Table 2.
Physician-reported responses in all evaluable patients participating in avelumab MCC EAP
| Response parameter* | All patients (n=240) | Immunocompromised patients (n=16) | 1L (n=15) | 2L+ (n=225) |
| ORR, % | 46.7 | 37.5 | 46.7 | 46.7 |
| DCR, %† | 71.2 | 68.8 | 66.7 | 71.6 |
| Confirmed BOR, n (%) | ||||
| CR | 55 (22.9) | 3 (18.8) | 2 (13.3) | 53 (23.6) |
| PR | 57 (23.8) | 3 (18.8) | 5 (33.3) | 52 (23.1) |
| SD | 59 (24.6) | 5 (31.3) | 3 (20.0) | 56 (24.9) |
| PD‡ | 69 (28.8) | 5 (31.3) | 5 (33.3) | 64 (28.4) |
| Duration of treatment in patients with response§ | ||||
| Median (range), months | 7.9 (1.0–41.7) | 5.2 (3.0–13.9) | 4.5 (3.0–19.8) | 7.9 (1.0–41.7) |
Immunocompromised, 1L, and 2L+ are subsets of the total number of evaluable patients.
*Response was reported according to treating physician assessment of follow-up scans at the time of resupply.
†Among patients treated for a minimum of 3 months with available data.
‡Patients with PD or AEs who required treatment discontinuation within the first 90 days were never resupplied and did not have a follow-up response evaluation; thus, these values may be under-reported.
§Duration of avelumab treatment/drug supply is reported as a surrogate for duration of response or clinical benefit.
AE, adverse event; BOR, best overall response; CR, complete response; DCR, disease control rate; EAP, expanded access program; 1L, first-line; 2L+, second-line or later; MCC, Merkel cell carcinoma; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.