TABLE 2.
Tumor response per RECIST version 1.1 by investigator assessment a .
| Variable | Overall study population | Japanese subgroup | ||
|---|---|---|---|---|
| Cemiplimab (n = 304) | Chemotherapy (n = 304) | Cemiplimab (n = 29) | Chemotherapy (n = 27) | |
| Objective response | ||||
| ORR (complete response + partial response), n (%) | 50 (16.4) | 19 (6.3) | 5 (17.2) | 2 (7.4) |
| 95% CI for ORR b | 12.5–21.1 | 3.8–9.6 | 5.8–35.8 | 0.9–24.3 |
| Best overall tumor response, n (%) | ||||
| Complete response c | 10 (3.3) | 3 (1.0) | 1 (3.4) | 1 (3.7) |
| Partial response c | 40 (13.2) | 16 (5.3) | 4 (13.8) | 1 (3.7) |
| Stable disease d | 125 (41.1) | 148 (48.7) | 15 (51.7) | 15 (55.6) |
| Progressive disease | 105 (34.5) | 88 (28.9) | 9 (31.0) | 7 (25.9) |
| Not evaluable | 24 (7.9) | 49 (16.1) | 0 | 3 (11.1) |
| Stratified Cochran–Mantel–Haenszel test 1‐sided p value e | <0.001 | NP | ||
| Odds ratio (95% CI) e | 2.984 (1.707–5.215) | 2.471 (0.436–13.990) | ||
| Kaplan–Meier estimated duration of response, median (95% CI), months f , g | 16.4 (12.4‐NE) | 6.9 (5.1–7.7) | NP | NP |
Abbreviations: CI, confidence interval; NE, not evaluable; NP, not performed; ORR, objective response rate; RECIST, Response Evaluation Criteria in Solid Tumors.
Data cutoff date: January 4, 2021.
Clopper‐Pearson exact CI.
Complete response and partial response must have been confirmed by repeated assessments ≥4 weeks apart.
Stable disease criteria must have been met at least once for ≥4 weeks after the first dose date.
For patients enrolled in Japan, odds ratio was determined using histology stratified by the Cochran–Mantel–Haenszel test. Statistical tests were not performed for the Japanese subgroup. For the overall study population, 1‐sided p values and odds ratios were determined using geographic region and histology stratified by the Cochran–Mantel–Haenszel test. Due to the low response rate in the chemotherapy group, the results from the Cochran–Mantel–Haenszel test should be interpreted with caution.
Based on patients with confirmed complete response or partial response.
Due to the number of responders (cemiplimab, n = 5; chemotherapy, n = 2) among patients enrolled in Japan, it was not possible to perform a Kaplan–Meier estimation of duration of response.