Table 7 Summary of efficacy outcomes
Outcome | US commercial cetuximab Arm A (N = 77) | BI-manufactured cetuximab Arm B (N = 71) | Unadjusted HR Arm A vs Arm B (95 % CI; p value) |
|---|---|---|---|
OS (months), median (95 % CI) | 9.23 (7.10, 11.80) | 9.46 (6.87, 11.43) | 0.92 (0.619, 1.368; p = 0.681) |
PFS (months), median (95 % CI) | 4.70 (3.52, 5.82) | 5.65 (4.04, 6.47) | 1.04 (0.717, 1.497; p = 0.850) |
Overall response rate, % (95 % CI) | 29.9 (19.6, 40.1) | 36.6 (25.4, 47.8) | NA |
Disease control rate, % (95 % CI) | 58.4 (47.4, 69.4) | 62.0 (50.7, 73.3) | NA |
Complete response, n (%) | 3 (3.9) | 3 (4.2) | NA |
Partial response, n (%) | 20 (26.0) | 23 (32.4) | NA |
Stable disease, n (%) | 22 (28.6 %) | 18 (25.4 %) | NA |