Phase 3 trials comparing novel agents to chemoimmunotherapy in treatment-naive CLL
| Reference . | Study name . | Regimen . | Eligibility . | n . | Survival . |
|---|---|---|---|---|---|
| Shanafelt et al1 | ECOG 1912 | Ibrutinib + rituximab vs FCR | ≤70 years old without del(17p) | (n = 529) | 5-year PFS: 78% vs 51% (P < .0001) 5-year OS: 95% vs 89% (P = .018) |
| Hillmen et al2 | NCRI FLAIR | Ibrutinib + rituximab vs FCR | ≤75 years old without del(17p) | (n = 771) | Median PFS not reached vs 67 months (P < .001) No difference in OS |
| Woyach et al3 | Alliance A041202 | Ibrutinib ± rituximab vs BR | ≥65 years old | (n = 547) | Median PFS not reached with either ibrutinib arm vs 44 months (P < .0001) No difference in OS |
| Moreno et al4 | ILLUMINATE | Ibrutinib + obinutuzumab vs obinutuzumab + chlorambucil | ≥65 years old or younger coexisting conditions | (n = 229) | Median PFS not reached vs 22 months (P < .0001) No difference in OS |
| Sharman et al5 | ELEVATE TN | Acalabrutinib ± obinutuzumab vs obinutuzumab + chlorambucil | ≥65 years old or younger with comorbidities | (n = 535) | Estimated 60-month PFS: 84% (A+O), 72% (A) vs 21% (O+C) No difference in OS |
| Tam et al27 | SEQUOIA | Zanubrutinib vs BR | Without del(17p) | (n = 479) | 2-year PFS: 86% vs 70% (p < .0001) No difference in OS |
| Al-Sawaf et al7 | CLL14 | Venetoclax + obinutuzumab vs chlorambucil + obinutuzumab | CIRS >6 and/or CrCl 30-69 mL/min | (n = 432) | Median PFS not reached vs 36 months (P < .0001) No difference in OS |
| Reference . | Study name . | Regimen . | Eligibility . | n . | Survival . |
|---|---|---|---|---|---|
| Shanafelt et al1 | ECOG 1912 | Ibrutinib + rituximab vs FCR | ≤70 years old without del(17p) | (n = 529) | 5-year PFS: 78% vs 51% (P < .0001) 5-year OS: 95% vs 89% (P = .018) |
| Hillmen et al2 | NCRI FLAIR | Ibrutinib + rituximab vs FCR | ≤75 years old without del(17p) | (n = 771) | Median PFS not reached vs 67 months (P < .001) No difference in OS |
| Woyach et al3 | Alliance A041202 | Ibrutinib ± rituximab vs BR | ≥65 years old | (n = 547) | Median PFS not reached with either ibrutinib arm vs 44 months (P < .0001) No difference in OS |
| Moreno et al4 | ILLUMINATE | Ibrutinib + obinutuzumab vs obinutuzumab + chlorambucil | ≥65 years old or younger coexisting conditions | (n = 229) | Median PFS not reached vs 22 months (P < .0001) No difference in OS |
| Sharman et al5 | ELEVATE TN | Acalabrutinib ± obinutuzumab vs obinutuzumab + chlorambucil | ≥65 years old or younger with comorbidities | (n = 535) | Estimated 60-month PFS: 84% (A+O), 72% (A) vs 21% (O+C) No difference in OS |
| Tam et al27 | SEQUOIA | Zanubrutinib vs BR | Without del(17p) | (n = 479) | 2-year PFS: 86% vs 70% (p < .0001) No difference in OS |
| Al-Sawaf et al7 | CLL14 | Venetoclax + obinutuzumab vs chlorambucil + obinutuzumab | CIRS >6 and/or CrCl 30-69 mL/min | (n = 432) | Median PFS not reached vs 36 months (P < .0001) No difference in OS |
CIRS, cumulative illness rating score; CrCl, creatinine clearance.