BMS Opdivo and Yervoy first-line treatment of malignant thoracic mesothelioma are to be included in the priority review

Screenshot Source: CDE.com Nivolumab, Opdivo is a PD-1 inhibitor that helps the body restore its anti-tumor immune response by utilizing 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 being reviewed and approved.
Screenshot Source: CDE Official Website The proposed adaptation to CDE to be included in the priority review is: Navuliyu single anti-combined epipentome for the treatment of non-extinct non-epithelial type malignant 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 Bureau Seminar: Interim 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%.
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.
study of CheckMate-743 (Photo: WCLC.com) Malignant thoracic mesothelioma 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, for 15 years, no new systemic treatments have been approved 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.
: The Drug Review Center of the State Drug Administration of China. Retrieved Nov 23, 2020, from s.2 s. navuliyu monoantiu monoantigen ipimu monoanti significantly prolongs the total survival of patients with malignant thoracic mesothelioma. Retrieved April 21, 2020, from [3]Dual Immunotherapy Prolongs Survival While Avoiding Chemotherapy in Malignant Pleural Mesothelioma. Retrieved Aug10, 2020, from Source: Medical Mission Hills