Abstract
Background: In the phase 2 EMPOWER-CSCC-1 study (NCT02760498), cemiplimab demonstrated antitumor activity against metastatic cutaneous squamous cell carcinoma (mCSCC) and locally advanced cutaneous squamous cell carcinoma (laCSCC). Objectives: To report final analysis of weight-based cemiplimab in mCSCC and laCSCC (groups 1 and 2), fixed-dose cemiplimab in mCSCC (group 3), and primary analysis of fixed-dose cemiplimab in mCSCC/laCSCC (group 6). Methods: Patients received cemiplimab (3 mg/kg intravenously every 2 weeks [groups 1 and 2]) or cemiplimab (350 mg intravenously [groups 3 and 6]) every 3 weeks. The primary end point was objective response rate (ORR). Duration of response (DOR) and progression-free survival (PFS) are presented per protocol, according to post-hoc sensitivity analyses that only include the period of protocol-mandated imaging assessments. Results: At 42.5 months, ORR for groups 1-3 (n = 193) was 47.2%, estimated 12-month DOR was 88.3%, and median PFS was 26.0 months. At 8.7 months, ORR for group 6 (n = 165 patients) was 44.8%; median DOR and median PFS were not reached. Serious treatment-emergent adverse event rates (grade ≥3) were groups 1-3: 31.1% and group 6: 34.5%. Limitations: Nonrandomized study, nonsurvival primary end point. Conclusion: EMPOWER-CSCC-1 provides the largest prospective data on long-term efficacy and safety for anti-programmed cell death-1 therapy in advanced CSCC.
Original language | English |
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Pages (from-to) | 68-77 |
Number of pages | 10 |
Journal | Journal of the American Academy of Dermatology |
Volume | 92 |
Issue number | 1 |
DOIs | |
State | Published - Jan 2025 |
Keywords
- Adult
- Aged
- Aged, 80 and over
- Antibodies
- Antibodies, Monoclonal, Humanized / pharmacology
- Antibodies, Monoclonal, Humanized / therapeutic use
- Carcinoma
- Carcinoma, Squamous Cell / pathology
- Female
- Follow-Up Studies
- Humanized
- Humans
- Male
- Middle Aged
- Monoclonal
- Skin Neoplasms / drug therapy
- Skin Neoplasms / pathology
- Squamous Cell / drug therapy
- Treatment Outcome
- advanced cutaneous squamous cell carcinoma
- cemiplimab
- cemiplimab
- clinical trials
- fixed dose
- immunotherapy
- skin cancer
- skin neoplasms