Abstract 4349
Background
BCC is the most common cancer worldwide. There is no approved agent to treat advanced BCC in patients who experience disease progression on, or who are intolerant of HHIs. Cemiplimab (REGN2810), an anti-PD-1 has demonstrated encouraging efficacy and favourable tolerability in a phase 1 study of patients with advanced malignancies (NCT02383212).
Trial design
We are conducting a phase 2, non-randomised, 2-group, multi-centre study of cemiplimab in patients with advanced BCC who experienced disease progression or are intolerant to HHI therapy (NCT03132636). Group 1 will enrol patients with both nodal and distant metastatic BCC. Group 2 will enrol patients with locally advanced BCC who are not candidates for surgery. Cemiplimab will be administered intravenously every 3 weeks in all patients. The primary objective of the study is to evaluate overall response rate (ORR) as determined by central review. The ORR will be assessed separately for patients in Group 1 or Group 2 (by RECIST 1.1 for radiology, and modified WHO for photography). Up to 137 patients will be enrolled. For Group 1, 50 patients are required to provide at least 85% power to reject a null hypothesis of an ORR of 15% at a 2-sided significance level of 5% if the true ORR is 34%. For Group 2, 80 patients are required to provide at least 85% power to reject a null hypothesis of an ORR of 20% at a 2-sided significance level of 5% if the true ORR is 35%. An additional 5% in sample size will account for patient withdrawals. This study is ongoing.
Clinical trial identification
NCT03132636.
Legal entity responsible for the study
Regeneron Pharmaceutical, Inc. and Sanofi.
Funding
Regeneron Pharmaceutical, Inc. and Sanofi.
Editorial Acknowledgement
Medical writing support under the direction of the authors was provided by Emmanuel Ogunnowo, PhD, of Prime (Knutsford, UK) and funded by Regeneron Pharmaceuticals, Inc. and Sanofi according to Good Publication Practice guidelines (http://annals.org/aim/article/2424869/good-publication-practice-communicating-company-sponsored-medical-research-gpp3).
Disclosure
K.D. Lewis: Research funding: Regeneron Pharmaceuticals, Inc. M.G. Fury: Shareholder, employee, patents, royalties, other intellectual property: Regeneron Pharmaceuticals, Inc. E. Stankevich: Shareholder, employee: Regeneron Pharmaceuticals, Inc.; Shareholder: Celgene, Bristol-Myers Squibb, Merck. M. Mathias, K.K. Mohan, S. Li, K. Nunnink, C. Perry, A. Narwal: Shareholder, employee: Regeneron Pharmaceuticals, Inc.
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