Table 2.
Summary of best overall response and clinical benefit response based on BIRC review.
| Grade ≥2 skin-related AE (n = 162) | No grade ≥2 skin-related AE (n = 65) | |
|---|---|---|
| Best overall response, n (%) | ||
| Complete response | 11 (6.8) | 1 (1.5) |
| Partial response | 119 (73.5) | 39 (60.0) |
| Stable/no response | 21 (13.0) | 9 (13.8) |
| Stable/no response and TTF ≥168 days | 11 (6.8) | 1 (1.5) |
| Stable/no response and TTF <168 days | 10 (6.2) | 8 (12.3) |
| Progressive disease | 5 (3.1) | 7 (10.8) |
| Indeterminate | 6 (3.7) | 9 (13.8) |
| Objective response rate (95% exact CI), % a | 80.2 (73.3–86.1) | 61.5 (48.6–73.3) |
| Nominal p valueb | 0.0033 | |
| Clinical benefit response rate (95% exact CI), % a | 87.0 (80.9–91.8) | 63.1 (50.2–74.7) |
| Nominal p valueb | <0.0001 | |
a
Using the exact method based on binomial distribution.
b
Two-sided, unstratified; not adjusted for multiplicity.
AE: Adverse event; BIRC: Blinded independent radiological central; CI: Confidence interval; TTF: Time to treatment failure.