Amgen Announces New Data From Phase 2 BLINCYTO Immunotherapy Study

(RTTNews) - Amgen (AMGN) announced new data from the Phase 2 BLAST study which evaluated the bispecific T cell engager or BiTE immunotherapy BLINCYTO (blinatumomab) in patients with minimal residual disease or MRD positive B-cell precursor acute lymphoblastic leukemia or ALL.

In the study, 78 percent of patients who received BLINCYTO experienced a complete MRD response (95 percent CI: 69-85 percent), a measure of eradication of residual disease at the molecular level, after one treatment cycle. Nearly all complete responses (98 percent) occurred within the first treatment cycle.

MRD is a state of disease in which the microscopic analysis does not show malignant cells, but more sensitive techniques still detect disease at the molecular level. Patients who have persistent or recurrent MRD after their first therapy have a higher risk of relapse than those with no detectable MRD.

In addition to the majority (78 percent) of patients achieving a compete MRD response within one cycle of treatment, 80 percent achieved a complete MRD response across all cycles. Responses occurred in all subgroups including older patients and patients with high MRD level; no predictive factor for MRD response was identified.

In the study, adverse events (AEs) of all grades occurring in 20 percent or more patients included pyrexia (90 percent), tremor (29 percent), chills (26 percent), fatigue (24 percent), nausea (22 percent), vomiting (22 percent) and diarrhea (20 percent). Grade =3 AEs occurring in five percent or more patients included neutropenia (16 percent), pyrexia (7 percent) and tremor (5 percent).

Two fatal AEs occurred on treatment: subdural hemorrhage and pneumonitis in conjunction with influenza (the latter was deemed treatment-related). Treatment interruptions due to AEs occurred in 31 percent of patients.