Malignant thoracic mesothelioma (MPM) has made significant progress in 15 years! Opdivo-Yervoy immunology portfolio application for listing: significantly extend the total lifetime!

!-- webeditor: page title, """""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""Divo, generic name: nivolumab, navuliyu monoanti) joint anti-CTLA-4 therapy Yervoy (ipilimumab, Iplimma) first-line treatment of malignant pleurisy mesothelioma (MPM) Category II change application, and began a centralized review process.
this Category II change application was supported by the Key III CheckMate-743 study.
note that CheckMate-743 is the first and only Phase III trial in which first-line immunotherapy significantly improves the survival of MPM patients.
results showed that in all randomized patients, Opdivo-Yervoy dual immunotherapy (OY combination) showed long-lasting survival benefits and achieved the primary endpoint of extended total lifetime (OS) compared to chemotherapy (Peme curvature and cisplatin or carbopent).
its security is consistent with previous studies of Opdivo and Yervoy.
Opdivo-Yervoy is a unique combination of 2 immuno-checkpoint inhibitors with potential synergistic mechanisms for 2 different checkpoints (PD-1 and CTLA-4) to help destroy tumor cells.
to date, Opdivo-Yervoy combination therapy has been approved for 6 therapeutic adaptations for 5 types of cancer (melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer). Sabine Maier, vice president of clinical development at
Centennial Mercer, said: "Malignant thoracic mesothelioma is not only a particularly aggressive cancer, it has proven to be difficult to treat and no new options have been approved for many years to meaningfully extend survival.
The CheckMate-743 test shows the potential of Opdivo-Yervoy to help address this significant unsepped demand.
look forward to working with the EMA to achieve the goal of applying this dual immunotherapy to patients in Europe.
"CheckMate-743 is an open-label, multi-center, randomized Phase III clinical trial that included 605 previously untreated, non-excisive MPM patients who evaluated the efficacy and safety of Opdivo-Yervoy dual immunotherapy for first-line therapy and compared it with chemotherapy (Peme curvature and cisplatin or carp platinum).
, patients were randomly assigned to receive Opdivo-Yervoy (n-303) and chemotherapy (n-302).
the Opdivo-Yervoy treatment group, Opdivo was given 3mg/kg once every two weeks and Yervoy was given 1mg/kg once every six weeks for 24 months or until the disease progressed or beedic of unacceptable toxicity.
chemotherapy group, receive cisplatin 75mg/m2 or carbapau AAUC 5 combined PPS 500mg/m2 for 21 days for a total of 6 cycles, or until the disease progresses or there is unacceptable toxicity.
end of the study was the total lifetime (OS) of all randomized patients.
results showed that the study reached the main endpoint: opdivo-Yervoy group OS improved significantly (medium LS: 18.1 months vs 14.1 months), reduced risk of death by 26% (HR-0.74; 96.6%CI:0.60-0.91; p-0.002).
two years, the survival rate was 41% in the Opdivo-Yervoy group and 27% in the chemotherapy group.
is a recognized prognosis factor for mesothelioma, and non-cortical patients usually have a poor prognosis.
in the CheckMate-743 study, Opdivo-Yervoy showed an increase in total survival in both non-supersethical and superseedd-like MPMs, and greater survival benefits were observed in the non-supersethic subgroups.
specific data are: the mesothyst OS was 18.7 months for upper-skin patients treated with Opdivo-Yervoy, 18.1 months for non-supersethic patients, 16.5 months for upper-skin patients treated with chemotherapy, and 8. 8 months (upper-skin subgroup: HR=0.86 (95%CI: 0.69, 1.08); non-upper-skin subgroup: HR=0.46 (95% CI: 0.31,0.68) ).
study, the safety of opdivo-Yervoy dual immunotherapy was consistent with previously reported studies, and no new safety signals were observed.
malignant thoracic mesothelioma (MPM) is a rare and invasive tumor formed in the lining of the lungs.
most common cause of the disease is exposure to asbestos. diagnosis of
MPM is often delayed, most patients are already in advanced or metastasis at the time of treatment, and the prognosis is usually poor: in previously untreated patients with advanced or metastasis MPM, the medium survival period is 1 year and the five-year survival rate is about 10%.
MPM is a devastating disease and progress in treatment has been limited over the past 15 years.
positive top-line results from the CheckMate-743 trial demonstrated the potential of the first-line treatment of MPM in the Opdivo-Yervoy combination drug programme, 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 both tumor immunotherapy (I-O), which targets different regulatory elements in the immune system, using the body's own immune system to fight tumors, with Opdivo targeting blocking PD-1/PD-L1 paths and Yervoy targeting CTLA-4.
currently, Shishi Shiguibao is developing an Opdivo-Yervoy immunology combination for the treatment of a variety of types of tumors.
Opdivo-Yervoy is the only dual immunotherapy approved by the FDA in the United States, with potential synergies for two different immune checkpoints (PD-1 and CTLA-4) and working in a complementary manner.
U.S. regulatory aspects, Opdivo-Yervoy combination therapy has been approved for six treatment adaptations for five types of cancer (melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer).
() !--/ewebeditor:page--!--ewebeditor:page title"--original source: European Medicines Agency Validates Bristol Myers Squibb's Type II Variation application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma !--/ewebeditor:page--.