Significant progress in malignant thoracic mesothelioma (MPM)! Opdivo-Yervoy USA approved: first-line immunotherapy, significantly extending survival!

October 07, 2020 // -- BMS recently announced that the U.S. Food and Drug Administration (FDA) has approved the anti-PD-1 therapy Opdivo (Odi) Waugh, generic name: nivolumab, Navuliyu monoanti, 360mg every 3 weeks) combined anti-CTLA-4 therapy Yervoy (ipilimumab, Iplimma) first-line treatment of non-extinct malignant pleurisy mesothelioma (MPM) adult patients.
medication, Opdivo is 360mg every 3 weeks and Yervoy is 1mg/kg every 6 weeks.
so far, the combination has been approved for the treatment of 3 chest tumors.
it's worth noting that Opdivo-Yervoy is the first and only immunotherapy to be approved for first-line treatment of non-excisible MPM, and the first new systematic therapy approved by the FDA in the past 15 years.
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 7 therapeutic adaptations for 6 types of cancer (melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant thoracic mesothelioma).
this approval is based on data from the Key III CheckMate-743 study, the first Phase III study in which first-line immunotherapy significantly improved overall survival in MPM patients.
results showed that in all randomized patients, Opdivo-Yervoy dual immunotherapy (OY combination) showed long-lasting survival benefits compared to chemotherapy (Pemite and cisplatin or carbopent), reaching the primary endpoint of extended total lifetime (OS).
its security is consistent with previous studies of Opdivo and Yervoy.
"Malignant thoracic mesothelioma is a rare cancer with limited treatment options," said Anne S. Tsao, an investigator on the Check Mate-743 study and director of the mesothelioma program at the University of Texas MD Anderson Cancer Center, a professor of thoracic oncology and director of the department.
when the disease is diagnosed at an advanced stage, the five-year survival rate is about 10%.
the survival results of the CheckMate-743 study, opdivo-Yervoy combined application will become a new first-line standard nursing choice.
this is exciting news and offers hope to patients with this devastating disease and to the health care providers who care for them.
"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 OS: 18.1 months vs 14.1 months), reduced risk of death by 26% (HR-0.74; 95%CI:0.61-0.89; 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 years, with a five-year survival rate of 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, which has a potentially synergistic mechanism for two different immune checkpoints (PD-1 and CTLA-4) and works in a complementary manner.
U.S. regulatory aspects, Opdivo-Yervoy combination therapy has been approved for seven therapeutic adaptations to six types of cancer (melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer).
() Origin: U.S. Food and Drug Administration approves Opdivo? (nivolumab) and Yervoy? (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma<!--/ewebeditor:page->.