Table 3 The comparison of clinical trials of ibrutinib regimens in TN CLL and R/R MCL population

TN-

CLL

(Burger et al. 2015) [3]

269 pts with a median age of 73 years;

Regimen, ibrutinib 560 mg per day

Outcome, 18.4-month PFS not reached, 2-year OS 98%, ORR 86%.

(Shanafelt et al. 2019)8 [3]

354 pts aged 70 years or younger;

Regimen, ibrutinib per day, 6 cycles rituximab;

Outcome, 33.6-month PFS 89.4%, OS 98.8%; 3-year PFS among pts with IGHV mutation 87.7%.

(Shanafelt et al. 2019) [48]

175 pts aged 70 years or younger;

Regimen, ibrutinib per day, 6 cycles of fludarabine, cyclophosphamide and rituximab;

Outcome, 33.6-month PFS 72.9%, OS 91.5%; 3-year PFS among pts with IGHV mutation 88%.

(Jain et al. 2019) [60]

80 high-risk and older pts with CLL;

Regimen, ibrutinib 420 mg once daily for 3 cycles, venetoclax (weekly dose escalation to 400 mg once daily);

Outcome, CR 96% after 18 cycles, and 69% had remission with undetectable MRD; 1-year PFS and OS were 98% and 99%.

R/R MCL

(Wang et al. 2013)¹7

111 pts with a median age of 68 years and 86% had intermediate or high-risk MCL;

Regimen, ibrutinib 560 mg per day

Outcome, ORR 68% (CR 21%, PR 47%); 15.3-month PFS was 13.9 months, 18-month OS 58%.

(Wang et al. 2016)⁴¹

50 pts with the median number of previous regimens were three;

Regimen, ibrutinib 560 mg per day, rituximab 375 mg/m2 once per week during cycle1, on day 1 of cycles 3–8, and thereafter once daily another cycle up to 2 years;

Outcome, 16.5-month ORR 88%, CR 44%, PR 44%.

(Karmali et al. 2019)⁵²

36 pts with CR or PR to frontline chemo-immunotherapy +/- auto-SCT ;

Regimen, Received I-M 560 mg/day for up to 4 years;

Outcome, I-M is feasible in these pts with manageable toxicities related to the known safety profile of Ibrutinib, but the PFS and OS data are needed larger clinical studies to access.

(Tam et al. 2018)⁵⁴

24 pts with previously untreated MCL and 75% had high-risk prognostic score;

Regimen, Ibrutinib 560 mg/day, venetoclax was weekly increasing dose to 400 mg/day after 4 weeks;

Outcome, 16-week CR 42%, 78% of the pts with responses were estimated to have ongoing responses at 15 months.