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April 21, 2020 / BioValley BIOON / -- Baishi Meishi Guibao (BMS) recently announced the evaluation of anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, Navulieu) The phase III CheckMate-743 study of the first-line treatment of malignant pleural mesothelioma (MPM) in the first-line phase of the combination anti-CTLA-4 therapy Yervoy (ipilimumab, eplimma) reached the primary endpoint of total survival (OS) CheckMate-743 is an open label, multicenter, randomized Phase III clinical trial that is evaluating the efficacy and safety of Opdivo-Yervoy's first-line treatment of MPM and comparing it with chemotherapy (pemecoce and cisplatin or caplatinum) In the study, Opdivo administered 3 mg/kg every two weeks and Yervoy 1 mg/kg every six weeks The main endpoint of the study was total lifetime (OS) Secondary endpoints include objective mitigation rate (ORR), disease control rate (DCR), no progression lifetime (PFS), and efficacy measurements based on PD-L1 expression levels results showed that, according to a pre-designated mid-term analysis conducted by the Independent Data Monitoring Committee (IDMC), the Opdivo-Yervoy combination of drugs significantly extended OS compared to chemotherapy (pemecoceander and cisplatin or caplon), which was statistically significant and clinical The safety of the Opdivo-Yervoy combination drug observed in this trial is consistent with the known safety of this combination detailed data on the study will be presented at a future medical conference and discussed with regulators malignant pleural mesothelioma (MPM) is a rare, highly invasive tumor that forms in the lining of the lungs The most common cause of the disease is exposure to asbestos Diagnosis of MPM is often delayed, and most patients are already in advanced or metastatic disease at the time of treatment, with a poor prognosis: in previously untreated late-stage or metastatic MPM patients, the median survival rate is about 10% in patients with previously untreated advanced or metastatic MPM MPM is a devastating disease that has made very limited progress in treatment over the past decade Positive top-line results from the CheckMate-743 trial demonstrate the potential of the Opdivo-Yervoy combination to treat MPM on the front line, and are another example of the efficacy and safety of this dual immunotherapy combination found in a variety of tumor types Opdivo and Yervoy are tumor immunotherapy (I-O), through the target immune system of different regulatory elements, the use of the body's own immune system to fight tumors, where Opdivo targeted blocking PD-1/PD-L1 pathway, Yervoy targeted blocking CTLA-4 At present, Boxei Is developing opdivo-Yervoy immunocombination for the treatment of a variety of types of tumors Opdivo-Yervoy is the only FDA-approved of the two-actia that has potential synergies for two different immunological checkpoints (PD-1 and CTLA-4) and works in a complementary manner In the United States, the Opdivo-Yervoy combination has been approved by the FDA to
treat four types of cancer (melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma) currently, two applications for license to supplementary biologics (BLA) in the Opdivo-Yervoy combination are under FDA priority review, including: (1) Opdivo-Yervoy combination first-line treatment of patients with no EGFR or ALK genomic tumor metastatic or recurrent non-small cell lung cancer (NSCLC), a prescription drug user of the BLA The PDUFA target date is May 15 this year; (2) Opdivo-Yervoy combined with a limited course of platinum-containing double-drug chemotherapy for first-line treatment of non-surgically rectructable, late- or recurrent non-small cell lung cancer (NSCLC) patients, with a PDUFA target date of August 6 this year