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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.

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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 of the American Academy of Dermatology Hughes, B. G., Guminski, A., Bowyer, S., Migden, M. R., Schmults, C. D., Khushalani, N. I., Chang, A. L., 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. 2024

Abstract

In the phase 2 EMPOWER-CSCC-1 study (NCT02760498), cemiplimab demonstrated antitumor activity against metastatic (mCSCC) and locally advanced cutaneous squamous cell carcinoma (laCSCC).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).Patients received cemiplimab (3 mg/kg intravenously [IV] every 2 weeks [Groups 1 and 2]) or cemiplimab (350 mg IV [Groups 3 and 6]) every 3 weeks. The primary endpoint 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.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%.Non-randomized study, non-survival primary endpoint.EMPOWER-CSCC-1 provides the largest prospective data on long-term efficacy and safety for anti-programmed cell death-1 therapy in advanced CSCC.

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