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Sarclisa for multiple myeloma could death risk by nearly half
Sarclisa for multiple myeloma could death risk by nearly half. Multiple myeloma is the second largest hematological malignancy, with a higher incidence than leukemia.
Not long ago, Abecma, the world’s first CAR-T therapy targeting BCMA, was approved for the treatment of adult patients with relapsed/refractory multiple myeloma. These patients have previously received at least 4 therapies (including proteasome inhibitors, immune The disease is still progressing after modulators, anti-CD38 antibodies).
Recently, there has been good news from the United States. The anti-CD38 antibody Isatuximab (Sarclisa) has been approved to be used in combination with carfilzomib and dexamethasone (Kd) to treat patients with relapsed/refractory multiple myeloma who have previously received 1 to 3 therapies.
This is the second FDA approval for Isatuximab, more than three months ahead of schedule.
▌MM’s “resistance curse”
Multiple myeloma (MM) is the second largest hematological malignancy after non-Hodgkin’s lymphoma and is more common than leukemia. It is characterized by abnormal proliferation of bone marrow plasma cells, which occurs mostly in old age. As some countries’s aging process accelerates, the incidence of multiple myeloma will continue to increase.
In recent years, although great progress has been made in chemotherapy, proteasome inhibitors, immunomodulators, and CD38 targeting antibodies, almost all patients will eventually develop resistance and relapse.
Moreover, with the increase in the number of treatments, the degree, duration, and survival of the patient’s response are gradually decreasing.
For patients with relapsed or refractory multiple myeloma with limited clinical treatment, the prognosis is poor, and the response rate is only 20%-30%, the survival rate is low, and better innovative therapies are urgently needed.
▌New antibody therapy: Isatuximab
Isatuximab is a monoclonal antibody that targets a specific epitope of the CD38 receptor on the surface of plasma cells and tumor cells. CD38 is highly expressed on the surface of MM cells and has become a potential target for antibody-based therapy.
Isatuximab can play a role through a variety of mechanisms of action, including promoting cell apoptosis and regulating immune responses.
In March last year, the FDA first approved Isatuximab combined with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received more than two therapies (including lenalidomide and proteasome inhibitors).
At present, the drug has also submitted a new trial application in China, and it is hoped that the drug can complete the trial as soon as possible and be approved for marketing.
▌The risk of death is reduced by 45%! Clinical trial data surprise
This FDA approval is based on positive data from the Phase 3 IKEMA clinical trial.
The study recruited 302 patients with relapsed/refractory multiple myeloma in 16 countries/regions and randomly divided them into two groups according to 3:2. One group used Isatuximab+Kd and the other group used Kd alone.
The results show that:
Compared with the current standard therapy Kd, the Isatuximab + Kd treatment group reduced the risk of disease progression or death by 45%.
However, in the pre-planned interim analysis, the combination therapy did not reach the median progression-free survival (PFS), but continued improvement in PFS was observed in each patient subgroup.
In addition, there was no statistically significant difference in the overall response rate (ORR) between the two groups. The ORR of the combination treatment group and the Kd group were 86.6% and 82.9%, respectively.
At present, the overall survival (OS) data is still immature.
At present, although there are many treatment methods for patients with multiple myeloma, the prognosis of drug-resistant patients who have experienced multiple relapses is poor.
After the approval of Isatuximab, it has now been included in the two standard treatment regimens for patients with multiple myeloma after the first relapse in the early stage. It is expected to become the first anti-CD38 monoclonal antibody for patients with relapsed drug resistance in the future.
In recent years, new therapies for multiple myeloma have ushered in a “bumper harvest”, which has won new treatment opportunities for relapsed/resistant patients, and the “drug resistance curse” is gradually being broken.
(source:internet, reference only)