: 12.5, 16.2)1.
    2-year survival rate was 41% for patients in the two-year immunotherapy group, compared with 27% in the chemotherapy group.
    "Malignant thoracic mesothelioma is a rare cancer with limited treatment options," said Dr. Anne S. Tsao, director of the Chest Medicine Oncology Division at the University of Texas Anderson Cancer Center and director of the mesothelioma program.
    for patients who were late at the time of diagnosis, the five-year survival rate was only 10%.
    2,4 CheckMate-743 show that Odivo combined with Ipimu monoantigen will become the new first-line standard treatment option.
    is exciting news, and it offers hope not only to patients with this serious disease, but also to the health care workers who care about them.
    " Odivo combined with EpiPen anti-treatment warnings and precautions include immuno-mediated adverse events, respectively, pneumonia, colitis, hepatitis, endocrine diseases, nephritis and renal inseventry, adverse skin reactions, encephalitis and other adverse reactions; Reactions: Complications of stem cell transplantation using donor stem cells (allogeneic transplants); embryo-fetal toxicity; increased mortality in patients with multiple myeloma when Odyssey is used in association with salidamine similars and dexamysong, and is therefore not recommended for use outside controlled clinical trials.
    1 Warnings and precautions for the use of Ipimu monoantigen are: severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation after Ipimu monoantigen use, embryo-fetal toxicity, and associated risks associated with Odivo.
    5 see the Important Security Information section below.
    this is the third adaptation certificate approved for first-line treatment in chest tumors by Odivo's joint Ipimu monoantigen.
    1 previously, the FDA had approved Odivo's combined ipso-monoantigen for first-line treatment in patients with metastasis non-small cell lung cancer (NSCLC), who were subject to FDA-approved PD-L1 testing to determine that their PD-L1 expression was ≥1% and that there were no EGFR or ALK gene mutations.
    1 In addition, the FDA has approved Odivo's combination of ipigo monoantigen and limited course chemotherapy for first-line treatment in adult patients without EGFR or ALC gene mutations, regardless of their PD-L1 expression.
    Lenkowsky, U.S. general manager and head of oncology, immunology and cardiovascular at 100m, said: "Chest tumors are complex and difficult to treat, and we are focused on developing immunotherapy that promises to prolong a patient's life.
    2,6 just a few months ago, immunotherapy based on Odivo's combined Ipimu monoantigen was approved for two first-line adaptations in specific patients with non-small cell lung cancer.
    now, Odivo's joint epipentome has been approved in another chest tumor for patients with previously untreated, non-removable malignant thoracic mesothelioma.
    based on today's approval, Odivo's joint Ipimu monotherapy will be the first new systemic therapy approved in the field in more than 15 years, promising to help these patients prolong their lives.
    " 1 Odivo combined Ipimu monoantigen is a unique combination of two immuno-checkpoint inhibitors with potential synergistic mechanisms for two different checkpoints (PD-1 and CTLA-4) to help eliminate tumor cells: Ibicox monoantigen helps activate and multiply T cells, while Odivo helps existing T-cells detect tumors.
    T cells activated by Ipimu monoantigen can be differentiated into memory T cells, which is expected to lead to a long-term immune response.
    7, 8, 9, 10, 11, 12 immunotherapy may also target normal cells, leading to adverse immune-mediated reactions.
    this reaction can be severe and can even be fatal1.
    see the Important Security Information section.
    , the FDA approved a new Supplemental Biologics License Application (SBLA) in less than six weeks through the Real-Time Oncology Review (RTOR) pilot program.
    RTOR program is designed to ensure safe and effective treatment for patients as early as possible.
    13 also joined the FDA's Orbis program, and health regulators in Australia, Canada and Singapore reviewed the application in sync with the FDA.
    (Ipymu monoantigen is not yet available on Chinese mainland) About CheckMate -743CheckMate-743 is an open label, multi-center, randomized, Phase III clinical study designed to evaluate and standard chemotherapy (Pemetroser combined with cisplatin or card Platinum) compared to Odivo's combined epipentome is used to treat patients with a malignant thoracic mesothelioma that has been confirmed to be non-removable by histological credit type and who have not under been systematically treated or palliative radiotherapy within 14 days prior to the start of treatment (n-605).
    1 this trial excluded patients with interstitific lung disease, active autoimmune disease, clinical need for systematic immunosuppression, or active brain metastasis.
    1 In this clinical study, 303 patients were randomly treated with Odivo (3 mg/kg, once every 2 weeks) and Ipimu monoantigen (1 mg/kg, once every 6 weeks).
    302 patients were randomly treated with cisplatin (75 mg/m2) or carptin (AUC 5) combined with 500 mg/m2 for 6 cycles every 3 weeks.
    1 group of patients continued treatment until the disease progressed or ben unacceptable toxicity.
    in the Odivo combined Ipimu monoantigroup, the maximum treatment time for patients was 24 months.
    The main endpoint of the
    1 trial was the total lifetime (OS) of all randomized patients,1 other efficacy indicators including progress-free lifetime (PFS), objective mitigation rate (ORR), and continuous mitigation time (DOR), which were evaluated by BICR against the revised RECIST criteria.
    1CheckMate-743 study partial safety data of patients receiving Odivo combined ipigo monoantigen therapy in 23% of patients with permanent discontinuation of treatment due to adverse reactions, 52% of patients due to adverse reactions at least once stopped treatment.
    4.7% of patients were permanently deactivant due to adverse reactions.
    54% of patients who received Odivo's combined Ipimu monotherapy had severe adverse reactions.
    1 The most common serious adverse reactions (≥2%) were pneumonia, fever, diarrhea, limited pneumonia, chest fluid build-up, dyspnea, acute kidney injury, infusion-related reactions, musculoskeletal pain and pulmonary embolism.
    14 (1.3%) patients had fatal adverse reactions, including limited pneumonia, acute heart failure, sepsis and encephalitis.
    1 The most common adverse reactions (≥20%) were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), difficulty breathing (27%), nausea (24%), decreased appetite (24%), cough (23%) and itching (21%).
    1 Odivo was 12 and ipigwood monotherapy was 4.
    3 about malignant thoracic mesothelioma mesothelioma is a rare and highly invasive malignancy native to mesothelioma cells.
    2,14 confirmed cases in China each year is about 3,000.
    16 malignant thoracic mesothelioma is the most common type of mesothelioma.
    2 is highly associated with asbestos exposure.
    delayed diagnosis, most patients were terminally ill at the time of diagnosis.
    the prognosis of 2,15 malignant thoracic mesothelioma is generally poor, the medium survival of patients with advanced malignant thoracic mesothelioma is about one year, and the five-year survival rate is about 10%.
    2 Reference 1, Opdivo Prescribing Information. Opdivo U.S. Product Information. Last updated: October, 2020. Princeton, NJ: Bristol-Myers Squibb Company.2, National Comprehensive Cancer Network. NCCN Clinical Practice Guides: Malignant Pleural Mesothelioma.Updated November 27, 2019. Accessed September 11, 2020.3, Baas P, Scherpereel A, Nowak A, et al. First-line nivolumuab s ipilimumab vs. Chevy in unresectable malignant pleural mesothelioma: CheckMate 743. Lecture presented at: World Conference on Lung Cancer (WCLC) Virtual Presidential Synposium. August 8,2020.4, SEER. Mesothelioma, CSR 1975-2016.5, Accessed September 11, 2020 6, Yervoy Prescribing Information. Yervoy U.S. Product Information. Last updated: October, 2020. Princeton, NJ: Bristol-Myers Squibb Company. 7, National Cancer Institute. Non-Small Cell Lung Cancer Treatment (PDQ ®) - Health Professional Version.Updated May 7, 2020. Accessed September 11, 2020.8, Weber J, Hamid Omid, Chasalow S, et al. Ipilimumab increases activated T cells and enhances humoral immunity in patients with advanced melanoma. J Immunother. 2012;35 (1): 89-97.9, Pico de Coana Y, Wolodarski M, Poschke I, et al. Ipilimumab treatment solutions monocytic MDSCs and increases CD8 effector memory T cells in long-term survivors with advanced melanoma. Oncotarget. 2017;8( 13): 21539-21553.10, Pedicord V, Montalvo W, Leiner I, et al. Single dose of anti-CTLA-4 enhances CD8 plus T-cell memory formation, function, and maintenance. Proc Natl Acad Sci USA. 2011;8( 1): 266-271.11, Felix J, Lambert J, Roelens M, et al. Ipilimumab reshapes T cell memory subsets in melanoma patients with clinical response. Oncoimmunology. 2016; 5 (7): 1-10.12, Ansell S, Hurvitz S, Keonig P, et al. Phase I study of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with relapsed and refractory B-cell non-Hodgkin lymphoma. Clin Cancer Res. 2009;15 (20): 6446-6453.13, Farber D, Yudanin N, Restifo N. Human.
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