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Table 1 Clinical trials with ibrutinib and idelalisib in CLL patients

From: Targeting neoplastic B cells and harnessing microenvironment: the “double face” of ibrutinib and idelalisib

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
  1. 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
  2. aThe percentages are the ORR (CR and PR) + the PR with persistent lymphocytosis
  3. bData of ibrutinib or idelalisib arm