Table 4.

Response data and response by frontline treatment status

Variable	All (%)	Primary refractory* (N = 18)	Relapse (N = 24)
Response after cycle 3 (n = 42) *	$\text{N}=42$	$\text{N}=18$	$\text{N}=24$
ORR	37 (88)	16 (89)	21 (87.5)
CR	26 (62)	11 (61)	15 (62.5)
PR	11 (26)	5 (28)	6 (25)
SD	2 (5)	0	2 (8)
PD	3 (7)	2 (11)	1 (4)
Response after cycle 6 (n = 37)†	$\text{N}=37$	$\text{N}=16$	$\text{N}=21$
ORR	33 (89)	14 (88)	19 (90)
CR	29 (78)	12 (75)	17 (81)
PR	4 (11)	2 (12.5)	2 (9.5)
SD	0 (0)	0	0
PD	4 (11)	2 (12.5)	2 (9.5)
Response at end of NIVO (n = 42) *	$\text{N}=42$	$\text{N}=18$	$\text{N}=24$
ORR	34 (81)	14 (78)	20 (83)
CR	30 (71)	12 (67)	18 (75)
PR	4 (10)	2 (11)	2 (8)
SD	1 (2)	0	1 (4)
PD	7 (17)	4 (22)	3 (12.5)
Response after NICE (n = 9)
ORR	9 (100)	5 (100)	4 (100)
CR	8 (89)	4 (80)	4 (100)
PR	1 (11)	1 (20)	0
SD	0 (0)	0	0
PD	0 (0)	0	0
Response at end of protocol therapy (n = 42) *	$\text{N}=42$	$\text{N}=18$	$\text{N}=24$
ORR	39 (93)	17 (94)	22 (92)
CR	38 (91)	16 (89)	22 (92)
PR	1 (2)	1 (5.5)	0
SD	0	0	0
PD	3 (7)	1 (5.5)	2 (8)

^*One primary refractory patient was inevaluable due to toxicity during cycle 1.

^†Six patients did not receive 6 cycles of Nivo, n = 3 due to toxicity, n = 3 due to insufficient response/progression.