Table 3.
Efficacy of treatment with durvalumab alone
| Clinical trial information | Subgroup | Evaluable patients (N) | PR (N) | CR (N) | SD (N) | ORR % (95% CI) | mPFS months (95% CI) | mOS months (95% CI) | |
|---|---|---|---|---|---|---|---|---|---|
| NCT01938612 | Solid tumors | 22 | 1 | NM | 6 | NM | NM | NM | |
| NCT02087423 | Cohort 2 | PD-L1 ≥25% of TCs | 146 | NM | NM | NM | 16.4 (10.8–23.5) | 3.3 (1.9–3.7) | 10.9 (8.6–13.6) |
| PD-L1 <25% of TCs | 53 | NM | NM | NM | 7.5 (3.1–14.9) | 1.9 (1.8–1.9) | 9.3 (5.9–10.8) | ||
| Cohort 3 | PD-L1 ≥90% of TCs | 68 | NM | NM | NM | 30.9 (20.2–43.3) | 2.4 (1.8–5.5) | NR (5.9–NE) | |
| NCT01693562 | UCC | PD-L1 high | 98 | 23 | 4 | NM | 27.6 (19.0–37.5) | 2.1 (1.4–2.8) | 20.0 (11.6–NE) |
| PD-L1 low/negative | 79 | 2 | 2 | NM | 5.1 (1.4–12.5) | 1.4 (1.3–1.5) | 8.1 (3.1–NE) | ||
| NCT01693562 | HCC | 30 | 4 | NM | 14 | 10.0 (2.8–23.7) | 2.7 (1.4–5.3) | 13.2 (6.3–21.1) | |
| NCT02336165 | Glioblastoma | Cohort B | 30 | 4 | NM | 14 | NM | NM | NM |
Notes: PD-L1 high, ≥25% of either tumor cells or immune cells expressing PD-L1; PD-L1 low or negative, <25% of both tumor cells and immune cells expressing PD-L1.
Abbreviations: CR, complete response; HCC, hepatocellular carcinoma; m, median; mOS, median overall survival; mPFS, median progression-free survival; NE, not estimated; NM, not mentioned; NR, not reached; ORR, objective response rate; OS, overall survival; PD-L1, programmed cell death ligand-1; PFS, progression-free survival; PR, partial response; SD, stable disease; TCs, tumor cells; UCC, urothelial carcinoma.