Daratumumab: a first-in-class CD38 monoclonal antibody for the treatment of multiple myeloma

Table 1 Clinical trials of daratumumab with available data

Study	NCT number (trial name)	Phase	Number	Regimen	ORR (%)	PFS rate (%) (1 year)	OS rate (%) (1 year)	Median PFS (months)
Clinical trials with daratumumab as monotherapy
Lokhorst et al. 2015 [22]	NCT00574288 (GEN501)	1/2	30	Daratumumab (8 mg/kg)	10	–	77	2.4
Lokhorst et al. 2015 [22]	NCT00574288 (GEN501)	1/2	42	Daratumumab (16 mg/kg)	36	65	77	5.6
Lonial et al. 2016 [23]	NCT01985126 (SIRIUS)	2	106	Daratumumab (16 mg/kg)	29	–	65	3.7
Clinical trials with daratumumab in combination regimens
Plesner et al. 2015 [27]	NCT01615029	1/2	32	Daratumumab (16 mg/kg) + Rd	88	–	–	–
Chari et al. 2015 [29] Mateos et al. 2015 [30]	NCT01998971	1	6	Daratumumab (16 mg/kg) + VD	100^a	–	–	–
			11	Daratumumab (16 mg/kg) + VTD	100^b	–	–	–
			8	Daratumumab (16 mg/kg) + VMP	100^c	–	–	–
			77	Daratumumab (16 mg/kg) + POM-D	59^d	–	–	–
Palumbo et al. 2016 [32]	NCT02136134 (CASTOR)	3	251	Daratumumab (16 mg/kg) + VD	83^e	–	–	NR^e
Palumbo et al. 2016 [32]	NCT02136134 (CASTOR)	3	247	VD	63^e	–	–	7.16^e

ORR overall response rate, PFS progression-free survival, OS overall survival, NR not reached, Rd lenalidomide and dexamethasone, VD bortezomib and dexamethasone, VTD bortezomib/thalidomide/dexamethasone, VMP bortezomib/melphalan/prednisone, POM-D pomalidomide/dexamethasone
^aMedian duration of follow-up days, 193
^bMedian duration of follow-up days, 164
^cMedian duration of follow-up days, 267
^dORR reported for 53 of 77 patients evaluable for efficacy; median duration of follow-up days, 148
^eMedian follow-up months, 7.4