MRD-positive BCP-ALL: blinatumomab+stem cell transplant yields better RFS

  • Gökbuget N & al.
  • Eur J Haematol
  • 25 Dec 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • In adults with minimal residual disease (MRD)-positive, Philadelphia chromosome (Ph)-negative B-cell precursor acute lymphoblastic leukemia (BCP-ALL), blinatumomab followed by hematopoietic stem cell transplant (HSCT) delivered a significant improvement in relapse-free survival (RFS) and a trend toward improved OS vs standard of care (SOC).

Why this matters

  • 30%-50% of adult patients with ALL in hematologic complete remission (CR) after induction/consolidation have MRD.

Study design

  • Study to investigate blinatumomab (73 patients from a phase 2 study) vs SOC (historic data set of 182 patients) for treatment of MRD in patients with Ph-negative BCP-ALL in first hematologic CR.
  • 67% of patients in the blinatumomab group and 40% in the SOC group underwent HSCT during CR.
  • Results for historic data sets were age-weighted to the blinatumomab group.
  • Funding: Amgen, Inc.

Key results

  • Median RFS with blinatumomab, 35.2 (95% CI, 18.9-not evaluable [NE]) months vs 7.8 (95% CI, 6.4-12.4) months with SOC.
    • HR for relapse/death with blinatumomab vs SOC, 0.50 (95% CI, 0.32-0.78; P=.002).
  • Median OS was NE (95% CI, 24.2 months-NE) with blinatumomab vs 25.9 (95% CI, 17.0-39.1) months with SOC.

Limitations

  • Post hoc, exploratory analysis.