Tumor response per independent central review
| Group 3 cemiplimab 350 mg intravenously Q3W (n=56) | Group 1 cemiplimab 3 mg/kg intravenously Q2W (n=59) | Total (Groups 1+3) (n=115) | |
| ORR, % (95% CI) | 41.1 (28.1 to 55.0) | 49.2 (35.9 to 62.5) | 45.2 (35.9 to 54.8) |
| Best overall response, n (%) | |||
| Complete response | 3 (5.4) | 10 (16.9) | 13 (11.3) |
| Partial response | 20 (35.7) | 19 (32.2) | 39 (33.9) |
| Stable disease | 8 (14.3) | 9 (15.3) | 17 (14.8) |
| Non-complete response/non-progressive disease | 5 (8.9) | 4 (6.8) | 9 (7.8) |
| Progressive disease | 14 (25.0) | 10 (16.9) | 24 (20.9) |
| Not evaluable | 6 (10.7) | 7 (11.9) | 13 (11.3) |
| Disease control rate, % (95% CI) | 64.3 (50.4 to 76.6) | 71.2 (57.9 to 82.2) | 67.8 (58.5 to 76.2) |
| Durable disease control rate*, % (95% CI) | 57.1 (43.2 to 70.3) | 61.0 (47.4 to 73.5) | 59.1 (49.6 to 68.2) |
| Median time to response, months (range)† | 2.1 (2.0 to 8.3) | 1.9 (1.7 to 9.1) | 2.1 (1.7 to 9.1) |
| Median DOR | Not reached | Not reached | Not reached |
| Kaplan–Meier 8-month estimate of DOR, % (95% CI)† | 95.0 (69.5 to 99.3) | 88.9 (69.3 to 96.3) | 90.0 (75.2 to 96.2) |
| Kaplan–Meier 12-month estimate of DOR, % (95% CI)† | Not evaluable | 88.9 (69.3 to 96.3) | 90.0 (75.2 to 96.2) |
Errata: after database lock, the central review vendor noted an error in their initial assessment of one patient in Group 3. This report contains the corrected data obtained after the vendor reviewed the case again. Also, the durable disease control rate for Group 1 was updated because one patient had tumor response after withdrawal of consent.
The ORR per investigator review was 51.8% (95% CI, 38.0% to 65.3%) in Group 3, 49.2% (95% CI, 35.9% to 62.5%) in Group 1, and 50.4% (95% CI, 41.0% to 59.9%) in both groups combined.
*Defined as the proportion of patients without progressive disease for at least 105 days.
†Data are based on number of patients with confirmed complete or partial response.
CI, confidence interval; DOR, duration of response; DOR, duration of response; ORR, objective response rate; ORR, objective response rate; Q2W, every 2 weeks; Q2W, every 2 weeks; Q3W, every 3 weeks; Q3W, every 3 weeks;