Table 1 Demographic and baseline disease characteristics for patients in the efficacy population

From: Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: clinical and immunologic analyses from the randomized phase 2 PRINCE trial

 

nivo/chemo (n = 34)

sotiga/chemo (n = 36)

sotiga/nivo/chemo (n = 35)

Characteristic

   

Age, years

 Median (range)

62.5 (47–75)

60.5 (35-78)

62.0 (41–78)

 ≥65 years, n (%)

14 (41)

14 (39)

13 (37)

Sex, n (%)

 Female

14 (41)

13 (36)

16 (46)

 Male

20 (59)

23 (64)

19 (54)

Race and ethnic group, n (%)

 Asian

3 (9)

4 (11)

0

 Black

0

3 (8)

2 (6)

 White

29 (85)

28 (78)

31 (89)

 Other

2 (6)

1 (3)

2 (6)

 Hispanic

1 (3)

1 (3)

1 (3)

ECOG performance status score, n (%)

 0

15 (44)

20 (56)

15 (43)

 1

19 (56)

16 (44)

20 (57)

Pancreatic tumor location, n (%)

 Head

14 (41)

17 (47)

19 (54)

 Body

12 (35)

9 (25)

10 (29)

 Tail

8 (24)

10 (28)

6 (17)

Select sites of metastatic disease, n (%)

 Liver

28 (82)

29 (81)

27 (77)

 Lung

10 (29)

10 (28)

11 (31)

 Peritoneum

8 (24)

9 (25)

11 (31)

Stage at initial PDAC diagnosis, n (%)

 Stages I−III

7 (21)

9 (25)

9 (26)

 Stage IV

27 (79)

27 (75)

26 (74)

Time from diagnosis to first dose—months, median (range)a

1.1 (0.4–69.8)

1.0 (0.4–29.1)

1.1 (0.4–45.3)

Prior cancer treatment, n (%)

 Chemotherapy

9 (27)

7 (19)

6 (17)

 Radiation therapy

7 (21)

1 (3)

4 (11)

 Surgery

11 (32)

11 (31)

8 (23)

Tumor burden (RECIST), mmb

 Median

78.5

68.5

79.0

 Range

13–160

19–214

10–194

  1. The efficacy population includes all randomized and dosed patients in phase 2 and DLT-evaluable patients from phase 1b enrolled at the recommended phase 2 dose of sotiga.
  2. aCalculations exclude one participant from nivo/chemo who did not report a date of diagnosis.
  3. bTumor burden is the sum of the largest diameters of all target lesions (shortest diameter for lymph nodes).
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