Baseline patient and disease characteristics
| Dose- escalation phase (n=53) | Dose-escalation phase pacmilimab 10 mg group (n=16) | Expansion phase | |||||||
| TNBC (n=14) | Anal SCC (n=14) | cSCC (n=14) | UPS (n=20) | SBA (n=14) | TET (n=8) | hTMB (n=14) | |||
| Median age, years (range) | 61 (22–81) | 57 (32–81) | 56 (32–72) | 64 (36–80) | 70 (58–83) | 63 (33–80) | 55 (34–67) | 52 (35–65) | 61 (48–83) |
| Sex, n (%) | |||||||||
| Male | 25 (47) | 7 (44) | 0 | 2 (14) | 7 (50) | 12 (60) | 8 (57) | 7 (88) | 2 (14) |
| Female | 28 (53) | 9 (56) | 14 (100) | 12 (86) | 7 (50) | 8 (40) | 6 (43) | 1 (13) | 12 (86) |
| Race, n (%) | |||||||||
| White | 44 (83) | 15 (94) | 7 (50) | 10 (71) | 11 (79) | 16 (80) | 9 (64) | 5 (63) | 9 (64) |
| Black | 1 (2) | 2 (14) | 0 | 0 | 2 (10) | 2 (14) | 2 (25) | 0 | |
| Asian | 1 (2) | 0 | 0 | 0 | 1 (5) | 0 | 1 (13) | 0 | |
| Unknown/other | 7 (13) | 1 (6) | 5 (36) | 4 (29) | 3 (21) | 1 (5) | 3 (21) | 0 | 5 (36) |
| ECOG PS, n (%) | |||||||||
| 0 | 23 (43) | 10 (63) | 6 (43) | 9 (64) | 6 (43) | 1 (5) | 6 (43) | 3 (38) | 5 (36) |
| 1 | 30 (57) | 6 (38) | 8 (57) | 5 (36) | 8 (57) | 19 (95) | 8 (57) | 5 (63) | 9 (64) |
| Median no. of prior cancer treatments (range) | 2.0 (0–11.0) | 2.0 (0–5.0) | 3.0 (1.0–7.0) | 2.0 (1.0–5.0) | 0.5 (0–4.0) | 2.5 (0–6.0) | 3.0 (1.0–6.0) | 2.5 (1.0–7.0) | 4.5 (0–12.0) |
| PD-L1 expression status,* n (%) | |||||||||
| High | 12 (23) | 5 (31) | 0 | 3 (21) | 4 (29) | 4 (20) | 0 | 3 (38) | 3 (21) |
| Low | 15 (28) | 4 (25) | 1 (7) | 9 (64) | 6 (43) | 6 (30) | 3 (21) | 3 (38) | 3 (21) |
| None | 18 (34) | 5 (31) | 13 (93) | 2 (14) | 2 (14) | 9 (45) | 11 (79) | 1 (13) | 6 (43) |
| Unknown | 8 (15) | 2 (13) | 0 | 0 | 2 (14) | 1 (5) | 0 | 1 (13) | 2 (14) |
*Measured prospectively and defined by Tumor Proportion Score (TPS) using the DAKO PD-L1 IHC 22C3 pharmDx assay (Agilent Technologies, Santa Clara, California, USA). High expression was defined as TPS >50% membrane staining, low expression was defined as TPS ≥1% and ≤50% membrane staining, and no expression was defined as TPS <1%.
cSCC, cutaneous squamous cell carcinoma; hTMB, high tumor mutational burden; PD-L1, programmed death ligand-1; ECOG PS, Eastern Cooperative Oncology Group performance status; SBA, small bowel adenocarcinoma; SCC, squamous cell carcinoma; TET, thymic epithelial tumor; TNBC, triple-negative breast cancer; UPS, undifferentiated pleiomorphic sarcoma.