R/R Ph+ ALL: blinatumomab delivers superior remission, survival vs standard of care

  • Rambaldi A & al.
  • Cancer
  • 18 Oct 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • Patients with relapsed/refractory Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia (R/R Ph+ ALL) achieved superior outcomes with blinatumomab vs standard of care (SOC) chemotherapy.

Why this matters

  • SOC for de novo Ph+ ALL comprises chemotherapy+a tyrosine kinase inhibitor (TKI); relapse in this setting is commonly associated with TKI-resistant mutations.

Study design

  • Phase 2 study to compare blinatumomab in 45 patients with R/R Ph+ ALL with SOC in an external historical control cohort (n=55) following ≥1 second-generation TKIs.
  • Outcomes were compared using propensity score analysis (PSA).
  • Median patient age:
    • Blinatumomab arm: 55 (range, 23-78) years.
    • SOC arm: 53 (range, 20-82) years.
  • Funding: Amgen, Inc., National Institutes of Health.

Key results

  • Rate of complete remission/complete remission with partial hematologic recovery (CR/CRh):
    • 36% (95% credible interval [CrI], 28%-46%) with blinatumomab vs 25% (95% CrI, 17%-34%) with external SOC: Bayesian-augmented (80% power) OR estimate=1.70 (95% CrI, 0.94-2.94; P=.076).
  • Probability of OS at 12 months:
    • 41% (95% CrI, 37%-44%) with blinatumomab vs 31% (95% CrI, 26%-35%) with external SOC: Bayesian-augmented (80% power) OR estimate=0.77 (95% CrI, 0.61-0.96; P=.031).

Limitations

  • Open-label, single-arm study design.