Blinatumomab regimen improves survival for certain patients with acute leukemia
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Key takeaways:
- Adding blinatumomab to consolidation chemotherapy improved 3-year OS and RFS.
- A higher percentage of patients assigned blinatumomab experienced neurology system side effects.
Use of blinatumomab with consolidation chemotherapy significantly extended OS for adults with minimal residual disease-negative B-cell precursor acute lymphoblastic leukemia, according to randomized phase 3 study results.
Findings from the E1910 trial support this treatment strategy as the new standard of care in this setting, Mark R. Litzow, MD, retired professor of medicine at Mayo Clinic, and colleagues concluded.
Blinatumomab (Blincyto, Amgen) — a bispecific T-cell engager that targets CD19 surface antigens on B cells— is approved for three indications in ALL.
The most recent indication — granted in June — applies to use of the agent in the consolidation phase of multiphase chemotherapy for adults or children with CD19-positive, Philadelphia chromosome-negative B-cell precursor ALL.
The FDA based that approval primarily on preliminary data from the E1910 trial, which included 224 patients aged 30 to 70 years who achieved minimal residual disease-negative remission after induction and intensification chemotherapy.
Researchers randomly assigned half of patients to four cycles of consolidation chemotherapy alone. The other half received consolidation chemotherapy plus four cycles of blinatumomab. Patients could undergo stem cell transplantation from a suitable donor at the discretion of their treating physician.
OS served as the primary endpoint.
Results of a third efficacy interim analysis — based on median follow-up of 43 months — showed median OS had not been reached in either group.
However, analyses of 3-year OS (85% vs. 68%; HR = 0.41; 95% CI, 0.23-0.73) and 3-year RFS (80% vs. 64%; HR = 0.53; 95% CI, 0.32-0.87) favored the blinatumomab group.
The trial did not have sufficient power to compare subgroups; however, researchers observed the greatest benefit among patients aged 30 to 55 years.
A higher percentage of patients assigned blinatumomab experienced neurologic system side effects (23% vs. 5%).
Seventeen patients assigned blinatumomab-chemotherapy died. Eight died of disease relapse. Infections accounted for most of the nonrelapse deaths.
Forty patients assigned chemotherapy alone died. Thirty-one died due to disease relapse. Seven died of nonrelapse causes — primarily infection — and two people died of unknown causes.
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