CML: final data from DADI trial show 44% TFR at 3 years

  • Okada M & al.
  • Clin Lymphoma Myeloma Leuk
  • 15 Mar 2018

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • Almost one-half of patients with chronic myeloid leukemia (CML) who discontinued second- or subsequent-line dasatinib after achieving deep molecular response (DMR) maintained treatment-free remission (TFR) at 3 years.
  • Imatinib-resistant patients were at greater risk for relapse.

Why this matters

  • Data are scarce regarding the discontinuation of second-generation tyrosine kinase inhibitors (TKIs) as second-line therapy.

Study design

  • Planned 3-year analysis of the phase 2 DADI (dasatinib discontinuation) trial in 63 patients receiving second- or subsequent-line dasatinib after achieving and maintaining DMR for ≥1 year.
  • DMR was defined as a sample with
  • Funding: Bristol-Myers Squibb, Novartis.  

Key results

  • 44 (interquartile range, 40.5-48) months median follow-up.
  • At 36 months:
    • 44% (95% CI, 32.0%-56.2%) of patients maintained TFR.
    • 8% (95% CI, 0%-29%) TFR in imatinib-resistant patients.
  • In multivariate analysis, absence of imatinib resistance and higher cytolytic natural killer cell count prior to TKI discontinuation were independently associated with maintenance of TFR.
  • Only 2 relapses were reported at 1 year.

Limitations

  • Single-arm study.
  • Japanese study population; results may not necessarily extrapolate to other subpopulations.

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