Table 1.
Baseline characteristics of approved patients in avelumab MCC EAP
| Characteristics | All approved patients (n=558) | Approved immunocompromised patients (n=37) |
Approved 1L patients (n=36) |
| Age (years), n (%) | |||
| <65 | 116 (20.8) | 6 (16.2) | 4 (11.1) |
| ≥65 | 442 (79.2) | 31 (83.8) | 32 (88.9) |
| Median (range) | 73 (23–95) | 74 (50–86) | 79 (46–95) |
| Sex, n (%) | |||
| Male | 372 (66.8) | 21 (56.8) | 24 (66.7) |
| Female | 185 (33.2) | 16 (43.2) | 12 (33.3) |
| Weight (kg), n (%)* | |||
| <80 | 229 (50.9) | 24 (64.9) | 16 (44.4) |
| ≥80 | 221 (49.1) | 13 (35.1) | 20 (55.6) |
| Median (range) | 78.8 (40–150) | 75 (41–124) | 80 (49–138) |
| ECOG PS, n (%)* | |||
| 0 | 175 (39.0) | 14 (37.8) | 15 (41.7) |
| 1 | 233 (51.9) | 18 (48.7) | 18 (50.0) |
| 2 | 33 (7.4) | 3 (8.1) | 3 (8.3) |
| 3 | 8 (1.8) | 2 (5.4) | 0 |
| Line of therapy, n (%) | |||
| 1 | 36 (6.5) | 4 (10.8) | 36 (100) |
| ≥2 | 522 (93.6) | 33 (89.2) | 0 |
*Weight and ECOG PS at baseline were available only for the 450 patients enrolled via the EAP portal.
EAP, expanded access program; ECOG PS, Eastern Cooperative Oncology Group performance status; 1L, first-line; MCC, Merkel cell carcinoma.