Emerging therapies in mantle cell lymphoma

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

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	139^a [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	43^b [10.3]	1	90^c [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

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
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
^aNumber enrolled in BTKi arm only
^b38 relapsed/refractory MCL, 5 patients were treatment naïve MCL
^cRelapsed/refractory MCL 88.9 [22.2], treatment naïve MCL, 100 [0]
*Median f/up in months

ISSN: 1756-8722