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▎ WuXi AppTec content team editor May 25, 2021, Oncopeptides AB announced that its peptide-conjugated drug Pepaxto (melphalan flufenamide) is in the treatment of relapsed/refractory multiple myeloma (R/R MM) phase 3 clinical trial Positive results were obtained in the experiment.
Pepaxto reached the standard of non-inferiority compared with commonly used diamine drugs on the primary endpoint of progression-free survival (PFS).
Compared with the active control group, the median PFS of the Pepaxto group was more than 40% higher, and the overall response rate (ORR) was also higher.
Pepaxto is the first anti-cancer peptide drug conjugate approved by the US FDA.
Based on these data, Oncopeptides plans to submit a supplementary new drug application (sNDA) to the US FDA in the fourth quarter of this year.
The Phase 3 clinical trial project was launched in 2017 and enrolled 495 patients from 21 countries to evaluate the efficacy and safety of Pepaxto in the treatment of patients with R/R MM compared with pomalidomide.
According to the evaluation of the independent review committee, for the primary endpoint of PFS, Pepaxto has a hazard ratio of 0.
817 (95% CI: 0.
659-1.
012, p=0.
0640) compared to the active control group, indicating that its effectiveness has reached the standard of non-inferiority.
According to the researchers' assessment, the hazard ratio of PFS is 0.
790 (95% CI: 0.
639-0.
976).
In both evaluations, the median PFS of the Pepaxto group was more than 40% higher than that of the active control group.
In addition, the ORR of Pepaxto was 32.
1%, which was higher than the 26.
5% of the active control group. The discontinuation rates of the two drugs due to adverse events are similar, and the safety of Pepaxto is consistent with previous studies, and remains consistent across different age subgroups.
Pepaxto is a "first-in-class" peptide-conjugated drug that couples alkylating agents with peptides that target aminopeptidase.
Aminopeptidase is overexpressed in tumor cells, especially in advanced cancers or tumors with high mutation burden.
In in vitro experiments, Pepaxto can increase the concentration of the alkylating agent in the cell, and its ability to kill MM cells is 50 times higher than that of the alkylating agent it carries.
The combination therapy consisting of Pepaxto and dexamethasone was approved by the U.
S.
FDA on February 26, 2021.
It is used to treat at least four previous therapies, and the disease has a risk of at least one proteasome inhibitor, one Immunomodulators and a CD38 monoclonal antibody that are resistant to MM patients.
"Following the accelerated approval of Pepaxto in the United States earlier this year, the positive results of this study mark another major milestone for Oncopeptides.
This is very exciting news for patients, indicating that Pepaxto may become a relapse/difficult Part of the standard treatment for curative myeloma.
" said Mr.
Marty J Duvall, CEO of Oncopeptides.
MM is a malignant blood cancer caused by abnormal proliferation of plasma cells in the bone marrow.
Cancerous plasma cells can affect the production of normal blood cells, leading to decreased blood cell index, bone damage and kidney damage.
Although in the past ten years, the emergence of innovative therapies has significantly revolutionized the treatment of MM.
However, many patients with MM will still relapse and develop resistance to existing therapies.
Therefore, these R/R MM patients still need new treatment options. Reference: [1] Phase 3 OCEAN study demonstrates that melflufen is at least as efficacious as pomalidomide, the most used medicine in relapsed refractory multiple myeloma.
Retrieved May 25, 2021, from media/press-releases/phase-3-ocean-study-demonstrates-that-melflufen-is-at-least-as-efficacious-as-pomalidomide-the-most-used-medicine-in-relapsed-refractory-multiple- myeloma Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need guidance on the treatment plan, please go to a regular hospital for treatment.
Pepaxto reached the standard of non-inferiority compared with commonly used diamine drugs on the primary endpoint of progression-free survival (PFS).
Compared with the active control group, the median PFS of the Pepaxto group was more than 40% higher, and the overall response rate (ORR) was also higher.
Pepaxto is the first anti-cancer peptide drug conjugate approved by the US FDA.
Based on these data, Oncopeptides plans to submit a supplementary new drug application (sNDA) to the US FDA in the fourth quarter of this year.
The Phase 3 clinical trial project was launched in 2017 and enrolled 495 patients from 21 countries to evaluate the efficacy and safety of Pepaxto in the treatment of patients with R/R MM compared with pomalidomide.
According to the evaluation of the independent review committee, for the primary endpoint of PFS, Pepaxto has a hazard ratio of 0.
817 (95% CI: 0.
659-1.
012, p=0.
0640) compared to the active control group, indicating that its effectiveness has reached the standard of non-inferiority.
According to the researchers' assessment, the hazard ratio of PFS is 0.
790 (95% CI: 0.
639-0.
976).
In both evaluations, the median PFS of the Pepaxto group was more than 40% higher than that of the active control group.
In addition, the ORR of Pepaxto was 32.
1%, which was higher than the 26.
5% of the active control group. The discontinuation rates of the two drugs due to adverse events are similar, and the safety of Pepaxto is consistent with previous studies, and remains consistent across different age subgroups.
Pepaxto is a "first-in-class" peptide-conjugated drug that couples alkylating agents with peptides that target aminopeptidase.
Aminopeptidase is overexpressed in tumor cells, especially in advanced cancers or tumors with high mutation burden.
In in vitro experiments, Pepaxto can increase the concentration of the alkylating agent in the cell, and its ability to kill MM cells is 50 times higher than that of the alkylating agent it carries.
The combination therapy consisting of Pepaxto and dexamethasone was approved by the U.
S.
FDA on February 26, 2021.
It is used to treat at least four previous therapies, and the disease has a risk of at least one proteasome inhibitor, one Immunomodulators and a CD38 monoclonal antibody that are resistant to MM patients.
"Following the accelerated approval of Pepaxto in the United States earlier this year, the positive results of this study mark another major milestone for Oncopeptides.
This is very exciting news for patients, indicating that Pepaxto may become a relapse/difficult Part of the standard treatment for curative myeloma.
" said Mr.
Marty J Duvall, CEO of Oncopeptides.
MM is a malignant blood cancer caused by abnormal proliferation of plasma cells in the bone marrow.
Cancerous plasma cells can affect the production of normal blood cells, leading to decreased blood cell index, bone damage and kidney damage.
Although in the past ten years, the emergence of innovative therapies has significantly revolutionized the treatment of MM.
However, many patients with MM will still relapse and develop resistance to existing therapies.
Therefore, these R/R MM patients still need new treatment options. Reference: [1] Phase 3 OCEAN study demonstrates that melflufen is at least as efficacious as pomalidomide, the most used medicine in relapsed refractory multiple myeloma.
Retrieved May 25, 2021, from media/press-releases/phase-3-ocean-study-demonstrates-that-melflufen-is-at-least-as-efficacious-as-pomalidomide-the-most-used-medicine-in-relapsed-refractory-multiple- myeloma Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need guidance on the treatment plan, please go to a regular hospital for treatment.
