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 Journal Article
| Authors: | Hughes, B. G. M.; Guminski, A.; Bowyer, S.; Migden, M. R.; Schmults, C. D.; Khushalani, N. I.; Chang, A. L. S.; Grob, J. J.; Lewis, K. D.; Ansstas, G.; Day, F.; Ladwa, R.; Stein, B. N.; Muñoz Couselo, E.; Meier, F.; Hauschild, A.; Schadendorf, D.; Basset-Seguin, N.; Modi, B.; Dalac-Rat, S.; Dunn, L. A.; Flatz, L.; Mortier, L.; Guégan, S.; Heinzerling, L. M.; Mehnert, J. M.; Trabelsi, S.; Soria-Rivas, A.; Stratigos, A. J.; Ulrich, C.; Wong, D. J.; Beylot-Barry, M.; Bossi, P.; Bugés Sánchez, C.; Chandra, S.; Robert, C.; Russell, J. S.; Silk, A. W.; Booth, J.; Yoo, S. Y.; Seebach, F.; Lowy, I.; Fury, M. G.; Rischin, D. |
| Article Title: | 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 |
| 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. © 2024 American Academy of Dermatology, Inc. |
| Keywords: | adult; treatment outcome; treatment response; aged; aged, 80 and over; middle aged; major clinical study; overall survival; constipation; fatigue; advanced cancer; diarrhea; drug safety; gastrointestinal hemorrhage; hypertension; side effect; follow-up studies; progression free survival; infection; phase 2 clinical trial; anemia; actinic keratosis; skin neoplasms; nausea; vomiting; skin cancer; cohort analysis; arthralgia; asthenia; coughing; pneumonia; pruritus; rash; lung embolism; maculopapular rash; immunotherapy; heart infarction; carcinoma; colitis; open study; headache; antibodies; hypothyroidism; mental deterioration; observational study; meningitis; clinical trials; upper respiratory tract infection; cellulitis; adrenal insufficiency; decreased appetite; sudden death; autoimmune hepatitis; lung edema; acute myeloid leukemia; monoclonal; general condition deterioration; humanized; humans; human; male; female; article; squamous cell skin carcinoma; cemiplimab; treatment response time; coronavirus disease 2019; advanced cutaneous squamous cell carcinoma; antibodies, monoclonal, humanized / pharmacology; antibodies, monoclonal, humanized / therapeutic use; carcinoma, squamous cell / pathology; fixed dose; skin neoplasms / drug therapy; skin neoplasms / pathology; squamous cell / drug therapy; locally advanced cutaneous squamous cell carcinoma; metastatic cutaneous squamous cell carcinoma |
| Journal Title: | Journal of the American Academy of Dermatology |
| Volume: | 92 |
| Issue: | 1 |
| ISSN: | 0190-9622 |
| Publisher: | Mosby Elsevier |
| Date Published: | 2025-01-01 |
| Start Page: | 68 |
| End Page: | 77 |
| Language: | English |
| DOI: | 10.1016/j.jaad.2024.06.108 |
| PUBMED: | 39245360 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
