Table 5.
Number of Patients | Patient Data (Sex, Age) |
Diagnosis | Avelumab Regimen | Outcome | Additional Information | Ref. |
---|---|---|---|---|---|---|
1 | M, 85 y | m-MCC | Not specified | CR | / | Eshghi et al., 2018 [96] |
1 | M, 73 y | m-MCC | 10 mg/kg IV every 2 weeks | PR | / | Zhao et al., 2018 [97] |
88 | 65 M, 23 F; median age: 72.5 y |
m-MCCs | 10 mg/kg IV every 2 weeks | Objective RR 33%; 10 CR (11.4%); 19 PR (21.6%); 9 SD (10.2%); 32 PD (36.4%) | JAVELIN Merkel 200 trial (NCT02155647, phase II study, part A–previously treated m-MCC) |
D’Angelo et al., 2020 [104] |
116 | 81 M; 35 F; median age 74 y | m-MCCs | 10 mg/kg IV every 2 weeks | Objective RR 39.7%; 19 CR (16.4%); 27 PR (23.3%); 12 SD (10.3%); 48 PD (41.4%) | JAVELIN Merkel 200 trial (NCT02155647, phase II study, part B–naïve m-MCC) |
D’Angelo et al., 2021 [100] |
102 (55 evaluable) | 78 M, 23 F, 1 unknown; median age 70.6 y | m-MCCs | 10 mg/kg IV every 2 weeks | 55 evaluable patients; overall RR 29.1%; 6 CR (10.9%); 10 PR (18.2%); 17 SD (30.9%); 22 PD (40%) |
Expanded access program compassionate use of avelumab | Grignani et al., 2021 [101] |
367 (150 evaluable) | 247 M, 119 F, 1 unknown; median age 71.6 y |
m-MCCs | 10 mg/kg IV every 2 weeks | 150 evaluable patients; overall RR 48%; 38 CR (25.3%); 34 PR (22.7%); 37 SD (24.7%); 41 PD (27.3%) |
Expanded access program compassionate use of avelumab | Ascierto et al., 2021 [102] |
94 (28 patients receiving avelumab; 26 non-avelumab immunotherapy [19 pembrolizumab; 7 nivolumab], 40 chemotherapy) | 64 M, 30 F; median age 73 y | 27 la-MCCs; 67 m-MCCs |
Not specified | Real-world overall RR 64.3% for avelumab; 61.5 for non-avelumab immunotherapy group | SPEAR-Merkel study | Bhanegaonkar et al., 2021 [105] |
20 | 10 M, 10 F; median age:74 y |
20 advanced MCCs | Not specified | Real-world overall RR 65%; 1 CR (5%); 13 PR (65%); 4 SD (20%); 2 PD (10%) |
/ | Badalamenti et al., 2022 [106] |
Note: Abbreviations: M (male); F (female); y (years); m-MCC (metastatic Merkel cell carcinoma); IV (intravenously); CR (complete response); PR (partial response); SD (stable disease); PD (progressive disease); RR (response rate).