Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma
- Author(s)
- Gross, ND; Miller, DM; Khushalani, NI; Divi, V; Ruiz, ES; Lipson, EJ; Meier, F; Su, YB; Swiecicki, PL; Atlas, J; Geiger, JL; Hauschild, A; Choe, JH; Hughes, BGM; Schadendorf, D; Patel, VA; Homsi, J; Taube, JM; Lim, AM; Ferrarotto, R; Kaufman, HL; Seebach, F; Lowy, I; Yoo, SY; Mathias, M; Fenech, K; Han, H; Fury, MG; Rischin, D;
- Details
- Publication Year 2022-10-27,Volume 387,Issue #17,Page 1557-1568
- Journal Title
- New England Journal of Medicine
- Publication Type
- Research article
- Abstract
- BACKGROUND: In a pilot study involving patients with cutaneous squamous-cell carcinoma, a high percentage of patients had a pathological complete response with the use of two doses of neoadjuvant cemiplimab before surgery. Data from a phase 2 study are needed to confirm these findings. METHODS: We conducted a phase 2, confirmatory, multicenter, nonrandomized study to evaluate cemiplimab as neoadjuvant therapy in patients with resectable stage II, III, or IV (M0) cutaneous squamous-cell carcinoma. Patients received cemiplimab, administered at a dose of 350 mg every 3 weeks for up to four doses, before undergoing surgery with curative intent. The primary end point was a pathological complete response (the absence of viable tumor cells in the surgical specimen) on independent review at a central laboratory, with a null hypothesis that a pathological complete response would be observed in 25% of patients. Key secondary end points included a pathological major response (the presence of viable tumor cells that constitute </=10% of the surgical specimen) on independent review, a pathological complete response and a pathological major response on investigator assessment at a local laboratory, an objective response on imaging, and adverse events. RESULTS: A total of 79 patients were enrolled and received neoadjuvant cemiplimab. On independent review, a pathological complete response was observed in 40 patients (51%; 95% confidence interval [CI], 39 to 62) and a pathological major response in 10 patients (13%; 95% CI, 6 to 22). These results were consistent with the pathological responses determined on investigator assessment. An objective response on imaging was observed in 54 patients (68%; 95% CI, 57 to 78). Adverse events of any grade that occurred during the study period, regardless of whether they were attributed to the study treatment, were observed in 69 patients (87%). Grade 3 or higher adverse events that occurred during the study period were observed in 14 patients (18%). CONCLUSIONS: Neoadjuvant therapy with cemiplimab was associated with a pathological complete response in a high percentage of patients with resectable cutaneous squamous-cell carcinoma. (Funded by Regeneron Pharmaceuticals and Sanofi; ClinicalTrials.gov number, NCT04154943.).
- Keywords
- Humans; Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse; effects/therapeutic use; *Carcinoma, Squamous Cell/drug therapy/surgery/pathology; *Neoadjuvant Therapy; Neoplasm Staging; Pilot Projects; *Skin Neoplasms/drug therapy/pathology/surgery; Remission Induction; Antineoplastic Agents, Immunological/administration & dosage/adverse; effects/therapeutic use
- Department(s)
- Medical Oncology
- PubMed ID
- 36094839
- Publisher's Version
- https://doi.org/10.1056/NEJMoa2209813
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2024-11-01 12:10:44
Last Modified: 2024-11-01 12:11:37