Blinatumomab Added to Consolidation Chemotherapy Improves Overall Survival Among Patients in MRD-Negative Remission From B-Cell Precursor ALL

The combination of blinatumomab and consolidation chemotherapy among adult patients in measurable residual disease (MRD)-negative remission from B-cell precursor acute lymphoblastic leukemia (BCP-ALL) significantly improved overall survival, according to phase 3 trial results.

“Many older adults with [BCP-ALL] have a relapse despite having a [MRD]–negative complete remission with combination chemotherapy,” explained lead study author Mark Litzow, MD, Mayo Clinic, Rochester, Minnesota, and colleagues.

Investigators randomly assigned patients aged 30 to 70 years with BCR::ABL1-negative BCP-ALL (with :: indicating fusion) who had MRD-negative remission (defined as <0.01% leukemic cells in bone marrow as assessed on flow cytometry) after induction and intensification chemotherapy to receive 4 cycles of blinatumomab in addition to 4 cycles of consolidation chemotherapy or to receive 4 cycles of consolidation chemotherapy alone. The primary end point was overall survival (OS), and relapse-free survival was a secondary end point.

Study results demonstrated that complete remission with or without full count recovery was observed in 395 out of 488 enrolled patients (81%). Of the 224 patients with MRD-negative status, 112 patients were assigned to each group. The characteristics of the participants were balanced between the groups. At the time of a median follow-up of 43 months, an advantage was observed in the blinatumomab group as compared with the chemotherapy-only group with regard to OS (at 3 years: 85% vs. 68%; hazard ratio [HR] for death, 0.41; 95% confidence interval [CI], 0.23 to 0.73; P = 0.002), and the 3-year relapse-free survival was 80% with blinatumomab and 64% with chemotherapy alone (HR for relapse or death, 0.53; 95% CI, 0.32 to 0.87). It was noted that a higher rate of neuropsychiatric events was reported within the blinatumomab group than in the chemotherapy-only group.

 “The addition of blinatumomab to consolidation chemotherapy in adult patients in MRD-negative remission from BCP-ALL significantly improved overall survival,” concluded Dr Litzow and colleagues.

Source:

Litzow M, Sun Z, Mattison R, et al. Blinatumomab for MRD-negative acute lymphoblastic leukemia in adults. NEJM. Published online July 24, 2024. doi: 10.1056/NEJMoa2312948