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News on May 27, 2021 /bioon.
com" target="_blank">/ --Ono Pharmaceutical recently announced that the Japanese regulatory agency has approved the anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, nivolumab) combined with anti-CTLA-4 therapy Yervoy (ipilimumab, Yi Primoma) immunocombination therapy, the first-line treatment for patients with unresectable advanced or recurrent malignant pleural mesothelioma (MPM).
bioon.com" target="_blank">/ --Ono Pharmaceutical recently announced that the Japanese regulatory agency has approved the anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, nivolumab) combined with anti-CTLA-4 therapy Yervoy (ipilimumab, Yi Primoma) immunocombination therapy, the first-line treatment for patients with unresectable advanced or recurrent malignant pleural mesothelioma (MPM).
com" target="_blank">
In the United States, the Opdivo+Yervoy program was approved by the FDA in October 2020 to treat adult patients with unresectable MPM as the first-line treatment.
It is worth mentioning that Opdivo+Yervoy is the first and only immunotherapy approved for the first-line treatment of unresectable MPM, and it is also the first new systemic therapy approved for the treatment of MPM in the past 15 years .
Currently, the Opdivo+Yervoy regimen for the treatment of MPM is also under review by the European Medicines Agency (EMA).
Opdivo+Yervoy is the first and only immunotherapy approved for the first-line treatment of unresectable MPM, and it is also the first new systemic therapy approved for the treatment of MPM in the past 15 yearsIt is worth mentioning that Opdivo+Yervoy is the first and only immunotherapy approved for the first-line treatment of unresectable MPM, and it is also the first new systemic therapy approved for the treatment of MPM in the past 15 years .
Currently, the Opdivo+Yervoy regimen for the treatment of MPM is also under review by the European Medicines Agency (EMA).
Opdivo+Yervoy is a unique combination of 2 immune checkpoint inhibitors, with a potential synergistic mechanism, targeting 2 different checkpoints (PD-1 and CTLA-4) to help destroy bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor cells.
Up to now, in terms of US regulation, the Opdivo+Yervoy combination therapy has been approved for 7 treatment indications for 6 types of cancer (melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelium) tumor).
In the European Union, a combination drug regimen based on Opdivo+Yervoy has been approved to treat 3 different types of advanced cancers: non-small cell lung cancer (NSCLC), bioon.
com/course_video/ge-tian831892.
html">melanoma, and renal cell carcinoma.
Opdivo+Yervoy is a unique combination of two immune checkpoint inhibitors, with a potential synergistic mechanism, targeting two different checkpoints (PD-1 and CTLA-4) to help destroy bioon.com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor cells.
Up to now, in terms of US regulation, the Opdivo+Yervoy combination therapy has been approved for 7 treatment indications for 6 types of cancer (melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelium) tumor).
In the European Union, a combination drug regimen based on Opdivo+Yervoy has been approved to treat 3 different types of advanced cancers: non-small cell lung cancer (NSCLC), bioon.
com/course_video/ge-tian831892.
html">melanoma, and renal cell carcinoma.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor cells.
bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">Tumor Approved for 7 Treatment Indications for 6 Types of Cancer bioon.
com/course_video/ge-tian831892.
html">Melanoma
The approval is based on data from the key Phase 3 CheckMate-743 trial, which is the first positive phase 3 immunotherapy trial for the first-line treatment of MPM.
The results showed that in all randomized patients, compared with standard-of-care chemotherapy (pemetrexed and cisplatin or carboplatin), Opdivo+Yervoy dual immunotherapy (OY combination) showed long-lasting survival benefits , reaching a prolonged total The primary end point of survival (OS).
Its security is consistent with previous research on Opdivo and Yervoy.
Compared with standard-of-care chemotherapy (pemetrexed and cisplatin or carboplatin), Opdivo+Yervoy dual immunotherapy (OY combination) shows long-lasting survival benefitsThe results showed that in all randomized patients, compared with standard-of-care chemotherapy (pemetrexed and cisplatin or carboplatin), Opdivo+Yervoy dual immunotherapy (OY combination) showed long-lasting survival benefits , reaching a prolonged total The primary end point of survival (OS).
Its security is consistent with previous research on Opdivo and Yervoy.
Malignant pleural mesothelioma (MPM, image source: ePainAssist.
com)
com)
CheckMate-743 is an open-label, multi-center, randomized phase III bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trial that enrolled 605 patients with previously untreated, unresectable MPM, and evaluated the efficacy of Opdivo+Yervoy dual immunotherapy for first-line treatment And safety, and compared with chemotherapy (pemetrexed + cisplatin or carboplatin).
In the study, patients were randomly assigned to receive Opdivo+Yervoy (n=303) and chemotherapy (n=302) treatment.
In the Opdivo+Yervoy treatment group, Opdivo was administered 3 mg/kg once every two weeks, and Yervoy was administered 1 mg/kg once every six weeks for 24 months or until disease progression or unacceptable toxicity occurred.
The chemotherapy group received cisplatin 75mg/m2 or carboplatin AUC 5 combined with pemetrexed 500mg/m2, 21 days as a cycle, a total of 6 cycles, or until the disease progressed or unacceptable toxicity appeared.
The primary endpoint of the study is the overall survival (OS) of all randomized patients.
bioon. com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trial that enrolled 605 patients with previously untreated, unresectable MPM, and evaluated the efficacy of Opdivo+Yervoy dual immunotherapy for first-line treatment And safety, and compared with chemotherapy (pemetrexed + cisplatin or carboplatin).
In the study, patients were randomly assigned to receive Opdivo+Yervoy (n=303) and chemotherapy (n=302) treatment.
In the Opdivo+Yervoy treatment group, Opdivo was administered 3 mg/kg once every two weeks, and Yervoy was administered 1 mg/kg once every six weeks for 24 months or until disease progression or unacceptable toxicity occurred.
The chemotherapy group received cisplatin 75mg/m2 or carboplatin AUC 5 combined with pemetrexed 500mg/m2, 21 days as a cycle, a total of 6 cycles, or until the disease progressed or unacceptable toxicity appeared.
The primary endpoint of the study is the overall survival (OS) of all randomized patients.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">Clinical Trials
The results showed that the study reached the primary endpoint: Compared with the chemotherapy group, the Opdivo+Yervoy group had a significant improvement in OS (median OS: 18.
1 months vs 14.
1 months), and a 26% reduction in the risk of death (HR=0.
74; 95%CI: 0.
61-0.
89; p=0.
002).
After 2 years, the survival rate of patients in the Opdivo+Yervoy group was 41% and that in the chemotherapy group was 27%.
Significant improvement in OS (median OS: 18. 1 months vs 14.
1 months), and a 26% reduction in the risk of death (HR=0.
74; 95%CI: 0.
61-0.
89; p=0.
002).
After 2 years, the survival rate of patients in the Opdivo+Yervoy group was 41% and that in the chemotherapy group was 27%.
1 months vs 14.
1 months) and a 26% reduction in the risk of death
Histology is a recognized prognostic factor for mesothelioma, and non-epithelial patients usually have a poor prognosis.
In the CheckMate-743 study, Opdivo+Yervoy showed an improvement in overall survival in both non-epithelial and epithelioid MPMs, and a greater survival benefit was observed in the non-epithelial subgroup.
The specific data are: the median OS of epithelioid patients treated with Opdivo+Yervoy was 18.
7 months, the median OS of non-epithelial patients was 18.
1 months, and the median OS of epithelioid patients treated with chemotherapy was 16.
5 months, non-epithelial patients The median OS of the patients was 8.
8 months (epitheloid subgroup: HR=0.
86 [95%CI: 0.
69, 1.
08]; non-epitheloid subgroup: HR=0.
46 [95%CI: 0.
31,0.
68]).
Opdivo+Yervoy showed improvement in overall survival in both non-epithelial and epithelioid MPMIn the CheckMate-743 study, Opdivo+Yervoy showed an improvement in overall survival in both non-epithelial and epithelioid MPMs, and a greater survival benefit was observed in the non-epithelial subgroup.
The specific data are: the median OS of epithelioid patients treated with Opdivo+Yervoy was 18.
7 months, the median OS of non-epithelial patients was 18.
1 months, and the median OS of epithelioid patients treated with chemotherapy was 16.
5 months, non-epithelial patients The median OS of the patients was 8.
8 months (epitheloid subgroup: HR=0.
86 [95%CI: 0.
69, 1.
08]; non-epitheloid subgroup: HR=0.
46 [95%CI: 0.
31,0.
68]).
In this study, the safety of Opdivo+Yervoy dual immunotherapy is consistent with previously reported studies, and no new safety signals have been observed.
Malignant pleural mesothelioma (MPM) is a rare and very aggressive bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor that forms in the lining of the lung.
The most common cause of the disease is related to the inhalation of asbestos in the occupation or living environment.
MPM occurs approximately 30-50 years after asbestos exposure, and its bioon.
com/vitroDiagnostics/" target="_blank">diagnosis is often delayed.
Most patients are already in advanced or metastatic disease at the time of treatment, and the prognosis is usually poor: in patients with advanced or metastatic MPM who have not been previously treated The median survival time is less than 1 year, and the 5-year survival rate is about 10%.
The most common cause of malignant pleural mesothelioma (MPM) bioon. com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor that forms in the lining of the lung.
The most common cause of the disease is related to the inhalation of asbestos in the occupation or living environment.
MPM occurs approximately 30-50 years after asbestos exposure, and its bioon.
com/vitroDiagnostics/" target="_blank">diagnosis is often delayed.
Most patients are already in advanced or metastatic disease at the time of treatment, and the prognosis is usually poor: in patients with advanced or metastatic MPM who have not been previously treated The median survival time is less than 1 year, and the 5-year survival rate is about 10%.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumors is related to the inhalation of asbestos in the occupation or living environment.
bioon.
com/vitroDiagnostics/" target="_blank">diagnosis
MPM is a devastating disease.
In the past 15 years, treatment progress has been very limited.
Standard care is a combination of pemetrexed and cisplatin.
The Opdivo+Yervoy combination regimen will become a new treatment option for this patient group.
The positive result from the CheckMate-743 trial proves the potential of this regimen in the first-line treatment of MPM and is another example of the efficacy and safety of this dual immunotherapy combination found in multiple bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor types.
bioon. In the past 15 years, treatment progress has been very limited.
Standard care is a combination of pemetrexed and cisplatin.
The Opdivo+Yervoy combination regimen will become a new treatment option for this patient group.
The positive result from the CheckMate-743 trial proves the potential of this regimen in the first-line treatment of MPM and is another example of the efficacy and safety of this dual immunotherapy combination found in multiple bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor types.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">Tumor
Both Opdivo and Yervoy are tumor immunotherapy (IO), which use the body's own immune system to fight bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumors by targeting different regulatory elements in the immune system .
Opdivo targets the PD-1/PD-L1 pathway and Yervoy targets To block CTLA-4.
bioon. com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumors by targeting different regulatory elements in the immune system .
Opdivo targets the PD-1/PD-L1 pathway and Yervoy targets To block CTLA-4.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">Tumor
Opdivo+Yervoy is the only dual immunotherapy that has received regulatory approval.
This therapy has a potential synergistic mechanism, targeting two different immune checkpoints (PD-1 and CTLA-4) and acting in a complementary manner .
Up to now, the Opdivo+Yervoy combination therapy has been approved for 7 treatment indications for 6 types of cancer ( bioon.
com/course_video/ge-tian831892.
html">melanoma , renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer), which vary from country to country.
bioon. This therapy has a potential synergistic mechanism, targeting two different immune checkpoints (PD-1 and CTLA-4) and acting in a complementary manner .
Up to now, the Opdivo+Yervoy combination therapy has been approved for 7 treatment indications for 6 types of cancer ( bioon.
com/course_video/ge-tian831892.
html">melanoma , renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer), which vary from country to country.
com/course_video/ge-tian831892.
html">Melanoma
Ono Pharmaceuticals is the original developer of Opdivo.
The company entered into a cooperation with Bristol-Myers Squibb in 2011 to authorize Bristol-Myers Squibb's Opdivo development and commercialization rights except Japan, South Korea, and Taiwan.
In July 2014, the two parties further expanded their strategic cooperation to develop and commercialize a variety of immunotherapies (including single-drug and combination therapies) for cancer patients in Japan, South Korea, and Taiwan.
Up to now, Opdivo has been approved in more than 60 countries including Japan, South Korea, China, the United States and the European Union.
()
The company entered into a cooperation with Bristol-Myers Squibb in 2011 to authorize Bristol-Myers Squibb's Opdivo development and commercialization rights except Japan, South Korea, and Taiwan.
In July 2014, the two parties further expanded their strategic cooperation to develop and commercialize a variety of immunotherapies (including single-drug and combination therapies) for cancer patients in Japan, South Korea, and Taiwan.
Up to now, Opdivo has been approved in more than 60 countries including Japan, South Korea, China, the United States and the European Union.
()
Original source: Opdivo and Yervoy Combination Therapy app roved in Japan for First-line Treatment of Unresectable Advanced or Recurrent Malignant Pleural Mesothelioma
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