Table 1.
Completed phase 3 clinical trials examining chemotherapy-free regimens vs standard of care in relapsed/refractory CLL
| Novel agent | Control arm | Prior lines of therapy in novel agent arm, median (range) | Patients with prior novel agent exposure | Outcomes (novel agent vs control arm) |
|---|---|---|---|---|
| Ibrutinib5 | Ofatumumab | 3 (1-12) | Not reported | ORR: 91% for ibrutinib |
| Median PFS: 44.1 vs 8.1 mo | ||||
| Median OS: 67.7 vs 65.1 mo | ||||
| Acalabrutinib6 | Investigator’s choice: bendamustine or idelalisib/rituximab | 1 (1-8) | Patients with prior BCRi or venetoclax were excluded | ORR: 81 vs 76% |
| 1-y PFS: 88% vs 68% vs 69% | ||||
| Idelalisib/rituximab7 | Placebo/rituximab | 3 (1-12) | None; prior BTK or PI3Ki as exclusion criteria | ORR: 81% vs 13% |
| 6-mo PFS: 93% vs 46% | ||||
| 1-y OS: 92% vs 80% | ||||
| Duvelisib8 | Ofatumumab | 2 (1-10) | None; prior BTK or PI3Ki as exclusion criteria | ORR: 74% vs 45% |
| Median PFS: 13.3 vs 9.9 mo | ||||
| Venetoclax/rituximab9,10 | Bendamustine | 1 (1->3) | BCRi in 5 patients (2.6%) | ORR 92% vs 72% |
| 3-y PFS: 71% vs 15% | ||||
| 3-y OS: 88% vs 80% |