CML-CP: low-dose dasatinib delivers durable efficacy with good tolerability

  • Naqvi K & al.
  • Cancer
  • 25 Sep 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • Patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) experienced high, durable responses at half the approved daily dose of dasatinib.

Why this matters

  • Reduced dasatinib dose may support maintained efficacy by reducing interruptions resulting from adverse events.

Study design

  • Study to provide updated long-term outcomes in 81 patients treated with low-dose (50 mg/day) frontline dasatinib for Ph+ CML-CP.
  • Funding: MD Anderson Cancer Center Leukemia Specialized Program of Research Excellence; Charif Souki Cancer Research Fund; NIH.

Key results

  • BCR-ABL1 transcripts at 3 months:
    • ≤10%: 96%.
    • ≤1%: 77%.
  • Cumulative complete cytogenetic response (CCyR):
    • 77% at 6 months; 95% at 12 months; 98% estimated at 18 months.
  • Cumulative major molecular responses (MMR):
    • 4.0-log reduction: 22% at 6 months; 55% at 12; 68% estimated at 18 months.
    • 4.5-log reduction: 15% at 6 months; 49% at 12; 59% estimated at 18 months.
  • At the time of analysis, 77 patients remained in the trial, 5 patients experienced treatment failure.
  • 100% 2-year event-free survival and OS.
  • Treatment was generally well tolerated.

Limitations

  • 66% of patients had low-risk disease per Sokal score.