Arm A avelumab N=30 | Arm B avelumab+cetuximab N=30 | |
Median follow-up time, months: 17.2 (IQR 15.7–18.2) | ||
Best overall response, n (%) | ||
CR | 0 | 0 |
PR | 3 (10) | 5 (17) |
SD | 12 (40) | 12 (40) |
PD | 15 (50) | 13 (43) |
ORR % (two-sided 95% CI) | 10 (2.1–26.5) | 17 (5.6–34.7) |
Median DOR (two-sided 95% CI), months | 5.5 (2.3–NE) | 7.6 (2.0–NE) |
DCR % (two-sided 95% CI) | 50 (31.3–68.7) | 57 (37.4–74.5) |
Median duration of disease control (two-sided 95% CI), months | 4.2 (1.8–8.6) | 4.6 (1.9–9.1) |
Median PFS (two-sided 95% CI), months | 2.0 (1.8–4.0) | 3.9 (2.1–5.6) |
Median OS (two-sided 95% CI), months | 12.8 (7.7–16.9) | 7.8 (6.2–11.2) |
Updated survival Median follow-up time, months: 26.7 (IQR 26.5–26.9) | ||
Median PFS (two-sided 95% CI), months | 2.0 (1.8–4.0) | 3.9 (2.1–5.6) |
Median OS (two-sided 95% CI), months | 13.9 (7.7–19.4) | 7.8 (6.2–11.2) |
CR, complete response; DCR, disease control rate; DOR, duration of responses; ITT, intention to treat; NE, not estimable; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.