Abstract 1094P
Background
Limited data exist on the clinical characteristics, management, disease progression and survivorship of patients with advanced CSCC in real-world clinical practice. We describe baseline demographics for the first set of patients enrolled in the C.A.S.E. study.
Methods
C.A.S.E. is a prospective, multicentre, longitudinal study evaluating the efficacy, safety, disease evolution, survivorship and quality of life in patients with advanced CSCC who initiate treatment with cemiplimab. Key endpoints include effectiveness of cemiplimab treatment, safety, patient reported outcomes, treatment adherence and health resource utilisation.
Results
As of 31 Jan, 2020, 61 patients were enrolled (median age: 78 years [IQR: 70–86]; 74% male; 97% Caucasian; and 21% immunocompromised or immunosuppressed including 5% who had solid organ transplant). 56% of patients had locally advanced CSCC and 44% had metastatic CSCC. 69% of patients had a head and neck primary CSCC tumour location. 54% of patients had multidisciplinary input in their advanced CSCC management. 75% had prior CSCC-related surgery and 41% received CSCC-related radiotherapy (RT). CSCC tumours were classified histologically as well differentiated, moderately differentiated, poorly differentiated and unknown for 23%, 38%, 20% and 20% of tumours. 21% of tumours had perineural invasion and 8% had histological heterogeneity. The most common reasons for cemiplimab treatment were locally advanced CSCC that is not a candidate for curative surgery or curative RT (34%), not a candidate for curative surgery (30%), local-regional disease (23%), metastatic disease (23%) and patient preference (15%).
Conclusions
This initial demographic analysis of patients with advanced CSCC receiving cemiplimab in real-world practice indicates that most patients were male, elderly, with 21% being immunosuppressed or immunocompromised to varying degrees. Only 54% of cases had multi-disciplinary input in their disease management. These data also suggest there are varying factors affecting treatment decisions in real-world clinical setting.
Clinical trial identification
NCT03836105.
Editorial acknowledgement
Editorial writing support was provided by Emmanuel Ogunnowo, PhD of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi.
Legal entity responsible for the study
Regeneron Pharmaceuticals, Inc., and Sanofi.
Funding
Regeneron Pharmaceuticals, Inc., and Sanofi.
Disclosure
G. Rabinowits: Advisory/Consultancy: EMD Serono Pfizer; Advisory/Consultancy: Sanofi; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Regeneron Pharmaceuticals Inc; Advisory/Consultancy: Merck; Advisory/Consultancy: Castle; Shareholder/Stockholder/Stock options: Syros Pharmaceuticals. J. Homsi: Advisory/Consultancy, Personal fees: Sanofi; Advisory/Consultancy, Personal fees: Novartis; Advisory/Consultancy, Personal fees: Regeneron Pharmaceuticals, Inc. M. Nikanjam: Research grant/Funding (institution), Support for running clinical trials: Regeneron Pharmaceuticals, Inc.; Research grant/Funding (institution), Support for running industry sponsored clinical trial: Idera Pharmaceuticals; Research grant/Funding (institution), Support for running industry sponsored clinical trial: BMS; Research grant/Funding (institution), Support for running industry sponsored clinical trial: Novartis; Research grant/Funding (institution), Support for running industry sponsored clinical trial: Immunocore. R. Gentry: Research grant/Funding (institution), Principal Investigator for the CASE Registry: Regeneron Pharmaceuticals. J. Strasswimmer: Research grant/Funding (institution), Reports grant as an investigator for the clinical trial: Regeneron Pharmaceuticals. M.R. Migden: Honoraria (self): Regeneron Pharmaceuticals, Inc.; Honoraria (self): Sanofi; Honoraria (self): Novartis; Honoraria (self): Genentech; Honoraria (self): Eli Lilly; Honoraria (self): Sun Pharma. S. Chandra: Advisory/Consultancy, Research grant/Funding (institution), + other conflicts: Bristol-Myers Squibb; Advisory/Consultancy, + other conflicts: EMD Serono; Advisory/Consultancy, + other conflicts: Biodesix; Advisory/Consultancy: Array BioPharma; Advisory/Consultancy: Novartis; Advisory/Consultancy, + other conflicts: Regeneron Pharmaceuticals, Inc. E. Ruiz: Advisory/Consultancy: Regeneron Pharmaceuticals, Inc.; Advisory/Consultancy: Leo Pharma; Advisory/Consultancy: Checkpoint Therapeutics; Advisory/Consultancy: Pellepharma. H.R. Zhang, J. McGinniss, J. Desai: Shareholder/Stockholder/Stock options, Full/Part-time employment: Regeneron Pharmaceuticals, Inc. A. Seluzhytsky: Full/Part-time employment: Sanofi Genzyme. All other authors have declared no conflicts of interest.