Cemiplimab Use Studied in Locally Advanced Basal Cell Carcinoma

Stratigos AJ, Sekulic A, Peris K, Bechter O, Prey S, Lewis KD, Basset-Seguin N, Chang ALS, Dalle S, Fernández Orland A, Licitra L, Robert C, Ulrich C, Hauschild A, Migden MR, Dummer R, Yoo SY, Okoye E, Bassukas I, Loquai C, De Giorgi V, Eroglu Z, Gutzmer R, Ulrich J, Puig S, Inocencio TJ, Chen CI, LaFontaine PR, Seebach F, Lowy I, Fury MG. Phase 2 open-label, multicenter, single-arm study of cemiplimab in patients with locally advanced basal cell carcinoma after hedgehog inhibitor therapy: Extended follow-up. J Am Acad Dermatol. 2024 Feb;90(2):414-418. doi: 10.1016/j.jaad.2023.08.111. Epub 2023 Oct 14. PMID: 37839734.

Providing more than an additional year’s experience of data, this study found that Cemiplimab remains effective and relatively safe for the treatment of locally advanced basal cell carcinoma following hedgehog inhibitor therapy.

Clinical Pearls

• This research letter published in the Journal of the American Academy of Dermatology provides extended follow-up data from the previously published Phase 2 open-label, multicenter, single-arm study of Cemiplimab in patients with advanced basal cell carcinoma following hedgehog inhibitor therapy

• Providing more than an additional year’s experience of data, this study found that Cemiplimab remains effective and relatively safe for the treatment of locally advanced basal cell carcinoma following hedgehog inhibitor therapy

Discussion:

In June of 2021, Stratigos et. al published their experience of Cemiplimab in locally advanced basal cell carcinoma following hedgehog inhibitor therapy in The Lancet Oncology (DOI: 10.1016/S1470-2045(21)00126-1). This initial study provided valuable data supporting the safety and efficacy of Cemiplimab in these patients.

The authors provided extended follow-up data in this research letter recently published in the Journal of the American Academy of Dermatology. The objective response rate (ORR) per independent central review improved with the extended data (32.1% from 31%). Additionally, durable disease control (proportion of patients without disease progression at ≥ 182 days) was found to occur in 59.5% ((95% CI: 48.3-70.1) of patients. Health related quality of life was additionally found to be maintained in the extended follow-up period.

The extended follow-up period also included an additional fatal adverse event (non-treatment related myocardial infarction) making the total 4 deaths for this study. Treatment-related adverse events were reported in 66 patients, all of which were nonfatal. There were 47 patients who experienced potential immune-related adverse events. A total of eight patients discontinued Cemiplimab. Overall, this additional data provides valuable supporting evidence for the use of Cemiplimab following hedgehog inhibitors in locally advanced basal cell carcinoma.