CLL: venetoclax-obinutuzumab induces deep, durable response

  • Flinn IW & al.
  • Blood
  • 12 Mar 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • Venetoclax+obinutuzumab demonstrated high, deep, durable response in first-line and relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL).

Why this matters

  • CLL treatment commonly involves limited remission or ongoing toxicity.

Study design

  • Phase 1b study of 6 cycles of venetoclax+obinutuzumab followed by venetoclax monotherapy in patients with first-line CLL (n=32) or R/R CLL (n=43).
  • Median patient age:
    • First-line CLL: 63 years (range, 47-73).
    • R/R CLL: 61 years (range, 42-80).
  • Funding: Genentech Inc; AbbVie.

Results

  • Grade 3/4 adverse events (AEs) in patients with first-line CLL/R/R CLL, respectively:
    • 66% and 76% of patients during combination treatment.
    • 34% and 54% during venetoclax monotherapy.
  • No clinical tumor lysis syndrome (TLS).
  • Overall response rate (ORR):
    • First-line CLL: 100% (95% CI, 89%-100%).
    • R/R CLL: 95% (95% CI, 84%-99%).
  • Complete response/complete response with incomplete marrow recovery (CR/Cri):
    • First-line CLL: 78% (95% CI, 60%-91%).
    • R/R CLL: 37% (95% CI, 23%-53%).
    • Responses were comparable across cytogenetic subgroups.
  • Undetectable minimal residual disease at ≥1 year in:
    • 63% of patients with R/R CLL after obinutuzumab completion.
    • 72% of first-line patients after completion of all treatment.

Limitations

  • Young patient population.

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