Blood: Isatuximab ± treatment of relapse/reassoilable multiple myeloma

Multiple myeloma (MM) is a malignant disease of abnormal proliferation of cloned plasma cells, which is the second most common malignant tumor in the blood system in many countries and is mostly in old age and is still incurable.
years, with the introduction of new drugs and the improvement of testing methods, MM diagnosis and treatment can be continuously improved and perfected, the survival of patients significantly improved.
, however, relapsed/resusable multiple myeloma (R/RMM) treatment is still one of the major challenges to disease management, and the treatment of R/RMM patients in China is very limited and the efficacy is not ideal.
Isatuximab is a IgG1 embedded monoclonal antibody developed by French pharmaceutical giant Sanofi that targets the specific cousin of the plasma cell CD38 subject, triggering a variety of unique mechanisms of action, including promoting programmed tumor cell death (apoptosis) and immunomodulation activity.
was approved by the FDA on March 2, 2020, for the treatment of adult patients with multiple myeloma who had received ≥ anti-cancer treatments, including lysamide and protease inhibitors.
is a new type of CD38 antibody for new immunotherapy for R/RMM in recent years, following Daratumumab.
this is a Phase 2 study that evaluates the efficacy of Isatuximab as a single therapy or a combination of symethon therapy for relapse/reassociative multiple myeloma (RRMM).
the subjects did not respond to immunomodulation drugs (IMIDs) and protease inhibitors (PI) therapy, or have been treated with ≥3 combined immunomodulation drugs and protease inhibitors in the past.
patients receive isatuximab single treatment (1st, 8th, 15th and 22nd days of cycle 1, 20 mg/kg, followed by 1st and 15th days of each course of treatment; ISA group) or combined sesamisong (40 mg/d patients ≥20 mg/d) 1 time per week; ISA-Dex group).
164 patients were recruited and four courses were treated in the middle.
ISA and ISA-Dex patients received a medium of 5 (1-24) and 7 (1-22) cycles, respectively, and at the end of the analysis, 13/109 (11.9%) and 15/55 (27.3%) patients were still receiving treatment.
the total mitigation rates (primary efficacy endpoints) of the ISA and ISA-Dex groups were 23.9% and 43.6%, respectively (advantage ratio, 0.405, P=0.008).
the medium progress-free and total lifetimes of the ISA group were 4.9 months and 18.9 months, respectively, while the Isa-Dex group was 10.2 months and 17.3 months, respectively.
infusion reactions (mostly 1/2 levels) and hematological abnormalities are the most common adverse events.
two groups ≥ level 3 infection rates (22.0 per cent and 21.8 per cent, respectively).
in general, Isatuximab combined with Symesong treatment improved the remission and survival rates of patients with relapsed/resuscable multiple myeloma without significant adverse reactions.
CD38 single resistance currently listed in China is Daratumumab, and the results of its Phase II study show that the objective remission rate (ORR) of single-drug therapy is 29.2%;
Ii study of Isatuximab showed a single drug effective rate of 26%.
based on Isatuximab's Phase III ICARIA-MM study data, Isatuximab combined pomadumam-desamisund can significantly extend a progress-free lifetime (medium PFS: 11.53 months vs 6.47) compared to standard treatment options (Pomadumamide-Desamisong) months;HR=0.596,95%CI:0.44-0.81, p=0.001), while significantly increasing the total mitigation rate (ORR:60.4% vs 35.3%, p<0.0001).
based on these clinical studies, CD38 monoantial therapy should be preferred for R/RMM.
With the deepening of clinical research on these drugs, CD38 monoantinance may gradually go from the second line to the first line, especially for some high-risk patients, early or even first-line use of CD38 monoantion and existing new drug treatment, may bring greater survival benefits to patients.