Adjuvant Cemiplimab or Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma
- Author(s)
- Rischin, D; Porceddu, S; Day, F; Brungs, DP; Christie, H; Jackson, JE; Stein, BN; Su, YB; Ladwa, R; Adams, G; Bowyer, SE; Otty, Z; Yamazaki, N; Bossi, P; Challapalli, A; Hauschild, A; Lim, AM; Patel, VA; Walker, JL; De Liz Vassen Schurmann, M; Queirolo, P; Cañueto, J; Ferreira da Silva, FA; Stratigos, A; Guminski, A; Lin, C; Damian, F; Flatz, L; Taylor, AE; Carr, DR; Harris, S; Kirtbaya, D; Quereux, G; Rutkowski, P; Basset-Seguin, N; Khushalani, NI; Robert, C; Ju, H; Joseph, C; Bansal, S; Chen, CI; Seebach, F; Yoo, SY; Lowy, I; Goncalves, P; Fury, MG; C-POST Trial Investigators;
- Journal Title
- New England Journal of Medicine
- Publication Type
- Online publication before print
- Abstract
- BACKGROUND: Patients who have cutaneous squamous-cell carcinoma with high-risk features are at risk for recurrence after definitive local therapy. The benefit of systemic adjuvant therapy options has not been well established in clinical trials. METHODS: In a phase 3, randomized trial, we enrolled patients with local or regional cutaneous squamous-cell carcinoma, after surgical resection and postoperative radiotherapy, at high risk for recurrence owing to nodal features (extracapsular extension with largest node ≥20 mm in diameter or at least three involved nodes) or nonnodal features (in-transit metastases, T4 lesion [with bone invasion], perineural invasion, or locally recurrent tumor with ≥1 additional risk feature). Patients were assigned in a 1:1 ratio to receive adjuvant cemiplimab (350 mg) or placebo, administered intravenously every 3 weeks for 12 weeks, followed by a dose increase to 700 mg administered every 6 weeks for up to 36 weeks (≤48 weeks total). The primary end point was disease-free survival. Secondary end points included freedom from locoregional recurrence, freedom from distant recurrence, and safety. RESULTS: A total of 415 patients were assigned to cemiplimab (209) or placebo (206). The median follow-up was 24 months. Cemiplimab was superior to placebo with respect to disease-free survival (24 vs. 65 events; hazard ratio for disease recurrence or death, 0.32; 95% confidence interval [CI], 0.20 to 0.51; P<0.001). The estimated 24-month disease-free survival was 87.1% (95% CI, 80.3 to 91.6) with cemiplimab and 64.1% (95% CI, 55.9 to 71.1) with placebo. Cemiplimab led to lower risks of locoregional recurrence (9 events, vs. 40 with placebo; hazard ratio, 0.20; 9% CI, 0.09 to 0.40) and distant recurrence (10 vs. 26 events; hazard ratio, 0.35; 95% CI, 0.17 to 0.72). Adverse events of grade 3 or higher occurred in 23.9% of the patients who received cemiplimab and in 14.2% of those who received placebo; discontinuation due to adverse events occurred in 9.8% and 1.5%, respectively. CONCLUSIONS: Adjuvant cemiplimab therapy led to longer disease-free survival than placebo among patients at high risk for recurrence of cutaneous squamous-cell carcinoma. (Funded by Regeneron Pharmaceuticals and Sanofi; C-POST ClinicalTrials.gov number, NCT03969004.).
- Department(s)
- Medical Oncology; Radiation Oncology
- Publisher's Version
- https://doi.org/10.1056/NEJMoa2502449
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- Refer to copyright notice on published article.
Creation Date: 2025-06-03 07:20:33
Last Modified: 2025-06-03 07:20:41