AML: add-on nivolumab safe, effective with standard induction therapy

  • Ravandi F, et al.
  • Lancet Haematol.
  • 7 Aug 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • Addition of nivolumab to induction idarubicin+cytarabine was safe in younger patients with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS); median OS and event-free survival (EFS) were not reached in patients who subsequently received allogeneic stem cell transplantation (allo-SCT).

Why this matters

  • Approximately 30%-50% of patients achieved long-term DFS with induction anthracycline+cytarabine.

Study design

  • Phase 2 study to investigate addition of nivolumab to induction idarubicin+cytarabine in 44 patients with newly diagnosed AML or high-risk MDS.
  • 54 (range, 26-66) years median patient age; 5% of patients had high-risk MDS.   
  • Funding: BMS Pharmaceuticals, MD Anderson Cancer Center, National Cancer Institute, Charif Souki Cancer Research Fund.

Key results

  • Median EFS was not reached (NR) (95% CI, 7.93-NR) at 17.25 (interquartile range [IQR], 0.50-30.40) months median follow-up.
  • 18.54 (95% CI, 10.81-28.81) months median OS.
  • 18.54 (95% CI, 8.20-23.22) months median relapse-free survival in 34 responders.
  • In 19 patients (43%) who received allo-SCT:
    • 25 (95% CI, 1-26) months median OS.
    • Median EFS not reached (95% CI, 10.61-NR).
  • Most common grade 3-4 adverse events: diarrhea (16%) and febrile neutropenia (32%).

Limitations

  • Limited sample size.