Baseline patient characteristics
| 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 mutationb | 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) |
| Otherc | 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) |
| Immunotherapyde | 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