Abstract 825P
Background
Cemiplimab is the first programmed cell death-1 inhibitor approved for the treatment of pts with locally advanced or metastatic CSCC who are not candidates for curative surgery or curative radiation. Here, we describe demographics, effectiveness, and safety results of cemiplimab in a general population of pts with advanced CSCC enrolled in the CASE study (NCT03836105).
Methods
CASE is a real-world study evaluating the effectiveness, safety, disease evolution, survivorship, and quality of life of pts with advanced CSCC treated in 43 US academic and community centres. Pts had received cemiplimab 350 mg intravenously every 3 weeks per standard of care. Prospective data are captured using an electronic case report form and include demographics, disease characteristics, efficacy, and quality-of-life data. Investigator assessment of objective response rate (ORR), survival, and safety was conducted. Data collected between June 2019 and October 2021 are presented. Recruitment is ongoing.
Results
As of 1 Oct 2021, 188 pts were enrolled in the CASE study. Median age was 76.0 years (range, 33.0–98.0), 76.9% were male, 90.9% were White, and 36 (19.1%) were considered immunocompromised or immunosuppressed (IC/IS). Median duration of cemiplimab exposure for all pts was 22.1 weeks (quartile [Q] 1–Q3, 9.1–46.4; range, 0–117). Efficacy was evaluated in pts enrolled before Cycle 3 (n=164), when a clear treatment outcome could be established. ORR for the overall population was 42.1% (95% confidence interval [CI], 34.4–50.0) and for the IC/IS population (n=27) was 44.4% (95% CI, 25.5–64.7). Eight (4.3%) pts experienced a treatment-related serious adverse event and 47 (25.3%) experienced a treatment-related immune-related adverse event. Cemiplimab was generally well tolerated in IC/IS pts. In total, 95 (48.2%) pts discontinued treatment.
Conclusions
At this timepoint, the safety, tolerability, and effectiveness of cemiplimab in this real-world study of pts with advanced CSCC were consistent with results observed in the registration clinical trial (NCT02383212, NCT02760498).
Clinical trial identification
NCT03836105.
Editorial acknowledgement
Editorial writing support was provided by Jenna Lee, MSc, 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: Financial Interests, Personal, Advisory Role: Sanofi, Regeneron Pharmaceuticals, Inc., and Castle Biosciences. N. Khushanlani: Financial Interests, Personal, Research Grant: Regeneron Pharmaceuticals, Inc., Bristol Myers Squibb, Merck, Novartis, Replimune, GlaxoSmithKline, HUYA, Celgene; Financial Interests, Personal, Advisory Board: Regeneron Pharmaceuticals, Inc., Bristol Myers Squibb, Merck, Novartis, Iovance, Instil Bio, Castle Biosciences, Nektar, Incyte, AstraZeneca; Financial Interests, Personal, Advisory Role, honoraria: Genzyme, Pfizer, Nektar; Financial Interests, Personal, Stocks/Shares: Bellicum Pharmaceuticals, Amarin, Transenetrix; Financial Interests, Personal, Advisory Role, Study steering committee: Bristol Myers Squibb, Regeneron Pharmaceuticals, Inc., and Replimune. D.M. Ellison: Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb, Illumina, Merck, Pfizer, Janssen. S.S. Venna: Financial Interests, Personal, Stocks/Shares: Amgen, CVS Health. J. Strasswimmer: Financial Interests, Personal, Advisory Role: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Speaker’s Bureau: Regeneron Pharmaceuticals, Inc., Sanofi, Genentech; Financial Interests, Personal, Research Grant: Biofrontera, Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Other, travel, accommodation, or expenses: Regeneron Pharmaceuticals, Inc., Sanofi. S. Chandra: Financial Interests, Institutional, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, EMD Serono, Biodesix, Array BioPharma, Novartis, Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, EMD Serono, Biodesix, Regeneron Pharmaceuticals, Inc. E.S. Ruiz: Financial Interests, Personal, Advisory Role: Regeneron Pharmaceuticals, Inc., Leo Pharma, Checkpoint Therapeutics, Genentech; Financial Interests, Personal, Research Grant: Regeneron Pharmaceuticals, Inc., Pellepharm. M.R. Migden: Financial Interests, Personal, Advisory Role, Honoraria: Regeneron Pharmaceuticals, Inc., Sanofi, Novartis, Genentech, Eli Lilly, Sun Pharma. S. Ibrahim: Financial Interests, Personal, Research Grant: Regeneron, Castle Biosciences, Replimune; Financial Interests, Personal, Speaker’s Bureau: Regeneron, Castle Biosciences; Financial Interests, Personal, Advisory Role: Regeneron, Castle Biosciences. N. Mehta: Financial Interests, Personal, Full or part-time Employment: Sanofi; Financial Interests, Personal, Stocks/Shares: Sanofi. X. He: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. H. Zhang: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. K.A. Gillis: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. J. Pouliot: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.