Table 1.
Clinical trials with ibrutinib and idelalisib in CLL patients
| Study | First line or treated subset | Phase | Number of patients | Age, median (range) | Scheme | ORR (CR) | PFS | TP53 (%) | ORR (CR) | PFS |
|---|---|---|---|---|---|---|---|---|---|---|
| All cases | All cases | TP53 subset | TP53 subset | |||||||
| Byrd, NEJM 2013 [3] | Relapsed | 1b/2 | 85 | 66 (37–82) | Ibru mono | 71 + 18a (2 %) | 75 % at 26 ms | 33 % | 68 % (4 %) | 57 % at 26 ms |
| O’Brian, Lancet Oncol 2014 [7] | First line | 1b/2 | 29 | 71 (65–84) | Ibru mono | 71 + 13 %a (13 %) | 96 % at 24 ms | 6 % | NA | NA |
| Farooqui, lancet Oncol 2015 [9] | Treated or untreated with TP53 aberrations | 2 | 51 | 62 (33–82) | Ibru mono | - | - | 100 % | 50 + 42 %a | 82 % at 24 ms |
| Byrd, NEJM 2014 [4] | Relapsed/refractory | 3 | 391 | 67 (30–86)b | Ibru vs. Ofa | 43 + 20 %a (0 %) | 88 % at 6 ms | 32 % | NA | 83 % at 6 ms |
| Burger, Lancet Oncol 2014 [6] | High-risk previously treated or untreated | 2 | 40 | 63 (35–82) | Ibru + RTX | 95 % (8 %) | 78 % at 18 ms | 50 % | 100 % (10 %) | 72 % at 18 ms |
| Brown, Blood 2014 [14] | Relapsed/refractory | 1 | 54 | 63 (37–82) | Ide mono | 39 + 33 %a (0 %) | 50 % at 16 ms | 24 % | 54 % (0 %) | 50 % at 3 ms |
| Furman, NEJM 2014 [15] | Relapsed | 3 | 220 | 71 (48–90)b | Ide + RTX vs. placebo | 81 % (0 %) | 93 % at 6 ms | 38 % | NA | NA |
Ibru ibrutinib, Ide idelalisib, RTX rituximab, Ofa ofatumumab, mono monotherapy, ORR overall response rate, CR complete response, PFS progression-free survival; ms months, NA not available
aThe percentages are the ORR (CR and PR) + the PR with persistent lymphocytosis
bData of ibrutinib or idelalisib arm