Table 4.
Tumor response assessments.
| A. ORR | |||||
|---|---|---|---|---|---|
| ORR | CR | PR | SD | PD | |
| Study phase/tumor type | n (%; 95% CI)a | n (%) | n (%) | n (%) | n (%) |
| Phase I/II (N = 114) | 12 (10.5; 5.6–17.7) | 3 (2.6) | 9 (7.9) | 33 (28.9) | 69 (61.5) |
| Phase I (n = 4) | 1 (25.0; 0.6–80.6) | 0 | 1 (25.0)b | 0 | 3 (75.0) |
| Phase II | |||||
| SCCHN (n = 10) | 1 (10.0; 0.3–44.5) | 0 | 1 (10.0) | 4 (40.0) | 5 (50.0) |
| NSCLC, nonsquamous cell, PD-L1 nonexpressing (n = 4) | 1 (25.0; 0.6–80.6) | 0 | 1 (25.0) | 1 (25.0) | 2 (50.0) |
| NSCLC, squamous cell (n = 5) | 1 (20.0; 0.5–71.6) | 0 | 1 (20.0) | 2 (40.0) | 2 (40.0) |
| Ovarian/fallopian tube/primary peritoneal cancer (n = 21) | 3 (14.3; 3.0–36.3) | 2 (9.5) | 1 (4.8) | 7 (33.3) | 11 (52.4) |
| Hepatocellular carcinoma (n = 24) | 4 (16.7; 4.7–37.4) | 1 (4.2) | 3 (12.5) | 11 (45.8) | 9 (37.5) |
| Colorectal cancer, non-MSI high (n = 29) | 1 (3.4; 0.1–17.8) | 0 | 1 (3.4) | 6 (20.7) | 22 (75.9) |
| Pancreatic adenocarcinoma (n = 17) | 0 (0; 0.0–19.5) | 0 | 0 | 2 (11.8) | 15 (88.2) |
| B. TTR, DOR, PFS, and OS | |
|---|---|
| Mogamulizumab 1 mg/kg + Nivolumab 240 mg | |
| Endpoint | (N = 114) |
| TTR, months, median (range) | 3.26 (2.2–13.4) |
| DOR, months, medianc (95% CI) | - (5.1, –)d |
| PFS, months, medianc (95% CI) | 2.6 (2.3–3.1) |
| OS, months, medianc (95% CI) | 9.5 (5.9–13.5) |
Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; MSI, microsatellite instability; NSCLC, non–small cell lung cancer; ORR, overall response rate; OS, overall survival; PD, progressive disease; PD-L1, programmed cell death ligand 1; PFS, progression-free survival; PR, partial response; SCCHN, squamous cell carcinoma of the head and neck; SD, stable disease; TTR, time to response.
aExact two-sided 95% CIs using Clopper–Pearson method.
bPatient with alveolar soft part sarcoma.
cKaplan–Meier estimate.
dMedian DOR for subjects with CR/PR only was 14.4 months while the Kaplan–Meier estimate of median DOR was not reached.