Tumor response to cemiplimab per independent central review
| Group 1 (mCSCC) 3 mg/kg Q2W (n=59) | Group 2 (laCSCC) 3 mg/kg Q2W (n=78) | Group 3 (mCSCC) 350 mg Q3W (n=56) | Total (N=193) | |
| Median duration of follow-up, months (range) | 18.5 (1.1–36.1) | 15.5 (0.8–35.6) | 17.3 (0.6–26.3) | 15.7 (0.6–36.1) |
| Objective response rate, % (95% CI) | 50.8 (37.5 to 64.1) | 44.9 (33.6 to 56.6) | 42.9 (29.7 to 56.8) | 46.1 (38.9 to 53.4) |
| Best overall response, n (%) | ||||
| Complete response | 12 (20.3) | 10 (12.8) | 9 (16.1) | 31 (16.1)* |
| Partial response | 18 (30.5) | 25 (32.1) | 15 (26.8) | 58 (30.1) |
| Stable disease | 9 (15.3) | 27 (34.6) | 10 (17.9) | 46 (23.8) |
| Non-complete response/non-progressive disease | 3 (5.1) | 0 | 2 (3.6) | 5 (2.6) |
| Progressive disease | 10 (16.9) | 10 (12.8) | 14 (25.0) | 34 (17.6) |
| Not evaluable | 7 (11.9) | 6 (7.7) | 6 (10.7) | 19 (9.8) |
| DCR, % (95% CI) | 71.2 (57.9 to 82.2) | 79.5 (68.8 to 87.8) | 64.3 (50.4 to 76.6) | 72.5 (65.7 to 78.7) |
| Durable DCR†, % (95% CI) | 61.0 (47.4 to 73.5) | 62.8 (51.1 to 73.5) | 57.1 (43.2 to 70.3) | 60.6 (53.3 to 67.6) |
| Median observed time to response, months (IQR)‡ | 1.9 (1.8–2.0) | 2.1 (1.9–3.8) | 2.1 (2.1–4.2) | 2.1 (1.9–3.7) |
| Median observed time to complete response, months (IQR)§ | 11.1 (7.5–18.4) | 10.5 (7.4–12.9) | 12.4 (8.2–16.6) | 11.2 (7.4–14.8) |
| Kaplan-Meier estimated median DOR, months (95% CI)‡ | NR (20.7 to NE) | NR (18.4 to NE) | NR (NE to NE) | NR (28.8 to NE) |
| Kaplan-Meier 12-month estimate of DOR, % (95% CI) | 89.5 (70.9 to 96.5) | 83.2 (64.1 to 92.7) | 91.7 (70.6 to 97.8) | 87.8 (78.5 to 93.3) |
| Kaplan-Meier 24-month estimate of DOR, % (95% CI) | 68.8 (46.9 to 83.2) | 62.5 (38.4 to 79.4) | NE (NE to NE) | 69.4 (55.6 to 79.6) |
ORR per INV was 54.4% (95% CI: 47.1% to 61.6%) for all patients; 50.8% (95% CI: 37.5% to 64.1%) for group 1, 56.4% (95% CI: 44.7% to 67.6%) for group 2, and 55.4% (95% CI: 41.5% to 68.7%) for group 3. ORR per ICR was 48.4% (95% CI: 39.5% to 57.4%) among treatment-naïve patients and 41.5% (95% CI: 29.4% to 54.4%) among previously treated patients.
*95% CI: 11.2 to 22.0
†Defined as the proportion of patients with objective response, stable disease, or non-complete response/non-progressive disease without progressive disease for at least 16 weeks, measured at least 105 days to account for scheduling windows in the protocol.
‡Based on number of patients with confirmed complete or partial response.
§Based on number of patients with confirmed complete response.
DCR, disease control rate; DOR, duration of response; ICR, independent central review; INV, investigator review; laCSCC, locally advanced cutaneous squamous cell carcinoma; mCSCC, metastatic cutaneous squamous cell carcinoma; NE, not evaluable; NR, not reported; ORR, objective response rate; Q2W, every 2 weeks; Q3W, every 3 weeks.