Comparative Analysis Of Safety And Short-term Efficacy Of Blinatumomab Versus CAR-T Cells In The Treatment Of Acute B Lymphoblastic Leukemia

Objective: To evaluate the safety,efficacy and short-term follow-up of Blinatumomab and CAR T cells in the treatment of acute B lymphoblastic leukemia.Methods: B-ALL patients treated with Blinatumomab from September 2021 to December 2022 and patients treated with CD19-targeted CAR T cells from October2016 to October 2020 were collected.The safety,efficacy,and short-term follow-up of the two treatment groups were compared according to different tumor loads.Results: A total of 21 patients treated with belintuo monotherapy and 80 patients treated with CAR-T cells were included.The proportion of patients with only positive MRD before treatment with Bellinto(P < 0.001)was significantly higher than that of patients treated with CAR-T.After dividing the patients into two subgroups of patients who were not in remission before treatment and those with only positive MRD before treatment,a comparison was made between treatment with Bellinto Euro monoclonal and treatment with CAR-T cells.For those with positive MRD only,the incidence of cytokine release syndrome(CRS)was 33.3%(4 cases)in the berintuo-treated group(12cases),with no severe CRS or neurotoxicity,and the MRD conversion rate was 100%(12 cases),with 2 cases(16.7%)progressing within six months;in the CAR-T-treated group(In the CAR-T treatment group(14 cases),CRS was evaluable in 9 cases,the incidence of CRS was 88.9%(8 cases),severe CRS in 2 cases(22.2%),neurotoxicity in1 case(7.1%),MRD regression rate was 92.9%(13 cases),and progression within 6months in 2 cases(14.3%);the severity of CRS was significantly less in the Berlintal treatment group than in the CAR-T treatment group(P= 0.027),and there was no significant difference in the incidence of neurotoxicity and MRD regression rate between the two groups.For unremitting patients,the incidence of CRS was 77.8%(7cases)in the berlinto-treated group(9 cases),with no severe CRS or neurotoxicity occurring,and the CR rate was 77.8%(7 cases);the incidence of CRS was 94.9%(56cases/59 cases)in the CAR-T-treated group(68 cases)of evaluable patients,with 24cases(40.7%)of severe CRS and neurotoxicity occurring in 12.1%(8 cases/66 cases),and the CR rate was 86.9%(53 cases/61 cases);the severity of CRS was significantly less in the Bellinto-treated group than in the CAR-T-treated group(P=0.001),and there was no significant difference in the incidence of neurotoxicity and CR rate between the two groups.The median granulocyte implantation days were(13.5-26.0)days in the Bellinto transplantation group,and the incidence of acute graft versus host disease(GVHD)was 16.7%(1 case),with no transplantation-related deaths.The median granulocyte implantation days in the CAR-T transplant group was 15.0(15.0-17.5)days,the incidence of acute GVHD was 54.5%(6 cases),and the transplant-related mortality rate was 27.3%,which was not statistically different.Median progression-free survival(PFS)was not achieved in patients treated with Bellinto overall,with a 6-month PFS rate of 79.7% and a 12-month PFS rate of 62.0%;median overall survival(OS)was not achieved,with a 6-month OS rate of 90.2% and a 12-month OS The median PFS for patients treated with CAR-T was 12.33 months overall,72.3% for 6-month PFS and52.0% for 12-month PFS;the overall median OS was 18.97 months,82.2% for 6-month OS and 62.4% for 12-month OS.Among those positive for MRD only prior to treatment,patients in the berinto transplant group had no primary progression or death events by the follow-up endpoint,and the longest PFS was 461 days,while the median PFS in the CAR-T transplant group was 638 days,with a 1-year PFS rate of 56.1%,a median OS of 531 days,and a 2-year OS rate of 45.5%.There was no statistical difference in PFS and OS between the two treatment groups.There were 4 cases(57.1%)of disease progression within 1 year in those without bridging transplantation after treatment with Bellinto,and the PFS was significantly worse than that of those with bridging transplantation after treatment with Bellinto(P=0.008),and there was no statistically significant difference in short-term OS between the two groups(P=0.157).Conclusion:The short-term efficacy of B-ALL patients who relapsed or were only MRD-positive with Blinatumomab was fair,with no significant difference compared with CAR T cell therapy,and the severity of CRS was less severe than those treated with CAR T cells.Blinatumomab patients who achieved remission had better PFS than those who did not,and there was no significant difference in the incidence,efficacy,or short-term follow-up of GVHD after transplantation compared with CAR T cell therapy.The above conclusions still need to be further verified by large samples and long-term follow-up results.