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News on April 24, 2021 // --Bristol-Myers Squibb (BMS) recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review suggesting the approval of the anti-PD-1 therapy Opdivo.
Name: nivolumab, nivolumab) combined with anti-CTLA-4 therapy Yervoy (ipilimumab, ipilimumab) immune combination therapy, first-line treatment of unresectable malignant pleural mesothelioma (MPM) adult patients
.
Now, CHMP’s opinions will be submitted to the European Commission (EC) for review, which usually makes a final review decision within 2 months
.
Name: nivolumab, nivolumab) combined with anti-CTLA-4 therapy Yervoy (ipilimumab, ipilimumab) immune combination therapy, first-line treatment of unresectable malignant pleural mesothelioma (MPM) adult patients
.
Now, CHMP’s opinions will be submitted to the European Commission (EC) for review, which usually makes a final review decision within 2 months
.
If approved, Opdivo+Yervoy will become the first new therapy in Europe to be proven to improve the survival of MPM patients in the past 15 years
.
The positive results from the Phase 3 CheckMate-743 trial showed that the Opdivo+Yervoy regimen has a significant advantage in overall survival (OS) compared with standard-of-care chemotherapy
.
CheckMate-743 is the first phase 3 trial that shows that immunotherapy is beneficial for the first-line treatment of MPM
.
Opdivo+Yervoy will be the first new therapy in Europe to be proven to improve the survival of MPM patients in the past 15 years.
The positive results from the Phase 3 CheckMate-743 trial showed that the Opdivo+Yervoy regimen has a significant advantage in overall survival (OS) compared with standard-of-care chemotherapy
.
CheckMate-743 is the first phase 3 trial that shows that immunotherapy is beneficial for the first-line treatment of MPM
.
.
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 by the US FDA for the treatment of MPM in the past 15 years
.
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 by the US FDA for the treatment of MPM in the past 15 years .
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 by the US FDA for the treatment of MPM in the past 15 years
.
.
FDA
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 tumor cells
.
Up to now, in terms of US regulation, the Opdivo+Yervoy combination therapy has been approved for 7 treatment indications for 6 cancers (melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelial 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), melanoma, and renal cell carcinoma
.
Tumor melanoma.
Up to now, in terms of US regulation, the Opdivo+Yervoy combination therapy has been approved for 7 treatment indications for 6 cancers (melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelial 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), melanoma, and renal cell carcinoma
.
CHMP’s positive review opinions are based on data from the key Phase 3 CheckMate-743 trial, which is the first and only positive Phase 3 immunotherapy trial for the first-line treatment of MPM
.
The results showed that in all randomized patients, compared with chemotherapy (pemetrexed and cisplatin or carboplatin), Opdivo+Yervoy dual immunotherapy (OY combination) showed a long-lasting survival benefit and achieved prolonged overall survival.
(OS) the primary end point
.
Its security is consistent with previous research on Opdivo and Yervoy
.
.
The results showed that in all randomized patients, compared with chemotherapy (pemetrexed and cisplatin or carboplatin), Opdivo+Yervoy dual immunotherapy (OY combination) showed a long-lasting survival benefit and achieved prolonged overall survival.
(OS) the primary end point
.
Its security is consistent with previous research on Opdivo and Yervoy
.
Dr.
Abderrahim Oukessou, Vice President of Bristol-Myers Squibb and Head of Thoracic Tumor Development, said: “In the past 15 years, no new treatment plan that can improve the survival of malignant pleural mesothelioma (MPM) has been approved.
It has only lived for more than a year since the date of this day
.
Now, CHMP’s positive opinion on the Opdivo+Yervoy program brings us one step closer to helping solve the urgent need for effective and proven treatments for this aggressive cancer in Europe
.
We look forward to launching the first immunocombination therapy to provide EU patients with the opportunity to prolong their lives
.
"
TumorAbderrahim Oukessou, Vice President of Bristol-Myers Squibb and Head of Thoracic Tumor Development, said: “In the past 15 years, no new treatment plan that can improve the survival of malignant pleural mesothelioma (MPM) has been approved.
It has only lived for more than a year since the date of this day
.
Now, CHMP’s positive opinion on the Opdivo+Yervoy program brings us one step closer to helping solve the urgent need for effective and proven treatments for this aggressive cancer in Europe
.
We look forward to launching the first immunocombination therapy to provide EU patients with the opportunity to prolong their lives
.
"
Malignant pleural mesothelioma (MPM, image source: ePainAssist.
com)
com)
CheckMate-743 is an open-label, multi-center, randomized phase III 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
.
Clinical Trials.
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
.
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)
.
Two years later, 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 (HR=0.
74; 95%CI: 0.
61-0.
89; p=0.
002)
.
Two years later, the survival rate of patients in the Opdivo+Yervoy group was 41% and that in the chemotherapy group was 27%
.
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-epithelial subgroup: HR=0.
46 [95%CI: 0.
31,0.
68])
.
.
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-epithelial 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 tumor that forms in the lining of the lung
.
The most common cause of the disease is exposure to asbestos
.
The diagnosis of MPM is often delayed.
Most patients are in advanced or metastatic disease at the time of treatment, and the prognosis is usually very poor: in patients with advanced or metastatic MPM who have not been treated previously, the median survival time is <1 to 5 years The survival rate is about 10%
.
Tumor diagnosis.
The most common cause of the disease is exposure to asbestos
.
The diagnosis of MPM is often delayed.
Most patients are in advanced or metastatic disease at the time of treatment, and the prognosis is usually very poor: in patients with advanced or metastatic MPM who have not been treated previously, the median survival time is <1 to 5 years The survival rate is about 10%
.
MPM is a devastating disease.
In the past 15 years, treatment progress has been very limited
.
The positive top-line results from the CheckMate-743 trial demonstrate the potential of the Opdivo+Yervoy combination regimen in the first-line treatment of MPM, and it is another example of the efficacy and safety of this dual immunotherapy combination found in multiple tumor types
.
TumorIn the past 15 years, treatment progress has been very limited
.
The positive top-line results from the CheckMate-743 trial demonstrate the potential of the Opdivo+Yervoy combination regimen in the first-line treatment of MPM, and it is another example of the efficacy and safety of this dual immunotherapy combination found in multiple tumor types
.
Both Opdivo and Yervoy are tumor immunotherapy (IO), which use the body's own immune system to fight tumors by targeting different regulatory elements in the immune system.
Among them, Opdivo targets to block the PD-1/PD-L1 pathway, while Yervoy targets To block CTLA-4
.
Currently, Bristol-Myers Squibb is developing the Opdivo+Yervoy immune combination for the treatment of various types of tumors
.
TumorAmong them, Opdivo targets to block the PD-1/PD-L1 pathway, while Yervoy targets To block CTLA-4
.
Currently, Bristol-Myers Squibb is developing the Opdivo+Yervoy immune combination for the treatment of various types of tumors
.
Opdivo+Yervoy is the only dual immunotherapy approved by the US FDA .
This therapy has a potential synergistic mechanism, targeting two different immune checkpoints (PD-1 and CTLA-4) and acting in a complementary manner
.
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)
.
()
FDA melanomaThis therapy has a potential synergistic mechanism, targeting two different immune checkpoints (PD-1 and CTLA-4) and acting in a complementary manner
.
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)
.
()
Original source: Bristol Myers Squibb Receives Positive CHMP Opinion Recommending app roval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma
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