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Table 1 BTK inhibitors in the treatment of relapsed/refractory MCL

From: Emerging therapies in mantle cell lymphoma

BTKi NCT#/publication Phase Sample size [median f/up*] Median lines of prior therapy ORR% [CR%] Median PFS (months) % bleeding events [grade ≥ 3] % A.fib [grade ≥ 3]
Ibrutinib NCT01236391 [8, 9] II 111 [26.7] 3 67 [23] 13 59 [5] 6 [5]
Ibrutinib NCT01646021 [10] III 139a [20] 2 72 [19] 14.6 10 [8] 4 [4]
Acalabrutinib NCT02213926 [11,12,13] II 124 [15.2] 2 81 [40] 20 33 [2] 0 [0]
Zanubrutinib NCT02343120 [14] Ib 43b [10.3] 1 90c [20] 18 30.2 [7] 4.7 [NP]
Zanubrutinib NCT03206970 [15] II 86 [9] 2 84 [59] NR 4.7 [1.2] 0 [0]
LOXO-305 NCT03740529 [16] I 8 [NP] 3 37.5 [0] NP 11 [0] 0 [0]
ARQ-531 NCT03162536 [17] I 1 [NP] NP NP NP NP NP
  1. If more than one B cell malignancy was enrolled, responses are for the MCL patients in the trial. Adverse events were for all patients in the trial
  2. Abbreviations: NR not reached, NP not presented, Btki Bruton’s tyrosine kinase inhibitor, ORR overall response rate, CR complete response, PFS progression-free survival, A.fib atrial fibrillation
  3. aNumber enrolled in BTKi arm only
  4. b38 relapsed/refractory MCL, 5 patients were treatment naïve MCL
  5. cRelapsed/refractory MCL 88.9 [22.2], treatment naïve MCL, 100 [0]
  6. *Median f/up in months