Phase 1/2 study of epacadostat in combination with ipilimumab in patients with unresectable or metastatic melanoma

Gibney, Geoffrey T.; Hamid, Omid; Lutzky, Jose; Olszanski, Anthony J.; Mitchell, Tara C.; Gajewski, Thomas F.; Chmielowski, Bartosz; Hanks, Brent A.; Zhao, Yufan; Newton, Robert C.; Maleski, Janet; Leopold, Lance; Weber, Jeffrey S.

doi:10.1186/s40425-019-0562-8

Table 2 Patient Demographics and Disease Characteristics at Baseline

From: Phase 1/2 study of epacadostat in combination with ipilimumab in patients with unresectable or metastatic melanoma

	25 mg BID (n = 8)	50 mg BID Cont’ (n = 18)	50 mg BID Int’ (n = 9)	75 mg Total Daily (n = 7)	100 mg BID^a (n = 1)	300 mg BID^a (n = 7)	Total (N = 50)
Age
Median (range), y	67 (34–81)	57 (25–78)	69 (49–77)	62 (35–81)	67 (67)	64 (47–81)	63 (25–81)
≤ 65 y, n (%)	3 (37.5)	14 (77.8)	2 (22.2)	4 (57.1)	0	5 (71.4)	28 (56.0)
White, n (%)	8 (100.0)	18 (100.0)	9 (100.0)	7 (100.0)	1 (100.0)	7 (100.0)	50 (100.0)
Men, n (%)	6 (75.0)	9 (50.0)	6 (66.7)	3 (42.9)	1 (100.0)	7 (100.0)	32 (64.0)
ECOG PS, n (%)
0	5 (62.5)	16 (88.9)	6 (66.7)	6 (85.7)	1 (100.0)	4 (57.1)	38 (76.0)
1	3 (37.5)	2 (11.1)	3 (33.3)	1 (14.3)	0	3 (42.9)	12 (24.0)
Current staging, n (%)
IIIB	1 (12.5)^b	0	0	0	0	0	1 (2.0)
IIIC	0	0	2 (22.2)	0	0	0	2 (4.0)
IV	7 (87.5)	18 (100.0)	7 (77.8)	7 (100.0)	1 (100.0)	7 (100.0)	47 (94.0)
Current M classification, n (%)
0	0	0	2 (22.2)	0	0	0	2 (4.0)
1a	1 (12.5)	3 (16.7)	0	2 (28.6)	0	2 (28.6)	8 (16.0)
1b	2 (25.0)	1 (5.6)	1 (11.1)	1 (14.3)	0	0	5 (10.0)
1c	5 (62.5)	14 (77.8)	6 (66.7)	4 (57.1)	1 (100.0)	5 (71.4)	35 (70.0)
Most common sites of metastases, n (%)
Lymph nodes	3 (37.5)	12 (66.7)	4 (44.4)	3 (42.9)	0	6 (85.7)	28 (56.0)
Lung	4 (50.0)	13 (72.2)	4 (44.4)	3 (42.9)	1 (100.0)	1 (14.3)	26 (52.0)
Liver	2 (25.0)	6 (33.3)	3 (33.3)	3 (42.9)	0	1 (14.3)	15 (30.0)
Abdomen	0	3 (16.7)	3 (33.3)	0	0	3 (42.9)	9 (18.0)
Skin	1 (12.5)	4 (22.2)	1 (11.1)	1 (14.3)	0	2 (28.6)	9 (18.0)
Adrenals	1 (12.5)	3 (16.7)	2 (22.2)	0	1 (100.0)	0	7 (14.0)
CNS/brain	1 (12.5)	4 (22.2)	0	1 (14.3)	0	0	6 (12.0)
Chest wall	0	2 (11.1)	0	1 (14.3)	0	2 (28.6)	5 (10.0)
Breast	0	3 (16.7)	0	0	0	0	3 (6.0)
Peritoneum	0	0	1 (11.1)	1 (14.3)	0	0	2 (4.0)
Bone	0	0	0	0	0	1 (14.3)	1 (2.0)
Pancreas	0	1 (5.6)	0	0	0	0	1 (2.0)
Pleura	0	1 (5.6)	0	0	0	0	1 (2.0)
Other	5 (62.5)	6 (33.3)	1 (11.1)	2 (28.6)	0	3 (42.9)	17 (34.0)
BRAF-mutant positive, n (%)	2 (25.0)	8 (44.4)	2 (22.2)	1 (14.3)	1 (100.0)	2 (28.6)	16 (32.0)
Elevated LDH level, n (%)	2 (25.0)	3 (16.7)	3 (33.3)	2 (28.6)	0	2 (28.6)	12 (24.0)
Prior radiation therapy, n (%)	4 (50.0)	8 (44.4)	2 (22.2)	3 (42.9)	0	3 (42.9)	20 (40.0)
Prior systemic regimens for advanced or metastatic disease, n (%)	1 (12.5)	12 (66.7)	3 (33.3)	2 (28.6)	1 (100.0)	4 (57.1)	23 (46.0)
Prior systemic therapy for advanced or metastatic disease, n (%)
Immunotherapy	0	6 (33.3)	3 (33.3)	1 (14.3)	0	1 (14.3)	11 (22.0)
Immune checkpoint inhibitor	0	3 (16.7)	2 (22.2)	1 (14.3)	0	0	6 (12.0)
Interferon	0	3 (16.7)	1 (11.1)	0	0	1 (14.3)	5 (10.0)
IL-2	0	1 (5.6)	1 (11.1)	0	0	0	2 (4.0)
Other	0	1 (5.6)	1 (11.1)	0	0	0	2 (4.0)
BRAF inhibitor	0	3 (16.7)	0	0	0	1 (14.3)	4 (8.0)
Chemotherapy	0	2 (11.1)	0	1 (14.3)	0	2 (28.6)	5 (10.0)
Other	0	4 (22.2)	1 (11.1)	2 (28.6)	1 (100.0)	1 (14.3)	9 (18.0)

BID twice daily, CNS central nervous system, cont’ continuous, ECOG PS Eastern Cooperative Oncology Group performance status, IL-2 interleukin 2, int’ intermittent, LDH lactate dehydrogenase
^a Epacadostat 100-mg BID and 300-mg BID dose cohorts were not re-explored in this study after protocol amendment to evaluate lower doses of epacadostat
^b Patient was incorrectly staged as IIIB by study site; this patient had metastases in the liver and therefore should have been reported as stage IV

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