- 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.
- 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.
- 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.
- Young patient population.