- 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.
- 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.
- 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.
- 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 conversion: HR, 0.19; 95% CI 0.12-0.30 (median time off-treatment, 19 months).
- The comparator group may only be applicable to a limited subgroup of frail patients.
- 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.