According to the results of the second phase of the study, the combination of standard-care chemotherapy drug azacitidine and the immune checkpoint inhibitor nivolumab ( nivolumab ) showed that the response rate and recurrence of patients with relapsed or refractory acute myeloid leukemia ( AML ) The overall survival rate is encouraging.
The study followed 70 patients. After an average of 2 lines of treatment, relapsed AML reported an overall response rate of 33 % and a complete response rate of 22 %. The drug combination is particularly effective for patients who have not previously received hypomethylation agents ( HMA ) such as azacitidine or decitabine, and the total effective rate of these patients is 52 %.
The researchers said that bone marrow samples collected before treatment showed that the frequency of prediction of bone marrow CD3 and CD8 cells before treatment was higher. In particular, CD3 seems to have a high sensitivity and specificity rate to predict the response, indicating that it can be used as a reliable biomarker for selecting patients for this combination therapy. “
Treatment includes intravenous or subcutaneous injection of azacitidine and intravenous injection of nivolumab . Although most patients have been successfully treated, 11 % of patients still have serious or potentially life-threatening side effects. The overall survival of all patients was 6.3 months. The survival rate of patients with first relapse was 10.6 months, which was twice the survival rate observed with azacitidine alone in similar patients in MD Anderson .
Researcher Daver said that the relevant randomized phase III study is ongoing, and we believe that the implementation of clinical and immune biomarkers for selecting patients may result in further improvements in these types of therapies in AML .