BMS Opdivo and Yervoy first-line treatment of malignant thoracic intersessives...

On November 23rd, the website of the Drug Review Center (CDE) of the State Drug Administration of China announced that the PD-1 inhibitor Navuliyu monoanti and CTLA-4 antibody Ipimu monoantigen combination therapy with "conditionally approved drugs" would be included in the priority review, and that the adaptation should be developed as: for the treatment of non-removable non-epithelial malignant mammalinoma patients for primary treatment.
it is worth noting that BMS, a dual immunotherapy, has made significant progress in pletrial mesothelioma and is expected to break the 15-year stalemate in the field without new drugs.
screenshot source: CDE's official website, nivolumab, Opdivo, is a PD-1 inhibitor that helps the body restore its anti-tumor immune response by harnessing the body's own immune system.
the product has been approved worldwide to treat advanced melanoma, lung cancer, renal cell carcinoma, Hodgkin's lymphoma and more than a dozen other adaptations.
in China, Navuliyu monoantigen was first approved for market in 2018, and the current adaptations in China are non-small cell lung cancer, head and neck squamous cell carcinoma, stomach/gastroesophageal connecting adenocarcinoma patients.
Yervoy is a CTLA-4 inhibitor.
as one of the main negative regulatory factors of T-cell reaction, CTLA-4 antibody enhances tumor killing ability by enhancing T-cell activity.
the product was approved by the FDA in 2011 for the treatment of advanced melanoma, the world's first approved CTLA-4 antibody drug.
in China, Ipsui has submitted an application for the listing of a new drug by the end of 2019, which is currently under review and approval.
screenshot source: CDE official website this time to be included in the CDE priority review of the proposed adaptation is: Navuliyu monoantigen ipimu monoantigen for the treatment of primary treatment of non-extinct non-epithelial malignant pletrial mesothelioma adult patients.
note that a key Phase 3 clinical trial of the combination therapy to treat previously untreated malignant thoracic mesothelioma has reached the end of the main study period of total survival (OS).
this is a multi-center, randomized, open-label phase 3 trial called CheckMate-743, which included 605 subjects and was randomly assigned to the trial and control groups.
, the subjects in the trial group received up to 2 years of Navuliyu monoanti-Ipimu monoanti-anti-treatment, and the control group subjects received six rounds of Python or carptonin.
Based on the latest results, released in August at the 21st WCLC Online Presidency, mid-term analysis data show that combination therapy extends the patient's mid-level OS by four months (18.1 months vs 14.1 months) compared to chemotherapy and reduces the risk of death by 26 percent.
24 months, 41 percent of the patients in the trial group survived (vs. 27 percent).
, the mesos in the upper and non-cort skin patients were 18.7 months (vs 16.5 months) and 18.1 months (vs 8.8 months), respectively.
of the results of the checkMate-743 study (Photo: WCLC.com) is a highly invasive cancer.
patients generally have poor prognosis, data show that the median survival of patients with untreated advanced or metastasis malignant thoracic mesothelioma is less than one year, the five-year survival rate is about 10%, after a variety of clinical treatment results are not ideal.
, according to an earlier BMS press release, there has been no new systematic treatment approved for 15 years in the field of malignant thoracic mesothelioma, and the survival time of patients cannot be extended.
CheckMate-743 is the first to demonstrate that dual immuno combination therapy can bring significant and lasting total survival benefits to patients with all types of malignant pleural mesothelioma on the front line compared to chemotherapy.
based on this study data, Navuliyu monoantigen combined Ipimu monoanti is expected to become the new standard treatment for such patients.
References: 1. Drug Review Center of the State Drug Administration of China. Retrieved Nov 23, 2020, from snavuliu monoantiu monoantigen ipimu monoanti significantly prolongs the total survival of patients with malignant thoracic mesothelioma. Retrieved April 21, 2020, from Immunotherapy Prolongs Survival While Avoiding Chemotherapy in Malignant Pleural Mesothelioma. Retrieved Aug10, 2020, from Source: Medical Mission Hills