- 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.
- 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.
- 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.”
- There were only 10 patients under the reduced therapy regimen.