Table 1.
Patient characteristics and summary of BOR and duration of responses by dose (RECIST).
| Ivuxolimab dose | |||||||
|---|---|---|---|---|---|---|---|
| 0.01 mg/kg | 0.1 mg/kg | 0.3 mg/kg | 1.5 mg/kg | 3 mg/kg | 10 mg/kg | Total | |
| Cohort | n = 2 | n = 10 | n = 11 | n = 12 | n = 13 | n = 4 | N = 52 |
| Age, mean (range), years | 53 (48–57) | 58 (40–79) | 52 (23–67) | 68 (54–78) | 62 (45–75) | 60 (41–74) | 60 (23–79) |
| Sex, n (%) | |||||||
| Male | 1 (50.0) | 8 (80.0) | 8 (72.7) | 11 (91.7) | 11 (84.6) | 4 (100) | 43 (82.7) |
| Female | 1 (50.0) | 2 (20.0) | 3 (27.3) | 1 (8.3) | 2 (15.4) | 0 | 9 (17.3) |
| ECOG PS, n (%) | |||||||
| 0 | 1 (50.0) | 6 (60.0) | 7 (63.6) | 4 (33.3) | 6 (46.2) | 2 (50.0) | 26 (50.0) |
| 1 | 1 (50.0) | 4 (40.0) | 4 (36.4) | 8 (66.7) | 7 (53.8) | 2 (50.0) | 26 (50.0) |
| Treatment duration, median (range), days | 43.5 (29–58) | 71.5 (27–183) | 74.0 (29–770) | 50.0 (27–281) | 98 (1–225) | 162 (1–555) | 71.5 (1–770) |
| Primary diagnosisa, n (%) | |||||||
| HCC | 1 (50) | 6 (60) | 3 (27) | 6 (50) | 3 (23) | 0 | 19 (37) |
| MELb | 1 (50) | 2 (20) | 4 (36) | 3 (25) | 4 (31) | 1 (25) | 15 (29) |
| RCC | 0 | 2 (20) | 3 (27) | 2 (17) | 2 (15) | 0 | 9 (17) |
| HNSCC | 0 | 0 | 1 (9) | 1 (8) | 4 (31) | 3 (75) | 9 (17) |
| Number of prior systemic therapies, mean (range) | 4.5 (2–7) | 2.8 (1–11) | 3.3 (1–10) | 3.8 (1–8) | 3.5 (1–8) | 2.3 (1–3) | 3.3 (1–11) |
| Number of prior immunotherapies, n (%) | |||||||
| Anti–CTLA-4 | 1 (50) | 2 (20) | 2 (18) | 3 (25) | 3 (23) | 1 (25) | 12 (23) |
| Anti–PD-1 | 1 (50) | 3 (30) | 5 (45) | 4 (33) | 3 (23) | 2 (50) | 18 (35) |
| Anti–PD-L1 | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (2) |
| Other immunotherapy | 0 | 1 (10) | 0 | 1 (8) | 0 | 0 | 2 (4) |
| BOR, n (%) | |||||||
| CR | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PR | 0 | 1 (10.0) | 1 (9.1) | 0 | 0 | 1 (25.0) | 3 (5.8) |
| SD | 0 | 5 (50.0) | 6 (54.5) | 6 (50.0) | 8 (61.5) | 1 (25.0) | 26 (50.0) |
| PD (%) | 2 (100.0) | 3 (30.0) | 4 (36.4) | 6 (50.0) | 3 (23.1) | 1 (25.0) | 19 (36.5) |
| Indeterminate (%) | 0 | 1 (10.0) | 0 | 0 | 0 | 0 | 1 (1.9) |
| NE (%) | 0 | 0 | 0 | 0 | 2 (15.4) | 1 (25.0) | 3 (5.8) |
| Mean DOR, weeks | — | 10.3 | 93.1 | — | — | 35.9 | 46.4 |
| Mean DOSD, weeks | — | 11.1 | 13.0 | 18.0 | 13.9 | 30.0 | 14.7 |
| Median time to first PD, weeks | 5.8 | 11.8 | 7.6 | 6.2 | 12.4 | 36.1 | 11.6 |
Note: Time to first PD is defined as time from start of treatment until date of first PD or the last non-PD assessment date prior to cutoff date.
Abbreviations: BOR, best overall response; CR, complete response; DOR, duration of response; DOSD, duration of SD; ECOG PS, Eastern Cooperative Oncology Group performance status; HCC, hepatocellular carcinoma; HNSCC, head and neck squamous cell carcinoma; MEL, malignant melanoma; NE, not evaluable; PD, progressive disease; PR, partial response; RCC, renal cell carcinoma; SD, stable disease.
aSince metastatic diagnosis.
b0.01 mg/kg: n = 1 cutaneous; 0.1 mg/kg: n = 1 cutaneous, n = 1 other; 0.3 mg/kg: n = 2 cutaneous, n = 1 acral, n = 1 other; 1.5 mg/kg: n = 2 cutaneous, n = 1 acral; 3.0 mg/kg: n = 2 cutaneous, n = 1 uveal, n = 1 other; 10 mg/kg: n = 1 cutaneous.