Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies

Naing, Aung; Infante, Jeffrey; Goel, Sanjay; Burris, Howard; Black, Chelsea; Marshall, Shannon; Achour, Ikbel; Barbee, Susannah; May, Rena; Morehouse, Chris; Pollizzi, Kristen; Song, Xuyang; Steele, Keith; Elgeioushi, Nairouz; Walcott, Farzana; Karakunnel, Joyson; LoRusso, Patricia; Weise, Amy; Eder, Joseph; Curti, Brendan; Oberst, Michael

doi:10.1186/s40425-019-0665-2

Table 1 Baseline patient characteristics

From: Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies

	Q3W (mg/kg)					Q2W (mg/kg)		QW × 2 (mg/kg)	QW × 4 (mg/kg)	Total
	0.1 (n = 5)	0.5 (n = 5)	2.5 (n = 3)	10 (n = 6)	20 (n = 9)	10 (n = 4)	20 (n = 18)	20 (n = 3)	20 (n = 5)	N = 58
Median age, years (range)	61 (23–69)	62 (54–74)	58 (51–69)	65 (55–78)	59 (46–81)	68.5 (46–75)	65.5 (48–86)	65 (61–70)	59 (50–64)	62.5 (23–86)
Male, n (%)	5 (100)	4 (80)	2 (67)	4 (67)	8 (89)	3 (75)	13 (72)	3 (100)	5 (100)	47 (81)
Race, n (%)
White	5 (100)	5 (100)	3 (100)	6 (100)	9 (100)	4 (100)	16 (89)	3 (100)	5 (100)	56 (97)
Asian	0	0	0	0	0	0	1 (6)	0	0	1 (2)
Other	0	0	0	0	0	0	1 (6)	0	0	1 (7)
ECOG status, n (%)^a
0	3 (60)	4 (80)	2 (67)	2 (40)	4 (44)	2 (50)	8 (44)	2 (67)	2 (40)	29 (51)
1	2 (40)	1 (20)	1 (33)	3 (60)	5 (56)	2 (50)	10 (56)	1 (33)	3 (60)	28 (49)
Median time from primary diagnosis to study entry, months (range)	48 (4–80)	10 (8–27)	66 (34–140)	26 (9–54)	18 (5–46)	47 (5–137)	15 (0–109)	72 (40–72)	32 (8–57)	19 (0–140)
Smoking history, (%)
Never smoked	3 (60)	1 (20)	2 (67)	3 (50)	4 (44)	2 (50)	8 (44)	0	3 (60)	26 (45)
Former/current smoker	2 (40)	4 (80)	1 (33)	3 (50)	5 (56)	2 (50)	10 (56)	3 (100)	2 (40)	32 (55)
Tumor type, n (%)
Renal cell	1 (20)	1 (20)	0	2 (33)	7 (78)	3 (75)	15 (83)	3 (100)	4 (80)	36 (62)
Melanoma with mutation^b	1 (20)	0	0	0	2 (22)	1 (25)	1 (6)	0	0	5 (9)
Non-squamous NSCLC	2 (40)	2 (40)	0	1 (17)	0	0	0	0	0	5 (9)
Melanoma-unknown	0	0	0	1 (17)	0	0	2 (11)	0	1 (20)	4 (7)
Other^c	0	1 (20)	2 (67)	0	0	0	0	0	0	3 (5)
Squamous NSCLC	1 (20)	1 (20)	0	0	0	0	0	0	0	2 (3)
Bladder	0	0	1 (33)	0	0	0	0	0	0	1 (2)
Ovarian	0	0	0	1 (17)	0	0	0	0	0	1 (2)
Prostate	0	0	0	1 (17)	0	0	0	0	0	1 (2)
Prior anti-cancer therapy, n (%)^a
Biologic	4 (80)	0	0	0	1 (11)	1 (25)	0	1 (33)	1 (20)	8 (14)
Immunotherapy^de	1 (20)	0	0	1 (17)	0	0	0	0	0	2 (4)
Chemotherapy	5 (100)	4 (80)	3 (100)	3 (50)	0	1 (25)	7 (39)	0	0	23 (40)
Surgery	2 (40)	3 (60)	2 (67)	4 (67)	5 (56)	2 (50)	15 (83)	2 (67)	4 (80)	39 (67)
Radiation	3 (60)	1 (20)	1 (33)	0	3 (33)	3 (75)	9 (50)	2 (67)	2 (40)	24 (41)
Other	3 (60)	1 (20)	2 (67)	4 (67)	5 (56)	2 (50)	9 (50)	3 (100)	3 (60)	32 (55)

Abbreviations: ECOG Eastern Cooperative Oncology Group, Fc fragment crystallizable, NSCLC non-small cell lung cancer, PD-L2 programmed cell death ligand-2 ^aData unavailable for 1 patient ^bAll tumors harboring mutations had BRAF mutations except for 1 with EGFR mutation ^cIncludes adenoma of unknown primary, cellular uterine leiomyoma, and fallopian tube carcinoma ^dIncludes 1 patient enrolled before the May 2014 amendment who received prior AMP-224 PD-L2 Fc fusion protein and 1 patient who received prior pegylated interferon alfa-2b, recorded as an immunotherapy by the investigator ^eIncludes 1 patient who received the therapeutic anticancer vaccine, rocapuldencel-T, plus sunitinib

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