Ibrutinib and venetoclax clinical trials for patients with CLL
| Clinical trial . | Cohort . | Combination regimen duration . | CR/CRi response rate . | MRD rate . | PFS rate . |
|---|---|---|---|---|---|
| MD Anderson60-62 | TN high-risk CLL, N = 120; del 17p/TP53 mutation, n = 27 | IBR, 3 cycles; IBR + VEN, 24 cycles ± additional 12 cycles | 59% at cycle 12 69% at cycle 24 | 52% (BM) at cycle 12 64% (BM) at cycle 24 | 90.1% at 5 y |
| MD Anderson63 | R/R, N = 80 | IBR, 3 cycles; IBR + VEN, 24 cycles ± additional 12 cycles | Not reported | 48% (BM) at cycle 12 67% (BM) at cycle 24 | ∼75% at 3 y |
| CAPTIVATE66,78 | TN FD, N = 159; MRD, N = 164; del 17p/TP53 mutation, n = 23 | IBR, 3 cycles; IBR + VEN, 12 cycles | FD cohort: 56% MRD cohort: 46% | FD cohort: 68% (PB) and 75% (PB) at cycle 12 MRD cohort: 75% (PB) and 68% (BM) at cycle 12 | FD cohort: 70% at 5 y uMRD cohort: 95% placebo vs 100% ibrutinib at 1 y |
| CLARITY69,71 | R/R, N = 50; del 17p/TP53 mutation, n = 10 | IBR 2, cycles; IBR + VEN, 12 cycles (if uMRD at 6 mo of combination) or 24 cycles (if uMRD achieved after 6 mo) | 51% | 40% (BM) at cycle 12 48% (BM) at cycle 24 | 98% at median FU of 21.1 mo |
| FLAIR75 | TN, N = 260; no del17p | IBR, 2 cycles; IBR + VEN, up to 72 cycles, defined by MRD | 59.2% | 52.4% (BM) at cycle 24 49.8% (BM) at 5 y | 97.2% at 3 y |
| GLOW76 | TN patients, >65 y or with comorbidities, N = 106; no del17p | IBR 3, cycles; IBR + VEN, 12 cycles | 45% | 55% (PB) at cycle 12 | 74.6% at 3.5 y |
| Clinical trial . | Cohort . | Combination regimen duration . | CR/CRi response rate . | MRD rate . | PFS rate . |
|---|---|---|---|---|---|
| MD Anderson60-62 | TN high-risk CLL, N = 120; del 17p/TP53 mutation, n = 27 | IBR, 3 cycles; IBR + VEN, 24 cycles ± additional 12 cycles | 59% at cycle 12 69% at cycle 24 | 52% (BM) at cycle 12 64% (BM) at cycle 24 | 90.1% at 5 y |
| MD Anderson63 | R/R, N = 80 | IBR, 3 cycles; IBR + VEN, 24 cycles ± additional 12 cycles | Not reported | 48% (BM) at cycle 12 67% (BM) at cycle 24 | ∼75% at 3 y |
| CAPTIVATE66,78 | TN FD, N = 159; MRD, N = 164; del 17p/TP53 mutation, n = 23 | IBR, 3 cycles; IBR + VEN, 12 cycles | FD cohort: 56% MRD cohort: 46% | FD cohort: 68% (PB) and 75% (PB) at cycle 12 MRD cohort: 75% (PB) and 68% (BM) at cycle 12 | FD cohort: 70% at 5 y uMRD cohort: 95% placebo vs 100% ibrutinib at 1 y |
| CLARITY69,71 | R/R, N = 50; del 17p/TP53 mutation, n = 10 | IBR 2, cycles; IBR + VEN, 12 cycles (if uMRD at 6 mo of combination) or 24 cycles (if uMRD achieved after 6 mo) | 51% | 40% (BM) at cycle 12 48% (BM) at cycle 24 | 98% at median FU of 21.1 mo |
| FLAIR75 | TN, N = 260; no del17p | IBR, 2 cycles; IBR + VEN, up to 72 cycles, defined by MRD | 59.2% | 52.4% (BM) at cycle 24 49.8% (BM) at 5 y | 97.2% at 3 y |
| GLOW76 | TN patients, >65 y or with comorbidities, N = 106; no del17p | IBR 3, cycles; IBR + VEN, 12 cycles | 45% | 55% (PB) at cycle 12 | 74.6% at 3.5 y |
CR/CRi, complete remission/CR with incomplete BM recovery; FD, fixed duration; FU, follow-up; IBR, ibrutinib; TN, treatment naïve; VEN, venetoclax.