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Table 1 Clinical trials of ibrutinib monotherapy in B-cell lymphoma

From: Ibrutinib in B-cell lymphoma: single fighter might be enough?

Disease Study (year) Phase Study details Efficacy Refs.
TN CLL Byrd et al. (2018) Ib/II 7-year follow up, 31 pts ORR 87%, PFS 80%, OS 75% [13]
  O’Brien et al. (2014) Ib/II 31 elderly pts Objective response 71%, CR 13%, PR 55% [15]
  Burger et al. (2015) III 269 elderly pts to compare ibrutinib with chloramnucil ORR (86% vs. 35%), 18.4-month PFS (not reached vs. 18.9 months); 24-month OS (98% vs. 85%) [39]
R/R CLL Byrd et al. (2018) Ib/II 7-year follow up, 101 pts ORR 89%, PFS 32%, OS 52% [13]
  Jones et al. (2018) III 230 pts with del17p 30-month PFS 57%, OS 69% [1]
  Byrd et al. (2013) Ib/II 85 pts, the majority of whom were considered to have high-risk disease, 51 received 420 mg, 34 received 840 mg ORR (71% vs. 71%), PR with lymphocytosis (20% vs. 15%), 24-month OS and PFS were 83% and 75% [11]
  O’Brien et al. (2016) II 145 pts with del17p ORR 83%, 26-month PFS 63%, 26-month OS 75%, [12]
  Byrd et al. (2014) III 391 pts at risk for a poor outcome, to compare ibrutinib with ofatumumab ORR (42.6% vs. 4.1%), PFS 88% and PR with lymphocytosis of ibrutinib group was 20%, 12-month OS (90% vs. 81%) [14]
R/R MCL Jeon et al. (2019) NA 33 pts ORR 33%, OS 35.1 months, PFS 27.4 months [21]
  Wang et al. (2015) II Long-term follow up of 111 pts, at a dose of 560 mg once daily ORR 67%, CR 23%, 24-month OS 47%, 24-month PFS 31% [17]
  Dreyling et al. (2016) III 280 pts to compare ibrutinib (n = 139) with temsirolimus (n = 141) ORR (72% vs. 40%), CR with ibrutinib was 19%, median PFS (14.6 vs. 6.2 months), OS (not reached vs. 21.3 months) [19]
R/R FL Advani et al. (2013) I 56 pts ORR 38% [29]
  Bartlett et al. (2017) II 40 pts with ibrutinib 560 mg once daily ORR 37.5%, CR 12.5%, 2-year PFS 20.4%, median PFS 14 months [30]
R/R ABC-DLBCL Wilson et al. (2017) I/II 38 pts CR or PR 37% [32]
PCNSL Grommes et al. (2017) I 13 pts ORR 77% [34]
  Lionakis et al. (2017) Ib 18 pts PR 83% [35]
R/R WM Dimopoulos et al. (2016) III 31 rituximab- refractory pts with a dose of 420 mg ORR 90%, MRR 71%, OS 97%, PFS 86% [44]
  Treon et al. (2015) II 63 pts with ibrutinib 420 mg once daily ORR 90.5%, MRR 73%, PFS 69.1%, OS 95.2% [25]
R/R MZL Noy et al. (2016) II 63 pts with ibrutinib 560 mg once daily ORR 48% (6 CRs, 26 PRs) [28]
  1. Pts, Patients; DLBCL, Diffuse large B-cell lymphoma; ABC, Activated B-cell like; non-GCB, Germinal center B cell-like; CLL/SLL, Chronic lymphocytic leukemia/small lymphocytic lymphoma; WM, Waldenstroms macroglobulinemia; FL, Follicular lymphoma; MCL, Mantle cell lymphoma; MZL, Marginal zone lymphoma; PFS, Progression-free survival; PR, Partial response; ORR, Overall response rate; MRR, Major response rate; R/R, Relapsed/refractory; TN, Treatment-native; del17p, 17p deletion; At risk for a poor outcome, A short duration of response to therapy or adverse cytogenetic abnormalities; High-risk, Pts with del17p, del11q or with TP53 mutations.