ASCO 2019 — Venetoclax+obinutuzumab extends PFS in frontline CLL


  • David Reilly
  • Oncology Conference reports
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Takeaway

  • A 12-month fixed-duration frontline regimen of venetoclax+obinutuzumab (VenG) yielded high and durable rates of minimal residual disease (MRD), translating to a significant advantage in PFS vs chlorambucil-obinutuzumab (ClbG) among elderly patients with chronic lymphocytic leukemia (CLL) and comorbidities.

Why this matters

  • Many patients in this setting are elderly, have comorbidities, and may be unfit for intensive chemotherapy.

Study design

  • Phase 3 CLL-14 study to investigate fixed-duration VenG (n=216) vs ClbG (n=216) in previously untreated patients with CLL and comorbidities.
  • Median patient age in the VenG group was 72 years vs 71 years in the ClbG group.
  • Funding: AbbVie; Genentech.

Key results

  • Responses:
    • 88% objective response rate (ORR) with VenG vs 71% with ClbG (P<.001>
    • VenG: 50% complete response (CR); 35% partial response (PR).
    • ClbG: 23% CR; 48% PR.
  • MRD-negativity at 3 months after treatment completion:
    • In peripheral blood (PB):
      • Negative (−4): 76% with VenG vs 35% with ClbG (P<.001>
    • In bone marrow (BM):
      • Negative (−4): 57% with VenG vs 17% with ClbG (P<.001>
  • MRD-negativity at 12 months posttherapy: 81% with VenG vs 27% with ClbG.
    • MRD conversion: HR, 0.19; 95% CI 0.12-0.30 (median time off-treatment, 19 months).
  • At 29-month median follow-up, VenG was associated with significantly extended PFS vs ClbG (HR, 0.35, P<.0001>

    Limitations

    • The comparator group may only be applicable to a limited subgroup of frail patients.

    Expert comment

    • Matthew S. Davids, MD, associate director of the CLL Center at Dana-Farber Cancer Institute and assistant professor of medicine at Harvard Medical School, Boston, Massachusetts, described CLL-14 as "an immediately practice-changing study," but also questioned whether the 12-month fixed-duration regimen should be applied to all patients or guided by MRD or genetic markers.
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