TABLE 2.
Post hoc cemiplimab PK parameters using the final PopPK model
| Parameter | Tumor type (study) a | Patients, N | Mean (CV%) | SD |
|---|---|---|---|---|
| Clearance at the first dose, L/day | All patients | 1062 | 0.246 (40.9) | 0.100 |
| CSCC (study 1540) | 188 | 0.214 (33.4) | 0.0715 | |
| BCC (study 1620) | 132 | 0.192 (35.0) | 0.0671 | |
| NSCLC (study 1624) | 345 | 0.265 (37.9) | 0.100 | |
| All solid tumors (study 1423) | 397 | 0.262 (42.5) | 0.111 | |
| Clearance at steady‐state, L/day | All patients | 1062 | 0.218 (43.7) | 0.0951 |
| CSCC (study 1540) | 188 | 0.187 (38.6) | 0.0721 | |
| BCC (study 1620) | 132 | 0.194 (36.0) | 0.0700 | |
| NSCLC (study 1624) | 345 | 0.227 (42.9) | 0.0972 | |
| All solid tumors (study 1423) | 397 | 0.232 (45.4) | 0.105 | |
| Change in clearance, % b | All patients | 1062 | −10.8 | 15.4 |
| CSCC (study 1540) | 188 | −12.6 | 11.9 | |
| BCC (study 1620) | 132 | 2.7 | 20.4 | |
| NSCLC (study 1624) | 345 | −14.3 | 15.4 | |
| All solid tumors (study 1423) | 397 | −11.3 | 12.3 | |
| Half‐life at the first dose, days | All patients | 1062 | 19.7 (41.4) | 8.18 |
| CSCC (study 1540) | 188 | 21.4 (29.0) | 6.22 | |
| BCC (study 1620) | 132 | 24.9 (31.6) | 7.85 | |
| NSCLC (study 1624) | 345 | 17.5 (56.5) | 9.88 | |
| All solid tumors (study 1423) | 397 | 19.2 (33.3) | 6.40 | |
| Half‐life at steady‐state, days | All patients | 1062 | 22.3 (41.9) | 9.32 |
| CSCC (study 1540) | 188 | 24.8 (31.2) | 7.74 | |
| BCC (study 1620) | 132 | 24.5 (26.9) | 6.58 | |
| NSCLC (study 1624) | 345 | 20.7 (58.5) | 12.1 | |
| All solid tumors (study 1423) | 397 | 21.8 (34.5) | 7.50 | |
| Accumulation index | All patients | 1062 | 2.05 (23.5) | 0.482 |
| CSCC (study 1540) | 188 | 2.22 (21.6) | 0.481 | |
| BCC (study 1620) | 132 | 2.07 (18.9) | 0.391 | |
| NSCLC (study 1624) | 345 | 1.98 (27.0) | 0.535 | |
| All solid tumors (study 1423) | 397 | 2.02 (21.9) | 0.441 | |
| Vss, L c | All patients | 1062 | 5.89 (28.8) | 1.70 |
| CSCC (study 1540) | 188 | 5.86 (26.8) | 1.57 | |
| BCC (study 1620) | 132 | 6.07 (27.8) | 1.68 | |
| NSCLC (study 1624) | 345 | 5.61 (33.9) | 1.90 | |
| All solid tumors (study 1423) | 397 | 6.10 (25.2) | 1.53 | |
| AUC3wks after the fifth dose, % | All patients | 1062 | 92.1 (11.6) | 10.7 |
| CSCC (study 1540) | 188 | 89.1 (8.76) | 7.80 | |
| BCC (study 1620) | 132 | 94.6 (11.5) | 10.9 | |
| NSCLC (study 1624) | 345 | 91.3 (15.2) | 13.9 | |
| All solid tumors (study 1423) | 397 | 93.3 (8.29) | 7.73 |
Note: One patient from study 1423 was excluded from the summary of post hoc parameter estimates due to extremely high predicted Vss of 183.6 L that was inconsistent with the typical distribution volume for monoclonal antibodies. Therefore, post hoc parameters are reported for 1062 patients.
Abbreviations: AUC3wks, area under the concentration time curve for a 3‐week dosing interval; BCC, basal cell carcinoma; CSCC, cutaneous squamous cell carcinoma; CV%, percentage coefficient of variation; NSCLC, non‐small cell lung cancer; PK, pharmacokinetic; PopPK, population PK; Vss, volume of distribution; V1, volume of the central compartment; V2, volume of the peripheral compartment.
ClinicalTrials.gov numbers are NCT02760498, NCT03132636, NCT03088540, and NCT02383212 for studies 1540, 1620, 1624, and 1423, respectively.
Change between initial clearance of cemiplimab at first dose and clearance of cemiplimab at steady‐state.
Vss = V1 + V2.