Table 2.
Reported cases of locally advanced and metastatic non-melanoma skin cancers treated with cemiplimab.
| Number of Patients | Patient Data (Sex, Age) |
Diagnosis | Cemiplimab Regimen | Outcome | Additional Information | Ref. |
|---|---|---|---|---|---|---|
| Cohort I: 26 Cohort II: 59 |
Cohort I: 21 M, 5 F; median age: 73 y Cohort II: 54 M, 5 F; median age: 71 y |
Cohort I: 10 la-cSCCs; 16 m-cSCCs Cohort II: 59 m-cSCCs |
3 mg/kg cemiplimab IV every 2 weeks | Cohort I: 0 CR (0%); 13 PR (50%); 6 SD (23%); 3 PD (12%) Cohort II: 4 CR (7%); 24 PR (41%); 9 SD (15%); 11 PD (19%) |
EMPOWER-CSCC-1 trial (phase I/II study). This trial led to drug approval for la-cSCC and m-cSCC | Migden et al., 2018 [38] |
| 78 | 59 M, 19 F; median age: 74 y |
la-cSCCs | 3 mg/kg cemiplimab IV every 2 weeks | 10 CR (12.8%); 24 PR (30.8%); 28 SD (35.9%); 9 PD (11.5%) | Phase II cohort from EMPOWER-CSCC-1 trial | Migden et al., 2019 [41] |
| 13 (in a cohort of 26 patients) | Data for the entire cohort: 19 M, 7 F; median age: 64.5 y |
Data for the entire cohort: 5 la-cSCCs; 21 m-cSCCs |
Not specified | RR 46.2% | The entire cohort included 26 patients treated with cemiplimab (13 patients), pembrolizumab (7) and nivolumab (6) | In et al., 2020 [42] |
| 18 | 16 M, 2 F; median age 80 y | 9 la-cSCCs; 5 m-cSCCs |
3 mg/kg cemiplimab IV every 2 weeks or 350 mg IV every 3 weeks |
Overall RR 67%; 6 CR (33%); 6 PR (33%); 1 SD (6%); 5 PD (28%) |
/ | Guillaume et al., 2021 [43] |
| 245 | 178 M, 73 F; mean age 77 y | 35% la-cSCCs; 65% m-cSCCs |
3 mg/kg cemiplimab IV every 2 weeks | Best overall RR 50%; CR 21%; PR 29%, SD 9%; PD 41% |
Real-life experience from the French CAREPI Study Group | Hober et al., 2021 [44] |
| 131 | 90 M, 41 F; median age 79 y | 91 la-cSCCs; 40 m-cSCCs |
350 mg IV every 3 weeks | Overall RR 58%; CR 21 (16%); PR 55 (42%), SD 18 (13.7%); PD 31 (23.7%) |
Real life data from Italian multicenter study | Baggi et al., 2021 [45] |
| 30 | 24 M, 6 F; median age 81 y | 25 la-cSCCs; 5 m-cSCCs |
350 mg IV every 3 weeks | Overall RR 76.7%; CR 9 (30%); PR 14 (46.7%), SD 1 (3%); PD 6 (20%) |
Cohort of elderly frail patients | Strippoli et al., 2021 [51] |
| 2 | F, 66 y; M, 52 y |
m-BCC; m-cSCC |
10 mg/kg cemiplimab IV every 2 weeks; 1 mg/kg cemiplimab IV every 2 weeks |
1 PR; 1 CR |
/ | Falchook et al., 2016 [47] |
| 2 | Not specified | la-BCCs | 1–10 mg/kg cemiplimab IV every 2 weeks ± hfRT ± cyclophosphamide | 1 PR; 1 SD |
Research conducted on 60 patients with different advanced solid cancers | Papadopoulos et al., 2020 [50] |
| 84 | 56 M, 28 F; median age: 70 y | la-BCCs, patients resistant or intolerant to HHI | 350 mg cemiplimab every 3 weeks | 5 CR (6%); 21 PR (25%); 41 SD (48.8%); 9 PD (10.7%) | NCT03132636 trial (phase II study) that has granted FDA approval for cemiplimab in la-BCC and m-BCC, resistant or intolerant to HHI | Stratigos et al., 2021 [12] |
| 1 | M; 80 y | la-cSCC + la-BCC |
350 mg cemiplimab every 3 weeks | CR for both lesions | / | Dumann et al., 2021 [48] |
| 1 | M, 78 y | la-BCC | 350 mg cemiplimab every 3 weeks | CR | Patient included in NCT03132636 trial |
De Giorgi et al., 2021 [49] |
| 2 | Not specified | la-MCCs | 3 mg/kg cemiplimab every 2 weeks + hfRT | 1 PR; 1 SD |
Research conducted 60 patients with different advanced solid cancers | Papadopoulos et al., 2020 [50] |
Note: Abbreviations: M (male); F (female); y (years); la-cSCC (locally advanced cutaneous squamous cell carcinoma); m-cSCC (metastatic cutaneous squamous cell carcinoma); la-BCC (locally advanced basal cell carcinoma); m-BCC (metastatic basal cell carcinoma); la-MCC (locally advanced Merkel cell carcinoma); IV (intravenously); HHI (hedgehog inhibitor); hfRT (hypofractionated radiotherapy); FDA (Food and Drug Administration); CR (complete response); PR (partial response); SD (stable disease); PD (progressive disease); RR (response rate).