Table 1.
Overview of phase 3 trials in tn CLL.
| Trial | Treatment Arms | ORR | OS | PFS | uMRD |
|---|---|---|---|---|---|
| ALLIANCE (A041202) Study [47] | Ibr vs. Ibr-R vs. BR | 81% (BR) vs. 93% (Ibr) vs. 94% (Ibr-R) | 2-year OS 95% (BR) vs. 90% (Ibr) vs. 94% (Ibr-R) |
2-year PFS 74% (BR) vs. 87% (Ibr) vs. 88% (Ibr-R) | 8% (BR) vs. 1% (Ibr) vs. 4% (Ibr-R) |
| E1912 study [74] | FCR vs. Ibr-R | 96% (Ibr-R) vs. 81% (FCR) | 3-year OS 92% (FCR) vs. 99% (Ibr-R) |
3-year PFS 73% (FCR) vs. 89% (Ibr-R) |
8% (Ibr-R) vs. 59% (FCR) |
| RESONATE-2 [19,54] | Ibr vs. Clb | 86% (Ibr) vs. 35% (Clb) | 5-year OS 83% (Ibr) vs. 68% (Clb) |
5-year PFS 70% (Ibr) vs. 12% (Clb) | N.A. |
| iLLUMINATE study [76] | G-Ibr vs. G-Clb | 88% (G-Ibr) vs. 73% (G-Clb) | Estimated 30-month OS 86% (G-Ibr) vs. 85% (G-Clb) |
Estimated 30-month PFS 79% (G-Ibr) vs. 31% (G-Clb) |
35% (G-Ibr) vs. 25% (G-Clb) |
| ELEVATE TN [82] | Acb vs. G-Acb vs. G-Clb | 94% (G-Acb) vs. 79% (G-Clb) vs. 85% (Acb) | Estimated 24-month OS 95% (G-Acb) vs. 95% (Acb) vs. 92% (G-Clb) |
Estimated 24-month PFS 93% (G-Acb) vs. 87% (Acb) vs. 47% (G-Clb) |
N.A. |
| CLL14 trial [27,126] | Ven-G vs. G-Clb | 85% (Ven-G) vs. 71% (G-Clb) | 24-month OS 92% (Ven-G) vs. 93% (G-Clb) |
3-year PFS 82% (Ven-G) vs. 50% (G-Clb) |
76% (Ven-G) vs. 35% (G-Clb) 18 months after treatment 47% (Ven-G) vs. 7% (G-Clb) |
Abbreviations: Ibr, ibrutinib; R, rituximab; F, fludarabine; C, cyclophosphamide; Clb, chlorambucil; G, obinutuzumab; Acb, acalabrutinib; Ven, venetoclax; N.A., not available.