Table 1.
Baseline demographic and clinicopathologic disease characteristics (efficacy cohort [N = 40])
| Patient/disease characteristic | Arm A Cy-GVAX n = 16 | Arm B Cy-GVAX PD-1 n = 14 | Arm C Cy-GVAX PD-1 CD137 n = 10 |
|---|---|---|---|
| Age (yr) at surgery median (min, max) | 68.0 (47.0, 85.0) | 67.5 (53.0, 76.0) | 70.0 (46.0, 83.0) |
| Sex: female | 7 (43.8%) | 6 (42.9%) | 7 (70%) |
| Race | |||
| white | 14 (87.5%) | 14 (100%) | 7 (70%) |
| Asian | 2 (12.5%) | 0 | 2 (20%) |
| Black | 0 | 0 | 1 (10%) |
| pT-Stage (AJCC 8th) | |||
| 1 | 3 (18.8%) | 2 (14.3%) | 3 (30.0%) |
| 2 | 10 (62.5%) | 12 (85.7%) | 6 (60.0%) |
| 3 | 2 (12.5%) | 0 (0%) | 1 (10.0%) |
| 4 | 1 (6.3%) | 0 (0%) | 0 (0%) |
| pN-Stage (AJCC 8th) | |||
| 0 | 5 (31.3%) | 4 (28.6%) | 3 (30.0%) |
| 1 | 2 (12.5%) | 5 (35.7%) | 4 (40.0%) |
| 2 | 9 (56.3%) | 5 (35.7%) | 3 (30.0%) |
| Tumor grade | |||
| Well (1) | 1 (6.3%) | 1 (7.1%) | 0 (0%) |
| Moderate (2) | 9 (56.3%) | 10 (71.4%) | 7 (70.0%) |
| Poor (3) | 6 (37.5%) | 3 (21.4%) | 3 (30.0%) |
| Resection status: R0 | 16 (100%) | 12 (85.7%) | 9 (90.0%) |
| LVI: present | 11 (68.8%) | 8 (57.1%) | 6 (60.0%) |
| PNS: present | 14 (87.5%) | 13 (92.9%) | 9 (90.0%) |
| Adjuvant SOC chemo | |||
| (m)FOLFIRINOX | 3 (18.8%) | 3 (21.4%) | 7 (70%) |
| Gem + Cap | 10 (62.5%) | 9 (64.3%) | 2 (20.0%) |
| Gem+ Nab-paclitaxel | 1 (6.3%) | 1 (7.1%) | 1 (10.0%) |
| Gem monotherapy | 1 (6.3%) | 2 (14.3%) | 1 (10.0%) |
| None | 3 (18.8%) | 0 (0%) | 0 (0%) |
| Time (days) from neoadjuvant study treatment to surgery | |||
| Median (Q1, Q3) | 12.5 (11, 15) | 14 (12.3, 15) | 14 (11, 15.8) |
| Mo. of SOC Chemo median (Q1, Q3) | 5.26 (3.98, 6.34) | 5.29 (1.92, 5.86) | 5.34 (4.59, 5.74) |
| Adjuvant radiation | 1 (6.3%) | 4 (28.6%) | 0 (0%) |
AJCC American Joint Committee on Cancer, LVI lymphovascular invasion, PNS perineural spread, SOC standard of care, (m)FOLFIRINOX (modified) FOLFIRINOX (oxaliplatin + irinotecan + leucovorin, 400 mg/m2 + infusional fluorouracil), Gem gemcitabine, Cap capecitabine.