EHA 2020 – Phase 3 trial follow-up confirms venetoclax-obinutuzumab in patients with previously untreated CLL


  • Michael Simm
  • Univadis
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Takeaway

  • After 40 months of follow-up of 432 patients with chronic lymphocytic leukemia (CLL), the combination of venetoclax and obinutuzumab (VO) continues to show superiority over the established standard regimen of chlorambucil-obinutuzumab (CO).

Why this matters

  • VO was associated with longer progression-free survival (PFS) than CO in the previously published CLL14 trial of 432 patients with previously untreated CLL and coexisting conditions, “probably quite representative of clinical practice.”

Study design

  • Follow-up of CLL14 at 40 months.
  • Funding: F. Hoffmann-La Roche and AbbVie.

Key results

  • Safety data show an increase of neoplasms from 1.4% to 6.4% after treatment with VO in comparison with CO (1.9%). “Needs more follow-up.”
  • Primary endpoint was PFS which has not reached the median yet after a follow-up of 40 months. The rates of 3-year PFS were 81.9% vs 49.5% (HR, 0.31; 95% CI, 0.22-0.44; P<.0001>
  • Patients with TP53 mutations/deletions and IGHV mutations also profited, but less so.
  • For overall survival (OS), median was not reached in either group and the 3-year rate showed no significant difference (89.9% vs 88.0%).
  • Median time to the next treatment was not reached in either group, but 3-year rates significantly favored VO (84.5% vs 72.1%).
  • Approximately half of the patients treated with VO maintained undetectable levels of minimal residual disease 2 years after treatment.