EHA 2020 – Fixed-duration ibrutinib in previously untreated CLL might spare immunotherapy for some


  • Michael Simm
  • Univadis
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Takeaway

  • Follow-up data from the ICLL-07 trial show 3-year progression-free survival (PFS) at 96.5% and 3-year overall survival (OS) at 97.7% for the total population. However, omitting immunochemotherapy was associated with less favorable rates of blood minimal residual disease.

Why this matters

  • While immunochemotherapy with fludarabine, cyclophosphamide, and rituximab (FCR) has been the first-line reference treatment for fit patients with chronic lymphocytic leukemia (CLL) without TP53 alteration, targeted therapies such as ibrutinib might spare some patients from the adverse effects of FCR.

Study design

  • The ICLL-07 trial enrolled 135 patients with a median age of 62 years. They received obinutuzumab (8×1000 mg) plus ibrutinib (420 mg/d) and were evaluated for complete responses (CR) with bone marrow minimal residual disease (BM MRD)
  • Funding: Roche and Janssen.

Key results

  • As published, the study met its primary endpoint at month 16, a greater than 30% of CR and BM MRD
  • 10 out of 123 evaluable patients had been spared the immunochemotherapy in the second half of the trial.
  • Follow-up analysis 2 years after the end of treatment was presented at the European Hematology Association and showed 3-year PFS as 96.5% and 3-year OS as 97.7%.
  • The rate of BM MRD
  • “Findings suggest that our fixed-duration approach could be, may be, an option for patients with good prognostic factors.”

Limitations

  • There were only 10 patients under the reduced therapy regimen.