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This article is from the NEJM Journal Watch A New Triplet Therapy Option for Multiple Myeloma.
Commentary Author: Michael E.
Williams, MD, ScM patients with relapsed or refractory myeloma The addition of monoclonal antibody isatuximab on the basis of combined therapy with dexamethasone can improve the outcome
.
For patients with multiple myeloma, the combination therapy (including immunomodulators, proteasome inhibitors, or both of the above and dexamethasone administered weekly) in addition to the use of anti-myeloma therapeutic monoclonal antibodies can improve the efficacy
.
The investigator reported the results of an industry-funded international, prospective, phase 3 trial that compared carfilzomib and dexamethasone (administered weekly) in combination with or without anti-CD38 The efficacy of monoclonal antibody isatuximab (administered at a dose of 10 mg/kg per week for 4 weeks, and then reduced to 10 mg/kg every 2 weeks)
.
Adult patients who had received first-line to third-line treatment were randomly assigned (in a ratio of 3:2) to the isatuximab group (n=179) or the control group (n=123)
.
The treatment is continued until the patient's disease progresses or toxicity occurs
.
At a median follow-up of 20.
7 months, the isatuximab group did not achieve progression-free survival (PFS) (primary endpoint), while the control group was 19 months (hazard ratio, 0.
53; P=0.
0007); 2-year PFS was 69% vs.
46% (P=0.
001)
.
The total remission rates of the two groups were similar (87% and 83%), but the proportion of patients in the isatuximab group who achieved very good partial remission or better efficacy was higher (73% vs.
56%; P=0.
001); The remission rate was 40% vs.
28%
.
In terms of the proportion of patients with no measurable residual disease (MRD), the isatuximab group also outperformed the control group (30% vs.
13%)
.
The toxicity of the two groups was similar.
The rate of discontinuation due to toxicity was 8% in the isatuximab group vs.
14% in the control group
.
Treatment-related mortality in both groups was 3%
.
Comment This study confirmed the benefits of isatuximab added to the combination therapy of carfilzomib and dexamethasone in adult patients with relapsed or refractory myeloma, and their PFS and response depth were improved
.
The US FDA recently approved this treatment plan based on the above results
.
Further research will help determine whether time-limited treatment can be used for patients who have achieved MRD-negative remission, and whether delayed toxicity, such as increased infections, can be observed after longer treatment
.
Moreau P et al.
Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): A multicentre, open-label, randomised phase 3 trial.
Lancet 2021 Jun 19; 397:2361.
(https://doi.
org/10.
1016/S0140-6736(21)00592-4) NEJM Journal Watch is published by NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field to help doctors understand and use the latest developments
.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat
.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by the Jiahui Medical Research and Education Group (J-Med) and the "New England Journal of Medicine" (NEJM)
.
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group
.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn
.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities
.
Commentary Author: Michael E.
Williams, MD, ScM patients with relapsed or refractory myeloma The addition of monoclonal antibody isatuximab on the basis of combined therapy with dexamethasone can improve the outcome
.
For patients with multiple myeloma, the combination therapy (including immunomodulators, proteasome inhibitors, or both of the above and dexamethasone administered weekly) in addition to the use of anti-myeloma therapeutic monoclonal antibodies can improve the efficacy
.
The investigator reported the results of an industry-funded international, prospective, phase 3 trial that compared carfilzomib and dexamethasone (administered weekly) in combination with or without anti-CD38 The efficacy of monoclonal antibody isatuximab (administered at a dose of 10 mg/kg per week for 4 weeks, and then reduced to 10 mg/kg every 2 weeks)
.
Adult patients who had received first-line to third-line treatment were randomly assigned (in a ratio of 3:2) to the isatuximab group (n=179) or the control group (n=123)
.
The treatment is continued until the patient's disease progresses or toxicity occurs
.
At a median follow-up of 20.
7 months, the isatuximab group did not achieve progression-free survival (PFS) (primary endpoint), while the control group was 19 months (hazard ratio, 0.
53; P=0.
0007); 2-year PFS was 69% vs.
46% (P=0.
001)
.
The total remission rates of the two groups were similar (87% and 83%), but the proportion of patients in the isatuximab group who achieved very good partial remission or better efficacy was higher (73% vs.
56%; P=0.
001); The remission rate was 40% vs.
28%
.
In terms of the proportion of patients with no measurable residual disease (MRD), the isatuximab group also outperformed the control group (30% vs.
13%)
.
The toxicity of the two groups was similar.
The rate of discontinuation due to toxicity was 8% in the isatuximab group vs.
14% in the control group
.
Treatment-related mortality in both groups was 3%
.
Comment This study confirmed the benefits of isatuximab added to the combination therapy of carfilzomib and dexamethasone in adult patients with relapsed or refractory myeloma, and their PFS and response depth were improved
.
The US FDA recently approved this treatment plan based on the above results
.
Further research will help determine whether time-limited treatment can be used for patients who have achieved MRD-negative remission, and whether delayed toxicity, such as increased infections, can be observed after longer treatment
.
Moreau P et al.
Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): A multicentre, open-label, randomised phase 3 trial.
Lancet 2021 Jun 19; 397:2361.
(https://doi.
org/10.
1016/S0140-6736(21)00592-4) NEJM Journal Watch is published by NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field to help doctors understand and use the latest developments
.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat
.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by the Jiahui Medical Research and Education Group (J-Med) and the "New England Journal of Medicine" (NEJM)
.
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group
.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn
.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities
.
