. 2021 Dec 14;17(1):69–84. doi: 10.1007/s11523-021-00857-8

Table 2.

Key clinical trials showing efficacy of BTK inhibitors in the treatment of relapsed/refractory mantle cell lymphoma

Trial	Phase	Treatment	No. of pts	Med. follow-up (mo.)	ORR^a (%)	CR^a (%)	Med. DOR^a (mo.)	Med. PFS^a (mo.)	Med. OS (mo.)
Single-arm monotherapy trials
NCT01236391 [33, 34]	II	Ibrutinib	111	15.3	68	21	17.5	13.9	NR
NCT01236391 [33, 34]	II	Ibrutinib	111	26.7	67	23	17.5	13.0	22.5
NCT01599949 [35]	II	Ibrutinib	120	14.9	63	21	14.9	10.5	NA
NCT02213926 [36, 38]	II	Acalabrutinib	124	15.2	81	40	NR	NR	NR
NCT02213926 [36, 38]	II	Acalabrutinib	124	38.1	81	48	28.6	22.0	NR
NCT03206970 [39, 42]	II	Zanubrutinib	86	18.4	84	69	19.5	22.1	NA
NCT03206970 [39, 42]	II	Zanubrutinib	86	35.3	84	67	NR	33.0	NR
NCT01659255; NCT02457559 [14, 43]	I	Tirabrutinib	16^b	10.2^c	92	42	NA	11.2^d	NA
NCT01659255; NCT02457559 [14, 43]	I	Tirabrutinib	16^b	22.3	69	38	NR	25.8	NA
NCT03494179 [44, 45]	I/II	Orelabrutinib	106	15.0	88	27	NR	NR	NR
BRUIN [20]	I/II	Pirtobrutinib	56	6	52	25	NA	NA	NA
Open-label randomised controlled monotherapy trial
RAY [40, 41]	III	Ibrutinib	139	20.0	72*	19	NR	14.6*	NR
		Ibrutinib	139	38.7	77*	23	23.1	15.6*	30.3
		Temsirolimus	141	20.0	40	1	7.0	6.2	21.3
		Temsirolimus	141	38.7	47	3	6.3	6.2	23.5

BTK Bruton tyrosine kinase, CR complete response, DOR duration of response, med. median, mo. month(s), NA not available, NR not reached, ORR overall response rate, OS overall survival, PFS progression-free survival, pt(s) patient(s)

*p < 0.0001 for ibrutinib vs temsirolimus at corresponding data cut-off (i.e. med. follow-up)

^aIn general, initial results are as assessed by an independent review committee; later results are investigator-assessed

^bData presented are for 12 evaluable pts at 10.2 mo.-med. follow-up data cut-off

^cCalculated from reported value of 309 days

^dMean; calculated from reported value of 341 days