The addition of blinatumomab into frontline chemotherapy achieved promising minimal residual disease (MRD) and clinical outcomes for patients with Philadelphia chromosome (PH)–negative B-cell acute lymphoblastic leukemia (B-ALL), according to data from the phase 2 GIMEMA LAL2317 trial published in Blood.
“This chemotherapy-blinatumomab risk-oriented program yielded remarkable results that need further improvement in higher-risk patients displaying early MRD persistence,” wrote the study’s authors, led by Renato Bassan, MD, of Ospedale dell’Angelo in Venice, Italy.
The trial enrolled 149 patients, of which 132 entered remission, 122 received blinatumomab, and 109 had MRD assessment before and after blinatumomab. The rate of MRD negativity increased from 72% to 93% (P<.001) after blinatumomab, with 23 out of 30 MRD–positive patients clearing their MRD.
After a median follow-up of 38.1 months (range, 0.5-62.8), the median overall survival (OS) and disease-free survival (DFS) were not reached, and estimated three-year OS and DFS rates were 71% and 65%, respectively. The DFS rate was 92% in patients aged 18 to 40 who achieved early MRD negativity. MRD positivity before blinatumomab predicted a worse outcome, especially in genetically high-risk patients, the authors wrote.
The three-year survival rate in patients treated with blinatumomab was 82%. The survival and relapse rates were 91% and 15% for patients assigned to standard chemotherapy, 59% and 35% for patients assigned to hematopoietic stem cell transplantation (HSCT), and 69% and 19% for patients who received HSCT, respectively. Blinatumumab toxicity was manageable, with only 8 permanent discontinuations, according to the report.
Overall, blinatumomab should be considered as a standard component of induction and consolidation for adult patients with Ph–negative B-ALL, Dr. Bassan and colleagues stated.
Reference
Bassan R, Chiaretti S, Della Starza I, et al. Up-front blinatumomab improves MRD clearance and outcome in adult Ph– B-lineage ALL: the GIMEMA LAL2317 phase 2 study. Blood 2025;145(21):2447-2459. doi:10.1182/blood.2024027500
Leave feedback about this