Table 1

Patient characteristics and associations with immune response

MMNSCLCPCOverallIR negativeIR positiveP value
n=11n=18n=22n=51n=11n=40
Age (years)Mean58.265.166.664.365.663.90.55
SD9.47.77.58.57.58.8
Gender (%)Male6 (54.5)8 (44.4)22 (100)36 (70.6)6 (54.5)30 (75)0.26
Female5 (45.5)10 (55.6)0 (0)15 (29.4)5 (45.5)10 (25)
Ethnicity (%)Caucasian11 (100)18 (100)21 (95.5)50 (98.0)11 (100)39 (97.5)1.0
Asian0 (0)0 (0)1 (4.5)1 (2.0)0 (0)1 (2.5)
ECOG (%)011 (100)14 (77.8)21 (95.5)46 (90.2)10 (90.9)36 (90)1.0
10 (0)4 (22.2)1 (4.5)5 (9.8)1 (9.1)4 (10)
Prior systemic therapy (%)Yes4 (36.4)18 (100)22 (100)44 (86.3)10 (90.9)34 (85)1.0
No7 (63.6)0 (0)0 (0)7 (13.7)1 (9.1)6 (15)
Stage (%)III0 (0)6 (33.3)0 (0)6 (11.8)2 (18.2)4 (10)0.39
III/IV0 (0)5 (27.8)0 (0)5 (9.8)2 (18.2)3 (7.5)
IV11 (100)7 (38.9)22 (100)40 (78.4)7 (63.6)33 (82.5)
Months since diagnosisMean43.922.03.718.828.116.20.30
SD58.323.81.733.432.133.7
LDH* (%)>ULN6 (54.5)6 (33.3)2 (9.1)14 (27.5)3 (27.3)11 (27.5)1.0
≤ULN5 (45.5)12 (66.7)20 (90.9)37 (72.5)8 (72.7)29 (72.5)
Lymphocytes* (%)<LLN1 (9.1)6 (33.3)1 (4.5)8 (15.7)2 (18.2)6 (15)1.0
≥LLN10 (90.9)12 (66.7)21 (95.5)43 (84.3)9 (81.8)34 (85)
Number of doses receivedMean5.712.413.411.410.811.50.60
SD2.52.72.53.93.64.1
Dose level (%)100 μg0 (0)6 (33.3)7 (31.8)13 (25.5)4 (36.4)9 (22.5)0.33
300 μg11 (100)6 (33.3)7 (31.8)24 (47.1)3 (27.3)21 (52.5)
700 μg0 (0)6 (33.3)8 (36.4)14 (27.5)4 (36.4)10 (25.0)
  • Demographics of immune response (IR) evaluable patients in each trial, and pooled IR negative and positive populations. The p values represent demographic differences between IR positive and negative populations.

  • *Levels of LDH and lymphocytes at baseline.

  • ECOG, eastern cooperative oncology group; LDH, lactate dehydrogenase; MM, malignant melanoma ; NSCLC, non-small cell lung cancer ; PC, prostate cancer.