A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6 - 18/12/24
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.
Le texte complet de cet article est disponible en PDF.Key words : advanced cutaneous squamous cell carcinoma, cemiplimab, clinical trials, fixed dose, immunotherapy, skin cancer, skin neoplasms
Abbreviations used : AE, CI, CR, CSCC, DOR, ICR, INV, irTEAE, IV, laCSCC, mCSCC, NE, NR, ORR, OS, PD-1, PD-L1, PFS, Q3W, TEAE
MeSH terms : Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized / pharmacology, Antibodies, Monoclonal, Humanized / therapeutic use, Carcinoma, Squamous Cell / drug therapy, Carcinoma, Squamous Cell / pathology, Female, Follow-Up Studies, Humans, Male, Middle Aged, Skin Neoplasms / drug therapy, Skin Neoplasms / pathology, Treatment Outcome
Substances : Antibodies, Monoclonal, Humanized, cemiplimab
Plan
Funding sources: This study was funded by Regeneron Pharmaceuticals, Inc., and Sanofi. |
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Patient consent: All patients provided written informed consent prior to enrollment. |
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IRB approval status: The study protocol and all amendments were approved by institutional review boards/ethics committee at each participating study site. |
Vol 92 - N° 1
P. 68-77 - janvier 2025 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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