Table 2.
Summary of tumor response per RECIST 1.1 by independent review committee in the intention-to-treat patient population
| Response | Cemiplimab + chemotherapy (n = 312) | Placebo + chemotherapy (n = 154) |
|---|---|---|
| Objective response | ||
| Patients, n | 135 | 35 |
| % (95% CI) | 43.3 (37.7–49.0) | 22.7 (16.4–30.2) |
| Odds ratio (95% CI) | 2.68 (1.72–4.19); P < 0.0001 | |
| Best overall response, n (%) | ||
| Complete response | 8 (2.6) | 0 |
| Partial response | 127 (40.7) | 35 (22.7) |
| Stable disease | 121 (38.8) | 74 (48.1) |
| Progressive disease | 22 (7.1) | 24 (15.6) |
| NE | 30 (9.6) | 20 (13.0) |
| Kaplan–Meier estimated DOR, median (95% CI), months | 15.6 (12.4–NE) | 7.3 (4.3–12.6) |
| Observed time to response, median (IQR), months | 2.1 (2.0–2.3) | 2.1 (2.1–3.9) |
Objective response and the corresponding two-sided 95% CI were calculated using the Clopper–Pearson method. The odds ratio and corresponding two-sided 95% CI of the objective response were calculated by the Cochran–Mantel–Haenszel method. The median DOR and corresponding two-sided 95% CI were estimated by the Kaplan–Meier method. Observed time to response and the corresponding IQR were summarized descriptively.