Efficacy of venetoclax-based treatment of CLL
| Study . | Phase . | Treatment . | Population . | n . | ORR, % . | CR/CRi, % . | uMRday 4, % . | mPFS, mo . | 24-mo PFS, % (mo) . | OS, % (mo) . | NCT # . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| M12-1752 | 1/2 | VEN cont | R/R | 116 | 79 | 20 | NP | 25 | 69 (15) | 84 (24) | 01328626 |
| M13-3656,13 | 1b | VEN cont | R/R | 49 | 86 | 51 | 57 (BM) | NR | 56 (60) | NP | 01682616 |
| M13-9821,18 | 2 | VEN cont | R/R Del(17p) | 158 | 77 | 20 | 30 (PB) | 27.2 | 54 | 73 (24) | 01889186 |
| M14-0323,4 | 2 | VEN cont | R/R | 02141282 | |||||||
| BTKi Ref/Intol | 91 | 65 | 9 | 26 (PB) | 24.7 | 80 (12) | NR | ||||
| PI3Ki Ref/Intol | 36 | 67 | 8 | 20 (PB) | NR | 79 (12) | NR | ||||
| MURANO6,28 | 3 | VEN 24 cycles | R/R | 194 | 92.3 | 8.2 | 62.4 (PB) | NR | 84.9 | 91.9 (24) | 02005471 |
| RIT 6 cycles vs BEN 6 cycles | 195 | 72.3 | 3.6 | 27.3 (BM) | 17 | 36.3 | 86.6 (24) | ||||
| OBIN 6 cycles | 13.3 (PB)1.5 (BM) | ||||||||||
| GNE27 | 1/2 | VEN 12 cycles | TN | 32 | 100 | 78 | 78/78 (PB/BM) | NR | 90.6 | NP | 01685892 |
| OBIN 6 cycles | R/R | 43 | 95 | 37 | 63/62 (PB/BM) | 85.4 | NP | ||||
| CLL147 | 3 | VEN 12 cycles | TN | 216 | 84.7 | 49.5 | 75.5 (PB) | NR | 88.2 | NR | 02242942 |
| OBIN 6 cycles vs CHLOR 12 cycles | 216 | 71.3 | 23.1 | 56.9 (BM) 35.2 (PB) | NR | 64.1 | NR | ||||
| OBIN 6 cycles | 17.1 (BM) | ||||||||||
| MDACC34 | 2 | VEN 24 cycles | TN | 80 | 100 (1 y) | 88 (1 y) | 61 (1 y) (BM) | NR | 98 (12) | 99 (12) | 02756897 |
| IBR 27+ cycles | |||||||||||
| CLARITY33 | 2 | VEN 12 cycles | R/R | 53 | 89 (1 y) | 51 (1 y) | 53 (PB) | NR | NP | 100 | NP |
| IBR 12 cycles | 36 (BM) | ||||||||||
| CLL2-BAG5 | 2 | BEN 2 cycles | TN | 34 | 100 | 9 | 91 (PB) | NR | 100 (15) | 100 (15) | 02401503 |
| OBIN 6 cycles,M | R/R | 29 | 90 | 7 | 12 (BM) 83 (PB) | NR | 83 (15) | 90 (15) | |||
| VEN cont | 14 (BM) |
| Study . | Phase . | Treatment . | Population . | n . | ORR, % . | CR/CRi, % . | uMRday 4, % . | mPFS, mo . | 24-mo PFS, % (mo) . | OS, % (mo) . | NCT # . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| M12-1752 | 1/2 | VEN cont | R/R | 116 | 79 | 20 | NP | 25 | 69 (15) | 84 (24) | 01328626 |
| M13-3656,13 | 1b | VEN cont | R/R | 49 | 86 | 51 | 57 (BM) | NR | 56 (60) | NP | 01682616 |
| M13-9821,18 | 2 | VEN cont | R/R Del(17p) | 158 | 77 | 20 | 30 (PB) | 27.2 | 54 | 73 (24) | 01889186 |
| M14-0323,4 | 2 | VEN cont | R/R | 02141282 | |||||||
| BTKi Ref/Intol | 91 | 65 | 9 | 26 (PB) | 24.7 | 80 (12) | NR | ||||
| PI3Ki Ref/Intol | 36 | 67 | 8 | 20 (PB) | NR | 79 (12) | NR | ||||
| MURANO6,28 | 3 | VEN 24 cycles | R/R | 194 | 92.3 | 8.2 | 62.4 (PB) | NR | 84.9 | 91.9 (24) | 02005471 |
| RIT 6 cycles vs BEN 6 cycles | 195 | 72.3 | 3.6 | 27.3 (BM) | 17 | 36.3 | 86.6 (24) | ||||
| OBIN 6 cycles | 13.3 (PB)1.5 (BM) | ||||||||||
| GNE27 | 1/2 | VEN 12 cycles | TN | 32 | 100 | 78 | 78/78 (PB/BM) | NR | 90.6 | NP | 01685892 |
| OBIN 6 cycles | R/R | 43 | 95 | 37 | 63/62 (PB/BM) | 85.4 | NP | ||||
| CLL147 | 3 | VEN 12 cycles | TN | 216 | 84.7 | 49.5 | 75.5 (PB) | NR | 88.2 | NR | 02242942 |
| OBIN 6 cycles vs CHLOR 12 cycles | 216 | 71.3 | 23.1 | 56.9 (BM) 35.2 (PB) | NR | 64.1 | NR | ||||
| OBIN 6 cycles | 17.1 (BM) | ||||||||||
| MDACC34 | 2 | VEN 24 cycles | TN | 80 | 100 (1 y) | 88 (1 y) | 61 (1 y) (BM) | NR | 98 (12) | 99 (12) | 02756897 |
| IBR 27+ cycles | |||||||||||
| CLARITY33 | 2 | VEN 12 cycles | R/R | 53 | 89 (1 y) | 51 (1 y) | 53 (PB) | NR | NP | 100 | NP |
| IBR 12 cycles | 36 (BM) | ||||||||||
| CLL2-BAG5 | 2 | BEN 2 cycles | TN | 34 | 100 | 9 | 91 (PB) | NR | 100 (15) | 100 (15) | 02401503 |
| OBIN 6 cycles,M | R/R | 29 | 90 | 7 | 12 (BM) 83 (PB) | NR | 83 (15) | 90 (15) | |||
| VEN cont | 14 (BM) |
BEN, bendamustine; BM, bone marrow; cont, continuous; CR/CRi, complete remission/complete remission with incomplete count recovery; GNE, Genentech sponsored study; IBR, ibrutinib; M, maintenance; MDACC, MD Anderson Cancer Center; mPFS, median PFS; number; NP, not provided; NR, not reached; ORR, overall response rate; PB, peripheral blood; Ref/Intol, refractory and/or intolerant; RIT, rituximab; TN, treatment naive; VEN, venetoclax.