- 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.
- 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.
- 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).
- Open-label, single-arm study design.