TABLE 3.
Response rates (ITT/randomized population).
| Isa (n = 34) | Isa + CemiQ2W (n = 36) | Isa + CemiQ4W (n = 36) | |
|---|---|---|---|
| Best overall response, n (%) | |||
| Stringent complete response | 0 | 0 | 0 |
| Complete response | 0 | 0 | 0 |
| Very good partial response | 2 (5.9) | 3 (8.3) | 2 (5.6) |
| Partial response | 2 (5.9) | 6 (16.7) | 6 (16.7) |
| Minimal response | 4 (11.8) | 4 (11.1) | 6 (16.7) |
| Stable disease | 14 (41.2) | 12 (33.3) | 16 (44.4) |
| Progressive disease | 7 (20.6) | 6 (16.7) | 4 (11.1) |
| Unconfirmed progressive disease | 1 (2.9) | 2 (5.6) | 1 (2.8) |
| Not evaluable/Not assessed | 4 (11.8) | 3 (8.3) | 1 (2.8) |
| Overall response | |||
| Responders (sCR, CR, VGPR, or PR) | 4 (11.8) | 9 (25.0) | 8 (22.2) |
| 95% CI a | 3.30–27.45 | 12.12–42.20 | 10.12–39.15 |
| Fisher's exact test p value b | |||
| Isa + CemiQ2W vs Isa | 0.1321 | ||
| Isa + CemiQ4W vs Isa | 0.2003 | ||
| Clinical benefit | |||
| Responders (MR or better) | 8 (23.5) | 13 (36.1) | 14 (38.9) |
| 95% CI a | 10.75–41.17 | 20.82–53.78 | 23.14–56.54 |
Abbreviations: Cemi, cemiplimab; CI, confidence interval; CR, complete response; Isa, isatuximab; ITT, intent‐to‐treat; MR, minimal response; PR, partial response; Q2W, every 2 weeks; Q4W, every 4 weeks; sCR, stringent complete response; VGPR, very good partial response.
a
Estimated using Clopper–Pearson method.
b
One‐sided significance level of 0.1.