Summary of confirmed BOR by RECIST version 1.1
| Parameter | HNSCC PD-1/PD-L1–naïve (n=18) | HNSCC prior PD-1/PD-L1 (n=19) | NSCLC PD-1/PD-L1–naïve (n=14) | NSCLC prior PD-1/PD-L1 (n=21) | Urothelial cancer (n=17) | Cutaneous melanoma (n=13) |
| CR | 1 (5.6) | 0 | 0 | 0 | 0 | 0 |
| PR | 5 (27.8) | 0 | 5 (35.7) | 2 (9.5) | 1 (5.9) | 1 (7.7) |
| ORR | 6 (33.3) | 0 | 5 (35.7) | 2 (9.5) | 1 (5.9) | 1 (7.7) |
| SD | 5 (27.8) | 9 (47.4) | 8 (57.1) | 11 (52.4) | 8 (47.1) | 5 (38.5) |
| Clinical benefit rate* | 11 (61.1) | 9 (47.4) | 13 (92.9) | 13 (61.9) | 9 (52.9) | 6 (46.2) |
| Progressive disease | 7 (38.9) | 10 (52.6) | 1 (7.1) | 8 (38.1) | 8 (47.1) | 6 (46.2) |
| NE | 0 | 0 | 0 | 0 | 0 | 1 (7.7)† |
| PFS, months | ||||||
| Median (95% CI) | 3.48 (1.35 to NR) | 1.45 (1.35 to 3.55) | 4.83 (2.60 to 12.22) | 3.45 (1.41 to 3.98) | 2.18 (1.28 to 5.52) | 2.07 (1.31 to 9.82) |
| Range | 0.03–27.1+ | 0.03–8.05 | 0.03–12.22 | 0.03–7.66 | 0–18.66 | 0.03–11.96 |
| 6-month rate | 42.1% | 7.5% | 43.3% | 13.9% | 14.0% | 25.0% |
| OS, months | ||||||
| Median (95% CI) | 17.38 (9.17 to NR) | 6.93 (3.12 to 9.69) | 12.32 (5.65 to NR) | 7.13 (3.06 to 14.85) | 5.72 (3.09 to 11.1) | 14.19 (4.76 to NR) |
| Range | 0.4–29.4+ | 0.8–15.5 | 2.4–17.8+ | 0.03–24.4 | 0.92–20.4 | 1.97–18.9+ |
| 6-month rate | 79.9% | 60.9% | 80.0% | 58.5% | 47.6% | 78.6% |
Data are shown as n (%) unless otherwise noted.
*Clinical benefit rate=CR+PR+SD.
†One patient with cutaneous melanoma has a response as NE.
BOR, best overall response; CR, complete response; HNSCC, head and neck squamous cell carcinoma; NE, not evaluable; NR, not reached; NSCLC, non–small cell lung cancer; ORR, overall response rate; OS, overall survival; PD-1, programmed cell death-1; PD-L1, programmed death-ligand 1; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.